The American Journal of Orthopedics

For the resident, the surgical residency is physically, emotionally, and intellectually demanding, requiring longitudinally concentrated effort. Although education of orthopedic surgeons necessarily occurs within the context of the health care delivery system, vital lessons also are taught in laboratories, skill stations, and surgical simulators. Before practice-based learning can take place, residents must gain experience and demonstrate growth in surgical skills, including decision-making and technical skills. These skill sets are difficult to systematically teach and objectively analyze.

The most effective way to teach and assess a resident’s knowledge of musculoskeletal medicine remains unclear at this point. Much of the current literature addresses the issue at the medical student level.^1-7 Some studies have shown the effectiveness of surgical training programs, both cadaveric and computer-based simulators, in teaching various surgical skill sets.^8-14 The orthopedic literature has seen a boom in surgical simulators aimed at the upper-level resident. Many of the topics involve use of arthroscopic simulators.^15-19 Evidence suggests that simulators can discriminate between novice and expert users, but discrimination between novice and intermediate trainees in surgical education should be paramount.²⁰

The American Board of Orthopaedic Surgery (ABOS) and the orthopedic Residency Review Committee (RRC) recommended new requirements for structured motor skills training in basic orthopedic surgery education,²¹ which were approved by the Accreditation Council for Graduate Medical Education (ACGME) board of directors and went into effect on July 1, 2013. In response to the new ACGME guidelines, our institution created a skills laboratory devoted to surgical simulation. Our focus in implementing this surgical skills simulation was junior-level, specifically postgraduate year 1 to 3 (PGY-1 to PGY-3), orthopedic residents. Our first goal was to set up a series of surgical training stations to educate junior-level residents in 4 core areas: handling and comfort with basic power equipment, casting/splinting, suturing, and surgical instrument identification. A secondary goal was to objectively evaluate the residents through written examinations (presession–postsession) and a novel ankle fracture model (pre–post).

Materials and Methods

Institutional review board approval was obtained before beginning the investigation.

Written Examination

We created a multiple-choice 25-question written examination (Appendix) and administered it to 11 junior residents before and after they participated in the training. This examination assessed their knowledge base of basic orthopedic tenets, including basic bone healing, basic fracture repair (Arbeitsgemeinschaft für Osteosynthesefragen [AO] principles²²), suturing, surgical instrument identification, casting/splinting, and elementary implant-design rationale.

Evaluator Scorecard

We created an evaluation scorecard (Figure 1) and had 2 faculty members and 2 senior-level residents complete it independently. Junior residents were evaluated on a sawbones lateral malleolar ankle fracture model at 2 time points. As with the written examinations, the junior residents completed the fracture model both before and immediately after the multiple skill sessions. Each of the 15 data points was scored from 1 to 4, for a total of 60 points.

Facility for Surgical Training Session

Our Clinical Skills Education and Assessment Center houses small-group interactive laboratories for administration, debriefing, and assessment of simulations with the latest in audiovisual equipment. Five stations were created: hands-on introduction to surgical power equipment using sawbones, wood, and polyvinylchloride (PVC) pipe; hands-on introduction to casting and splinting; hands-on introduction to suturing; hands-on interaction with surgical scrub technician assisting with instrument identification; and didactic PowerPoint (Microsoft, Redmond, Washington) presentation focusing on core trauma competencies, basic orthopedic design rationale, and basic bone biology.

Development of Surgical Skills Training Session

Multiple faculty members and senior-level residents collaborated to create the skill stations (Figure 2), which were designed based on ACGME recommendations and on weaknesses our program had seen in junior-level residents. We devoted an afternoon to this session, excusing our program’s junior residents from clinical responsibilities. Four PGY-1, 5 PGY-2, and 2 PGY-3 residents participated. (Four of our 15 junior residents were unable to attend because of clinical responsibilities.) The afternoon started by dividing the 11 junior residents into 2 groups. Before the session, while one group performed the ankle fracture model and was being evaluated, the other took the written examination. This closely timed portion was allotted only 20 minutes. Then residents were divided into 5 groups of 2 or 3 and were rotated through all 5 stations. Forty minutes were allotted for each station. Residents were not evaluated during this portion. The stations were intended solely for education, and each station was staffed by a faculty member and/or senior-level resident.

Cordless reciprocating saws and drills were purchased to introduce and refine junior residents’ motor skills. Sawbones, 2×4-in sections of wood, and PVC pipe were used in the training. Emphasis was placed on tactile feel and feedback with both sawing and drilling. For the casting and splinting session, we used 4-in fiberglass, 4-in plaster rolls, and cotton soft roll to demonstrate a multitude of common casts and splints (Figure 3). Casts included short- and long-arm casts and short-leg casts. Splinting included coaptation, sugar tong, and ulnar gutter splints for the upper extremity and a short-leg posterior splint for the lower extremity.

The didactic PowerPoint presentation drew largely from content in chapters of the book AO Principles of Fracture Management.²² Content included condensed, to-the-point high-yield summaries of AO tenets, basic bone healing and biology, and orthopedic implant-design rationale focused on these elementary principles:

◾ Basic screw design, including cortical, cancellous, and locking screw designs.

◾ Evolution of plate osteosynthesis to currently used locking compression plate.

◾ Locking plate principles.

◾ Lag technique.

◾ Plate use: compression mode, neutralization, bridging, buttress, anti-glide.

The suturing portion was performed with thawed ham hocks (Figure 4). This model replicates live tissue layers and allows a layered closure technique as a training tool. Both 0 and 2-0 absorbable suture were available for a layered, deep fascial closure; also available was 2-0 nonabsorbable nylon for the skin. Staple guns were available, as were basic surgical instruments, including quality needle drivers, Adson forceps, and suture scissors. The knots demonstrated included simple, horizontal mattress, vertical mattress, and tension-relieving. One- and 2-hand tying and instrument tying were reinforced.

The final session consisted of surgical instrument identification. A certified orthopedic scrub technician participated. On site were multiple trays, including a basic bone set, a hand-and-foot set, small and large fragment sets, and a hip set. A detailed review of each set was led by the surgical technician. This review was followed by a question-and-answer session with the junior residents. After the session, we ended with the written examination and the ankle fracture model.

Statistical Methods

We report presession and postsession means, modes, and medians as measures of score-central tendencies. Our small sample size makes the assumption of Gaussian distribution tenuous and more susceptible to outliers. Therefore, in addition to reporting means, we include medians and modes to more accurately account for outliers. Moreover, the κ statistic is a robust measure of interrater agreement for 2 or more groups. We report κ statistics to determine the interrater reliability of 4 independent observers.

Results

Written Examination

Eleven residents (PGY-1 to PGY-3) completed the examination (Table 1). For the entire group, mean (SD) presession percentile was 87.3 (10.4), median was 88, and mode was 96; mean (SD) was 80 (12.6) for PGY-1, 89.6 (6.7) for PGY-2, and 96 (5.7) for PGY-3. For the entire group, mean (SD) postsession percentile was 92 (8.4), median was 96, and mode was 96; mean (SD) was 85 (10.5) for PGY-1, 96 (4) for PGY-2, and 96 (0) for PGY-3 (Table 2).

There was a significant presession–postsession difference in scores among all test takers, regardless of training level (P = .019). The PGY-1 level did not reach statistical significance in improvement from presession to postsession (P = .080); the PGY-2 level also did not reach statistical significance in improvement (P = .099); the PGY-3 level did not have enough participants to calculate a P value based on a paired Student t test.

Ankle Fracture Model

Actual percentile scores are listed in Table 3. For the entire group, mean (SD) overall presession percentile was 68.6 (13.9), median was 67, and mode was 67; mean (SD) was 58.8 (9.8) for PGY-1, 76.1 (13.6) for PGY-2, and 69.5 (9.8) for PGY-3. For the entire group, mean (SD) postsession percentile was 95.2 (5.2), median was 97, and mode was 97; mean (SD) was 91.8 (6.3) for PGY-1, 97.1 (3.5) for PGY-2, and 97.3 (2.4) for PGY-3.

There was a large and significant presession–postsession difference in scores among all test takers, regardless of training level (P = .03). Each group reached statistical significance in improvement from presession to postsession: PGY-1 (P = .04), PGY-2 (P = .01), and PGY-3 (P = .03).

For κ calculations, we adjusted all scores to ordinal data and thus used a standard grading system:

Score            Grade

90–100             A

80–89               B

70–79               C

60–69               D

0–59                 F

For the presession fracture model, the κ among the 4 independent observational scorers was 0.1148 (Table 4), which is poor based on κ scoring criteria and which we attribute to the particularly harsh grading by 1 observational scorer (faculty 1) relative to the other scorers’. Examination of the κ scores of faculty 1 and faculty 2 indicated only 9.09% agreement. Conversely, the κ among resident scorers agreed 54.55% of the time. Removing faculty 1 as an outlier raised the κ score dramatically, to 0.3125 (fair interobserver agreement).

For the postsession fracture model, the κ among the 4 independent observational scorers improved only marginally, to 0.1156 (still poor), again attributed to a difference in severity of grading: faculty 1 (harsh) versus faculty 2 (relatively kind). Examination of the κ scores of faculty 1 and faculty 2 revealed 72.73% agreement; residents agreed 81.82% of the time.

Discussion

The importance of surgical skill development in resident education is emphasized in the ACGME Core Competencies.²³ The ACGME instructed all programs to require residents to gain competency in 6 areas: patient care, interpersonal and communication skills, medical knowledge, professionalism, practice-based learning and systems-based practice. Although many surgeon educators and residents are focused on these 6 Core Competencies, current standards do not require surgical skills laboratory training and simply require residents to log cases into the ACGME website. Minimal case number recommendations are in place for graduating senior residents, but these numbers are based on averages with no strong scientific basis.

Although sweeping changes in orthopedic residency training went into effect July 1, 2013, this system remains untested and may offer room for improvement. One change is the restructuring of the PGY-1 internship. A basic surgical skills curriculum must include goals, objectives, and assessment metrics; skills used in the initial management of injured patients, including splinting, casting, application of traction devices, and other types of immobilization; and basic operative skills, including soft-tissue management, suturing, bone management, arthroscopy, fluoroscopy, and use of basic orthopedic equipment.²¹

Orthopedic program directors and residents were recently surveyed regarding the current state of orthopedic motor skills training.²⁴ Three key findings deserve emphasis: There is a lack of objective criteria for evaluating resident performance in the skills laboratory; most program directors who have a laboratory do not understand the associated costs; and the most significant issue for program directors is the financial challenge of operating a motor skills laboratory. The survey findings strongly suggest that proposed changes in skills training should be accompanied by careful cost analysis before widespread implementation.

Although various online demonstrations of entire surgeries are available, as are textbooks describing a generalized approach to musculoskeletal surgery, we assume that, as laid out in the Core Competencies, residents are fine-tuning their surgical skills by actively participating in operating rooms under direct observation of attending physicians. To our knowledge, however, there are no data regarding how often this happens in the operative setting, where volume and efficiency are becoming increasingly scrutinized. There has been much concern over how hour restrictions will affect residents’ total operative experience.^25,26 Finally, we have no means to objectively evaluate residents’ surgical skills on graduation.

Other programs have implemented surgical skill simulators, but an orthopedics-specific surgical skills laboratory, to our knowledge, has been discussed in only 1 study.²¹ Results from randomized controlled trials reported in the general surgery literature have proved simulation-based training leads to detectable benefits for learners in clinical settings.^27-29 Over the past decade, some alternative surgical skills training methods have been adopted in orthopedic surgery as well. These methods include hands-on training in specifically designed surgical skills laboratories using cadaver models or synthetic bones; software tools; and computerized simulators. In recent years, numerous studies reported in the orthopedic literature have examined arthroscopic simulators in residency training.^18-20,30-34 However, these studies are arguably more specific to sports subspecialties and thus more pertinent to upper-level trainees.

Our study results showed that surgical skills laboratory training should be a required aspect of our residents’ training. Although less of a dramatic improvement was noted in the written examination component of the laboratory, the overall knowledge base improved (Table 3). This was especially evident at the PGY-1 level, where written examination scores increased from a presession median of 80% to a postsession median of 85%. A larger degree of improvement was found with the ankle fracture model, and there was statistical improvement at all training levels, from PGY-1 to PGY-3. Previous work has shown that intensive laboratory-based training can be effective, particularly for first-year residents. Sonnadara and colleagues³⁵ demonstrated that a 30-day intensive surgical skills course effectively helped first-year orthopedic residents develop targeted basic surgical skills. In a follow-up study, Sonnadara and colleagues³⁶ demonstrated that a surgical skills course completed at the beginning of a residency was effective in teaching targeted technical skills, and that skills taught in this manner can have excellent retention rates.

There are limitations inherent in our skills course. The κ agreement in the ankle fracture model was low before and after administration, which we attribute to 1 observer outlier. This could be amended by removing outliers and further objectifying and simplifying the scoring system (A–F). Right now, we do not have enough data to determine whether the scores actually improve significantly through the training years or whether they will correlate with operating room experience. Our study had no control. For future investigations, we are considering having general orthopedic surgeons from the community perform the same scenarios and be graded with the same checklists as a control. Implementation, however, may be a challenge. Both our written examination and our ankle fracture model checklist have not been validated—this is one of our next steps. The point system used to score the ankle fracture model was subjectively developed and would benefit from further standardization before drawing conclusions about true validity.

Conclusion

Orthopedic residency programs, like programs in other surgical specialties, are increasingly focused on teaching and documenting the learning of core competencies, even as work-hour restrictions and demands for clinical efficiency limit the amount of time residents spend in the operating room. We have demonstrated the potential value of an intensive laboratory in improving junior-level residents’ basic surgical skills and knowledge. We will continue to refine our methods, with a goal being to create reproducible models that could be adapted by other orthopedic residency programs and by other surgical educators.

For the resident, the surgical residency is physically, emotionally, and intellectually demanding, requiring longitudinally concentrated effort. Although education of orthopedic surgeons necessarily occurs within the context of the health care delivery system, vital lessons also are taught in laboratories, skill stations, and surgical simulators. Before practice-based learning can take place, residents must gain experience and demonstrate growth in surgical skills, including decision-making and technical skills. These skill sets are difficult to systematically teach and objectively analyze.

The most effective way to teach and assess a resident’s knowledge of musculoskeletal medicine remains unclear at this point. Much of the current literature addresses the issue at the medical student level.^1-7 Some studies have shown the effectiveness of surgical training programs, both cadaveric and computer-based simulators, in teaching various surgical skill sets.^8-14 The orthopedic literature has seen a boom in surgical simulators aimed at the upper-level resident. Many of the topics involve use of arthroscopic simulators.^15-19 Evidence suggests that simulators can discriminate between novice and expert users, but discrimination between novice and intermediate trainees in surgical education should be paramount.²⁰

The American Board of Orthopaedic Surgery (ABOS) and the orthopedic Residency Review Committee (RRC) recommended new requirements for structured motor skills training in basic orthopedic surgery education,²¹ which were approved by the Accreditation Council for Graduate Medical Education (ACGME) board of directors and went into effect on July 1, 2013. In response to the new ACGME guidelines, our institution created a skills laboratory devoted to surgical simulation. Our focus in implementing this surgical skills simulation was junior-level, specifically postgraduate year 1 to 3 (PGY-1 to PGY-3), orthopedic residents. Our first goal was to set up a series of surgical training stations to educate junior-level residents in 4 core areas: handling and comfort with basic power equipment, casting/splinting, suturing, and surgical instrument identification. A secondary goal was to objectively evaluate the residents through written examinations (presession–postsession) and a novel ankle fracture model (pre–post).

Materials and Methods

Institutional review board approval was obtained before beginning the investigation.

Written Examination

We created a multiple-choice 25-question written examination (Appendix) and administered it to 11 junior residents before and after they participated in the training. This examination assessed their knowledge base of basic orthopedic tenets, including basic bone healing, basic fracture repair (Arbeitsgemeinschaft für Osteosynthesefragen [AO] principles²²), suturing, surgical instrument identification, casting/splinting, and elementary implant-design rationale.

Evaluator Scorecard

We created an evaluation scorecard (Figure 1) and had 2 faculty members and 2 senior-level residents complete it independently. Junior residents were evaluated on a sawbones lateral malleolar ankle fracture model at 2 time points. As with the written examinations, the junior residents completed the fracture model both before and immediately after the multiple skill sessions. Each of the 15 data points was scored from 1 to 4, for a total of 60 points.

Facility for Surgical Training Session

Our Clinical Skills Education and Assessment Center houses small-group interactive laboratories for administration, debriefing, and assessment of simulations with the latest in audiovisual equipment. Five stations were created: hands-on introduction to surgical power equipment using sawbones, wood, and polyvinylchloride (PVC) pipe; hands-on introduction to casting and splinting; hands-on introduction to suturing; hands-on interaction with surgical scrub technician assisting with instrument identification; and didactic PowerPoint (Microsoft, Redmond, Washington) presentation focusing on core trauma competencies, basic orthopedic design rationale, and basic bone biology.

Development of Surgical Skills Training Session

Multiple faculty members and senior-level residents collaborated to create the skill stations (Figure 2), which were designed based on ACGME recommendations and on weaknesses our program had seen in junior-level residents. We devoted an afternoon to this session, excusing our program’s junior residents from clinical responsibilities. Four PGY-1, 5 PGY-2, and 2 PGY-3 residents participated. (Four of our 15 junior residents were unable to attend because of clinical responsibilities.) The afternoon started by dividing the 11 junior residents into 2 groups. Before the session, while one group performed the ankle fracture model and was being evaluated, the other took the written examination. This closely timed portion was allotted only 20 minutes. Then residents were divided into 5 groups of 2 or 3 and were rotated through all 5 stations. Forty minutes were allotted for each station. Residents were not evaluated during this portion. The stations were intended solely for education, and each station was staffed by a faculty member and/or senior-level resident.

Cordless reciprocating saws and drills were purchased to introduce and refine junior residents’ motor skills. Sawbones, 2×4-in sections of wood, and PVC pipe were used in the training. Emphasis was placed on tactile feel and feedback with both sawing and drilling. For the casting and splinting session, we used 4-in fiberglass, 4-in plaster rolls, and cotton soft roll to demonstrate a multitude of common casts and splints (Figure 3). Casts included short- and long-arm casts and short-leg casts. Splinting included coaptation, sugar tong, and ulnar gutter splints for the upper extremity and a short-leg posterior splint for the lower extremity.

The didactic PowerPoint presentation drew largely from content in chapters of the book AO Principles of Fracture Management.²² Content included condensed, to-the-point high-yield summaries of AO tenets, basic bone healing and biology, and orthopedic implant-design rationale focused on these elementary principles:

◾ Basic screw design, including cortical, cancellous, and locking screw designs.

◾ Evolution of plate osteosynthesis to currently used locking compression plate.

◾ Locking plate principles.

◾ Lag technique.

◾ Plate use: compression mode, neutralization, bridging, buttress, anti-glide.

The suturing portion was performed with thawed ham hocks (Figure 4). This model replicates live tissue layers and allows a layered closure technique as a training tool. Both 0 and 2-0 absorbable suture were available for a layered, deep fascial closure; also available was 2-0 nonabsorbable nylon for the skin. Staple guns were available, as were basic surgical instruments, including quality needle drivers, Adson forceps, and suture scissors. The knots demonstrated included simple, horizontal mattress, vertical mattress, and tension-relieving. One- and 2-hand tying and instrument tying were reinforced.

The final session consisted of surgical instrument identification. A certified orthopedic scrub technician participated. On site were multiple trays, including a basic bone set, a hand-and-foot set, small and large fragment sets, and a hip set. A detailed review of each set was led by the surgical technician. This review was followed by a question-and-answer session with the junior residents. After the session, we ended with the written examination and the ankle fracture model.

Statistical Methods

We report presession and postsession means, modes, and medians as measures of score-central tendencies. Our small sample size makes the assumption of Gaussian distribution tenuous and more susceptible to outliers. Therefore, in addition to reporting means, we include medians and modes to more accurately account for outliers. Moreover, the κ statistic is a robust measure of interrater agreement for 2 or more groups. We report κ statistics to determine the interrater reliability of 4 independent observers.

Results

Written Examination

Eleven residents (PGY-1 to PGY-3) completed the examination (Table 1). For the entire group, mean (SD) presession percentile was 87.3 (10.4), median was 88, and mode was 96; mean (SD) was 80 (12.6) for PGY-1, 89.6 (6.7) for PGY-2, and 96 (5.7) for PGY-3. For the entire group, mean (SD) postsession percentile was 92 (8.4), median was 96, and mode was 96; mean (SD) was 85 (10.5) for PGY-1, 96 (4) for PGY-2, and 96 (0) for PGY-3 (Table 2).

There was a significant presession–postsession difference in scores among all test takers, regardless of training level (P = .019). The PGY-1 level did not reach statistical significance in improvement from presession to postsession (P = .080); the PGY-2 level also did not reach statistical significance in improvement (P = .099); the PGY-3 level did not have enough participants to calculate a P value based on a paired Student t test.

Ankle Fracture Model

Actual percentile scores are listed in Table 3. For the entire group, mean (SD) overall presession percentile was 68.6 (13.9), median was 67, and mode was 67; mean (SD) was 58.8 (9.8) for PGY-1, 76.1 (13.6) for PGY-2, and 69.5 (9.8) for PGY-3. For the entire group, mean (SD) postsession percentile was 95.2 (5.2), median was 97, and mode was 97; mean (SD) was 91.8 (6.3) for PGY-1, 97.1 (3.5) for PGY-2, and 97.3 (2.4) for PGY-3.

There was a large and significant presession–postsession difference in scores among all test takers, regardless of training level (P = .03). Each group reached statistical significance in improvement from presession to postsession: PGY-1 (P = .04), PGY-2 (P = .01), and PGY-3 (P = .03).

For κ calculations, we adjusted all scores to ordinal data and thus used a standard grading system:

Score            Grade

90–100             A

80–89               B

70–79               C

60–69               D

0–59                 F

For the presession fracture model, the κ among the 4 independent observational scorers was 0.1148 (Table 4), which is poor based on κ scoring criteria and which we attribute to the particularly harsh grading by 1 observational scorer (faculty 1) relative to the other scorers’. Examination of the κ scores of faculty 1 and faculty 2 indicated only 9.09% agreement. Conversely, the κ among resident scorers agreed 54.55% of the time. Removing faculty 1 as an outlier raised the κ score dramatically, to 0.3125 (fair interobserver agreement).

For the postsession fracture model, the κ among the 4 independent observational scorers improved only marginally, to 0.1156 (still poor), again attributed to a difference in severity of grading: faculty 1 (harsh) versus faculty 2 (relatively kind). Examination of the κ scores of faculty 1 and faculty 2 revealed 72.73% agreement; residents agreed 81.82% of the time.

Discussion

The importance of surgical skill development in resident education is emphasized in the ACGME Core Competencies.²³ The ACGME instructed all programs to require residents to gain competency in 6 areas: patient care, interpersonal and communication skills, medical knowledge, professionalism, practice-based learning and systems-based practice. Although many surgeon educators and residents are focused on these 6 Core Competencies, current standards do not require surgical skills laboratory training and simply require residents to log cases into the ACGME website. Minimal case number recommendations are in place for graduating senior residents, but these numbers are based on averages with no strong scientific basis.

Although sweeping changes in orthopedic residency training went into effect July 1, 2013, this system remains untested and may offer room for improvement. One change is the restructuring of the PGY-1 internship. A basic surgical skills curriculum must include goals, objectives, and assessment metrics; skills used in the initial management of injured patients, including splinting, casting, application of traction devices, and other types of immobilization; and basic operative skills, including soft-tissue management, suturing, bone management, arthroscopy, fluoroscopy, and use of basic orthopedic equipment.²¹

Orthopedic program directors and residents were recently surveyed regarding the current state of orthopedic motor skills training.²⁴ Three key findings deserve emphasis: There is a lack of objective criteria for evaluating resident performance in the skills laboratory; most program directors who have a laboratory do not understand the associated costs; and the most significant issue for program directors is the financial challenge of operating a motor skills laboratory. The survey findings strongly suggest that proposed changes in skills training should be accompanied by careful cost analysis before widespread implementation.

Although various online demonstrations of entire surgeries are available, as are textbooks describing a generalized approach to musculoskeletal surgery, we assume that, as laid out in the Core Competencies, residents are fine-tuning their surgical skills by actively participating in operating rooms under direct observation of attending physicians. To our knowledge, however, there are no data regarding how often this happens in the operative setting, where volume and efficiency are becoming increasingly scrutinized. There has been much concern over how hour restrictions will affect residents’ total operative experience.^25,26 Finally, we have no means to objectively evaluate residents’ surgical skills on graduation.

Other programs have implemented surgical skill simulators, but an orthopedics-specific surgical skills laboratory, to our knowledge, has been discussed in only 1 study.²¹ Results from randomized controlled trials reported in the general surgery literature have proved simulation-based training leads to detectable benefits for learners in clinical settings.^27-29 Over the past decade, some alternative surgical skills training methods have been adopted in orthopedic surgery as well. These methods include hands-on training in specifically designed surgical skills laboratories using cadaver models or synthetic bones; software tools; and computerized simulators. In recent years, numerous studies reported in the orthopedic literature have examined arthroscopic simulators in residency training.^18-20,30-34 However, these studies are arguably more specific to sports subspecialties and thus more pertinent to upper-level trainees.

Our study results showed that surgical skills laboratory training should be a required aspect of our residents’ training. Although less of a dramatic improvement was noted in the written examination component of the laboratory, the overall knowledge base improved (Table 3). This was especially evident at the PGY-1 level, where written examination scores increased from a presession median of 80% to a postsession median of 85%. A larger degree of improvement was found with the ankle fracture model, and there was statistical improvement at all training levels, from PGY-1 to PGY-3. Previous work has shown that intensive laboratory-based training can be effective, particularly for first-year residents. Sonnadara and colleagues³⁵ demonstrated that a 30-day intensive surgical skills course effectively helped first-year orthopedic residents develop targeted basic surgical skills. In a follow-up study, Sonnadara and colleagues³⁶ demonstrated that a surgical skills course completed at the beginning of a residency was effective in teaching targeted technical skills, and that skills taught in this manner can have excellent retention rates.

There are limitations inherent in our skills course. The κ agreement in the ankle fracture model was low before and after administration, which we attribute to 1 observer outlier. This could be amended by removing outliers and further objectifying and simplifying the scoring system (A–F). Right now, we do not have enough data to determine whether the scores actually improve significantly through the training years or whether they will correlate with operating room experience. Our study had no control. For future investigations, we are considering having general orthopedic surgeons from the community perform the same scenarios and be graded with the same checklists as a control. Implementation, however, may be a challenge. Both our written examination and our ankle fracture model checklist have not been validated—this is one of our next steps. The point system used to score the ankle fracture model was subjectively developed and would benefit from further standardization before drawing conclusions about true validity.

Conclusion

Orthopedic residency programs, like programs in other surgical specialties, are increasingly focused on teaching and documenting the learning of core competencies, even as work-hour restrictions and demands for clinical efficiency limit the amount of time residents spend in the operating room. We have demonstrated the potential value of an intensive laboratory in improving junior-level residents’ basic surgical skills and knowledge. We will continue to refine our methods, with a goal being to create reproducible models that could be adapted by other orthopedic residency programs and by other surgical educators.

For the resident, the surgical residency is physically, emotionally, and intellectually demanding, requiring longitudinally concentrated effort. Although education of orthopedic surgeons necessarily occurs within the context of the health care delivery system, vital lessons also are taught in laboratories, skill stations, and surgical simulators. Before practice-based learning can take place, residents must gain experience and demonstrate growth in surgical skills, including decision-making and technical skills. These skill sets are difficult to systematically teach and objectively analyze.

The most effective way to teach and assess a resident’s knowledge of musculoskeletal medicine remains unclear at this point. Much of the current literature addresses the issue at the medical student level.^1-7 Some studies have shown the effectiveness of surgical training programs, both cadaveric and computer-based simulators, in teaching various surgical skill sets.^8-14 The orthopedic literature has seen a boom in surgical simulators aimed at the upper-level resident. Many of the topics involve use of arthroscopic simulators.^15-19 Evidence suggests that simulators can discriminate between novice and expert users, but discrimination between novice and intermediate trainees in surgical education should be paramount.²⁰

The American Board of Orthopaedic Surgery (ABOS) and the orthopedic Residency Review Committee (RRC) recommended new requirements for structured motor skills training in basic orthopedic surgery education,²¹ which were approved by the Accreditation Council for Graduate Medical Education (ACGME) board of directors and went into effect on July 1, 2013. In response to the new ACGME guidelines, our institution created a skills laboratory devoted to surgical simulation. Our focus in implementing this surgical skills simulation was junior-level, specifically postgraduate year 1 to 3 (PGY-1 to PGY-3), orthopedic residents. Our first goal was to set up a series of surgical training stations to educate junior-level residents in 4 core areas: handling and comfort with basic power equipment, casting/splinting, suturing, and surgical instrument identification. A secondary goal was to objectively evaluate the residents through written examinations (presession–postsession) and a novel ankle fracture model (pre–post).

Materials and Methods

Institutional review board approval was obtained before beginning the investigation.

Written Examination

We created a multiple-choice 25-question written examination (Appendix) and administered it to 11 junior residents before and after they participated in the training. This examination assessed their knowledge base of basic orthopedic tenets, including basic bone healing, basic fracture repair (Arbeitsgemeinschaft für Osteosynthesefragen [AO] principles²²), suturing, surgical instrument identification, casting/splinting, and elementary implant-design rationale.

Evaluator Scorecard

We created an evaluation scorecard (Figure 1) and had 2 faculty members and 2 senior-level residents complete it independently. Junior residents were evaluated on a sawbones lateral malleolar ankle fracture model at 2 time points. As with the written examinations, the junior residents completed the fracture model both before and immediately after the multiple skill sessions. Each of the 15 data points was scored from 1 to 4, for a total of 60 points.

Facility for Surgical Training Session

Our Clinical Skills Education and Assessment Center houses small-group interactive laboratories for administration, debriefing, and assessment of simulations with the latest in audiovisual equipment. Five stations were created: hands-on introduction to surgical power equipment using sawbones, wood, and polyvinylchloride (PVC) pipe; hands-on introduction to casting and splinting; hands-on introduction to suturing; hands-on interaction with surgical scrub technician assisting with instrument identification; and didactic PowerPoint (Microsoft, Redmond, Washington) presentation focusing on core trauma competencies, basic orthopedic design rationale, and basic bone biology.

Development of Surgical Skills Training Session

Multiple faculty members and senior-level residents collaborated to create the skill stations (Figure 2), which were designed based on ACGME recommendations and on weaknesses our program had seen in junior-level residents. We devoted an afternoon to this session, excusing our program’s junior residents from clinical responsibilities. Four PGY-1, 5 PGY-2, and 2 PGY-3 residents participated. (Four of our 15 junior residents were unable to attend because of clinical responsibilities.) The afternoon started by dividing the 11 junior residents into 2 groups. Before the session, while one group performed the ankle fracture model and was being evaluated, the other took the written examination. This closely timed portion was allotted only 20 minutes. Then residents were divided into 5 groups of 2 or 3 and were rotated through all 5 stations. Forty minutes were allotted for each station. Residents were not evaluated during this portion. The stations were intended solely for education, and each station was staffed by a faculty member and/or senior-level resident.

Cordless reciprocating saws and drills were purchased to introduce and refine junior residents’ motor skills. Sawbones, 2×4-in sections of wood, and PVC pipe were used in the training. Emphasis was placed on tactile feel and feedback with both sawing and drilling. For the casting and splinting session, we used 4-in fiberglass, 4-in plaster rolls, and cotton soft roll to demonstrate a multitude of common casts and splints (Figure 3). Casts included short- and long-arm casts and short-leg casts. Splinting included coaptation, sugar tong, and ulnar gutter splints for the upper extremity and a short-leg posterior splint for the lower extremity.

The didactic PowerPoint presentation drew largely from content in chapters of the book AO Principles of Fracture Management.²² Content included condensed, to-the-point high-yield summaries of AO tenets, basic bone healing and biology, and orthopedic implant-design rationale focused on these elementary principles:

◾ Basic screw design, including cortical, cancellous, and locking screw designs.

◾ Evolution of plate osteosynthesis to currently used locking compression plate.

◾ Locking plate principles.

◾ Lag technique.

◾ Plate use: compression mode, neutralization, bridging, buttress, anti-glide.

The suturing portion was performed with thawed ham hocks (Figure 4). This model replicates live tissue layers and allows a layered closure technique as a training tool. Both 0 and 2-0 absorbable suture were available for a layered, deep fascial closure; also available was 2-0 nonabsorbable nylon for the skin. Staple guns were available, as were basic surgical instruments, including quality needle drivers, Adson forceps, and suture scissors. The knots demonstrated included simple, horizontal mattress, vertical mattress, and tension-relieving. One- and 2-hand tying and instrument tying were reinforced.

The final session consisted of surgical instrument identification. A certified orthopedic scrub technician participated. On site were multiple trays, including a basic bone set, a hand-and-foot set, small and large fragment sets, and a hip set. A detailed review of each set was led by the surgical technician. This review was followed by a question-and-answer session with the junior residents. After the session, we ended with the written examination and the ankle fracture model.

Statistical Methods

We report presession and postsession means, modes, and medians as measures of score-central tendencies. Our small sample size makes the assumption of Gaussian distribution tenuous and more susceptible to outliers. Therefore, in addition to reporting means, we include medians and modes to more accurately account for outliers. Moreover, the κ statistic is a robust measure of interrater agreement for 2 or more groups. We report κ statistics to determine the interrater reliability of 4 independent observers.

Results

Written Examination

Eleven residents (PGY-1 to PGY-3) completed the examination (Table 1). For the entire group, mean (SD) presession percentile was 87.3 (10.4), median was 88, and mode was 96; mean (SD) was 80 (12.6) for PGY-1, 89.6 (6.7) for PGY-2, and 96 (5.7) for PGY-3. For the entire group, mean (SD) postsession percentile was 92 (8.4), median was 96, and mode was 96; mean (SD) was 85 (10.5) for PGY-1, 96 (4) for PGY-2, and 96 (0) for PGY-3 (Table 2).

There was a significant presession–postsession difference in scores among all test takers, regardless of training level (P = .019). The PGY-1 level did not reach statistical significance in improvement from presession to postsession (P = .080); the PGY-2 level also did not reach statistical significance in improvement (P = .099); the PGY-3 level did not have enough participants to calculate a P value based on a paired Student t test.

Ankle Fracture Model

Actual percentile scores are listed in Table 3. For the entire group, mean (SD) overall presession percentile was 68.6 (13.9), median was 67, and mode was 67; mean (SD) was 58.8 (9.8) for PGY-1, 76.1 (13.6) for PGY-2, and 69.5 (9.8) for PGY-3. For the entire group, mean (SD) postsession percentile was 95.2 (5.2), median was 97, and mode was 97; mean (SD) was 91.8 (6.3) for PGY-1, 97.1 (3.5) for PGY-2, and 97.3 (2.4) for PGY-3.

There was a large and significant presession–postsession difference in scores among all test takers, regardless of training level (P = .03). Each group reached statistical significance in improvement from presession to postsession: PGY-1 (P = .04), PGY-2 (P = .01), and PGY-3 (P = .03).

For κ calculations, we adjusted all scores to ordinal data and thus used a standard grading system:

Score            Grade

90–100             A

80–89               B

70–79               C

60–69               D

0–59                 F

For the presession fracture model, the κ among the 4 independent observational scorers was 0.1148 (Table 4), which is poor based on κ scoring criteria and which we attribute to the particularly harsh grading by 1 observational scorer (faculty 1) relative to the other scorers’. Examination of the κ scores of faculty 1 and faculty 2 indicated only 9.09% agreement. Conversely, the κ among resident scorers agreed 54.55% of the time. Removing faculty 1 as an outlier raised the κ score dramatically, to 0.3125 (fair interobserver agreement).

For the postsession fracture model, the κ among the 4 independent observational scorers improved only marginally, to 0.1156 (still poor), again attributed to a difference in severity of grading: faculty 1 (harsh) versus faculty 2 (relatively kind). Examination of the κ scores of faculty 1 and faculty 2 revealed 72.73% agreement; residents agreed 81.82% of the time.

Discussion

The importance of surgical skill development in resident education is emphasized in the ACGME Core Competencies.²³ The ACGME instructed all programs to require residents to gain competency in 6 areas: patient care, interpersonal and communication skills, medical knowledge, professionalism, practice-based learning and systems-based practice. Although many surgeon educators and residents are focused on these 6 Core Competencies, current standards do not require surgical skills laboratory training and simply require residents to log cases into the ACGME website. Minimal case number recommendations are in place for graduating senior residents, but these numbers are based on averages with no strong scientific basis.

Although sweeping changes in orthopedic residency training went into effect July 1, 2013, this system remains untested and may offer room for improvement. One change is the restructuring of the PGY-1 internship. A basic surgical skills curriculum must include goals, objectives, and assessment metrics; skills used in the initial management of injured patients, including splinting, casting, application of traction devices, and other types of immobilization; and basic operative skills, including soft-tissue management, suturing, bone management, arthroscopy, fluoroscopy, and use of basic orthopedic equipment.²¹

Orthopedic program directors and residents were recently surveyed regarding the current state of orthopedic motor skills training.²⁴ Three key findings deserve emphasis: There is a lack of objective criteria for evaluating resident performance in the skills laboratory; most program directors who have a laboratory do not understand the associated costs; and the most significant issue for program directors is the financial challenge of operating a motor skills laboratory. The survey findings strongly suggest that proposed changes in skills training should be accompanied by careful cost analysis before widespread implementation.

Although various online demonstrations of entire surgeries are available, as are textbooks describing a generalized approach to musculoskeletal surgery, we assume that, as laid out in the Core Competencies, residents are fine-tuning their surgical skills by actively participating in operating rooms under direct observation of attending physicians. To our knowledge, however, there are no data regarding how often this happens in the operative setting, where volume and efficiency are becoming increasingly scrutinized. There has been much concern over how hour restrictions will affect residents’ total operative experience.^25,26 Finally, we have no means to objectively evaluate residents’ surgical skills on graduation.

Other programs have implemented surgical skill simulators, but an orthopedics-specific surgical skills laboratory, to our knowledge, has been discussed in only 1 study.²¹ Results from randomized controlled trials reported in the general surgery literature have proved simulation-based training leads to detectable benefits for learners in clinical settings.^27-29 Over the past decade, some alternative surgical skills training methods have been adopted in orthopedic surgery as well. These methods include hands-on training in specifically designed surgical skills laboratories using cadaver models or synthetic bones; software tools; and computerized simulators. In recent years, numerous studies reported in the orthopedic literature have examined arthroscopic simulators in residency training.^18-20,30-34 However, these studies are arguably more specific to sports subspecialties and thus more pertinent to upper-level trainees.

Our study results showed that surgical skills laboratory training should be a required aspect of our residents’ training. Although less of a dramatic improvement was noted in the written examination component of the laboratory, the overall knowledge base improved (Table 3). This was especially evident at the PGY-1 level, where written examination scores increased from a presession median of 80% to a postsession median of 85%. A larger degree of improvement was found with the ankle fracture model, and there was statistical improvement at all training levels, from PGY-1 to PGY-3. Previous work has shown that intensive laboratory-based training can be effective, particularly for first-year residents. Sonnadara and colleagues³⁵ demonstrated that a 30-day intensive surgical skills course effectively helped first-year orthopedic residents develop targeted basic surgical skills. In a follow-up study, Sonnadara and colleagues³⁶ demonstrated that a surgical skills course completed at the beginning of a residency was effective in teaching targeted technical skills, and that skills taught in this manner can have excellent retention rates.

There are limitations inherent in our skills course. The κ agreement in the ankle fracture model was low before and after administration, which we attribute to 1 observer outlier. This could be amended by removing outliers and further objectifying and simplifying the scoring system (A–F). Right now, we do not have enough data to determine whether the scores actually improve significantly through the training years or whether they will correlate with operating room experience. Our study had no control. For future investigations, we are considering having general orthopedic surgeons from the community perform the same scenarios and be graded with the same checklists as a control. Implementation, however, may be a challenge. Both our written examination and our ankle fracture model checklist have not been validated—this is one of our next steps. The point system used to score the ankle fracture model was subjectively developed and would benefit from further standardization before drawing conclusions about true validity.

Conclusion

Orthopedic residency programs, like programs in other surgical specialties, are increasingly focused on teaching and documenting the learning of core competencies, even as work-hour restrictions and demands for clinical efficiency limit the amount of time residents spend in the operating room. We have demonstrated the potential value of an intensive laboratory in improving junior-level residents’ basic surgical skills and knowledge. We will continue to refine our methods, with a goal being to create reproducible models that could be adapted by other orthopedic residency programs and by other surgical educators.

Letter to the Editor

Universal Hepatitis C Screening
and Surgeon Safety

I read with interest the article “Risk of Hepatitis C Virus Exposure in Orthopedic Surgery: Is Universal Screening Needed?” by Dr. DelSole and colleagues (Am J Orthop. 2014;43(6):E117-E123). The authors make a compelling case for universal hepatitis C screening, and I agree that this program may have significant benefits, including risk stratification for elective surgery and identification of patients for antiviral treatment. However, based largely on personal experiences, I disagree that preoperative knowledge of the patient’s seropositive status will improve surgeon safety.

The authors list a number of interventions to decrease the risk of exposure, such as the use of Kevlar gloves, double gloving, eye protection, and others. However, perhaps the largest barrier to their use is their perceived inconvenience. Surgeons often cite decreased dexterity and sensation in their opposition to double or thick gloves, for instance. My concern is that with the advent of universal screening, many surgeons will abandon their universal approach and only wear Kevlar or double gloves on infected cases.

I have observed first-hand such a policy this year, when I spent 3 months in orthopedic centers in Russia. In Russia, all patients undergo routine preoperative testing for both hepatitis C virus and human immunodeficiency virus (HIV). While the policy of standard precautions exists, the majority of surgeons used single gloves and did not use eye protection for most cases, but took additional measures when operating on seropositive patients. Paradoxically, I witnessed numerous needle sticks during those cases, precisely because the surgeons and staff were not comfortable with wearing double gloves or hands-free passing of sharp instruments. Even goggles often ended up being removed during the cases, because the surgeons were not accustomed to using them.

Like any surgical skill, standard precautions require repetition and practice. Therefore, I am concerned that with adoption of universal screening in the United States, we will become complacent and accustomed to unsafe practices, which may paradoxically increase the risk of operating on infected patients.

Igor Immerman, MD

Pleasanton, CA

Author’s Disclosure Statement: The author reports no actual or potential conflict of interest in relation to this letter.

Author’s Response

Edward M. DelSole, MD

We appreciate the response of the reader. This is indeed an interesting paradox—that an effort to improve safety in the operating room might yield the opposite effect owing to a heightened sense of protection, which induces a laxity in adhering to standard precautions. This possibility does create a real concern for the safety of the surgical team. Although we do recommend preoperative screening for hepatitis C virus (HCV), our intent was not in any way to diminish the need for adhering to standard precautions.

The foundation of standard precautions rests upon the universal assumption of infectivity of blood exposures—this is why the precautions are “standard” and should be adhered to during all operative procedures.

First and foremost, identification of patients with hepatitis C infection offers the chance for referral for care, which in many cases is curative thanks to recent advances in hepatitis C therapy. Whether or not the patient accepts the referral for hepatitis C treatment should not, as we emphasize in our paper, affect the plan for surgery.

Secondly, a negative preoperative test should in no way alter normal intraoperative safety practices. The test results could be falsely negative due to human or mechanical error. In addition, the patient could have other transmissible diseases such as HIV, hepatitis B, or other less common yet transmissible viral infections. Importantly, given the historical narratives of the HIV and HCV epidemics, we as surgeons hold the responsibility to never be complacent about the next “unknown” novel viral agent that has yet to reveal itself.

Thirdly, perceived inconvenience of protective equipment is largely a matter of training. At our institution residents infrequently wear single layers of gloves, masks without eye protection, body suits for arthroplasty, lead vests without thyroid shields, etc. We suspect similar practice occurs at other teaching hospitals as well. As today’s residents learn the craft in an environment of heightened protection, it is our hope that they will carry these good habits into their own practice as orthopedic surgeons and that patient outcomes will not differ.

The goal of screening is to create an improved environment of safety and health awareness for the patient and the surgical team, the foundation of which is standard precautions in the operating room. We advocate strongly that standard precautions continue to be the basis of intraoperative safety and that they be used for all patients indiscriminately.

Author’s Disclosure Statement: The author reports no actual or potential conflict of interest in relation to this letter.

The journal welcomes Letters to the Editor. Letters are not peer reviewed. Opinions expressed in letters published here do not necessarily reflect those of the editorial board or the publishing company and its employees.

Letter to the Editor

Universal Hepatitis C Screening
and Surgeon Safety

I read with interest the article “Risk of Hepatitis C Virus Exposure in Orthopedic Surgery: Is Universal Screening Needed?” by Dr. DelSole and colleagues (Am J Orthop. 2014;43(6):E117-E123). The authors make a compelling case for universal hepatitis C screening, and I agree that this program may have significant benefits, including risk stratification for elective surgery and identification of patients for antiviral treatment. However, based largely on personal experiences, I disagree that preoperative knowledge of the patient’s seropositive status will improve surgeon safety.

The authors list a number of interventions to decrease the risk of exposure, such as the use of Kevlar gloves, double gloving, eye protection, and others. However, perhaps the largest barrier to their use is their perceived inconvenience. Surgeons often cite decreased dexterity and sensation in their opposition to double or thick gloves, for instance. My concern is that with the advent of universal screening, many surgeons will abandon their universal approach and only wear Kevlar or double gloves on infected cases.

I have observed first-hand such a policy this year, when I spent 3 months in orthopedic centers in Russia. In Russia, all patients undergo routine preoperative testing for both hepatitis C virus and human immunodeficiency virus (HIV). While the policy of standard precautions exists, the majority of surgeons used single gloves and did not use eye protection for most cases, but took additional measures when operating on seropositive patients. Paradoxically, I witnessed numerous needle sticks during those cases, precisely because the surgeons and staff were not comfortable with wearing double gloves or hands-free passing of sharp instruments. Even goggles often ended up being removed during the cases, because the surgeons were not accustomed to using them.

Like any surgical skill, standard precautions require repetition and practice. Therefore, I am concerned that with adoption of universal screening in the United States, we will become complacent and accustomed to unsafe practices, which may paradoxically increase the risk of operating on infected patients.

Igor Immerman, MD

Pleasanton, CA

Author’s Disclosure Statement: The author reports no actual or potential conflict of interest in relation to this letter.

Author’s Response

Edward M. DelSole, MD

We appreciate the response of the reader. This is indeed an interesting paradox—that an effort to improve safety in the operating room might yield the opposite effect owing to a heightened sense of protection, which induces a laxity in adhering to standard precautions. This possibility does create a real concern for the safety of the surgical team. Although we do recommend preoperative screening for hepatitis C virus (HCV), our intent was not in any way to diminish the need for adhering to standard precautions.

The foundation of standard precautions rests upon the universal assumption of infectivity of blood exposures—this is why the precautions are “standard” and should be adhered to during all operative procedures.

First and foremost, identification of patients with hepatitis C infection offers the chance for referral for care, which in many cases is curative thanks to recent advances in hepatitis C therapy. Whether or not the patient accepts the referral for hepatitis C treatment should not, as we emphasize in our paper, affect the plan for surgery.

Secondly, a negative preoperative test should in no way alter normal intraoperative safety practices. The test results could be falsely negative due to human or mechanical error. In addition, the patient could have other transmissible diseases such as HIV, hepatitis B, or other less common yet transmissible viral infections. Importantly, given the historical narratives of the HIV and HCV epidemics, we as surgeons hold the responsibility to never be complacent about the next “unknown” novel viral agent that has yet to reveal itself.

Thirdly, perceived inconvenience of protective equipment is largely a matter of training. At our institution residents infrequently wear single layers of gloves, masks without eye protection, body suits for arthroplasty, lead vests without thyroid shields, etc. We suspect similar practice occurs at other teaching hospitals as well. As today’s residents learn the craft in an environment of heightened protection, it is our hope that they will carry these good habits into their own practice as orthopedic surgeons and that patient outcomes will not differ.

The goal of screening is to create an improved environment of safety and health awareness for the patient and the surgical team, the foundation of which is standard precautions in the operating room. We advocate strongly that standard precautions continue to be the basis of intraoperative safety and that they be used for all patients indiscriminately.

Author’s Disclosure Statement: The author reports no actual or potential conflict of interest in relation to this letter.

The journal welcomes Letters to the Editor. Letters are not peer reviewed. Opinions expressed in letters published here do not necessarily reflect those of the editorial board or the publishing company and its employees.

Letter to the Editor

Universal Hepatitis C Screening
and Surgeon Safety

I read with interest the article “Risk of Hepatitis C Virus Exposure in Orthopedic Surgery: Is Universal Screening Needed?” by Dr. DelSole and colleagues (Am J Orthop. 2014;43(6):E117-E123). The authors make a compelling case for universal hepatitis C screening, and I agree that this program may have significant benefits, including risk stratification for elective surgery and identification of patients for antiviral treatment. However, based largely on personal experiences, I disagree that preoperative knowledge of the patient’s seropositive status will improve surgeon safety.

The authors list a number of interventions to decrease the risk of exposure, such as the use of Kevlar gloves, double gloving, eye protection, and others. However, perhaps the largest barrier to their use is their perceived inconvenience. Surgeons often cite decreased dexterity and sensation in their opposition to double or thick gloves, for instance. My concern is that with the advent of universal screening, many surgeons will abandon their universal approach and only wear Kevlar or double gloves on infected cases.

I have observed first-hand such a policy this year, when I spent 3 months in orthopedic centers in Russia. In Russia, all patients undergo routine preoperative testing for both hepatitis C virus and human immunodeficiency virus (HIV). While the policy of standard precautions exists, the majority of surgeons used single gloves and did not use eye protection for most cases, but took additional measures when operating on seropositive patients. Paradoxically, I witnessed numerous needle sticks during those cases, precisely because the surgeons and staff were not comfortable with wearing double gloves or hands-free passing of sharp instruments. Even goggles often ended up being removed during the cases, because the surgeons were not accustomed to using them.

Like any surgical skill, standard precautions require repetition and practice. Therefore, I am concerned that with adoption of universal screening in the United States, we will become complacent and accustomed to unsafe practices, which may paradoxically increase the risk of operating on infected patients.

Igor Immerman, MD

Pleasanton, CA

Author’s Disclosure Statement: The author reports no actual or potential conflict of interest in relation to this letter.

Author’s Response

Edward M. DelSole, MD

We appreciate the response of the reader. This is indeed an interesting paradox—that an effort to improve safety in the operating room might yield the opposite effect owing to a heightened sense of protection, which induces a laxity in adhering to standard precautions. This possibility does create a real concern for the safety of the surgical team. Although we do recommend preoperative screening for hepatitis C virus (HCV), our intent was not in any way to diminish the need for adhering to standard precautions.

The foundation of standard precautions rests upon the universal assumption of infectivity of blood exposures—this is why the precautions are “standard” and should be adhered to during all operative procedures.

First and foremost, identification of patients with hepatitis C infection offers the chance for referral for care, which in many cases is curative thanks to recent advances in hepatitis C therapy. Whether or not the patient accepts the referral for hepatitis C treatment should not, as we emphasize in our paper, affect the plan for surgery.

Secondly, a negative preoperative test should in no way alter normal intraoperative safety practices. The test results could be falsely negative due to human or mechanical error. In addition, the patient could have other transmissible diseases such as HIV, hepatitis B, or other less common yet transmissible viral infections. Importantly, given the historical narratives of the HIV and HCV epidemics, we as surgeons hold the responsibility to never be complacent about the next “unknown” novel viral agent that has yet to reveal itself.

Thirdly, perceived inconvenience of protective equipment is largely a matter of training. At our institution residents infrequently wear single layers of gloves, masks without eye protection, body suits for arthroplasty, lead vests without thyroid shields, etc. We suspect similar practice occurs at other teaching hospitals as well. As today’s residents learn the craft in an environment of heightened protection, it is our hope that they will carry these good habits into their own practice as orthopedic surgeons and that patient outcomes will not differ.

The goal of screening is to create an improved environment of safety and health awareness for the patient and the surgical team, the foundation of which is standard precautions in the operating room. We advocate strongly that standard precautions continue to be the basis of intraoperative safety and that they be used for all patients indiscriminately.

Author’s Disclosure Statement: The author reports no actual or potential conflict of interest in relation to this letter.

The journal welcomes Letters to the Editor. Letters are not peer reviewed. Opinions expressed in letters published here do not necessarily reflect those of the editorial board or the publishing company and its employees.

You currently offer a physical therapy (PT) service line but feel like it could be doing better, or you are thinking of adding PT services and are not sure where to begin. Either way, the thought of your patients and bottom line benefiting from PT services within your practice but without you having to manage another service line is appealing. Although related to orthopedic surgery and an obvious ancillary service, PT is a different type of practice that requires active management of the professionals, revenue cycle, operations, regulatory requirements, and changing coding and reimbursement protocols. There are more and more companies nationwide that claim a mastery of the PT management niche and would be more than happy to shoulder your burden and share in your profits. Whether you already have PT services in your practice or are looking to add them, proceed with care and caution as you consider partnering with a PT management company. 

Drawing on my involvement with both successful PT management–orthopedic practice partnerships and the arduous, expensive demise of one, this article offers my recommendations for determining if a PT management partnership is best for your practice. Many of the contracts last for several years and include clauses that are extremely binding even after the contract conclusion. As with any decision to outsource, the decision to outsource PT services deserves a comprehensive request for proposal (RFP) to multiple candidate companies, a thorough vetting and decision process that includes all partners or an executive committee/board, and legal review of the contract by an experienced health care attorney representing the practice.

Request for Proposal

Begin the RFP with a reference to your website and a brief description of the practice and current PT services. For example, state that you don’t have PT and are looking to start it, or, if your practice offers PT, include a description of the number of locations, square footage allocation, and number of full-time equivalent (FTE) physical therapists, occupational therapists, physical therapy assistants, and support staff of the existing program. Also mention whether the billing is done within the practice or is outsourced.

Next, you want to learn about the company. Ask about its number of years in PT management and the history of the company. Ask them to provide the previous business names and an overview of the history of ownership. You want to know this because the national PT management community is relatively small and includes frequent acquisitions and mergers. Just as important as the company’s history is any future plans it has to acquire or be acquired. This is all part of knowing who you may be partnering with.

You will want to know how many other practices the company provides PT/occupational therapy (OT) management services for, in what states those practices are located, and a breakdown of specialties. The number of physician providers the company represents along with the answers to the other questions will give you an idea of its size, experience, location, alignment, and focus. Some of these companies manage PT in family practices. You will want to know how many orthopedic practices the company partners with. If your practice has subspecialties, ask about its experience with subspecialty orthopedics.

Ask for the company’s website so that you can get an idea of the company and its mission, vision, and values. Even though you will likely be interacting with regional representatives, you will be signing the contract with the company leadership, so be sure to learn—either from the company’s website or its response to the RFP—about the individuals leading the organization and any parent company. Ask for a list of officers, board of directors, managers, and perhaps an organization chart with titles and names. Because you are looking to partner with the company, it might be good to ask for managerial turnover rates in the last few years. PT is a professional health care service, so take note of the number of licensed therapists the company has in leadership positions. If you were partnering with a medical organization, you would certainly want physicians in leadership positions, and this is no different. Determine if the company is publicly traded or privately held. You may also consider requesting the company’s last few annual reports to learn more.

Exclusivity

Some PT management companies have their own facilities and are partnering with practices in the same market despite the seemingly inherent conflict. As part of your RFP, ask the company to include the names of practices, their specialties, and site locations where it already has a presence as well as a list of its own (independent of a physician practice) locations in the state or region. Future plans are important here too; if the company does not currently have a presence in the region, what commitment will it make to exclusivity or noncompete?

Human Resources

In many cases, the PT management company actually employs the entire staff for the service line. If you already have PT in your practice, this means the employees will transition from your employment to another company. After the contract is signed, some of the employees will get paychecks and benefits from your practice and be subject to your practice’s policies, while others will not. Having 2 different employers in the same practice can have an impact on employee morale and satisfaction. Find out during the proposal process if the company’s typical model is based on the company’s or the practice’s employment of the professional and support staff.             

Obtain the following information from the management company if it is to be the employer:

1.  Titles and compensation ranges for each position

2.  Description of all bonuses and incentive structures

3.  Paid time off (PTO) policies and accrual rates

4.  Paid holidays

5.  Details of employee benefits, such as employee out-of-pocket premiums for individual and family health care coverage, availability of vision and dental coverage, and investment and match for retirement or 401(k) plans.

6.  Human resources (HR) support. Describe how employees get needed support from human resources, such as questions about benefits, FMLA (Family Medical Leave Act), HR policies, and other issues.

7.  Results of any employee satisfaction surveys completed in the last 2 years

8.  Nonrecruitment. In what ways will the professional staff’s careers be affected by this partnership? Will the professional staff have to sign employment agreements? If so, please provide a sample. Will there be covenants not to compete for the professional staff?

9.  Provide a schematic on how you typically cover professional staff vacation and family leave.

10. Does your organization provide accredited continuing education for professional staff or do you send staff to state and national meetings and courses to maintain their CEU (continuing education units) requirement?

11. Do you provide annual regulatory training, such as HIPAA (Health Insurance Portability and Accountability Act) training, for all staff or is the practice responsible for that?

12. Professional liability coverage for the therapists.

Initially, the company may say they are open to doing it either way and you may proceed with the process without answers to these questions. If at any point, you explore a situation in which the employer is not the practice, you must get answers to these questions before agreeing to anything. Number 8 above is extremely important. Many PT management companies will include a nonrecruitment clause in their contracts so that neither party can recruit therapists from the engagement. Depending on how the clause is written, you may not be able to legally hire therapists who were with you for years before the management agreement at the conclusion of the contract. Individual therapists can find themselves very limited in where they can work in the community depending on a covenant not to compete. And while covenants not to compete and nonrecruitment clauses may be generalized as “indefensible,” it is expensive, time-consuming, and exhausting to get one rendered as such after the fact.

Operations

Operational compatibility is essential to a smooth transition or start-up. As part of your RFP, let the candidate companies know which electronic medical record (EMR) and electronic practice management (EPM) systems you use and ask about their experience level with those. Ask if it is expected that PT will operate on the practice’s EMR and EPM systems or if the company will be having PT operate on separate systems. If the company will be implementing different systems, find out which one and then do an accounting of the costs for interface, training, and other compatibility elements.

Inquire as to each candidate company’s standard operations policies and procedures as well as the operational and productivity standards the company maintains. For example, ask for a range of how many patients a physical therapist should be able to see (including documentation) in an 8-hour day? If you already have a PT service line, compare the company’s productivity standards to what your therapists are currently doing. Of the many enhancements a therapy management company can bring, an increase in productivity is essential. Request a description of productivity incentive programs for the professional staff so that you can determine if you are comfortable with them. By the same token, ask if the company has a comprehensive compliance program including procedures and policies.

Any outsourcing agreements will be subject to operational and contractual compliance elements such as HIPAA, business associates agreement, and all other applicable regulations through state, federal, and payor entities. Ask each candidate company about its compliance program.

Revenue Cycle

Some therapy management companies will leave the billing and collections to the practice, while others have their own operations. As part of the RFP, ask the company which way it is done in its standard model. If the company manages the revenue cycle, ask which key revenue cycle performance indicators it monitors, how it calculates them, and with what frequency it tracks and reports them. Ask how the company has approached a revenue cycle performance improvement effort and what successes it has had. And definitely ask about the emphasis, training, and performance standards on point-of-service (POS) collections. In PT, successful, service-oriented POS collections are essential to cash flow and patient satisfaction. Typically, there is a copayment for each visit, and patients come 3 times or more per week. When patients pay the copayment before each visit, it feels manageable to them. If they get a bill for 6 copayments 2 weeks into PT, they often get angry and do not see the value of the therapy. 

Seek specifics on the elements of the company’s performance improvement. A number of companies will default to providing incentive bonuses for POS collections and other revenue cycle improvements. Incentive bonuses for collections can compromise the coding and billing integrity of the practice and are guaranteed to cause discontent among support staff. Everyone who works hard should be recognized, not just the staff in a position to collect money. On top of this, if the PT reception staff are getting paid POS collections bonuses and the practice reception staff are not, a managerial dichotomy ensues.

Accounting and Financial Reporting

In your RFP, ask about the accounting and financial model that each candidate company most often uses. Inquire as to which—the practice or the management company—is responsible for monthly, quarterly, and annual accounting and financial reporting and what typical monthly reconcilement process the company recommends. Include the following requests in your RFP:

1.  Please provide samples of the monthly financials produced or preferred.

2.  Describe your annual expense and revenue budgeting and approval processes.

3.  Please address how you recommend handling the purchase of new equipment and supplies as well as the handling of existing equipment and supplies. 

4.  Will you rent our current space? Will you look to move the PT department into an alternate space in the future? If so, where?

General

Make some general inquiries that will help you get to know each organization and determine which one may be the best fit for a long, committed relationship with your practice. Find out how often the organization will have corporate representatives in the practice and at physician board meetings. Inquire as to the types of referral reports they generate and share with the practice. Request the names and contact information of 3 to 5 orthopedic surgery practice managers or physician leaders whom you can contact as references for the company. 

If you have an existing PT service line, ask the company how it proposes to enhance the services, quality, and bottom line. What value will the company’s management services add to an existing program?

Get to know the organization by asking how many of its partnering practices have terminated their agreements with the management company and if it has any current or past litigation with partner practices. These are detailed, binding contracts with the potential for a lot of money. When the relationships or even the local markets change, suits are filed.

As part of the RFP, inquire as to the standard proposed model for income distribution between the practice and the management company.

Conclusion

If your RFP covers all of the inquiries discussed in this article, it will be necessarily comprehensive. Send it to several companies with a clear indication of the response deadline and the contact person for the response and for any questions they may have. The contact person is typically the practice manager or executive administrator. Individual physicians in your group may have relationships with local representatives of a PT management company, and it can put them in an awkward position during the proposal submission and evaluation process.

Some companies may not respond to an RFP this comprehensive, which provides an unequivocal answer that they are not qualified to be your practice’s partner. Compare the responses you receive and set up presentations or conference calls for those companies whose proposals warrant it.

Hire your own health care attorney to review any and all contracts before signing. The HR support, exclusivity, income distribution models, compliance, and duration of these contracts must be approved by an experienced attorney that advocates for the practice alone.

You currently offer a physical therapy (PT) service line but feel like it could be doing better, or you are thinking of adding PT services and are not sure where to begin. Either way, the thought of your patients and bottom line benefiting from PT services within your practice but without you having to manage another service line is appealing. Although related to orthopedic surgery and an obvious ancillary service, PT is a different type of practice that requires active management of the professionals, revenue cycle, operations, regulatory requirements, and changing coding and reimbursement protocols. There are more and more companies nationwide that claim a mastery of the PT management niche and would be more than happy to shoulder your burden and share in your profits. Whether you already have PT services in your practice or are looking to add them, proceed with care and caution as you consider partnering with a PT management company. 

Drawing on my involvement with both successful PT management–orthopedic practice partnerships and the arduous, expensive demise of one, this article offers my recommendations for determining if a PT management partnership is best for your practice. Many of the contracts last for several years and include clauses that are extremely binding even after the contract conclusion. As with any decision to outsource, the decision to outsource PT services deserves a comprehensive request for proposal (RFP) to multiple candidate companies, a thorough vetting and decision process that includes all partners or an executive committee/board, and legal review of the contract by an experienced health care attorney representing the practice.

Request for Proposal

Begin the RFP with a reference to your website and a brief description of the practice and current PT services. For example, state that you don’t have PT and are looking to start it, or, if your practice offers PT, include a description of the number of locations, square footage allocation, and number of full-time equivalent (FTE) physical therapists, occupational therapists, physical therapy assistants, and support staff of the existing program. Also mention whether the billing is done within the practice or is outsourced.

Next, you want to learn about the company. Ask about its number of years in PT management and the history of the company. Ask them to provide the previous business names and an overview of the history of ownership. You want to know this because the national PT management community is relatively small and includes frequent acquisitions and mergers. Just as important as the company’s history is any future plans it has to acquire or be acquired. This is all part of knowing who you may be partnering with.

You will want to know how many other practices the company provides PT/occupational therapy (OT) management services for, in what states those practices are located, and a breakdown of specialties. The number of physician providers the company represents along with the answers to the other questions will give you an idea of its size, experience, location, alignment, and focus. Some of these companies manage PT in family practices. You will want to know how many orthopedic practices the company partners with. If your practice has subspecialties, ask about its experience with subspecialty orthopedics.

Ask for the company’s website so that you can get an idea of the company and its mission, vision, and values. Even though you will likely be interacting with regional representatives, you will be signing the contract with the company leadership, so be sure to learn—either from the company’s website or its response to the RFP—about the individuals leading the organization and any parent company. Ask for a list of officers, board of directors, managers, and perhaps an organization chart with titles and names. Because you are looking to partner with the company, it might be good to ask for managerial turnover rates in the last few years. PT is a professional health care service, so take note of the number of licensed therapists the company has in leadership positions. If you were partnering with a medical organization, you would certainly want physicians in leadership positions, and this is no different. Determine if the company is publicly traded or privately held. You may also consider requesting the company’s last few annual reports to learn more.

Exclusivity

Some PT management companies have their own facilities and are partnering with practices in the same market despite the seemingly inherent conflict. As part of your RFP, ask the company to include the names of practices, their specialties, and site locations where it already has a presence as well as a list of its own (independent of a physician practice) locations in the state or region. Future plans are important here too; if the company does not currently have a presence in the region, what commitment will it make to exclusivity or noncompete?

Human Resources

In many cases, the PT management company actually employs the entire staff for the service line. If you already have PT in your practice, this means the employees will transition from your employment to another company. After the contract is signed, some of the employees will get paychecks and benefits from your practice and be subject to your practice’s policies, while others will not. Having 2 different employers in the same practice can have an impact on employee morale and satisfaction. Find out during the proposal process if the company’s typical model is based on the company’s or the practice’s employment of the professional and support staff.             

Obtain the following information from the management company if it is to be the employer:

1.  Titles and compensation ranges for each position

2.  Description of all bonuses and incentive structures

3.  Paid time off (PTO) policies and accrual rates

4.  Paid holidays

5.  Details of employee benefits, such as employee out-of-pocket premiums for individual and family health care coverage, availability of vision and dental coverage, and investment and match for retirement or 401(k) plans.

6.  Human resources (HR) support. Describe how employees get needed support from human resources, such as questions about benefits, FMLA (Family Medical Leave Act), HR policies, and other issues.

7.  Results of any employee satisfaction surveys completed in the last 2 years

8.  Nonrecruitment. In what ways will the professional staff’s careers be affected by this partnership? Will the professional staff have to sign employment agreements? If so, please provide a sample. Will there be covenants not to compete for the professional staff?

9.  Provide a schematic on how you typically cover professional staff vacation and family leave.

10. Does your organization provide accredited continuing education for professional staff or do you send staff to state and national meetings and courses to maintain their CEU (continuing education units) requirement?

11. Do you provide annual regulatory training, such as HIPAA (Health Insurance Portability and Accountability Act) training, for all staff or is the practice responsible for that?

12. Professional liability coverage for the therapists.

Initially, the company may say they are open to doing it either way and you may proceed with the process without answers to these questions. If at any point, you explore a situation in which the employer is not the practice, you must get answers to these questions before agreeing to anything. Number 8 above is extremely important. Many PT management companies will include a nonrecruitment clause in their contracts so that neither party can recruit therapists from the engagement. Depending on how the clause is written, you may not be able to legally hire therapists who were with you for years before the management agreement at the conclusion of the contract. Individual therapists can find themselves very limited in where they can work in the community depending on a covenant not to compete. And while covenants not to compete and nonrecruitment clauses may be generalized as “indefensible,” it is expensive, time-consuming, and exhausting to get one rendered as such after the fact.

Operations

Operational compatibility is essential to a smooth transition or start-up. As part of your RFP, let the candidate companies know which electronic medical record (EMR) and electronic practice management (EPM) systems you use and ask about their experience level with those. Ask if it is expected that PT will operate on the practice’s EMR and EPM systems or if the company will be having PT operate on separate systems. If the company will be implementing different systems, find out which one and then do an accounting of the costs for interface, training, and other compatibility elements.

Inquire as to each candidate company’s standard operations policies and procedures as well as the operational and productivity standards the company maintains. For example, ask for a range of how many patients a physical therapist should be able to see (including documentation) in an 8-hour day? If you already have a PT service line, compare the company’s productivity standards to what your therapists are currently doing. Of the many enhancements a therapy management company can bring, an increase in productivity is essential. Request a description of productivity incentive programs for the professional staff so that you can determine if you are comfortable with them. By the same token, ask if the company has a comprehensive compliance program including procedures and policies.

Any outsourcing agreements will be subject to operational and contractual compliance elements such as HIPAA, business associates agreement, and all other applicable regulations through state, federal, and payor entities. Ask each candidate company about its compliance program.

Revenue Cycle

Some therapy management companies will leave the billing and collections to the practice, while others have their own operations. As part of the RFP, ask the company which way it is done in its standard model. If the company manages the revenue cycle, ask which key revenue cycle performance indicators it monitors, how it calculates them, and with what frequency it tracks and reports them. Ask how the company has approached a revenue cycle performance improvement effort and what successes it has had. And definitely ask about the emphasis, training, and performance standards on point-of-service (POS) collections. In PT, successful, service-oriented POS collections are essential to cash flow and patient satisfaction. Typically, there is a copayment for each visit, and patients come 3 times or more per week. When patients pay the copayment before each visit, it feels manageable to them. If they get a bill for 6 copayments 2 weeks into PT, they often get angry and do not see the value of the therapy. 

Seek specifics on the elements of the company’s performance improvement. A number of companies will default to providing incentive bonuses for POS collections and other revenue cycle improvements. Incentive bonuses for collections can compromise the coding and billing integrity of the practice and are guaranteed to cause discontent among support staff. Everyone who works hard should be recognized, not just the staff in a position to collect money. On top of this, if the PT reception staff are getting paid POS collections bonuses and the practice reception staff are not, a managerial dichotomy ensues.

Accounting and Financial Reporting

In your RFP, ask about the accounting and financial model that each candidate company most often uses. Inquire as to which—the practice or the management company—is responsible for monthly, quarterly, and annual accounting and financial reporting and what typical monthly reconcilement process the company recommends. Include the following requests in your RFP:

1.  Please provide samples of the monthly financials produced or preferred.

2.  Describe your annual expense and revenue budgeting and approval processes.

3.  Please address how you recommend handling the purchase of new equipment and supplies as well as the handling of existing equipment and supplies. 

4.  Will you rent our current space? Will you look to move the PT department into an alternate space in the future? If so, where?

General

Make some general inquiries that will help you get to know each organization and determine which one may be the best fit for a long, committed relationship with your practice. Find out how often the organization will have corporate representatives in the practice and at physician board meetings. Inquire as to the types of referral reports they generate and share with the practice. Request the names and contact information of 3 to 5 orthopedic surgery practice managers or physician leaders whom you can contact as references for the company. 

If you have an existing PT service line, ask the company how it proposes to enhance the services, quality, and bottom line. What value will the company’s management services add to an existing program?

Get to know the organization by asking how many of its partnering practices have terminated their agreements with the management company and if it has any current or past litigation with partner practices. These are detailed, binding contracts with the potential for a lot of money. When the relationships or even the local markets change, suits are filed.

As part of the RFP, inquire as to the standard proposed model for income distribution between the practice and the management company.

Conclusion

If your RFP covers all of the inquiries discussed in this article, it will be necessarily comprehensive. Send it to several companies with a clear indication of the response deadline and the contact person for the response and for any questions they may have. The contact person is typically the practice manager or executive administrator. Individual physicians in your group may have relationships with local representatives of a PT management company, and it can put them in an awkward position during the proposal submission and evaluation process.

Some companies may not respond to an RFP this comprehensive, which provides an unequivocal answer that they are not qualified to be your practice’s partner. Compare the responses you receive and set up presentations or conference calls for those companies whose proposals warrant it.

Hire your own health care attorney to review any and all contracts before signing. The HR support, exclusivity, income distribution models, compliance, and duration of these contracts must be approved by an experienced attorney that advocates for the practice alone.

You currently offer a physical therapy (PT) service line but feel like it could be doing better, or you are thinking of adding PT services and are not sure where to begin. Either way, the thought of your patients and bottom line benefiting from PT services within your practice but without you having to manage another service line is appealing. Although related to orthopedic surgery and an obvious ancillary service, PT is a different type of practice that requires active management of the professionals, revenue cycle, operations, regulatory requirements, and changing coding and reimbursement protocols. There are more and more companies nationwide that claim a mastery of the PT management niche and would be more than happy to shoulder your burden and share in your profits. Whether you already have PT services in your practice or are looking to add them, proceed with care and caution as you consider partnering with a PT management company. 

Drawing on my involvement with both successful PT management–orthopedic practice partnerships and the arduous, expensive demise of one, this article offers my recommendations for determining if a PT management partnership is best for your practice. Many of the contracts last for several years and include clauses that are extremely binding even after the contract conclusion. As with any decision to outsource, the decision to outsource PT services deserves a comprehensive request for proposal (RFP) to multiple candidate companies, a thorough vetting and decision process that includes all partners or an executive committee/board, and legal review of the contract by an experienced health care attorney representing the practice.

Request for Proposal

Begin the RFP with a reference to your website and a brief description of the practice and current PT services. For example, state that you don’t have PT and are looking to start it, or, if your practice offers PT, include a description of the number of locations, square footage allocation, and number of full-time equivalent (FTE) physical therapists, occupational therapists, physical therapy assistants, and support staff of the existing program. Also mention whether the billing is done within the practice or is outsourced.

Next, you want to learn about the company. Ask about its number of years in PT management and the history of the company. Ask them to provide the previous business names and an overview of the history of ownership. You want to know this because the national PT management community is relatively small and includes frequent acquisitions and mergers. Just as important as the company’s history is any future plans it has to acquire or be acquired. This is all part of knowing who you may be partnering with.

You will want to know how many other practices the company provides PT/occupational therapy (OT) management services for, in what states those practices are located, and a breakdown of specialties. The number of physician providers the company represents along with the answers to the other questions will give you an idea of its size, experience, location, alignment, and focus. Some of these companies manage PT in family practices. You will want to know how many orthopedic practices the company partners with. If your practice has subspecialties, ask about its experience with subspecialty orthopedics.

Ask for the company’s website so that you can get an idea of the company and its mission, vision, and values. Even though you will likely be interacting with regional representatives, you will be signing the contract with the company leadership, so be sure to learn—either from the company’s website or its response to the RFP—about the individuals leading the organization and any parent company. Ask for a list of officers, board of directors, managers, and perhaps an organization chart with titles and names. Because you are looking to partner with the company, it might be good to ask for managerial turnover rates in the last few years. PT is a professional health care service, so take note of the number of licensed therapists the company has in leadership positions. If you were partnering with a medical organization, you would certainly want physicians in leadership positions, and this is no different. Determine if the company is publicly traded or privately held. You may also consider requesting the company’s last few annual reports to learn more.

Exclusivity

Some PT management companies have their own facilities and are partnering with practices in the same market despite the seemingly inherent conflict. As part of your RFP, ask the company to include the names of practices, their specialties, and site locations where it already has a presence as well as a list of its own (independent of a physician practice) locations in the state or region. Future plans are important here too; if the company does not currently have a presence in the region, what commitment will it make to exclusivity or noncompete?

Human Resources

In many cases, the PT management company actually employs the entire staff for the service line. If you already have PT in your practice, this means the employees will transition from your employment to another company. After the contract is signed, some of the employees will get paychecks and benefits from your practice and be subject to your practice’s policies, while others will not. Having 2 different employers in the same practice can have an impact on employee morale and satisfaction. Find out during the proposal process if the company’s typical model is based on the company’s or the practice’s employment of the professional and support staff.             

Obtain the following information from the management company if it is to be the employer:

1.  Titles and compensation ranges for each position

2.  Description of all bonuses and incentive structures

3.  Paid time off (PTO) policies and accrual rates

4.  Paid holidays

5.  Details of employee benefits, such as employee out-of-pocket premiums for individual and family health care coverage, availability of vision and dental coverage, and investment and match for retirement or 401(k) plans.

6.  Human resources (HR) support. Describe how employees get needed support from human resources, such as questions about benefits, FMLA (Family Medical Leave Act), HR policies, and other issues.

7.  Results of any employee satisfaction surveys completed in the last 2 years

8.  Nonrecruitment. In what ways will the professional staff’s careers be affected by this partnership? Will the professional staff have to sign employment agreements? If so, please provide a sample. Will there be covenants not to compete for the professional staff?

9.  Provide a schematic on how you typically cover professional staff vacation and family leave.

10. Does your organization provide accredited continuing education for professional staff or do you send staff to state and national meetings and courses to maintain their CEU (continuing education units) requirement?

11. Do you provide annual regulatory training, such as HIPAA (Health Insurance Portability and Accountability Act) training, for all staff or is the practice responsible for that?

12. Professional liability coverage for the therapists.

Initially, the company may say they are open to doing it either way and you may proceed with the process without answers to these questions. If at any point, you explore a situation in which the employer is not the practice, you must get answers to these questions before agreeing to anything. Number 8 above is extremely important. Many PT management companies will include a nonrecruitment clause in their contracts so that neither party can recruit therapists from the engagement. Depending on how the clause is written, you may not be able to legally hire therapists who were with you for years before the management agreement at the conclusion of the contract. Individual therapists can find themselves very limited in where they can work in the community depending on a covenant not to compete. And while covenants not to compete and nonrecruitment clauses may be generalized as “indefensible,” it is expensive, time-consuming, and exhausting to get one rendered as such after the fact.

Operations

Operational compatibility is essential to a smooth transition or start-up. As part of your RFP, let the candidate companies know which electronic medical record (EMR) and electronic practice management (EPM) systems you use and ask about their experience level with those. Ask if it is expected that PT will operate on the practice’s EMR and EPM systems or if the company will be having PT operate on separate systems. If the company will be implementing different systems, find out which one and then do an accounting of the costs for interface, training, and other compatibility elements.

Inquire as to each candidate company’s standard operations policies and procedures as well as the operational and productivity standards the company maintains. For example, ask for a range of how many patients a physical therapist should be able to see (including documentation) in an 8-hour day? If you already have a PT service line, compare the company’s productivity standards to what your therapists are currently doing. Of the many enhancements a therapy management company can bring, an increase in productivity is essential. Request a description of productivity incentive programs for the professional staff so that you can determine if you are comfortable with them. By the same token, ask if the company has a comprehensive compliance program including procedures and policies.

Any outsourcing agreements will be subject to operational and contractual compliance elements such as HIPAA, business associates agreement, and all other applicable regulations through state, federal, and payor entities. Ask each candidate company about its compliance program.

Revenue Cycle

Some therapy management companies will leave the billing and collections to the practice, while others have their own operations. As part of the RFP, ask the company which way it is done in its standard model. If the company manages the revenue cycle, ask which key revenue cycle performance indicators it monitors, how it calculates them, and with what frequency it tracks and reports them. Ask how the company has approached a revenue cycle performance improvement effort and what successes it has had. And definitely ask about the emphasis, training, and performance standards on point-of-service (POS) collections. In PT, successful, service-oriented POS collections are essential to cash flow and patient satisfaction. Typically, there is a copayment for each visit, and patients come 3 times or more per week. When patients pay the copayment before each visit, it feels manageable to them. If they get a bill for 6 copayments 2 weeks into PT, they often get angry and do not see the value of the therapy. 

Seek specifics on the elements of the company’s performance improvement. A number of companies will default to providing incentive bonuses for POS collections and other revenue cycle improvements. Incentive bonuses for collections can compromise the coding and billing integrity of the practice and are guaranteed to cause discontent among support staff. Everyone who works hard should be recognized, not just the staff in a position to collect money. On top of this, if the PT reception staff are getting paid POS collections bonuses and the practice reception staff are not, a managerial dichotomy ensues.

Accounting and Financial Reporting

In your RFP, ask about the accounting and financial model that each candidate company most often uses. Inquire as to which—the practice or the management company—is responsible for monthly, quarterly, and annual accounting and financial reporting and what typical monthly reconcilement process the company recommends. Include the following requests in your RFP:

1.  Please provide samples of the monthly financials produced or preferred.

2.  Describe your annual expense and revenue budgeting and approval processes.

3.  Please address how you recommend handling the purchase of new equipment and supplies as well as the handling of existing equipment and supplies. 

4.  Will you rent our current space? Will you look to move the PT department into an alternate space in the future? If so, where?

General

Make some general inquiries that will help you get to know each organization and determine which one may be the best fit for a long, committed relationship with your practice. Find out how often the organization will have corporate representatives in the practice and at physician board meetings. Inquire as to the types of referral reports they generate and share with the practice. Request the names and contact information of 3 to 5 orthopedic surgery practice managers or physician leaders whom you can contact as references for the company. 

If you have an existing PT service line, ask the company how it proposes to enhance the services, quality, and bottom line. What value will the company’s management services add to an existing program?

Get to know the organization by asking how many of its partnering practices have terminated their agreements with the management company and if it has any current or past litigation with partner practices. These are detailed, binding contracts with the potential for a lot of money. When the relationships or even the local markets change, suits are filed.

As part of the RFP, inquire as to the standard proposed model for income distribution between the practice and the management company.

Conclusion

If your RFP covers all of the inquiries discussed in this article, it will be necessarily comprehensive. Send it to several companies with a clear indication of the response deadline and the contact person for the response and for any questions they may have. The contact person is typically the practice manager or executive administrator. Individual physicians in your group may have relationships with local representatives of a PT management company, and it can put them in an awkward position during the proposal submission and evaluation process.

Some companies may not respond to an RFP this comprehensive, which provides an unequivocal answer that they are not qualified to be your practice’s partner. Compare the responses you receive and set up presentations or conference calls for those companies whose proposals warrant it.

Hire your own health care attorney to review any and all contracts before signing. The HR support, exclusivity, income distribution models, compliance, and duration of these contracts must be approved by an experienced attorney that advocates for the practice alone.

The value of preoperative planning and templating has been well-established in fracture surgery.^1,2 Traditionally, this involves writing a surgical tactic and tracing the radiographs on paper to plan the ultimate reduction and implant placement.¹ The advent of sophisticated computer programs has allowed electronic preoperative planning in trauma and arthroplasty surgery.^3,4 Software for computer templating of acetabular fractures is available.⁵ Still, the renderings generated in these exercises are 2-dimensional, and their quality is somewhat dependent on the surgeon’s artistic ability. Ultimately, drawing a fracture is meant to help the surgeon understand its 3-dimensional (3-D) characteristics. This can be difficult working in 2 dimensions especially for bones, such as the pelvis, with complex 3-D structures. A useful alternative is to draw the fracture on a plastic-bone model.

We plan all acetabular fracture surgeries on 3-D models (plastic bones). These models are commonly provided to residents and fellows through educational courses or can be purchased online. Residents, fellows, and staff have their own models for planning, and we typically keep several models in the operating room for teaching before the surgery. Although these models are ideal for visualizing the bony anatomy, they are less than ideal for drawing fracture lines. Ink pens do not leave lines, and lines from markers and pencils cannot be easily erased. After a few planning sessions, the models typically look like a city map, making it difficult to tell the current fracture from those previously evaluated.

Here we describe a technique for turning standard plastic models into white boards so that lines can be drawn clearly with a marker and easily erased. To facilitate the correction of errors and reuse for future cases, we coat pelvic models with dry-erase epoxy resin. Although there is a commercially available product that has similar capabilities, our technique creates a significantly less expensive model that will likely be appealing to residents and fellows.   

Technique

Throughout the process of creating the pelvic model, it is important to work in a well-ventilated area. Gloves should be worn at all times. The working surface should be protected with an impervious plastic sheet to avoid primer or epoxy soaking through.

In creating our dry-erase pelvic models, we use the Sawbones large male solid-foam pelvic model (Figure 1; Model 1301, Pacific Research Laboratories, Vashon, Washington). These models are often available to residents and fellows after Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association (AO/OTA) trauma courses or resident educational sessions. Alternatively, they can be purchased online.

We sand the model to smooth out surface irregularities and to prepare it to accept primer. First, use 100-grit and then 220-grit sandpaper to create the optimum surface. We recommend suspending the pelvis from string by placing an eyelet screw into the top of the sacrum or looping a string through 1 of the sacral foramen while priming, painting, and curing. To prime the pelvic model, we have used KILZ original spray primer (Masterchem Industries, Imperial, Missouri). It is important that the entire model be well coated with primer because the epoxy resin will not adhere to unprimed plastic-foam surface. Take care to apply an even coat and to avoid drip formation.  

Once the primer is completely dry, apply the dry-erase epoxy resin (Rust-Oleum, Vernon Hills, Illinois). Mix the 2 parts of the epoxy resin and apply to the pelvic model with a foam brush. It is important to cover the entire surface of the model with enough epoxy to give a smooth, even finish. This requires 2 to 3 coats applied approximately 30 minutes apart (the epoxy will remain wet but will take additional coats well).

Once the final coat has been applied, the model takes about 48 hours to cure. Hang in a dry, well-ventilated location until it is fully cured. Then, use a dry-erase marker to trace fracture lines and the planned location of plates and screws (Figure 2).

An alternative to creating a dry-erase pelvis is to create a blackboard pelvis. Use Chalkboard Spray (Rust-Oleum) to create a surface that will accept white and colored chalk. The application of this product is much easier than the dry-erase epoxy, because it can be applied in a similar fashion as the spray primer. This creates a black model that can be marked with chalk. However, we have found these models to be less useful than the dry-erase versions, because chalk leaves less precise lines and is harder to remove from the model.

Once created, the pelvic model can be used intraoperatively to help understand fracture reduction and to facilitate the precontouring of pelvic and acetabular plates. We place the model in a sterile radiographic cassette bag (Figure 3). This gives the operating team access to the model and is useful in teaching anatomy, and particularly, screw placement. Further, the model allows an assistant to precontour plates to the model during the exposure portion of the case (Figure 4). While the precontoured plate is not always a perfect fit, it can usually be adjusted easily to fit the unique anatomy of the patient.

Discussion

Understanding the complex anatomy of pelvic and acetabular fractures can be challenging. We use models in the teaching of anatomy, in the interpretation of radiographs and computed tomography (CT) scans, and in preoperative planning. Fracture lines are traced on the pelvic model based on radiographs and/or CT scans and then compared with 3-D reconstruction images and, eventually, with operative findings. The use of our dry-erase models allows for easy correction of mistakes and reuse for further cases.

We have found dry-erase pelvic models to be an invaluable tool for resident and fellow education. While conventional 2-dimensional planning is adequate for most long-bone and periarticular fractures, the creation of these 3-D planning tools is useful in understanding the anatomy and surgical treatment of pelvic and acetabular fractures.

The value of preoperative planning and templating has been well-established in fracture surgery.^1,2 Traditionally, this involves writing a surgical tactic and tracing the radiographs on paper to plan the ultimate reduction and implant placement.¹ The advent of sophisticated computer programs has allowed electronic preoperative planning in trauma and arthroplasty surgery.^3,4 Software for computer templating of acetabular fractures is available.⁵ Still, the renderings generated in these exercises are 2-dimensional, and their quality is somewhat dependent on the surgeon’s artistic ability. Ultimately, drawing a fracture is meant to help the surgeon understand its 3-dimensional (3-D) characteristics. This can be difficult working in 2 dimensions especially for bones, such as the pelvis, with complex 3-D structures. A useful alternative is to draw the fracture on a plastic-bone model.

We plan all acetabular fracture surgeries on 3-D models (plastic bones). These models are commonly provided to residents and fellows through educational courses or can be purchased online. Residents, fellows, and staff have their own models for planning, and we typically keep several models in the operating room for teaching before the surgery. Although these models are ideal for visualizing the bony anatomy, they are less than ideal for drawing fracture lines. Ink pens do not leave lines, and lines from markers and pencils cannot be easily erased. After a few planning sessions, the models typically look like a city map, making it difficult to tell the current fracture from those previously evaluated.

Here we describe a technique for turning standard plastic models into white boards so that lines can be drawn clearly with a marker and easily erased. To facilitate the correction of errors and reuse for future cases, we coat pelvic models with dry-erase epoxy resin. Although there is a commercially available product that has similar capabilities, our technique creates a significantly less expensive model that will likely be appealing to residents and fellows.   

Technique

Throughout the process of creating the pelvic model, it is important to work in a well-ventilated area. Gloves should be worn at all times. The working surface should be protected with an impervious plastic sheet to avoid primer or epoxy soaking through.

In creating our dry-erase pelvic models, we use the Sawbones large male solid-foam pelvic model (Figure 1; Model 1301, Pacific Research Laboratories, Vashon, Washington). These models are often available to residents and fellows after Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association (AO/OTA) trauma courses or resident educational sessions. Alternatively, they can be purchased online.

We sand the model to smooth out surface irregularities and to prepare it to accept primer. First, use 100-grit and then 220-grit sandpaper to create the optimum surface. We recommend suspending the pelvis from string by placing an eyelet screw into the top of the sacrum or looping a string through 1 of the sacral foramen while priming, painting, and curing. To prime the pelvic model, we have used KILZ original spray primer (Masterchem Industries, Imperial, Missouri). It is important that the entire model be well coated with primer because the epoxy resin will not adhere to unprimed plastic-foam surface. Take care to apply an even coat and to avoid drip formation.  

Once the primer is completely dry, apply the dry-erase epoxy resin (Rust-Oleum, Vernon Hills, Illinois). Mix the 2 parts of the epoxy resin and apply to the pelvic model with a foam brush. It is important to cover the entire surface of the model with enough epoxy to give a smooth, even finish. This requires 2 to 3 coats applied approximately 30 minutes apart (the epoxy will remain wet but will take additional coats well).

Once the final coat has been applied, the model takes about 48 hours to cure. Hang in a dry, well-ventilated location until it is fully cured. Then, use a dry-erase marker to trace fracture lines and the planned location of plates and screws (Figure 2).

An alternative to creating a dry-erase pelvis is to create a blackboard pelvis. Use Chalkboard Spray (Rust-Oleum) to create a surface that will accept white and colored chalk. The application of this product is much easier than the dry-erase epoxy, because it can be applied in a similar fashion as the spray primer. This creates a black model that can be marked with chalk. However, we have found these models to be less useful than the dry-erase versions, because chalk leaves less precise lines and is harder to remove from the model.

Once created, the pelvic model can be used intraoperatively to help understand fracture reduction and to facilitate the precontouring of pelvic and acetabular plates. We place the model in a sterile radiographic cassette bag (Figure 3). This gives the operating team access to the model and is useful in teaching anatomy, and particularly, screw placement. Further, the model allows an assistant to precontour plates to the model during the exposure portion of the case (Figure 4). While the precontoured plate is not always a perfect fit, it can usually be adjusted easily to fit the unique anatomy of the patient.

Discussion

Understanding the complex anatomy of pelvic and acetabular fractures can be challenging. We use models in the teaching of anatomy, in the interpretation of radiographs and computed tomography (CT) scans, and in preoperative planning. Fracture lines are traced on the pelvic model based on radiographs and/or CT scans and then compared with 3-D reconstruction images and, eventually, with operative findings. The use of our dry-erase models allows for easy correction of mistakes and reuse for further cases.

We have found dry-erase pelvic models to be an invaluable tool for resident and fellow education. While conventional 2-dimensional planning is adequate for most long-bone and periarticular fractures, the creation of these 3-D planning tools is useful in understanding the anatomy and surgical treatment of pelvic and acetabular fractures.

The value of preoperative planning and templating has been well-established in fracture surgery.^1,2 Traditionally, this involves writing a surgical tactic and tracing the radiographs on paper to plan the ultimate reduction and implant placement.¹ The advent of sophisticated computer programs has allowed electronic preoperative planning in trauma and arthroplasty surgery.^3,4 Software for computer templating of acetabular fractures is available.⁵ Still, the renderings generated in these exercises are 2-dimensional, and their quality is somewhat dependent on the surgeon’s artistic ability. Ultimately, drawing a fracture is meant to help the surgeon understand its 3-dimensional (3-D) characteristics. This can be difficult working in 2 dimensions especially for bones, such as the pelvis, with complex 3-D structures. A useful alternative is to draw the fracture on a plastic-bone model.

We plan all acetabular fracture surgeries on 3-D models (plastic bones). These models are commonly provided to residents and fellows through educational courses or can be purchased online. Residents, fellows, and staff have their own models for planning, and we typically keep several models in the operating room for teaching before the surgery. Although these models are ideal for visualizing the bony anatomy, they are less than ideal for drawing fracture lines. Ink pens do not leave lines, and lines from markers and pencils cannot be easily erased. After a few planning sessions, the models typically look like a city map, making it difficult to tell the current fracture from those previously evaluated.

Here we describe a technique for turning standard plastic models into white boards so that lines can be drawn clearly with a marker and easily erased. To facilitate the correction of errors and reuse for future cases, we coat pelvic models with dry-erase epoxy resin. Although there is a commercially available product that has similar capabilities, our technique creates a significantly less expensive model that will likely be appealing to residents and fellows.   

Technique

Throughout the process of creating the pelvic model, it is important to work in a well-ventilated area. Gloves should be worn at all times. The working surface should be protected with an impervious plastic sheet to avoid primer or epoxy soaking through.

In creating our dry-erase pelvic models, we use the Sawbones large male solid-foam pelvic model (Figure 1; Model 1301, Pacific Research Laboratories, Vashon, Washington). These models are often available to residents and fellows after Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association (AO/OTA) trauma courses or resident educational sessions. Alternatively, they can be purchased online.

We sand the model to smooth out surface irregularities and to prepare it to accept primer. First, use 100-grit and then 220-grit sandpaper to create the optimum surface. We recommend suspending the pelvis from string by placing an eyelet screw into the top of the sacrum or looping a string through 1 of the sacral foramen while priming, painting, and curing. To prime the pelvic model, we have used KILZ original spray primer (Masterchem Industries, Imperial, Missouri). It is important that the entire model be well coated with primer because the epoxy resin will not adhere to unprimed plastic-foam surface. Take care to apply an even coat and to avoid drip formation.  

Once the primer is completely dry, apply the dry-erase epoxy resin (Rust-Oleum, Vernon Hills, Illinois). Mix the 2 parts of the epoxy resin and apply to the pelvic model with a foam brush. It is important to cover the entire surface of the model with enough epoxy to give a smooth, even finish. This requires 2 to 3 coats applied approximately 30 minutes apart (the epoxy will remain wet but will take additional coats well).

Once the final coat has been applied, the model takes about 48 hours to cure. Hang in a dry, well-ventilated location until it is fully cured. Then, use a dry-erase marker to trace fracture lines and the planned location of plates and screws (Figure 2).

An alternative to creating a dry-erase pelvis is to create a blackboard pelvis. Use Chalkboard Spray (Rust-Oleum) to create a surface that will accept white and colored chalk. The application of this product is much easier than the dry-erase epoxy, because it can be applied in a similar fashion as the spray primer. This creates a black model that can be marked with chalk. However, we have found these models to be less useful than the dry-erase versions, because chalk leaves less precise lines and is harder to remove from the model.

Once created, the pelvic model can be used intraoperatively to help understand fracture reduction and to facilitate the precontouring of pelvic and acetabular plates. We place the model in a sterile radiographic cassette bag (Figure 3). This gives the operating team access to the model and is useful in teaching anatomy, and particularly, screw placement. Further, the model allows an assistant to precontour plates to the model during the exposure portion of the case (Figure 4). While the precontoured plate is not always a perfect fit, it can usually be adjusted easily to fit the unique anatomy of the patient.

Discussion

Understanding the complex anatomy of pelvic and acetabular fractures can be challenging. We use models in the teaching of anatomy, in the interpretation of radiographs and computed tomography (CT) scans, and in preoperative planning. Fracture lines are traced on the pelvic model based on radiographs and/or CT scans and then compared with 3-D reconstruction images and, eventually, with operative findings. The use of our dry-erase models allows for easy correction of mistakes and reuse for further cases.

We have found dry-erase pelvic models to be an invaluable tool for resident and fellow education. While conventional 2-dimensional planning is adequate for most long-bone and periarticular fractures, the creation of these 3-D planning tools is useful in understanding the anatomy and surgical treatment of pelvic and acetabular fractures.

A common cause for total hip arthroplasty (THA) revision is joint instability.^1,2 The reported incidence of dislocation in primary THA ranges from 0.4% to 5.8%,^3-5 but this rate increases after revision surgery.^1,3-8 Use of large-diameter femoral heads has been proposed to decrease the risks for instability and to improve impingement-free range of motion (ROM).

The biomechanical rationale for using large-diameter femoral heads is that they must travel farther before subluxation or dislocation occurs (jump distance). Despite these benefits, there were initial concerns that catastrophic failure and high levels of volumetric wear would occur if these heads were used with conventional polyethylene liners. These concerns led to the development of alternative bearing surfaces, particularly metal-on-metal bearings, which offered theoretical benefits of large-diameter articulations that improved stability while purportedly being highly wear-resistant.^9-11 However, concerns about adverse local soft-tissue reactions and high blood concentrations of metal ions tempered the initial enthusiasm for metal bearings.^12-16 Fortunately, highly cross-linked polyethylene and fourth-generation ceramic bearing surfaces, with improved toughness and better wear properties, may allow use of large-diameter heads without the need for metal-on-metal bearings.^17,18

In this article, we review the concepts and principles behind use of large-diameter ceramic or cobalt-chromium femoral heads on polyethylene-bearing surfaces in THA with particular attention to biomechanics, early concerns about polyethylene wear and rim fractures, recent improvements in material properties of polyethylene and ceramic bearings, dislocation rates, and clinical and functional outcomes.

Definitions

For this review, we define large-diameter femoral heads as having diameters of 36 mm or more and conventional or small-diameter femoral heads as having diameters between 22 and 32 mm.

Biomechanics

Head–Neck Ratio, Impingement-Free ROM, and Jump Distance

Several implant design principles have been proposed to reduce the risks for impingement and dislocation. Of these, large femoral head diameters have been extensively studied.^19,20 It is well known that impingement of the femoral neck on the cup edge promotes edge loading and higher wear rates. In addition, impingement increases the tendency of the head to sublux from the acetabulum. One strategy for avoiding this component-to-component impingement is to increase the head–neck ratio (HNR), the ratio of the femoral head to the neck diameter. Biomechanically, increased HNRs lead to delayed contact between the femoral neck and the acetabular liner.^21,22 Therefore, with large femoral heads, which have large HNRs, impingement occurs later and at larger ROMs—compared with small-diameter femoral heads, which have lower HNRs and are more prone to early impingement and subluxation (Figure 1).^23-26

In a cadaveric study of 6 hips, Bartz and colleagues²³ reported a significantly higher preimpingement ROM when the prosthetic head size increased from 22 mm to 28 mm (P < .05). They found a change from prosthetic to osseous impingement when the head size increased from 22 mm to 32 mm. Similar results were observed in a computer simulation model by Cinotti and colleagues,²⁷ who demonstrated that increasing the femoral head size from 28 mm to 38 mm resulted in a 5° improvement in ROM. However, the largest gains were observed when the heads with the smallest diameters were upsized; ROM improved only marginally when femoral head size was further increased from 32 mm to 38 mm. The primary reason for the lack of expected improvement in ROM with head sizes of more than 32 mm is often bone-on-bone impingement. Burroughs and colleagues²⁸ demonstrated that the 38-mm and 44-mm heads virtually eliminated component-to-component impingement except in extremes of external rotation. However, there were no differences in ROM between 38-mm and 44-mm heads because of osseous impingement. In addition, large heads are less likely to sublux or dislocate, as they need to travel farther before reaching the edge of the acetabular cup before dislocation. This is known as the jump distance, and it corresponds to the depth of the acetabular shell, which in turn equates with the radius of the femoral head (Figures 2A, 2B).  For this reason, the larger the femoral head diameter, the farther the jump distance and, correspondingly, the lower the risk for dislocation.²⁹

Elevated liners historically were used to increase the jump distance for dislocation.³⁰ These liners, however, can increase impingement at the extremes of motion.³¹ Some of these problems can be avoided with use of larger heads, which have increased jump distances without additional risks for impingement. Moreover, large heads create a suction effect that provides passive resistance to dislocation.³² With head diameters beyond 38 mm, impingement-free ROM often plateaus. However, the jump distance required for dislocations to occur continues to increase as femoral head diameters increase in size. Thus, patients may experience fewer motion benefits but continue to benefit from overall stability with femoral head sizes increasing beyond 38 mm.

Current evidence suggests there may be substantial benefits toward improved stability from increasing head diameters from 22 mm to 38 mm because of the increase in jump distances and improvements in prosthetic impingement-free ROM. However, there may be little gain in ROM from increasing the head diameters beyond these dimensions because of the potential risks of bony impingement. Nevertheless, there may be some additional benefits toward stability from improvement in jump distances with incremental head sizes
beyond 38 mm.^29,33,34

Finite Element Analysis Studies

Finite element analysis of large-diameter heads in THA has shown that, at optimal cup inclination (45°), most stresses occur on the articular surface of the liner. However, these stresses remain well below the yield strength of the polyethylene liners.²⁹ With increasing abduction angles, the stress concentration increases substantially because of the decreased contact surface area. At these angles, the point of maximum contact moves toward the rim of the polyethylene liner, which can lead to rim fractures or failure of locking mechanisms.^29,35,36

Early Concerns With Large-Diameter Femoral Heads: Wear, Liner Failure, and Fracture of Ceramic Components

Use of small-diameter femoral heads started with the first report by Charnley³⁷ of “low frictional torque arthroplasty.” Charnley initially considered a 41.5-mm femoral head, but he thought it would increase risks for acetabular loosening from high frictional torque generated by the large head, and he switched to a small-diameter (22.5 mm) design. One of the tradeoffs with smaller diameter heads was decreased jump height in addition to increased linear wear.

Large femoral heads used with cemented polyethylene acetabular components historically have been associated with increased rates of volumetric wear but low rates of linear wear, which potentially may increase the risk for osteolysis.^38-40 However, newer highly cross-linked polyethylene liners have shown improved in vitro and in vivo volumetric wear characteristics and potentially lower linear wear rates compared with earlier designs (Table 1).^28,41-43

Another concern about earlier generations of large femoral heads was the risk for catastrophic liner failure on conventional polyethylene. This was originally reported by Berry and colleagues,⁴⁷ who described wear-through and failure in patients with thin (< 5 mm) acetabular cups. However, these concerns have been largely addressed by the development of highly cross-linked polyethylene, which has improved wear characteristics and fatigue resistance.⁴⁸

Recent Improvements in Material Properties of Polyethylene and Ceramic Bearings

The development of highly cross-linked polyethylene and fourth-generation ceramics has renewed interest in large-diameter bearings in THA. These bearing surfaces improve wear, enhance material properties, and have superior oxidation resistance.^42,48-53

We now briefly describe the methods used to improve the material properties of polyethylene and ceramics. Studies have shown that increasing the radiation dose (up to 200 kGy)  increases cross-linking and causes an inverse exponential decrease in polyethylene wear.^28,41,48-51 However, increasing radiation doses also increases production of free radicals, which diminish the material strength of these polyethylenes. The  current generation of highly cross-linked polyethylene liners is produced through a variety of manufacturing strategies to improve cross-linking and reduce wear. These strategies include differential radiation doses (50-100 kGy), techniques (electron beam, radiation), and thermal treatments (melting, annealing). Moreover, to enhance the material properties and reduce the incidence of rim cracking and delamination, authors have proposed using vitamin E supplementation to minimize the amount of subsurface oxidation that occurs as an inevitable consequence of free radical formation during fabrication.^54,55  A terminal sterilization process (eg, gas plasma, ethylene oxide, or gamma sterilization in nitrogen) is needed to make commercial, highly cross-linked polyethylene.^52,53

Fourth-generation ceramics manufactured with nano-sized yttria-stabilized tetragonal zirconia particles in a stable alumina matrix have more fracture toughness and improved wear characteristics.^54,55 In addition, oxide additives (eg, chromium oxide, strontium oxide) improve hardness and dissipate energy by deflecting cracks to prevent their propagation.⁵⁶ Moreover, the smaller grain sizes of fourth-generation ceramic bearings compared with third-generation designs (0.8 µm vs 1-5 µm) cause less disruption of the fluid film layer, which ultimately results in improved wear performance.⁵⁷

Multiple studies have found reduced wear rates with metal and ceramic large heads coupled with highly cross-linked polyethylene-bearings (Table 2).^17,41,50,58 Bragdon and colleagues,⁵⁸ using radiostereometric analysis in 25 patients, found no significant differences in mean head penetration rates between 36-mm and 28-mm cobalt-chromium (Co-Cr) heads articulating with highly cross-linked polyethylene cups at a mean follow-up of 3 years (0.035 mm/y vs 0.046 mm/y; P = .11). Geller and colleagues,⁶⁴ in their study of 42 patients with large-diameter (> 32 mm) Co-Cr femoral heads, found low mean (SD) linear wear rates of 0.06 (0.41) mm/y at a mean follow-up of 3 years. D’Antonio and colleagues,⁶⁵ in a multicenter study, reported low average linear wear (0.015 mm/y) and volumetric wear (12.1 mm³/y) over 5 years using sequentially annealed cross-linked polyethylene. In vitro reports suggest that large-diameter ceramic heads may have lower wear properties than Co-Cr heads do. Galvin and colleagues,⁶⁶ in an in vitro hip simulator study, found that large-diameter ceramic heads on highly cross-linked ultrahigh-molecular-weight polyethylene had 40% reductions in steady-state wear rates compared with Co-Cr heads on highly cross-linked bearings (4.7 vs 8.1 mm³/million cycles; P < 0.01).

Dislocation Rates

Several patient, surgeon, and implant factors affect the rate of dislocations after THA. Multiple implant options utilize the biomechanical advantage that large-diameter heads have in improving stability. Various alternatives include use of constrained tripolar heads, dual-mobility bearings, and conventional large-diameter heads with standard liners.^67-69

Large-Diameter Heads

Despite the biomechanical advantages of large-diameter metal-on-polyethylene bearings, prior studies have questioned use of these bearings because of risks for increased wear and rim failures. However, the improved wear properties of highly cross-linked polyethylene, elaborated earlier, have led to a reappraisal of this option (Table 2).^4,70 Howie and colleagues,⁷¹ in a randomized control trial of 644 patients, also found significantly lower rates of dislocation after primary THA with 36-mm heads compared with 28-mm heads (1.3% vs 5.4%; P = .012); in addition, fewer dislocations occurred with 36-mm heads than with 28-mm heads (4.9% vs 12.2%; P = .27) in a series of 44 patients in revision settings. Similarly, in a study conducted with 39,271 Medicare patients between 1998 and 2007, Malkani and colleagues⁷² found a decrease in the dislocation rate, from 4.21% to 2.14%, with use of large-diameter femoral heads. These results have been confirmed by several other authors.^34,66,73,74 Similar results were observed in 65,992 patients in the Australian National Joint Replacement Registry by Conroy and colleagues,⁷⁵ who reported a significant decrease in the risk for dislocation with large heads (≥ 30 mm) compared with 22-mm heads (relative risk, 1.0 vs 3.1; P ≤ .001).

Few studies have analyzed the role of large-diameter femoral heads in the presence of compromised soft tissues around the hip. Kung and Ries,⁷⁶ evaluating the influence of large-diameter heads in the presence and absence of a deficient abductor mechanism, demonstrated statistically significant reductions in rates of dislocation after 230 revision THAs when the abductor mechanism was intact with use of 36-mm heads compared with 28-mm heads (12.7% vs 0%; P = .015). With abductor deficiency, though, the positive effect of large heads in reducing dislocation rates was substantially reduced and was similar to that of small heads (P = .74).⁷⁶

Large heads considerably improve overall stability and lower dislocation rates in THA. With the development of newer ceramics and highly cross-linked polyethylenes, the wear rates reported in multiple studies appear to be less concerning.

Constrained Tripolar Heads

Tripolar heads have been proposed as treatment options for improving stability in patients with chronic and recurrent instability after THA. The tripolar implant consists of a metal head that snap-fits into a polyethylene liner with a polished Co-Cr backing. This bipolar head articulates with a polyethylene bearing that is press-fitted onto a metal acetabular shell and constrained by a metal ring snapped to the outer polyethylene bearing. The bipolar component behaves as a large-diameter femoral head, and the metal ring provides additional restraint, further improving stability.

Williams and colleagues⁷⁷ performed a systematic review and reported on the outcomes of constrained tripolar liners in 1199 hips at a mean follow-up of 4 years (range, 2-10 years). The mean dislocation rate was 10%, and the mean rate of revision surgery unrelated to instability was 4%. In a study of 43 hips at a mean follow-up of 4 years (range, 2-9 years), Zywiel and colleagues⁷⁸ reported on the clinical and radiographic outcomes of tripolar constrained liners. Their study group had a mean Harris Hip Score (HHS) of 82 points (range, 38-100 points) and overall survival of 91%, with no evidence of radiographic loosening during follow-up. Despite the improvements in stability with constrained tripolar liners, some authors have reported multiple mechanisms of failure with these devices.^79-81 In a study of 43 failed constrained tripolar liners with a mean time to failure of about 2 years, Guyen and colleagues⁷⁹ identified 5 different failure modes (types 1-5) involving all 4 interfaces in these components.

Encouraging outcomes have been reported at midterm follow-up with tripolar constrained liners. However, concerns about failure at the interfaces suggest that use of these components should be restricted to patients with deficient abductor mechanisms or neuromuscular compromise, low-demand elderly patients, and salvage cases of recurrent dislocations.⁷⁹

Dual-Mobility Bearings

For more than 20 years, different dual-mobility bearings have been used for difficult acetabular reconstructive scenarios and prevention of instability.^82,83 Dual-mobility cups provide constructs that snap-fit a small-diameter femoral head within a large polyethylene insert that articulates with a fixed metal shell. This effectively increases the functional head diameter.

Various authors have reported excellent survivorship rates (92%-99%) and low dislocation rates for these bearings at 5- to 10-year follow-up.^82,84-90 Philippot and colleagues,⁸⁶ in a recent study of 438 hips with dual-mobility cups, reported excellent survivorship (96%) and no early or late instability within a 15-year follow-up. Bouchet and colleagues⁶⁹ compared dual-mobility bearings (105 hips) with conventional metal-on-polythene bearings (108 hips) and found significantly (P < .05) lower dislocation rates for the dual-mobility implants at a minimum 1-year follow-up. The French Society of Orthopaedics and Traumatology performed a multicenter analysis of 3473 hips with dual-mobility cups implanted in France between January 1998 and December 2003.⁸⁷ During a mean follow-up of 7 years (range, 5-11 years), there were 15 dislocations (0.43%), 14 of which occurred early, within 3 months of implantation (0.4%). Aseptic implant survivorship was 95% at 10-year follow-up.

Use of these bearings has recently increased in the United States. Short-term and midterm follow-up data show low rates of dislocation and wear. Long-term data are to come.

Clinical and Functional Outcomes of Large-Diameter Femoral Heads

There is a paucity of long-term outcomes data on use of large-diameter heads with highly cross-linked polyethylene bearings. Short-term and midterm clinical results appear to be excellent, with low rates of wear, osteolysis, and aseptic loosening.^{28,41,73,89-92}

Plate and colleagues⁹¹ compared the effects of large-diameter (≥ 36 mm) and small-diameter (26 mm, 28 mm) metal heads on highly cross-linked polyethylene bearings. At a mean follow-up of 5 years (range, 4-8.4 years), the large-head cohort had a mean HHS of 90 points (range, 50-100 points) and no dislocations or radiographic evidence of stem or cup loosening. Similarly, Meftah and colleagues⁹³ reported 100% stem survivorship and excellent clinical outcomes—a mean Western Ontario and McMaster Universities Arthritis Index (WOMAC) score of 30 points—for 72 hips with use of large ceramic heads (≥ 32 mm) on highly cross-linked polyethylene at a mean follow-up of 3 years. Gagala and colleagues⁹⁴ reported excellent clinical and radiographic outcomes in 50 hips (18 ceramic on ceramic, 32 ceramic on polyethylene; 36-mm heads) at a mean follow-up of 3.5 years. Mean HHS was 94 points, and there was no evidence of liner fractures, aseptic loosening, or osteolysis.

In summary, large-diameter femoral heads in THA have become increasingly popular because of improvements in the material properties and wear characteristics of highly cross-linked polyethylene and fourth-generation ceramics. Despite the potential advantages of large heads in preventing dislocations, the basic surgical tenets of placing the acetabular component in appropriate alignment remain firmly established. Implants with functionally large heads (eg, dual-mobility bearings, constrained tripolar liners) may play an important role in patients at high risk for dislocation—particularly elderly patients with poor neuromuscular muscle coordination or deficient abductors, trauma patients, and patients with prior dislocations. Short-term and midterm results are excellent; rates of wear, aseptic loosening, and osteolysis are low. However, long-term outcomes data are needed to support widespread use of large heads in younger and more active patients.

A common cause for total hip arthroplasty (THA) revision is joint instability.^1,2 The reported incidence of dislocation in primary THA ranges from 0.4% to 5.8%,^3-5 but this rate increases after revision surgery.^1,3-8 Use of large-diameter femoral heads has been proposed to decrease the risks for instability and to improve impingement-free range of motion (ROM).

The biomechanical rationale for using large-diameter femoral heads is that they must travel farther before subluxation or dislocation occurs (jump distance). Despite these benefits, there were initial concerns that catastrophic failure and high levels of volumetric wear would occur if these heads were used with conventional polyethylene liners. These concerns led to the development of alternative bearing surfaces, particularly metal-on-metal bearings, which offered theoretical benefits of large-diameter articulations that improved stability while purportedly being highly wear-resistant.^9-11 However, concerns about adverse local soft-tissue reactions and high blood concentrations of metal ions tempered the initial enthusiasm for metal bearings.^12-16 Fortunately, highly cross-linked polyethylene and fourth-generation ceramic bearing surfaces, with improved toughness and better wear properties, may allow use of large-diameter heads without the need for metal-on-metal bearings.^17,18

In this article, we review the concepts and principles behind use of large-diameter ceramic or cobalt-chromium femoral heads on polyethylene-bearing surfaces in THA with particular attention to biomechanics, early concerns about polyethylene wear and rim fractures, recent improvements in material properties of polyethylene and ceramic bearings, dislocation rates, and clinical and functional outcomes.

Definitions

For this review, we define large-diameter femoral heads as having diameters of 36 mm or more and conventional or small-diameter femoral heads as having diameters between 22 and 32 mm.

Biomechanics

Head–Neck Ratio, Impingement-Free ROM, and Jump Distance

Several implant design principles have been proposed to reduce the risks for impingement and dislocation. Of these, large femoral head diameters have been extensively studied.^19,20 It is well known that impingement of the femoral neck on the cup edge promotes edge loading and higher wear rates. In addition, impingement increases the tendency of the head to sublux from the acetabulum. One strategy for avoiding this component-to-component impingement is to increase the head–neck ratio (HNR), the ratio of the femoral head to the neck diameter. Biomechanically, increased HNRs lead to delayed contact between the femoral neck and the acetabular liner.^21,22 Therefore, with large femoral heads, which have large HNRs, impingement occurs later and at larger ROMs—compared with small-diameter femoral heads, which have lower HNRs and are more prone to early impingement and subluxation (Figure 1).^23-26

In a cadaveric study of 6 hips, Bartz and colleagues²³ reported a significantly higher preimpingement ROM when the prosthetic head size increased from 22 mm to 28 mm (P < .05). They found a change from prosthetic to osseous impingement when the head size increased from 22 mm to 32 mm. Similar results were observed in a computer simulation model by Cinotti and colleagues,²⁷ who demonstrated that increasing the femoral head size from 28 mm to 38 mm resulted in a 5° improvement in ROM. However, the largest gains were observed when the heads with the smallest diameters were upsized; ROM improved only marginally when femoral head size was further increased from 32 mm to 38 mm. The primary reason for the lack of expected improvement in ROM with head sizes of more than 32 mm is often bone-on-bone impingement. Burroughs and colleagues²⁸ demonstrated that the 38-mm and 44-mm heads virtually eliminated component-to-component impingement except in extremes of external rotation. However, there were no differences in ROM between 38-mm and 44-mm heads because of osseous impingement. In addition, large heads are less likely to sublux or dislocate, as they need to travel farther before reaching the edge of the acetabular cup before dislocation. This is known as the jump distance, and it corresponds to the depth of the acetabular shell, which in turn equates with the radius of the femoral head (Figures 2A, 2B).  For this reason, the larger the femoral head diameter, the farther the jump distance and, correspondingly, the lower the risk for dislocation.²⁹

Elevated liners historically were used to increase the jump distance for dislocation.³⁰ These liners, however, can increase impingement at the extremes of motion.³¹ Some of these problems can be avoided with use of larger heads, which have increased jump distances without additional risks for impingement. Moreover, large heads create a suction effect that provides passive resistance to dislocation.³² With head diameters beyond 38 mm, impingement-free ROM often plateaus. However, the jump distance required for dislocations to occur continues to increase as femoral head diameters increase in size. Thus, patients may experience fewer motion benefits but continue to benefit from overall stability with femoral head sizes increasing beyond 38 mm.

Current evidence suggests there may be substantial benefits toward improved stability from increasing head diameters from 22 mm to 38 mm because of the increase in jump distances and improvements in prosthetic impingement-free ROM. However, there may be little gain in ROM from increasing the head diameters beyond these dimensions because of the potential risks of bony impingement. Nevertheless, there may be some additional benefits toward stability from improvement in jump distances with incremental head sizes
beyond 38 mm.^29,33,34

Finite Element Analysis Studies

Finite element analysis of large-diameter heads in THA has shown that, at optimal cup inclination (45°), most stresses occur on the articular surface of the liner. However, these stresses remain well below the yield strength of the polyethylene liners.²⁹ With increasing abduction angles, the stress concentration increases substantially because of the decreased contact surface area. At these angles, the point of maximum contact moves toward the rim of the polyethylene liner, which can lead to rim fractures or failure of locking mechanisms.^29,35,36

Early Concerns With Large-Diameter Femoral Heads: Wear, Liner Failure, and Fracture of Ceramic Components

Use of small-diameter femoral heads started with the first report by Charnley³⁷ of “low frictional torque arthroplasty.” Charnley initially considered a 41.5-mm femoral head, but he thought it would increase risks for acetabular loosening from high frictional torque generated by the large head, and he switched to a small-diameter (22.5 mm) design. One of the tradeoffs with smaller diameter heads was decreased jump height in addition to increased linear wear.

Large femoral heads used with cemented polyethylene acetabular components historically have been associated with increased rates of volumetric wear but low rates of linear wear, which potentially may increase the risk for osteolysis.^38-40 However, newer highly cross-linked polyethylene liners have shown improved in vitro and in vivo volumetric wear characteristics and potentially lower linear wear rates compared with earlier designs (Table 1).^28,41-43

Another concern about earlier generations of large femoral heads was the risk for catastrophic liner failure on conventional polyethylene. This was originally reported by Berry and colleagues,⁴⁷ who described wear-through and failure in patients with thin (< 5 mm) acetabular cups. However, these concerns have been largely addressed by the development of highly cross-linked polyethylene, which has improved wear characteristics and fatigue resistance.⁴⁸

Recent Improvements in Material Properties of Polyethylene and Ceramic Bearings

The development of highly cross-linked polyethylene and fourth-generation ceramics has renewed interest in large-diameter bearings in THA. These bearing surfaces improve wear, enhance material properties, and have superior oxidation resistance.^42,48-53

We now briefly describe the methods used to improve the material properties of polyethylene and ceramics. Studies have shown that increasing the radiation dose (up to 200 kGy)  increases cross-linking and causes an inverse exponential decrease in polyethylene wear.^28,41,48-51 However, increasing radiation doses also increases production of free radicals, which diminish the material strength of these polyethylenes. The  current generation of highly cross-linked polyethylene liners is produced through a variety of manufacturing strategies to improve cross-linking and reduce wear. These strategies include differential radiation doses (50-100 kGy), techniques (electron beam, radiation), and thermal treatments (melting, annealing). Moreover, to enhance the material properties and reduce the incidence of rim cracking and delamination, authors have proposed using vitamin E supplementation to minimize the amount of subsurface oxidation that occurs as an inevitable consequence of free radical formation during fabrication.^54,55  A terminal sterilization process (eg, gas plasma, ethylene oxide, or gamma sterilization in nitrogen) is needed to make commercial, highly cross-linked polyethylene.^52,53

Fourth-generation ceramics manufactured with nano-sized yttria-stabilized tetragonal zirconia particles in a stable alumina matrix have more fracture toughness and improved wear characteristics.^54,55 In addition, oxide additives (eg, chromium oxide, strontium oxide) improve hardness and dissipate energy by deflecting cracks to prevent their propagation.⁵⁶ Moreover, the smaller grain sizes of fourth-generation ceramic bearings compared with third-generation designs (0.8 µm vs 1-5 µm) cause less disruption of the fluid film layer, which ultimately results in improved wear performance.⁵⁷

Multiple studies have found reduced wear rates with metal and ceramic large heads coupled with highly cross-linked polyethylene-bearings (Table 2).^17,41,50,58 Bragdon and colleagues,⁵⁸ using radiostereometric analysis in 25 patients, found no significant differences in mean head penetration rates between 36-mm and 28-mm cobalt-chromium (Co-Cr) heads articulating with highly cross-linked polyethylene cups at a mean follow-up of 3 years (0.035 mm/y vs 0.046 mm/y; P = .11). Geller and colleagues,⁶⁴ in their study of 42 patients with large-diameter (> 32 mm) Co-Cr femoral heads, found low mean (SD) linear wear rates of 0.06 (0.41) mm/y at a mean follow-up of 3 years. D’Antonio and colleagues,⁶⁵ in a multicenter study, reported low average linear wear (0.015 mm/y) and volumetric wear (12.1 mm³/y) over 5 years using sequentially annealed cross-linked polyethylene. In vitro reports suggest that large-diameter ceramic heads may have lower wear properties than Co-Cr heads do. Galvin and colleagues,⁶⁶ in an in vitro hip simulator study, found that large-diameter ceramic heads on highly cross-linked ultrahigh-molecular-weight polyethylene had 40% reductions in steady-state wear rates compared with Co-Cr heads on highly cross-linked bearings (4.7 vs 8.1 mm³/million cycles; P < 0.01).

Dislocation Rates

Several patient, surgeon, and implant factors affect the rate of dislocations after THA. Multiple implant options utilize the biomechanical advantage that large-diameter heads have in improving stability. Various alternatives include use of constrained tripolar heads, dual-mobility bearings, and conventional large-diameter heads with standard liners.^67-69

Large-Diameter Heads

Despite the biomechanical advantages of large-diameter metal-on-polyethylene bearings, prior studies have questioned use of these bearings because of risks for increased wear and rim failures. However, the improved wear properties of highly cross-linked polyethylene, elaborated earlier, have led to a reappraisal of this option (Table 2).^4,70 Howie and colleagues,⁷¹ in a randomized control trial of 644 patients, also found significantly lower rates of dislocation after primary THA with 36-mm heads compared with 28-mm heads (1.3% vs 5.4%; P = .012); in addition, fewer dislocations occurred with 36-mm heads than with 28-mm heads (4.9% vs 12.2%; P = .27) in a series of 44 patients in revision settings. Similarly, in a study conducted with 39,271 Medicare patients between 1998 and 2007, Malkani and colleagues⁷² found a decrease in the dislocation rate, from 4.21% to 2.14%, with use of large-diameter femoral heads. These results have been confirmed by several other authors.^34,66,73,74 Similar results were observed in 65,992 patients in the Australian National Joint Replacement Registry by Conroy and colleagues,⁷⁵ who reported a significant decrease in the risk for dislocation with large heads (≥ 30 mm) compared with 22-mm heads (relative risk, 1.0 vs 3.1; P ≤ .001).

Few studies have analyzed the role of large-diameter femoral heads in the presence of compromised soft tissues around the hip. Kung and Ries,⁷⁶ evaluating the influence of large-diameter heads in the presence and absence of a deficient abductor mechanism, demonstrated statistically significant reductions in rates of dislocation after 230 revision THAs when the abductor mechanism was intact with use of 36-mm heads compared with 28-mm heads (12.7% vs 0%; P = .015). With abductor deficiency, though, the positive effect of large heads in reducing dislocation rates was substantially reduced and was similar to that of small heads (P = .74).⁷⁶

Large heads considerably improve overall stability and lower dislocation rates in THA. With the development of newer ceramics and highly cross-linked polyethylenes, the wear rates reported in multiple studies appear to be less concerning.

Constrained Tripolar Heads

Tripolar heads have been proposed as treatment options for improving stability in patients with chronic and recurrent instability after THA. The tripolar implant consists of a metal head that snap-fits into a polyethylene liner with a polished Co-Cr backing. This bipolar head articulates with a polyethylene bearing that is press-fitted onto a metal acetabular shell and constrained by a metal ring snapped to the outer polyethylene bearing. The bipolar component behaves as a large-diameter femoral head, and the metal ring provides additional restraint, further improving stability.

Williams and colleagues⁷⁷ performed a systematic review and reported on the outcomes of constrained tripolar liners in 1199 hips at a mean follow-up of 4 years (range, 2-10 years). The mean dislocation rate was 10%, and the mean rate of revision surgery unrelated to instability was 4%. In a study of 43 hips at a mean follow-up of 4 years (range, 2-9 years), Zywiel and colleagues⁷⁸ reported on the clinical and radiographic outcomes of tripolar constrained liners. Their study group had a mean Harris Hip Score (HHS) of 82 points (range, 38-100 points) and overall survival of 91%, with no evidence of radiographic loosening during follow-up. Despite the improvements in stability with constrained tripolar liners, some authors have reported multiple mechanisms of failure with these devices.^79-81 In a study of 43 failed constrained tripolar liners with a mean time to failure of about 2 years, Guyen and colleagues⁷⁹ identified 5 different failure modes (types 1-5) involving all 4 interfaces in these components.

Encouraging outcomes have been reported at midterm follow-up with tripolar constrained liners. However, concerns about failure at the interfaces suggest that use of these components should be restricted to patients with deficient abductor mechanisms or neuromuscular compromise, low-demand elderly patients, and salvage cases of recurrent dislocations.⁷⁹

Dual-Mobility Bearings

For more than 20 years, different dual-mobility bearings have been used for difficult acetabular reconstructive scenarios and prevention of instability.^82,83 Dual-mobility cups provide constructs that snap-fit a small-diameter femoral head within a large polyethylene insert that articulates with a fixed metal shell. This effectively increases the functional head diameter.

Various authors have reported excellent survivorship rates (92%-99%) and low dislocation rates for these bearings at 5- to 10-year follow-up.^82,84-90 Philippot and colleagues,⁸⁶ in a recent study of 438 hips with dual-mobility cups, reported excellent survivorship (96%) and no early or late instability within a 15-year follow-up. Bouchet and colleagues⁶⁹ compared dual-mobility bearings (105 hips) with conventional metal-on-polythene bearings (108 hips) and found significantly (P < .05) lower dislocation rates for the dual-mobility implants at a minimum 1-year follow-up. The French Society of Orthopaedics and Traumatology performed a multicenter analysis of 3473 hips with dual-mobility cups implanted in France between January 1998 and December 2003.⁸⁷ During a mean follow-up of 7 years (range, 5-11 years), there were 15 dislocations (0.43%), 14 of which occurred early, within 3 months of implantation (0.4%). Aseptic implant survivorship was 95% at 10-year follow-up.

Use of these bearings has recently increased in the United States. Short-term and midterm follow-up data show low rates of dislocation and wear. Long-term data are to come.

Clinical and Functional Outcomes of Large-Diameter Femoral Heads

There is a paucity of long-term outcomes data on use of large-diameter heads with highly cross-linked polyethylene bearings. Short-term and midterm clinical results appear to be excellent, with low rates of wear, osteolysis, and aseptic loosening.^{28,41,73,89-92}

Plate and colleagues⁹¹ compared the effects of large-diameter (≥ 36 mm) and small-diameter (26 mm, 28 mm) metal heads on highly cross-linked polyethylene bearings. At a mean follow-up of 5 years (range, 4-8.4 years), the large-head cohort had a mean HHS of 90 points (range, 50-100 points) and no dislocations or radiographic evidence of stem or cup loosening. Similarly, Meftah and colleagues⁹³ reported 100% stem survivorship and excellent clinical outcomes—a mean Western Ontario and McMaster Universities Arthritis Index (WOMAC) score of 30 points—for 72 hips with use of large ceramic heads (≥ 32 mm) on highly cross-linked polyethylene at a mean follow-up of 3 years. Gagala and colleagues⁹⁴ reported excellent clinical and radiographic outcomes in 50 hips (18 ceramic on ceramic, 32 ceramic on polyethylene; 36-mm heads) at a mean follow-up of 3.5 years. Mean HHS was 94 points, and there was no evidence of liner fractures, aseptic loosening, or osteolysis.

In summary, large-diameter femoral heads in THA have become increasingly popular because of improvements in the material properties and wear characteristics of highly cross-linked polyethylene and fourth-generation ceramics. Despite the potential advantages of large heads in preventing dislocations, the basic surgical tenets of placing the acetabular component in appropriate alignment remain firmly established. Implants with functionally large heads (eg, dual-mobility bearings, constrained tripolar liners) may play an important role in patients at high risk for dislocation—particularly elderly patients with poor neuromuscular muscle coordination or deficient abductors, trauma patients, and patients with prior dislocations. Short-term and midterm results are excellent; rates of wear, aseptic loosening, and osteolysis are low. However, long-term outcomes data are needed to support widespread use of large heads in younger and more active patients.

A common cause for total hip arthroplasty (THA) revision is joint instability.^1,2 The reported incidence of dislocation in primary THA ranges from 0.4% to 5.8%,^3-5 but this rate increases after revision surgery.^1,3-8 Use of large-diameter femoral heads has been proposed to decrease the risks for instability and to improve impingement-free range of motion (ROM).

The biomechanical rationale for using large-diameter femoral heads is that they must travel farther before subluxation or dislocation occurs (jump distance). Despite these benefits, there were initial concerns that catastrophic failure and high levels of volumetric wear would occur if these heads were used with conventional polyethylene liners. These concerns led to the development of alternative bearing surfaces, particularly metal-on-metal bearings, which offered theoretical benefits of large-diameter articulations that improved stability while purportedly being highly wear-resistant.^9-11 However, concerns about adverse local soft-tissue reactions and high blood concentrations of metal ions tempered the initial enthusiasm for metal bearings.^12-16 Fortunately, highly cross-linked polyethylene and fourth-generation ceramic bearing surfaces, with improved toughness and better wear properties, may allow use of large-diameter heads without the need for metal-on-metal bearings.^17,18

In this article, we review the concepts and principles behind use of large-diameter ceramic or cobalt-chromium femoral heads on polyethylene-bearing surfaces in THA with particular attention to biomechanics, early concerns about polyethylene wear and rim fractures, recent improvements in material properties of polyethylene and ceramic bearings, dislocation rates, and clinical and functional outcomes.

Definitions

For this review, we define large-diameter femoral heads as having diameters of 36 mm or more and conventional or small-diameter femoral heads as having diameters between 22 and 32 mm.

Biomechanics

Head–Neck Ratio, Impingement-Free ROM, and Jump Distance

Several implant design principles have been proposed to reduce the risks for impingement and dislocation. Of these, large femoral head diameters have been extensively studied.^19,20 It is well known that impingement of the femoral neck on the cup edge promotes edge loading and higher wear rates. In addition, impingement increases the tendency of the head to sublux from the acetabulum. One strategy for avoiding this component-to-component impingement is to increase the head–neck ratio (HNR), the ratio of the femoral head to the neck diameter. Biomechanically, increased HNRs lead to delayed contact between the femoral neck and the acetabular liner.^21,22 Therefore, with large femoral heads, which have large HNRs, impingement occurs later and at larger ROMs—compared with small-diameter femoral heads, which have lower HNRs and are more prone to early impingement and subluxation (Figure 1).^23-26

In a cadaveric study of 6 hips, Bartz and colleagues²³ reported a significantly higher preimpingement ROM when the prosthetic head size increased from 22 mm to 28 mm (P < .05). They found a change from prosthetic to osseous impingement when the head size increased from 22 mm to 32 mm. Similar results were observed in a computer simulation model by Cinotti and colleagues,²⁷ who demonstrated that increasing the femoral head size from 28 mm to 38 mm resulted in a 5° improvement in ROM. However, the largest gains were observed when the heads with the smallest diameters were upsized; ROM improved only marginally when femoral head size was further increased from 32 mm to 38 mm. The primary reason for the lack of expected improvement in ROM with head sizes of more than 32 mm is often bone-on-bone impingement. Burroughs and colleagues²⁸ demonstrated that the 38-mm and 44-mm heads virtually eliminated component-to-component impingement except in extremes of external rotation. However, there were no differences in ROM between 38-mm and 44-mm heads because of osseous impingement. In addition, large heads are less likely to sublux or dislocate, as they need to travel farther before reaching the edge of the acetabular cup before dislocation. This is known as the jump distance, and it corresponds to the depth of the acetabular shell, which in turn equates with the radius of the femoral head (Figures 2A, 2B).  For this reason, the larger the femoral head diameter, the farther the jump distance and, correspondingly, the lower the risk for dislocation.²⁹

Elevated liners historically were used to increase the jump distance for dislocation.³⁰ These liners, however, can increase impingement at the extremes of motion.³¹ Some of these problems can be avoided with use of larger heads, which have increased jump distances without additional risks for impingement. Moreover, large heads create a suction effect that provides passive resistance to dislocation.³² With head diameters beyond 38 mm, impingement-free ROM often plateaus. However, the jump distance required for dislocations to occur continues to increase as femoral head diameters increase in size. Thus, patients may experience fewer motion benefits but continue to benefit from overall stability with femoral head sizes increasing beyond 38 mm.

Current evidence suggests there may be substantial benefits toward improved stability from increasing head diameters from 22 mm to 38 mm because of the increase in jump distances and improvements in prosthetic impingement-free ROM. However, there may be little gain in ROM from increasing the head diameters beyond these dimensions because of the potential risks of bony impingement. Nevertheless, there may be some additional benefits toward stability from improvement in jump distances with incremental head sizes
beyond 38 mm.^29,33,34

Finite Element Analysis Studies

Finite element analysis of large-diameter heads in THA has shown that, at optimal cup inclination (45°), most stresses occur on the articular surface of the liner. However, these stresses remain well below the yield strength of the polyethylene liners.²⁹ With increasing abduction angles, the stress concentration increases substantially because of the decreased contact surface area. At these angles, the point of maximum contact moves toward the rim of the polyethylene liner, which can lead to rim fractures or failure of locking mechanisms.^29,35,36

Early Concerns With Large-Diameter Femoral Heads: Wear, Liner Failure, and Fracture of Ceramic Components

Use of small-diameter femoral heads started with the first report by Charnley³⁷ of “low frictional torque arthroplasty.” Charnley initially considered a 41.5-mm femoral head, but he thought it would increase risks for acetabular loosening from high frictional torque generated by the large head, and he switched to a small-diameter (22.5 mm) design. One of the tradeoffs with smaller diameter heads was decreased jump height in addition to increased linear wear.

Large femoral heads used with cemented polyethylene acetabular components historically have been associated with increased rates of volumetric wear but low rates of linear wear, which potentially may increase the risk for osteolysis.^38-40 However, newer highly cross-linked polyethylene liners have shown improved in vitro and in vivo volumetric wear characteristics and potentially lower linear wear rates compared with earlier designs (Table 1).^28,41-43

Another concern about earlier generations of large femoral heads was the risk for catastrophic liner failure on conventional polyethylene. This was originally reported by Berry and colleagues,⁴⁷ who described wear-through and failure in patients with thin (< 5 mm) acetabular cups. However, these concerns have been largely addressed by the development of highly cross-linked polyethylene, which has improved wear characteristics and fatigue resistance.⁴⁸

Recent Improvements in Material Properties of Polyethylene and Ceramic Bearings

The development of highly cross-linked polyethylene and fourth-generation ceramics has renewed interest in large-diameter bearings in THA. These bearing surfaces improve wear, enhance material properties, and have superior oxidation resistance.^42,48-53

We now briefly describe the methods used to improve the material properties of polyethylene and ceramics. Studies have shown that increasing the radiation dose (up to 200 kGy)  increases cross-linking and causes an inverse exponential decrease in polyethylene wear.^28,41,48-51 However, increasing radiation doses also increases production of free radicals, which diminish the material strength of these polyethylenes. The  current generation of highly cross-linked polyethylene liners is produced through a variety of manufacturing strategies to improve cross-linking and reduce wear. These strategies include differential radiation doses (50-100 kGy), techniques (electron beam, radiation), and thermal treatments (melting, annealing). Moreover, to enhance the material properties and reduce the incidence of rim cracking and delamination, authors have proposed using vitamin E supplementation to minimize the amount of subsurface oxidation that occurs as an inevitable consequence of free radical formation during fabrication.^54,55  A terminal sterilization process (eg, gas plasma, ethylene oxide, or gamma sterilization in nitrogen) is needed to make commercial, highly cross-linked polyethylene.^52,53

Fourth-generation ceramics manufactured with nano-sized yttria-stabilized tetragonal zirconia particles in a stable alumina matrix have more fracture toughness and improved wear characteristics.^54,55 In addition, oxide additives (eg, chromium oxide, strontium oxide) improve hardness and dissipate energy by deflecting cracks to prevent their propagation.⁵⁶ Moreover, the smaller grain sizes of fourth-generation ceramic bearings compared with third-generation designs (0.8 µm vs 1-5 µm) cause less disruption of the fluid film layer, which ultimately results in improved wear performance.⁵⁷

Multiple studies have found reduced wear rates with metal and ceramic large heads coupled with highly cross-linked polyethylene-bearings (Table 2).^17,41,50,58 Bragdon and colleagues,⁵⁸ using radiostereometric analysis in 25 patients, found no significant differences in mean head penetration rates between 36-mm and 28-mm cobalt-chromium (Co-Cr) heads articulating with highly cross-linked polyethylene cups at a mean follow-up of 3 years (0.035 mm/y vs 0.046 mm/y; P = .11). Geller and colleagues,⁶⁴ in their study of 42 patients with large-diameter (> 32 mm) Co-Cr femoral heads, found low mean (SD) linear wear rates of 0.06 (0.41) mm/y at a mean follow-up of 3 years. D’Antonio and colleagues,⁶⁵ in a multicenter study, reported low average linear wear (0.015 mm/y) and volumetric wear (12.1 mm³/y) over 5 years using sequentially annealed cross-linked polyethylene. In vitro reports suggest that large-diameter ceramic heads may have lower wear properties than Co-Cr heads do. Galvin and colleagues,⁶⁶ in an in vitro hip simulator study, found that large-diameter ceramic heads on highly cross-linked ultrahigh-molecular-weight polyethylene had 40% reductions in steady-state wear rates compared with Co-Cr heads on highly cross-linked bearings (4.7 vs 8.1 mm³/million cycles; P < 0.01).

Dislocation Rates

Several patient, surgeon, and implant factors affect the rate of dislocations after THA. Multiple implant options utilize the biomechanical advantage that large-diameter heads have in improving stability. Various alternatives include use of constrained tripolar heads, dual-mobility bearings, and conventional large-diameter heads with standard liners.^67-69

Large-Diameter Heads

Despite the biomechanical advantages of large-diameter metal-on-polyethylene bearings, prior studies have questioned use of these bearings because of risks for increased wear and rim failures. However, the improved wear properties of highly cross-linked polyethylene, elaborated earlier, have led to a reappraisal of this option (Table 2).^4,70 Howie and colleagues,⁷¹ in a randomized control trial of 644 patients, also found significantly lower rates of dislocation after primary THA with 36-mm heads compared with 28-mm heads (1.3% vs 5.4%; P = .012); in addition, fewer dislocations occurred with 36-mm heads than with 28-mm heads (4.9% vs 12.2%; P = .27) in a series of 44 patients in revision settings. Similarly, in a study conducted with 39,271 Medicare patients between 1998 and 2007, Malkani and colleagues⁷² found a decrease in the dislocation rate, from 4.21% to 2.14%, with use of large-diameter femoral heads. These results have been confirmed by several other authors.^34,66,73,74 Similar results were observed in 65,992 patients in the Australian National Joint Replacement Registry by Conroy and colleagues,⁷⁵ who reported a significant decrease in the risk for dislocation with large heads (≥ 30 mm) compared with 22-mm heads (relative risk, 1.0 vs 3.1; P ≤ .001).

Few studies have analyzed the role of large-diameter femoral heads in the presence of compromised soft tissues around the hip. Kung and Ries,⁷⁶ evaluating the influence of large-diameter heads in the presence and absence of a deficient abductor mechanism, demonstrated statistically significant reductions in rates of dislocation after 230 revision THAs when the abductor mechanism was intact with use of 36-mm heads compared with 28-mm heads (12.7% vs 0%; P = .015). With abductor deficiency, though, the positive effect of large heads in reducing dislocation rates was substantially reduced and was similar to that of small heads (P = .74).⁷⁶

Large heads considerably improve overall stability and lower dislocation rates in THA. With the development of newer ceramics and highly cross-linked polyethylenes, the wear rates reported in multiple studies appear to be less concerning.

Constrained Tripolar Heads

Tripolar heads have been proposed as treatment options for improving stability in patients with chronic and recurrent instability after THA. The tripolar implant consists of a metal head that snap-fits into a polyethylene liner with a polished Co-Cr backing. This bipolar head articulates with a polyethylene bearing that is press-fitted onto a metal acetabular shell and constrained by a metal ring snapped to the outer polyethylene bearing. The bipolar component behaves as a large-diameter femoral head, and the metal ring provides additional restraint, further improving stability.

Williams and colleagues⁷⁷ performed a systematic review and reported on the outcomes of constrained tripolar liners in 1199 hips at a mean follow-up of 4 years (range, 2-10 years). The mean dislocation rate was 10%, and the mean rate of revision surgery unrelated to instability was 4%. In a study of 43 hips at a mean follow-up of 4 years (range, 2-9 years), Zywiel and colleagues⁷⁸ reported on the clinical and radiographic outcomes of tripolar constrained liners. Their study group had a mean Harris Hip Score (HHS) of 82 points (range, 38-100 points) and overall survival of 91%, with no evidence of radiographic loosening during follow-up. Despite the improvements in stability with constrained tripolar liners, some authors have reported multiple mechanisms of failure with these devices.^79-81 In a study of 43 failed constrained tripolar liners with a mean time to failure of about 2 years, Guyen and colleagues⁷⁹ identified 5 different failure modes (types 1-5) involving all 4 interfaces in these components.

Encouraging outcomes have been reported at midterm follow-up with tripolar constrained liners. However, concerns about failure at the interfaces suggest that use of these components should be restricted to patients with deficient abductor mechanisms or neuromuscular compromise, low-demand elderly patients, and salvage cases of recurrent dislocations.⁷⁹

Dual-Mobility Bearings

For more than 20 years, different dual-mobility bearings have been used for difficult acetabular reconstructive scenarios and prevention of instability.^82,83 Dual-mobility cups provide constructs that snap-fit a small-diameter femoral head within a large polyethylene insert that articulates with a fixed metal shell. This effectively increases the functional head diameter.

Various authors have reported excellent survivorship rates (92%-99%) and low dislocation rates for these bearings at 5- to 10-year follow-up.^82,84-90 Philippot and colleagues,⁸⁶ in a recent study of 438 hips with dual-mobility cups, reported excellent survivorship (96%) and no early or late instability within a 15-year follow-up. Bouchet and colleagues⁶⁹ compared dual-mobility bearings (105 hips) with conventional metal-on-polythene bearings (108 hips) and found significantly (P < .05) lower dislocation rates for the dual-mobility implants at a minimum 1-year follow-up. The French Society of Orthopaedics and Traumatology performed a multicenter analysis of 3473 hips with dual-mobility cups implanted in France between January 1998 and December 2003.⁸⁷ During a mean follow-up of 7 years (range, 5-11 years), there were 15 dislocations (0.43%), 14 of which occurred early, within 3 months of implantation (0.4%). Aseptic implant survivorship was 95% at 10-year follow-up.

Use of these bearings has recently increased in the United States. Short-term and midterm follow-up data show low rates of dislocation and wear. Long-term data are to come.

Clinical and Functional Outcomes of Large-Diameter Femoral Heads

There is a paucity of long-term outcomes data on use of large-diameter heads with highly cross-linked polyethylene bearings. Short-term and midterm clinical results appear to be excellent, with low rates of wear, osteolysis, and aseptic loosening.^{28,41,73,89-92}

Plate and colleagues⁹¹ compared the effects of large-diameter (≥ 36 mm) and small-diameter (26 mm, 28 mm) metal heads on highly cross-linked polyethylene bearings. At a mean follow-up of 5 years (range, 4-8.4 years), the large-head cohort had a mean HHS of 90 points (range, 50-100 points) and no dislocations or radiographic evidence of stem or cup loosening. Similarly, Meftah and colleagues⁹³ reported 100% stem survivorship and excellent clinical outcomes—a mean Western Ontario and McMaster Universities Arthritis Index (WOMAC) score of 30 points—for 72 hips with use of large ceramic heads (≥ 32 mm) on highly cross-linked polyethylene at a mean follow-up of 3 years. Gagala and colleagues⁹⁴ reported excellent clinical and radiographic outcomes in 50 hips (18 ceramic on ceramic, 32 ceramic on polyethylene; 36-mm heads) at a mean follow-up of 3.5 years. Mean HHS was 94 points, and there was no evidence of liner fractures, aseptic loosening, or osteolysis.

In summary, large-diameter femoral heads in THA have become increasingly popular because of improvements in the material properties and wear characteristics of highly cross-linked polyethylene and fourth-generation ceramics. Despite the potential advantages of large heads in preventing dislocations, the basic surgical tenets of placing the acetabular component in appropriate alignment remain firmly established. Implants with functionally large heads (eg, dual-mobility bearings, constrained tripolar liners) may play an important role in patients at high risk for dislocation—particularly elderly patients with poor neuromuscular muscle coordination or deficient abductors, trauma patients, and patients with prior dislocations. Short-term and midterm results are excellent; rates of wear, aseptic loosening, and osteolysis are low. However, long-term outcomes data are needed to support widespread use of large heads in younger and more active patients.

Technology creates change, and change is moving fast and is relentless. Physicians, on the other hand, are generally slow to change. Wisely, we question change—we observe it, we study it, and we try to ensure our patients will benefit from it over time. Maybe as a result of this or as a consequence of our often myopic view of the world, we mistakenly let others lead the way and dictate how we must change and what our practices must absorb. We must turn this around and be the agents of change for our profession so we can appropriately use the available technology and create systems for managing the demands of a society that expects instant answers with fewer doctor resources devoted to the answer. The insurance industry is encouraging a wholesale dismantling of the classic patient visit to be replaced by nonphysician interactions, virtual diagnostics, and electronic medical records. We must not allow this and must ensure that we safeguard our profession by employing traditional skills, utilizing our 5 senses, and incorporating technology as a tool for better diagnosis and treatment but not as a substitute for the same.  

Great doctors are often described as having a sixth sense—an intuition that guides them in diagnosing and treating patients. It is assumed, therefore, that the good doctor will have the benefit of 5 senses: sight, sound, touch, smell, and taste. Sound: What does the patient tell or neglect to tell the doctor? What sounds does a joint produce when it moves? Sight: How does the patient present? Are they weary from pain or chronic disease? Touch: What does the joint feel like? How does it move? What is the patient’s response to stabilization of a joint? Smell: Is there an odor that helps detect the presence of infection or decay? Is the patient coming into contact with a substance causing harm or preventing healing?

A good doctor must employ these senses first to understand the patient’s needs and then to treat the patient. The sixth sense is a gift, one that comes from years of experience, an attention to detail, and a commitment to the craft of medicine. A recent trend toward virtual medicine is a dangerous path that must be walked with care and discretion so that the 6 senses are maintained and nurtured. Technology must be used to enhance and not limit these senses. The patient cannot be reduced to a 2-dimensional version of his/herself so that the doctor’s powers of diagnosis and healing are similarly limited.

Change in the office has occurred with mandates for electronic medical records and work-hour restrictions for residents. Data do not support that either change has resulted in a net benefit to patients. We are mandated to invest scarce capital to support new technology, resulting in increased pressure to recoup investment. Where there is a cap on revenue, the only way to increase net profit is to increase volume and decrease services. Physician time is the variable and can be streamlined by performing video conferences or smartphone consultations. Change may bring higher order, as the English philosopher John Locke said, but it is time for all of us as physicians to step back and question that this type of change is the path we must take. An office with a schedule of 80 patients seen at 5-minute intervals by physician assistants has no place in medicine. The pressure imposed by the insurance industry or hospital administrators to meet quotas has gotten out of hand and the time is now to say with a strong but fair voice a resounding NO!

The office visit with a history and physical examination is the most exciting and effective time to meet, console, and relate to our patients. The use of the 5 senses is critical. We must not let technological advancements (eg, smartphones, the Internet, and electronic medical records) destroy what was created and taught to us all through our training. The reward that is accomplished by placing one’s hand on a patient’s knee to understand its warmth and swelling, the tactile feeling of a fluid wave, or performing carefully with compassion a provocative maneuver that gives by sight a grimace of discomfort can tell so much more than a status update on the phone. We must not allow ourselves to be replaced by ancillary services for so-called efficiency and cost saving. Rather, we must be innovative and sharp. We must find the way to use the wonders of the virtual world without giving up the human consult.

Imagine that you are able to travel to Iguazu Falls, South America, to see one of the wonders of our world. You sit in that life raft moving upstream to feel the heat from the water as it crushes the rocks below, and you feel the mist on your face. You see the majesty and hear the screams and breadth of excitement of those around you, while you listen to the deafening sounds created by this waterfall. Now imagine you are required to report on this same experience through a video or some form of technology that the world has convinced us is the best and far cheaper substitute. This is our electronic medical record. A tool we are forced to use, and while it has a purpose, it is a sterile tool that fails to provide information that will give clues to awaken the sixth sense. It is a checklist that could allow for completion of a task—like how to fix a leaky faucet.

How then do we accomplish walking the fine line of working with nonphysicians and technology and yet delivering pinnacle care? The answer isn’t simple but it must include education and a commitment to the profession. We must make the public aware that we are one of the few professions that dedicate our lives to others by promoting health and advancing research. My colleagues, the pendulum has swung too far; it is time to take back our great profession through education of ourselves and the public. While technology may help the world connect, it has a limited role unless we first use our 6 senses to help our patients. We must not submit to a compassionless and callous approach that is the inevitable outcome of virtual medicine done with speed. We must maintain our dignity and let the public understand how many years of sacrifice has taken place to earn a sixth sense and not allow a third party to take it away. We are the only source of protection for our patients and we need each one of our senses to perform this task.

Advancing research has been a cornerstone for the orthopedic surgeon. Position statements through meta-analyses and systematic reviews of the literature have recently been utilized with increasing frequency. Combining data of potentially flawed studies can often lead to erroneous conclusions and may stray away from best practices. Is this where we want evidence-based medicine to go? The end result is that decisions are made by insurance companies who rely on these flawed studies to force clinical decisions on the physician, as was most recently seen by the investigation of viscosupplementation for knee osteoarthritis.¹

In a 2007 study published in JAMA (The Journal of the American Medical Association), only 62% of residents could appropriately interpret a P value.² How can we expect young clinicians to evaluate, interpret, and apply the multitude of evidence in the literature to everyday practice? We must marry the use of best evidence with our expertise to make the most informed decision while managing the expectations of our patients. In order to achieve that balance, we must rely on our intuition, our sixth sense. There is too much patient individuality and complexity surrounding each individual’s situation for a one-size-fits-all approach and for wholesale reliance on research to address each unique situation.

If Nathan Davis in 1845 was able to convince the New York Medical Society to establish a nationwide professional association to assist in regulating the practice of medicine, then it is time for all of us to stand up and insist on a code of ethics that is unrelenting and uncompromising. Our wise leaders of the American Orthopaedic Association (AOA) who founded the formation of orthopedics in America knew guidelines were needed to “foster advances in the care of patients, improve the teaching of orthopaedic surgery in medical schools and formal orthopaedic training, and to promote orthopaedic surgery as a surgical discipline worldwide.”³ It is now our turn to renew the guidelines and encourage our leaders to help educate ourselves and patients as we work with technology and administrators, nurses and physician assistants to deliver pinnacle care. We must reform medical education and the practice of medicine so that technology is used as a companion but not a substitute for our 6 senses.

The next time a patient comes into the exam room, sit down, look the patient in the eye, listen, touch, console anxiety, make a human connection, and form a lasting relationship. By all means apologize to your patients as you fill out the electronic medical record and insurance forms. Discuss how we are in the same crisis together and ask for their help as they have come to you for yours.

Technology creates change, and change is moving fast and is relentless. Physicians, on the other hand, are generally slow to change. Wisely, we question change—we observe it, we study it, and we try to ensure our patients will benefit from it over time. Maybe as a result of this or as a consequence of our often myopic view of the world, we mistakenly let others lead the way and dictate how we must change and what our practices must absorb. We must turn this around and be the agents of change for our profession so we can appropriately use the available technology and create systems for managing the demands of a society that expects instant answers with fewer doctor resources devoted to the answer. The insurance industry is encouraging a wholesale dismantling of the classic patient visit to be replaced by nonphysician interactions, virtual diagnostics, and electronic medical records. We must not allow this and must ensure that we safeguard our profession by employing traditional skills, utilizing our 5 senses, and incorporating technology as a tool for better diagnosis and treatment but not as a substitute for the same.  

Great doctors are often described as having a sixth sense—an intuition that guides them in diagnosing and treating patients. It is assumed, therefore, that the good doctor will have the benefit of 5 senses: sight, sound, touch, smell, and taste. Sound: What does the patient tell or neglect to tell the doctor? What sounds does a joint produce when it moves? Sight: How does the patient present? Are they weary from pain or chronic disease? Touch: What does the joint feel like? How does it move? What is the patient’s response to stabilization of a joint? Smell: Is there an odor that helps detect the presence of infection or decay? Is the patient coming into contact with a substance causing harm or preventing healing?

A good doctor must employ these senses first to understand the patient’s needs and then to treat the patient. The sixth sense is a gift, one that comes from years of experience, an attention to detail, and a commitment to the craft of medicine. A recent trend toward virtual medicine is a dangerous path that must be walked with care and discretion so that the 6 senses are maintained and nurtured. Technology must be used to enhance and not limit these senses. The patient cannot be reduced to a 2-dimensional version of his/herself so that the doctor’s powers of diagnosis and healing are similarly limited.

Change in the office has occurred with mandates for electronic medical records and work-hour restrictions for residents. Data do not support that either change has resulted in a net benefit to patients. We are mandated to invest scarce capital to support new technology, resulting in increased pressure to recoup investment. Where there is a cap on revenue, the only way to increase net profit is to increase volume and decrease services. Physician time is the variable and can be streamlined by performing video conferences or smartphone consultations. Change may bring higher order, as the English philosopher John Locke said, but it is time for all of us as physicians to step back and question that this type of change is the path we must take. An office with a schedule of 80 patients seen at 5-minute intervals by physician assistants has no place in medicine. The pressure imposed by the insurance industry or hospital administrators to meet quotas has gotten out of hand and the time is now to say with a strong but fair voice a resounding NO!

The office visit with a history and physical examination is the most exciting and effective time to meet, console, and relate to our patients. The use of the 5 senses is critical. We must not let technological advancements (eg, smartphones, the Internet, and electronic medical records) destroy what was created and taught to us all through our training. The reward that is accomplished by placing one’s hand on a patient’s knee to understand its warmth and swelling, the tactile feeling of a fluid wave, or performing carefully with compassion a provocative maneuver that gives by sight a grimace of discomfort can tell so much more than a status update on the phone. We must not allow ourselves to be replaced by ancillary services for so-called efficiency and cost saving. Rather, we must be innovative and sharp. We must find the way to use the wonders of the virtual world without giving up the human consult.

Imagine that you are able to travel to Iguazu Falls, South America, to see one of the wonders of our world. You sit in that life raft moving upstream to feel the heat from the water as it crushes the rocks below, and you feel the mist on your face. You see the majesty and hear the screams and breadth of excitement of those around you, while you listen to the deafening sounds created by this waterfall. Now imagine you are required to report on this same experience through a video or some form of technology that the world has convinced us is the best and far cheaper substitute. This is our electronic medical record. A tool we are forced to use, and while it has a purpose, it is a sterile tool that fails to provide information that will give clues to awaken the sixth sense. It is a checklist that could allow for completion of a task—like how to fix a leaky faucet.

How then do we accomplish walking the fine line of working with nonphysicians and technology and yet delivering pinnacle care? The answer isn’t simple but it must include education and a commitment to the profession. We must make the public aware that we are one of the few professions that dedicate our lives to others by promoting health and advancing research. My colleagues, the pendulum has swung too far; it is time to take back our great profession through education of ourselves and the public. While technology may help the world connect, it has a limited role unless we first use our 6 senses to help our patients. We must not submit to a compassionless and callous approach that is the inevitable outcome of virtual medicine done with speed. We must maintain our dignity and let the public understand how many years of sacrifice has taken place to earn a sixth sense and not allow a third party to take it away. We are the only source of protection for our patients and we need each one of our senses to perform this task.

Advancing research has been a cornerstone for the orthopedic surgeon. Position statements through meta-analyses and systematic reviews of the literature have recently been utilized with increasing frequency. Combining data of potentially flawed studies can often lead to erroneous conclusions and may stray away from best practices. Is this where we want evidence-based medicine to go? The end result is that decisions are made by insurance companies who rely on these flawed studies to force clinical decisions on the physician, as was most recently seen by the investigation of viscosupplementation for knee osteoarthritis.¹

In a 2007 study published in JAMA (The Journal of the American Medical Association), only 62% of residents could appropriately interpret a P value.² How can we expect young clinicians to evaluate, interpret, and apply the multitude of evidence in the literature to everyday practice? We must marry the use of best evidence with our expertise to make the most informed decision while managing the expectations of our patients. In order to achieve that balance, we must rely on our intuition, our sixth sense. There is too much patient individuality and complexity surrounding each individual’s situation for a one-size-fits-all approach and for wholesale reliance on research to address each unique situation.

If Nathan Davis in 1845 was able to convince the New York Medical Society to establish a nationwide professional association to assist in regulating the practice of medicine, then it is time for all of us to stand up and insist on a code of ethics that is unrelenting and uncompromising. Our wise leaders of the American Orthopaedic Association (AOA) who founded the formation of orthopedics in America knew guidelines were needed to “foster advances in the care of patients, improve the teaching of orthopaedic surgery in medical schools and formal orthopaedic training, and to promote orthopaedic surgery as a surgical discipline worldwide.”³ It is now our turn to renew the guidelines and encourage our leaders to help educate ourselves and patients as we work with technology and administrators, nurses and physician assistants to deliver pinnacle care. We must reform medical education and the practice of medicine so that technology is used as a companion but not a substitute for our 6 senses.

The next time a patient comes into the exam room, sit down, look the patient in the eye, listen, touch, console anxiety, make a human connection, and form a lasting relationship. By all means apologize to your patients as you fill out the electronic medical record and insurance forms. Discuss how we are in the same crisis together and ask for their help as they have come to you for yours.

Technology creates change, and change is moving fast and is relentless. Physicians, on the other hand, are generally slow to change. Wisely, we question change—we observe it, we study it, and we try to ensure our patients will benefit from it over time. Maybe as a result of this or as a consequence of our often myopic view of the world, we mistakenly let others lead the way and dictate how we must change and what our practices must absorb. We must turn this around and be the agents of change for our profession so we can appropriately use the available technology and create systems for managing the demands of a society that expects instant answers with fewer doctor resources devoted to the answer. The insurance industry is encouraging a wholesale dismantling of the classic patient visit to be replaced by nonphysician interactions, virtual diagnostics, and electronic medical records. We must not allow this and must ensure that we safeguard our profession by employing traditional skills, utilizing our 5 senses, and incorporating technology as a tool for better diagnosis and treatment but not as a substitute for the same.  

Great doctors are often described as having a sixth sense—an intuition that guides them in diagnosing and treating patients. It is assumed, therefore, that the good doctor will have the benefit of 5 senses: sight, sound, touch, smell, and taste. Sound: What does the patient tell or neglect to tell the doctor? What sounds does a joint produce when it moves? Sight: How does the patient present? Are they weary from pain or chronic disease? Touch: What does the joint feel like? How does it move? What is the patient’s response to stabilization of a joint? Smell: Is there an odor that helps detect the presence of infection or decay? Is the patient coming into contact with a substance causing harm or preventing healing?

A good doctor must employ these senses first to understand the patient’s needs and then to treat the patient. The sixth sense is a gift, one that comes from years of experience, an attention to detail, and a commitment to the craft of medicine. A recent trend toward virtual medicine is a dangerous path that must be walked with care and discretion so that the 6 senses are maintained and nurtured. Technology must be used to enhance and not limit these senses. The patient cannot be reduced to a 2-dimensional version of his/herself so that the doctor’s powers of diagnosis and healing are similarly limited.

Change in the office has occurred with mandates for electronic medical records and work-hour restrictions for residents. Data do not support that either change has resulted in a net benefit to patients. We are mandated to invest scarce capital to support new technology, resulting in increased pressure to recoup investment. Where there is a cap on revenue, the only way to increase net profit is to increase volume and decrease services. Physician time is the variable and can be streamlined by performing video conferences or smartphone consultations. Change may bring higher order, as the English philosopher John Locke said, but it is time for all of us as physicians to step back and question that this type of change is the path we must take. An office with a schedule of 80 patients seen at 5-minute intervals by physician assistants has no place in medicine. The pressure imposed by the insurance industry or hospital administrators to meet quotas has gotten out of hand and the time is now to say with a strong but fair voice a resounding NO!

The office visit with a history and physical examination is the most exciting and effective time to meet, console, and relate to our patients. The use of the 5 senses is critical. We must not let technological advancements (eg, smartphones, the Internet, and electronic medical records) destroy what was created and taught to us all through our training. The reward that is accomplished by placing one’s hand on a patient’s knee to understand its warmth and swelling, the tactile feeling of a fluid wave, or performing carefully with compassion a provocative maneuver that gives by sight a grimace of discomfort can tell so much more than a status update on the phone. We must not allow ourselves to be replaced by ancillary services for so-called efficiency and cost saving. Rather, we must be innovative and sharp. We must find the way to use the wonders of the virtual world without giving up the human consult.

Imagine that you are able to travel to Iguazu Falls, South America, to see one of the wonders of our world. You sit in that life raft moving upstream to feel the heat from the water as it crushes the rocks below, and you feel the mist on your face. You see the majesty and hear the screams and breadth of excitement of those around you, while you listen to the deafening sounds created by this waterfall. Now imagine you are required to report on this same experience through a video or some form of technology that the world has convinced us is the best and far cheaper substitute. This is our electronic medical record. A tool we are forced to use, and while it has a purpose, it is a sterile tool that fails to provide information that will give clues to awaken the sixth sense. It is a checklist that could allow for completion of a task—like how to fix a leaky faucet.

How then do we accomplish walking the fine line of working with nonphysicians and technology and yet delivering pinnacle care? The answer isn’t simple but it must include education and a commitment to the profession. We must make the public aware that we are one of the few professions that dedicate our lives to others by promoting health and advancing research. My colleagues, the pendulum has swung too far; it is time to take back our great profession through education of ourselves and the public. While technology may help the world connect, it has a limited role unless we first use our 6 senses to help our patients. We must not submit to a compassionless and callous approach that is the inevitable outcome of virtual medicine done with speed. We must maintain our dignity and let the public understand how many years of sacrifice has taken place to earn a sixth sense and not allow a third party to take it away. We are the only source of protection for our patients and we need each one of our senses to perform this task.

Advancing research has been a cornerstone for the orthopedic surgeon. Position statements through meta-analyses and systematic reviews of the literature have recently been utilized with increasing frequency. Combining data of potentially flawed studies can often lead to erroneous conclusions and may stray away from best practices. Is this where we want evidence-based medicine to go? The end result is that decisions are made by insurance companies who rely on these flawed studies to force clinical decisions on the physician, as was most recently seen by the investigation of viscosupplementation for knee osteoarthritis.¹

In a 2007 study published in JAMA (The Journal of the American Medical Association), only 62% of residents could appropriately interpret a P value.² How can we expect young clinicians to evaluate, interpret, and apply the multitude of evidence in the literature to everyday practice? We must marry the use of best evidence with our expertise to make the most informed decision while managing the expectations of our patients. In order to achieve that balance, we must rely on our intuition, our sixth sense. There is too much patient individuality and complexity surrounding each individual’s situation for a one-size-fits-all approach and for wholesale reliance on research to address each unique situation.

If Nathan Davis in 1845 was able to convince the New York Medical Society to establish a nationwide professional association to assist in regulating the practice of medicine, then it is time for all of us to stand up and insist on a code of ethics that is unrelenting and uncompromising. Our wise leaders of the American Orthopaedic Association (AOA) who founded the formation of orthopedics in America knew guidelines were needed to “foster advances in the care of patients, improve the teaching of orthopaedic surgery in medical schools and formal orthopaedic training, and to promote orthopaedic surgery as a surgical discipline worldwide.”³ It is now our turn to renew the guidelines and encourage our leaders to help educate ourselves and patients as we work with technology and administrators, nurses and physician assistants to deliver pinnacle care. We must reform medical education and the practice of medicine so that technology is used as a companion but not a substitute for our 6 senses.

The next time a patient comes into the exam room, sit down, look the patient in the eye, listen, touch, console anxiety, make a human connection, and form a lasting relationship. By all means apologize to your patients as you fill out the electronic medical record and insurance forms. Discuss how we are in the same crisis together and ask for their help as they have come to you for yours.