ABSTRACT

The purpose of this study is to determine the relationship of body mass index (BMI), age, smoking status, and other comorbid conditions to the rate and type of complications occurring in the perioperative period following periacetabular osteotomy. A retrospective review was performed on 80 hips to determine demographic information as well as pre- and postoperative pain scores, center-edge angle, Tönnis angle, intraoperative blood loss, and perioperative complications within 90 days of surgery. Patients were placed into high- (>30) and low- (<30) BMI groups to determine any correlation between complications and BMI. The high-BMI group had a significantly greater rate of perioperative complications than the low-BMI group (30% vs 8%) and, correspondingly, patients with complications had significantly higher BMI than those without (30.9 ± 9.5, 26.2 ± 5.6) (P = .03). Center-edge angle and Tönnis angle were corrected in both groups. Improvement in postoperative pain scores and radiographically measured acetabular correction can be achieved in high- and low-BMI patients. High-BMI patients have a higher rate of perioperative wound complications.

Continue to: The Bernese periacetabular osteotomy...

The Bernese periacetabular osteotomy (PAO) has become a widely used procedure for hip preservation in adolescent and young adult patients with symptomatic anatomic aberrancies of the acetabulum due to developmental hip dysplasia, trauma, infection, femoroacetabular impingement, and other causes.^1-6 Acetabular dysplasia is one of the most common causes of secondary osteoarthritis, and the goal of PAO is to slow or halt the progression of arthrosis to prolong or potentially eliminate the need for total hip arthroplasty while relieving pain and increasing function and activity.^1,7,8

The PAO involves realigning the acetabulum to improve anterior and lateral coverage of the femoral head, acetabular anteversion, and medicalization of the joint.^5,6 It is preferred over other described acetabular osteotomies due to its inherent stability given that the posterior column is not violated.^3,5,6,9 Since its initial description in 1988,⁵ short-, medium- and long-term outcomes have been reported with excellent patient satisfaction and function.^2,7,10-15 The radiographic, functional, and patient satisfaction outcomes are excellent; therefore, this has become an accepted form of treatment for acetabular dysplasia.¹⁶ Additional procedures, such as hip arthroscopy, have also been combined with PAO to treat intra-articular pathologies without open arthrotomy.¹⁷ Several studies have evaluated preoperative radiographic factors, such as Tönnis grade, previous surgeries, and morphology of the hip; as well as demographic factors, such as age, body mass index (BMI), comorbid diseases, and activity level, which seem to play a role in the final outcome.^11,18,19 This work has advanced our understanding and allowed surgeons to apply selection criteria to improve patient outcomes.

There are multiple reported complications of the PAO procedure, including infection,² wound dehiscence,²⁰ periacetabular fracture,²¹ intra-articular extension of the osteotomy,²² excessive acetabular retroversion,^23,24 hardware failure, femoral or sciatic nerve palsy,²⁵ heterotopic ossification, prominent hardware, deep vein thrombosis or pulmonary embolism,²⁶ osteonecrosis of the femoral head or acetabulum,²⁴ non-union,²⁴ intrapelvic bleeding,²⁴ incisional hernia,²⁷ lateral femoral cutaneous nerve palsy,^20,28 and reflex sympathetic dystrophy.^1,2,29 There are also several studies reporting a learning curve phenomenon, in which the proportion of complications is higher in the initial series of surgeries performed by each specific surgeon.^22,20,29

Despite the widely reported short-, medium-, and long-term results of this treatment, no study thus far has attempted to correlate preoperative patient factors with early perioperative outcomes and complications. This information would be useful in patient counseling and decision making in the early postoperative period. Therefore, the purpose of this study is to analyze data from the perioperative period in patients who have undergone the PAO performed by a single surgeon at our institution to determine any correlation between patient characteristics such as age, comorbid disease, hip pathologic diagnosis, BMI, or previous procedures and perioperative complications occurring within the first 90 days.

Continue to: MATERIALS AND METHODS...

MATERIALS AND METHODS

After Institutional Review Board approval was obtained, a search was performed on the basis of operative report Current Procedural Terminology (CPT) codes for all patients who underwent PAO performed by a single surgeon between 2005 and 2013. Patients were included if they had PAO surgery with at least 90 days of follow-up. There was no exclusion for age, previous surgery, or underlying hip or medical diagnosis. A retrospective review of electronic medical records and radiographic imaging was undertaken to determine pre- and postoperative demographic information, pain scores, center-edge angle of Weiberg and Tönnis angles, intraoperative estimated blood loss, and all perioperative complications. Weight and height were recorded from the immediate preoperative visit and measured in kilograms (kg) and meters (m), respectively. BMI was derived from these measurements. Pain was assessed via visual analog scale at the preoperative visit as well as at 12 weeks postoperatively. Preoperative and 12-week postoperative Tönnis and center-edge angles were measured by a single orthopedic surgeon. All radiographs were deemed adequate in position and penetration for measurement of these parameters. Evidence of osteonecrosis of the femoral head was evaluated on all postoperative radiographs within this perioperative period. Estimated blood loss was established by review of operative records and anesthesia notes.

Perioperative complications were classified using the Clavien-Dindo system, which has previously been validated for use in hip preservation surgery.³⁰ This includes 5 grades of complications based on the treatment needed and severity of resulting long-term disability. Grade I complications do not require any change in the postoperative course and were therefore left out of our statistical analysis. Examples include symptomatic hardware, mild heterotopic ossification, and iliopsoas tendonitis. Grade II complications are those that require a change in outpatient management, such as delayed wound healing, superficial infection, transient nerve palsy, violation of the posterior column, and intra-articular osteotomy. Grade III complications require invasive or surgical treatment but leave the patient with no long-term disability. Examples include wound dehiscence, hematoma or infection necessitating surgical débridement and irrigation, and revision of the osteotomy due to hardware malposition or hip instability. Grade IV complications involve both surgery and long-term disability. Grade IV complications applicable to hip preservation surgery are osteonecrosis, permanent nerve injury, major vascular injury, or pulmonary embolism. A grade V complication is death.

For analysis and correlation between demographics and perioperative outcomes and complications, patients were grouped into several groups for comparison. Low (<30) vs high (>30) BMI, smokers vs non-smokers, diabetic vs non-diabetic patients, and those who had previous surgery vs those who did not were compared. A two-tailed t test was used for normally distributed continuous variables and a Mann-Whitney U test, for non-parametric data to compare postoperative radiographic correction, pain scores, and complication rates between each of these groups.

The operative technique for PAO as described by Ganz and colleagues⁵ in 1988 was utilized in all patients. When preoperative imaging showed evidence of labral pathology, a Cam lesion of the femoral head and neck junction, abnormal proximal femoral anatomy, osteonecrosis of the femoral head, or an os acetabulum, a concomitant procedure was performed. Seventeen patients underwent débridement of a Cam lesion noted to be impinging following PAO. Seventeen patients underwent labral débridement and 4 underwent labral repair. Four patients underwent intertrochanteric osteotomy and 1 underwent greater trochanteric slide. Two patients underwent free-vascularized fibular grafting to the ipsilateral femoral head and 5 underwent fixation of an os acetabulum.

Continue to: RESULTS...

RESULTS

A total of 80 hips in 73 patients underwent PAO with adequate perioperative follow-up and records in the inclusion period. Figures A-E represent a patient pre-procedure, immediately post procedure, and 6 months after successful PAO. The average age was 27.5 years (12.8-43.6 years), and the average BMI was 26.8 (18.7-52.2). Four patients had diabetes, 8 were smokers, and 10 had undergone previous surgeries including arthroscopic labral débridement, 3 open reduction with Salter osteotomy, 3 open reduction with internal fixation of a femoral neck fracture, 1 core decompression for femoral head osteonecrosis, 3 subtrochanteric osteotomy and subsequent non-union treated with cephalomedullary nailing, and 1 previous PAO requiring revision.¹

There were 11 perioperative complications in 10 patients (12.5%). The majority of these were infection (n = 10). Overall complications categorized by BMI are summarized in Table 1. Age was similar in patients with complications (27.4 ± 8.8 years) and those without (27.5 ± 8.2 years) (P = .99). Patients with complications had significantly higher BMI than those without (30.9.3 ± 9.5, 26.2 ± 5.6) (P = .03). There was no effect of concomitant procedures on the complication rate. Of the patients who had complications, 60% (6/10) had concomitant procedures, vs 63% (44/70) of those who had no complications (P = .86) Two of 4 patients with diabetes mellitus developed complications, both of which were wound infections. One of these required incision and débridement. There were no perioperative complications in any of the 7 smokers.  

Abbreviation: BMI, body mass index.

Twenty hips were in the high-BMI (>30) and 60 were in the low-BMI (<30) patient groups. There were 6 total perioperative complications in the high-BMI group (30%) and 5 in the low-BMI group (8%). The most common complications in the low-BMI group were superficial infections.⁴ There were 6 total complications in the high-BMI group: 2 deep and 4 superficial infections. There were 3 reoperations (5%) in the low-BMI group during the perioperative period. Two patients underwent successful débridement and irrigation of a superficial wound, and 1 patient required removal of a prominent screw. There were 3 reoperations in the high-BMI group, all of which were débridement and irrigations for wound infections. The rate of wound dehiscence and wound infection was significantly higher in high-BMI patients (30% [6/20]) than in low-BMI patients (8.3% [4/60]) (P = .006). The mean estimated blood loss in the high-BMI group was greater at 923.75 mL vs 779.25 mL in the low-BMI patients; however, this did not reach statistical significance (P = .350). Seventy percent (14/20) of patients who were obese had concomitant procedures vs 60% (36/60) of those who had normal BMI (P = .42 by chi-square analysis). There was no difference in estimated blood loss in patients who underwent concomitant procedures (Table 2).

Abbreviations: BMI, body mass index; EBL, estimated blood loss.

Preoperative pain scores improved from 4.9 (range, 0-10) to 1.9 (range, 0-6) in the high-BMI group and 4.2 (range, 0-10) to 1.2 (range, 0-6) in the low-BMI group (P = .260). The preoperative center-edge angle in the high-BMI group improved from 6.63° ± 6.5° to 28.53° ± 6.7°, and the Tönnis angle from 24.96° ± 6.3° to 10.06° ± 7.7°. In the low-BMI group the center-edge angle improved from 10.53° ± 11.77° to 27.07° ± 13.9°, and the Tönnis angle from 19.00° ± 10.3° to 2.79° ± 8.3°. There was no difference in postoperative center-edge angle between the high-BMI and low-BMI groups (P = .66). There was a trend toward significance in the postoperative Tönnis angle between the high-BMI and low-BMI groups (P = .051).

Continue to: DISCUSSION...

DISCUSSION

There have been 4 previously published articles specifically on complications following PAO. Each of these encompassed follow-up visits including both the perioperative period and at least 2 years of follow-up.^20,22,24,29 Davey and Santore²⁹ reported an overall rate of complications of 10% in a series of 70 patients. These authors classified complications into minor, moderate, and major for purposes of research and discussion, and this classification system has been utilized or modified within the literature to discuss complications in most other articles. Complications within the perioperative period included 2 cases of excessive intraoperative bleeding, 2 cases of reflex sympathetic dystrophy, and 1 case each of unresolved sciatic nerve palsy and deep vein thrombosis.²⁹ Hussell and colleagues²² reported on a large series of 508 PAOs and analyzed the technical complications that occurred during the procedure and caused either immediate or longer-term problems for the patients. Notably, they concluded that 85% of the technical complications occurred with the initial 50 PAOs performed, signifying a steep learning curve for this technically demanding procedure. Perioperative complications reported were intra-articular osteotomy in 2.2%, femoral nerve palsy in 0.6%, sciatic nerve palsy in 1.0%, posterior column insufficiency in 1.2%, and symptomatic hardware in 3.0%.²² Biedermann and colleagues²⁰ found that 47 out of 60 PAOs in their series had at least 1 minor complication. The most common perioperative complications were lateral femoral cutaneous nerve dysesthesia in 33%, delayed wound healing infection in 15%, major blood loss in 8.3%, sciatic or peroneal nerve palsy in 10%, posterior column discontinuity in 6.7%, and intra-articular osteotomy in 1.6%.²⁰ Most recently, complications of PAO in an adolescent population were evaluated.²⁴ The overall rate of complications was 37%. Major perioperative complications included 1 patient with excessive bleeding due to an aberrant artery at the medial wall of the pelvis thought to be due to revascularization following a previous Dega osteotomy. Two patients required immediate revision of the osteotomy due to excessive anterior coverage noted on postoperative radiographs. There were 5% with superficial stitch abscess causing minor infection, 5% with transient lateral femoral cutaneous nerve palsy, and 15 patients with symptomatic hardware.²⁴

At 12.5%, our overall complication rate is slightly lower than that previously reported in the literature. This may be due to the difference in the scope of this study, which reported only perioperative complications. We also chose to utilize the modified Clavien-Dindo classification system for reporting our complications rather than classifying them as minor or major as in the above studies. This classification system has been validated for use in reporting complications of hip preservation surgery. We considered only Grade II complications and higher for statistical analysis as these required a change in postoperative management, which may have artificially lowered our complication rate.

The data in this study indicate that, compared with patients with a BMI of <30, obese patients have a higher rate of perioperative complications and reoperations. Additionally, the proportion of Grade II and higher complications, importantly deep infection, was higher in obese patients. We did not have any reported incidence of deep vein thrombosis or pulmonary embolism, urinary tract infection, intra-articular osteotomy, acetabular or pelvic fracture, femoral or sciatic nerve palsy, or long-term lateral femoral cutaneous nerve palsy in this series of patients. The most common complication in the low-BMI group was symptomatic hardware. Sixteen patients had this complaint; however, this was not considered a Grade II complication as there would be no change in management during the study period, including the perioperative time frame. Two out of 4 patients with diabetes mellitus developed wound infections, both of which required reoperation. However, the number of patients with diabetes mellitus was not large enough to draw any conclusions from this information. There were no perioperative complications in smokers. We hypothesized that there may be a higher rate of wound complications in this population, and although the data in our patients did not support this hypothesis, a larger cohort of smokers is needed to make this determination. Another potential complication in smokers is non-union, which was not reported in this study on perioperative complications. Although it did not reach statistical significance, the intraoperative blood loss was almost 150 mL greater in high-BMI patients (924 mL vs 779 mL). Additionally, there appears to be no effect of concomitant procedure on estimated blood loss in either low- or high-BMI groups. Age was not a risk factor for the development of perioperative complications in this cohort. Pain was reliably improved in both the high- and low-BMI groups at the 12-week follow-up visit. The center-edge angle could be normalized in both groups to 28.53° in the high-BMI group and 27.07° in the low-BMI group, with a similar final correction between groups. The Tönnis angle was also improved in both groups, but the final Tönnis angle strongly trended toward statistical significance (2.79° in the low-BMI group vs 10.06° in the high-BMI group).

This study has limitations in that it is a retrospective review of patient information based on medical records and therefore relied on documentation performed at the time of service. There also may have been a difference in the intraoperative or postoperative protocol for wound monitoring or rehabilitation among patients based on body habitus, which we are not able to detect from the medical records. Although the overall number of patients in this cohort is comparable to other studies on the outcomes of patients after PAO, the number of patients in each BMI group was not evenly matched. Without randomization, selection bias occurred at the time of the procedure as some obese patients were not offered this procedure based on the senior surgeon’s discretion. Additionally, when subgroups such as patients with diabetes mellitus or smokers were analyzed, the number of subjects was too small for statistical analysis; therefore, no conclusions could be made as to the risk of perioperative complications in these populations.

CONCLUSION

Despite the limitations in this study, based on the data from this cohort, we concluded that the goal of PAO of restoring more normal hip joint anatomy can be achieved in both low- and high-BMI patients. However, patients with a BMI >30 should be counseled on their increased risk of major perioperative complications, specifically wound dehiscence and infection, and the higher likelihood of reoperation for treatment of these complications. Diabetic patients can be counseled that they may have a higher risk of infection as well, but future studies with larger numbers will be needed to confirm this. Patients with low BMI should be counseled about the potential for prominent or symptomatic hardware, which may necessitate removal following osteotomy union.

ABSTRACT

The purpose of this study is to determine the relationship of body mass index (BMI), age, smoking status, and other comorbid conditions to the rate and type of complications occurring in the perioperative period following periacetabular osteotomy. A retrospective review was performed on 80 hips to determine demographic information as well as pre- and postoperative pain scores, center-edge angle, Tönnis angle, intraoperative blood loss, and perioperative complications within 90 days of surgery. Patients were placed into high- (>30) and low- (<30) BMI groups to determine any correlation between complications and BMI. The high-BMI group had a significantly greater rate of perioperative complications than the low-BMI group (30% vs 8%) and, correspondingly, patients with complications had significantly higher BMI than those without (30.9 ± 9.5, 26.2 ± 5.6) (P = .03). Center-edge angle and Tönnis angle were corrected in both groups. Improvement in postoperative pain scores and radiographically measured acetabular correction can be achieved in high- and low-BMI patients. High-BMI patients have a higher rate of perioperative wound complications.

Continue to: The Bernese periacetabular osteotomy...

The Bernese periacetabular osteotomy (PAO) has become a widely used procedure for hip preservation in adolescent and young adult patients with symptomatic anatomic aberrancies of the acetabulum due to developmental hip dysplasia, trauma, infection, femoroacetabular impingement, and other causes.^1-6 Acetabular dysplasia is one of the most common causes of secondary osteoarthritis, and the goal of PAO is to slow or halt the progression of arthrosis to prolong or potentially eliminate the need for total hip arthroplasty while relieving pain and increasing function and activity.^1,7,8

The PAO involves realigning the acetabulum to improve anterior and lateral coverage of the femoral head, acetabular anteversion, and medicalization of the joint.^5,6 It is preferred over other described acetabular osteotomies due to its inherent stability given that the posterior column is not violated.^3,5,6,9 Since its initial description in 1988,⁵ short-, medium- and long-term outcomes have been reported with excellent patient satisfaction and function.^2,7,10-15 The radiographic, functional, and patient satisfaction outcomes are excellent; therefore, this has become an accepted form of treatment for acetabular dysplasia.¹⁶ Additional procedures, such as hip arthroscopy, have also been combined with PAO to treat intra-articular pathologies without open arthrotomy.¹⁷ Several studies have evaluated preoperative radiographic factors, such as Tönnis grade, previous surgeries, and morphology of the hip; as well as demographic factors, such as age, body mass index (BMI), comorbid diseases, and activity level, which seem to play a role in the final outcome.^11,18,19 This work has advanced our understanding and allowed surgeons to apply selection criteria to improve patient outcomes.

There are multiple reported complications of the PAO procedure, including infection,² wound dehiscence,²⁰ periacetabular fracture,²¹ intra-articular extension of the osteotomy,²² excessive acetabular retroversion,^23,24 hardware failure, femoral or sciatic nerve palsy,²⁵ heterotopic ossification, prominent hardware, deep vein thrombosis or pulmonary embolism,²⁶ osteonecrosis of the femoral head or acetabulum,²⁴ non-union,²⁴ intrapelvic bleeding,²⁴ incisional hernia,²⁷ lateral femoral cutaneous nerve palsy,^20,28 and reflex sympathetic dystrophy.^1,2,29 There are also several studies reporting a learning curve phenomenon, in which the proportion of complications is higher in the initial series of surgeries performed by each specific surgeon.^22,20,29

Despite the widely reported short-, medium-, and long-term results of this treatment, no study thus far has attempted to correlate preoperative patient factors with early perioperative outcomes and complications. This information would be useful in patient counseling and decision making in the early postoperative period. Therefore, the purpose of this study is to analyze data from the perioperative period in patients who have undergone the PAO performed by a single surgeon at our institution to determine any correlation between patient characteristics such as age, comorbid disease, hip pathologic diagnosis, BMI, or previous procedures and perioperative complications occurring within the first 90 days.

Continue to: MATERIALS AND METHODS...

MATERIALS AND METHODS

After Institutional Review Board approval was obtained, a search was performed on the basis of operative report Current Procedural Terminology (CPT) codes for all patients who underwent PAO performed by a single surgeon between 2005 and 2013. Patients were included if they had PAO surgery with at least 90 days of follow-up. There was no exclusion for age, previous surgery, or underlying hip or medical diagnosis. A retrospective review of electronic medical records and radiographic imaging was undertaken to determine pre- and postoperative demographic information, pain scores, center-edge angle of Weiberg and Tönnis angles, intraoperative estimated blood loss, and all perioperative complications. Weight and height were recorded from the immediate preoperative visit and measured in kilograms (kg) and meters (m), respectively. BMI was derived from these measurements. Pain was assessed via visual analog scale at the preoperative visit as well as at 12 weeks postoperatively. Preoperative and 12-week postoperative Tönnis and center-edge angles were measured by a single orthopedic surgeon. All radiographs were deemed adequate in position and penetration for measurement of these parameters. Evidence of osteonecrosis of the femoral head was evaluated on all postoperative radiographs within this perioperative period. Estimated blood loss was established by review of operative records and anesthesia notes.

Perioperative complications were classified using the Clavien-Dindo system, which has previously been validated for use in hip preservation surgery.³⁰ This includes 5 grades of complications based on the treatment needed and severity of resulting long-term disability. Grade I complications do not require any change in the postoperative course and were therefore left out of our statistical analysis. Examples include symptomatic hardware, mild heterotopic ossification, and iliopsoas tendonitis. Grade II complications are those that require a change in outpatient management, such as delayed wound healing, superficial infection, transient nerve palsy, violation of the posterior column, and intra-articular osteotomy. Grade III complications require invasive or surgical treatment but leave the patient with no long-term disability. Examples include wound dehiscence, hematoma or infection necessitating surgical débridement and irrigation, and revision of the osteotomy due to hardware malposition or hip instability. Grade IV complications involve both surgery and long-term disability. Grade IV complications applicable to hip preservation surgery are osteonecrosis, permanent nerve injury, major vascular injury, or pulmonary embolism. A grade V complication is death.

For analysis and correlation between demographics and perioperative outcomes and complications, patients were grouped into several groups for comparison. Low (<30) vs high (>30) BMI, smokers vs non-smokers, diabetic vs non-diabetic patients, and those who had previous surgery vs those who did not were compared. A two-tailed t test was used for normally distributed continuous variables and a Mann-Whitney U test, for non-parametric data to compare postoperative radiographic correction, pain scores, and complication rates between each of these groups.

The operative technique for PAO as described by Ganz and colleagues⁵ in 1988 was utilized in all patients. When preoperative imaging showed evidence of labral pathology, a Cam lesion of the femoral head and neck junction, abnormal proximal femoral anatomy, osteonecrosis of the femoral head, or an os acetabulum, a concomitant procedure was performed. Seventeen patients underwent débridement of a Cam lesion noted to be impinging following PAO. Seventeen patients underwent labral débridement and 4 underwent labral repair. Four patients underwent intertrochanteric osteotomy and 1 underwent greater trochanteric slide. Two patients underwent free-vascularized fibular grafting to the ipsilateral femoral head and 5 underwent fixation of an os acetabulum.

Continue to: RESULTS...

RESULTS

A total of 80 hips in 73 patients underwent PAO with adequate perioperative follow-up and records in the inclusion period. Figures A-E represent a patient pre-procedure, immediately post procedure, and 6 months after successful PAO. The average age was 27.5 years (12.8-43.6 years), and the average BMI was 26.8 (18.7-52.2). Four patients had diabetes, 8 were smokers, and 10 had undergone previous surgeries including arthroscopic labral débridement, 3 open reduction with Salter osteotomy, 3 open reduction with internal fixation of a femoral neck fracture, 1 core decompression for femoral head osteonecrosis, 3 subtrochanteric osteotomy and subsequent non-union treated with cephalomedullary nailing, and 1 previous PAO requiring revision.¹

There were 11 perioperative complications in 10 patients (12.5%). The majority of these were infection (n = 10). Overall complications categorized by BMI are summarized in Table 1. Age was similar in patients with complications (27.4 ± 8.8 years) and those without (27.5 ± 8.2 years) (P = .99). Patients with complications had significantly higher BMI than those without (30.9.3 ± 9.5, 26.2 ± 5.6) (P = .03). There was no effect of concomitant procedures on the complication rate. Of the patients who had complications, 60% (6/10) had concomitant procedures, vs 63% (44/70) of those who had no complications (P = .86) Two of 4 patients with diabetes mellitus developed complications, both of which were wound infections. One of these required incision and débridement. There were no perioperative complications in any of the 7 smokers.  

Abbreviation: BMI, body mass index.

Twenty hips were in the high-BMI (>30) and 60 were in the low-BMI (<30) patient groups. There were 6 total perioperative complications in the high-BMI group (30%) and 5 in the low-BMI group (8%). The most common complications in the low-BMI group were superficial infections.⁴ There were 6 total complications in the high-BMI group: 2 deep and 4 superficial infections. There were 3 reoperations (5%) in the low-BMI group during the perioperative period. Two patients underwent successful débridement and irrigation of a superficial wound, and 1 patient required removal of a prominent screw. There were 3 reoperations in the high-BMI group, all of which were débridement and irrigations for wound infections. The rate of wound dehiscence and wound infection was significantly higher in high-BMI patients (30% [6/20]) than in low-BMI patients (8.3% [4/60]) (P = .006). The mean estimated blood loss in the high-BMI group was greater at 923.75 mL vs 779.25 mL in the low-BMI patients; however, this did not reach statistical significance (P = .350). Seventy percent (14/20) of patients who were obese had concomitant procedures vs 60% (36/60) of those who had normal BMI (P = .42 by chi-square analysis). There was no difference in estimated blood loss in patients who underwent concomitant procedures (Table 2).

Abbreviations: BMI, body mass index; EBL, estimated blood loss.

Preoperative pain scores improved from 4.9 (range, 0-10) to 1.9 (range, 0-6) in the high-BMI group and 4.2 (range, 0-10) to 1.2 (range, 0-6) in the low-BMI group (P = .260). The preoperative center-edge angle in the high-BMI group improved from 6.63° ± 6.5° to 28.53° ± 6.7°, and the Tönnis angle from 24.96° ± 6.3° to 10.06° ± 7.7°. In the low-BMI group the center-edge angle improved from 10.53° ± 11.77° to 27.07° ± 13.9°, and the Tönnis angle from 19.00° ± 10.3° to 2.79° ± 8.3°. There was no difference in postoperative center-edge angle between the high-BMI and low-BMI groups (P = .66). There was a trend toward significance in the postoperative Tönnis angle between the high-BMI and low-BMI groups (P = .051).

Continue to: DISCUSSION...

DISCUSSION

There have been 4 previously published articles specifically on complications following PAO. Each of these encompassed follow-up visits including both the perioperative period and at least 2 years of follow-up.^20,22,24,29 Davey and Santore²⁹ reported an overall rate of complications of 10% in a series of 70 patients. These authors classified complications into minor, moderate, and major for purposes of research and discussion, and this classification system has been utilized or modified within the literature to discuss complications in most other articles. Complications within the perioperative period included 2 cases of excessive intraoperative bleeding, 2 cases of reflex sympathetic dystrophy, and 1 case each of unresolved sciatic nerve palsy and deep vein thrombosis.²⁹ Hussell and colleagues²² reported on a large series of 508 PAOs and analyzed the technical complications that occurred during the procedure and caused either immediate or longer-term problems for the patients. Notably, they concluded that 85% of the technical complications occurred with the initial 50 PAOs performed, signifying a steep learning curve for this technically demanding procedure. Perioperative complications reported were intra-articular osteotomy in 2.2%, femoral nerve palsy in 0.6%, sciatic nerve palsy in 1.0%, posterior column insufficiency in 1.2%, and symptomatic hardware in 3.0%.²² Biedermann and colleagues²⁰ found that 47 out of 60 PAOs in their series had at least 1 minor complication. The most common perioperative complications were lateral femoral cutaneous nerve dysesthesia in 33%, delayed wound healing infection in 15%, major blood loss in 8.3%, sciatic or peroneal nerve palsy in 10%, posterior column discontinuity in 6.7%, and intra-articular osteotomy in 1.6%.²⁰ Most recently, complications of PAO in an adolescent population were evaluated.²⁴ The overall rate of complications was 37%. Major perioperative complications included 1 patient with excessive bleeding due to an aberrant artery at the medial wall of the pelvis thought to be due to revascularization following a previous Dega osteotomy. Two patients required immediate revision of the osteotomy due to excessive anterior coverage noted on postoperative radiographs. There were 5% with superficial stitch abscess causing minor infection, 5% with transient lateral femoral cutaneous nerve palsy, and 15 patients with symptomatic hardware.²⁴

At 12.5%, our overall complication rate is slightly lower than that previously reported in the literature. This may be due to the difference in the scope of this study, which reported only perioperative complications. We also chose to utilize the modified Clavien-Dindo classification system for reporting our complications rather than classifying them as minor or major as in the above studies. This classification system has been validated for use in reporting complications of hip preservation surgery. We considered only Grade II complications and higher for statistical analysis as these required a change in postoperative management, which may have artificially lowered our complication rate.

The data in this study indicate that, compared with patients with a BMI of <30, obese patients have a higher rate of perioperative complications and reoperations. Additionally, the proportion of Grade II and higher complications, importantly deep infection, was higher in obese patients. We did not have any reported incidence of deep vein thrombosis or pulmonary embolism, urinary tract infection, intra-articular osteotomy, acetabular or pelvic fracture, femoral or sciatic nerve palsy, or long-term lateral femoral cutaneous nerve palsy in this series of patients. The most common complication in the low-BMI group was symptomatic hardware. Sixteen patients had this complaint; however, this was not considered a Grade II complication as there would be no change in management during the study period, including the perioperative time frame. Two out of 4 patients with diabetes mellitus developed wound infections, both of which required reoperation. However, the number of patients with diabetes mellitus was not large enough to draw any conclusions from this information. There were no perioperative complications in smokers. We hypothesized that there may be a higher rate of wound complications in this population, and although the data in our patients did not support this hypothesis, a larger cohort of smokers is needed to make this determination. Another potential complication in smokers is non-union, which was not reported in this study on perioperative complications. Although it did not reach statistical significance, the intraoperative blood loss was almost 150 mL greater in high-BMI patients (924 mL vs 779 mL). Additionally, there appears to be no effect of concomitant procedure on estimated blood loss in either low- or high-BMI groups. Age was not a risk factor for the development of perioperative complications in this cohort. Pain was reliably improved in both the high- and low-BMI groups at the 12-week follow-up visit. The center-edge angle could be normalized in both groups to 28.53° in the high-BMI group and 27.07° in the low-BMI group, with a similar final correction between groups. The Tönnis angle was also improved in both groups, but the final Tönnis angle strongly trended toward statistical significance (2.79° in the low-BMI group vs 10.06° in the high-BMI group).

This study has limitations in that it is a retrospective review of patient information based on medical records and therefore relied on documentation performed at the time of service. There also may have been a difference in the intraoperative or postoperative protocol for wound monitoring or rehabilitation among patients based on body habitus, which we are not able to detect from the medical records. Although the overall number of patients in this cohort is comparable to other studies on the outcomes of patients after PAO, the number of patients in each BMI group was not evenly matched. Without randomization, selection bias occurred at the time of the procedure as some obese patients were not offered this procedure based on the senior surgeon’s discretion. Additionally, when subgroups such as patients with diabetes mellitus or smokers were analyzed, the number of subjects was too small for statistical analysis; therefore, no conclusions could be made as to the risk of perioperative complications in these populations.

CONCLUSION

Despite the limitations in this study, based on the data from this cohort, we concluded that the goal of PAO of restoring more normal hip joint anatomy can be achieved in both low- and high-BMI patients. However, patients with a BMI >30 should be counseled on their increased risk of major perioperative complications, specifically wound dehiscence and infection, and the higher likelihood of reoperation for treatment of these complications. Diabetic patients can be counseled that they may have a higher risk of infection as well, but future studies with larger numbers will be needed to confirm this. Patients with low BMI should be counseled about the potential for prominent or symptomatic hardware, which may necessitate removal following osteotomy union.

ABSTRACT

The purpose of this study is to determine the relationship of body mass index (BMI), age, smoking status, and other comorbid conditions to the rate and type of complications occurring in the perioperative period following periacetabular osteotomy. A retrospective review was performed on 80 hips to determine demographic information as well as pre- and postoperative pain scores, center-edge angle, Tönnis angle, intraoperative blood loss, and perioperative complications within 90 days of surgery. Patients were placed into high- (>30) and low- (<30) BMI groups to determine any correlation between complications and BMI. The high-BMI group had a significantly greater rate of perioperative complications than the low-BMI group (30% vs 8%) and, correspondingly, patients with complications had significantly higher BMI than those without (30.9 ± 9.5, 26.2 ± 5.6) (P = .03). Center-edge angle and Tönnis angle were corrected in both groups. Improvement in postoperative pain scores and radiographically measured acetabular correction can be achieved in high- and low-BMI patients. High-BMI patients have a higher rate of perioperative wound complications.

Continue to: The Bernese periacetabular osteotomy...

The Bernese periacetabular osteotomy (PAO) has become a widely used procedure for hip preservation in adolescent and young adult patients with symptomatic anatomic aberrancies of the acetabulum due to developmental hip dysplasia, trauma, infection, femoroacetabular impingement, and other causes.^1-6 Acetabular dysplasia is one of the most common causes of secondary osteoarthritis, and the goal of PAO is to slow or halt the progression of arthrosis to prolong or potentially eliminate the need for total hip arthroplasty while relieving pain and increasing function and activity.^1,7,8

The PAO involves realigning the acetabulum to improve anterior and lateral coverage of the femoral head, acetabular anteversion, and medicalization of the joint.^5,6 It is preferred over other described acetabular osteotomies due to its inherent stability given that the posterior column is not violated.^3,5,6,9 Since its initial description in 1988,⁵ short-, medium- and long-term outcomes have been reported with excellent patient satisfaction and function.^2,7,10-15 The radiographic, functional, and patient satisfaction outcomes are excellent; therefore, this has become an accepted form of treatment for acetabular dysplasia.¹⁶ Additional procedures, such as hip arthroscopy, have also been combined with PAO to treat intra-articular pathologies without open arthrotomy.¹⁷ Several studies have evaluated preoperative radiographic factors, such as Tönnis grade, previous surgeries, and morphology of the hip; as well as demographic factors, such as age, body mass index (BMI), comorbid diseases, and activity level, which seem to play a role in the final outcome.^11,18,19 This work has advanced our understanding and allowed surgeons to apply selection criteria to improve patient outcomes.

There are multiple reported complications of the PAO procedure, including infection,² wound dehiscence,²⁰ periacetabular fracture,²¹ intra-articular extension of the osteotomy,²² excessive acetabular retroversion,^23,24 hardware failure, femoral or sciatic nerve palsy,²⁵ heterotopic ossification, prominent hardware, deep vein thrombosis or pulmonary embolism,²⁶ osteonecrosis of the femoral head or acetabulum,²⁴ non-union,²⁴ intrapelvic bleeding,²⁴ incisional hernia,²⁷ lateral femoral cutaneous nerve palsy,^20,28 and reflex sympathetic dystrophy.^1,2,29 There are also several studies reporting a learning curve phenomenon, in which the proportion of complications is higher in the initial series of surgeries performed by each specific surgeon.^22,20,29

Despite the widely reported short-, medium-, and long-term results of this treatment, no study thus far has attempted to correlate preoperative patient factors with early perioperative outcomes and complications. This information would be useful in patient counseling and decision making in the early postoperative period. Therefore, the purpose of this study is to analyze data from the perioperative period in patients who have undergone the PAO performed by a single surgeon at our institution to determine any correlation between patient characteristics such as age, comorbid disease, hip pathologic diagnosis, BMI, or previous procedures and perioperative complications occurring within the first 90 days.

Continue to: MATERIALS AND METHODS...

MATERIALS AND METHODS

After Institutional Review Board approval was obtained, a search was performed on the basis of operative report Current Procedural Terminology (CPT) codes for all patients who underwent PAO performed by a single surgeon between 2005 and 2013. Patients were included if they had PAO surgery with at least 90 days of follow-up. There was no exclusion for age, previous surgery, or underlying hip or medical diagnosis. A retrospective review of electronic medical records and radiographic imaging was undertaken to determine pre- and postoperative demographic information, pain scores, center-edge angle of Weiberg and Tönnis angles, intraoperative estimated blood loss, and all perioperative complications. Weight and height were recorded from the immediate preoperative visit and measured in kilograms (kg) and meters (m), respectively. BMI was derived from these measurements. Pain was assessed via visual analog scale at the preoperative visit as well as at 12 weeks postoperatively. Preoperative and 12-week postoperative Tönnis and center-edge angles were measured by a single orthopedic surgeon. All radiographs were deemed adequate in position and penetration for measurement of these parameters. Evidence of osteonecrosis of the femoral head was evaluated on all postoperative radiographs within this perioperative period. Estimated blood loss was established by review of operative records and anesthesia notes.

Perioperative complications were classified using the Clavien-Dindo system, which has previously been validated for use in hip preservation surgery.³⁰ This includes 5 grades of complications based on the treatment needed and severity of resulting long-term disability. Grade I complications do not require any change in the postoperative course and were therefore left out of our statistical analysis. Examples include symptomatic hardware, mild heterotopic ossification, and iliopsoas tendonitis. Grade II complications are those that require a change in outpatient management, such as delayed wound healing, superficial infection, transient nerve palsy, violation of the posterior column, and intra-articular osteotomy. Grade III complications require invasive or surgical treatment but leave the patient with no long-term disability. Examples include wound dehiscence, hematoma or infection necessitating surgical débridement and irrigation, and revision of the osteotomy due to hardware malposition or hip instability. Grade IV complications involve both surgery and long-term disability. Grade IV complications applicable to hip preservation surgery are osteonecrosis, permanent nerve injury, major vascular injury, or pulmonary embolism. A grade V complication is death.

For analysis and correlation between demographics and perioperative outcomes and complications, patients were grouped into several groups for comparison. Low (<30) vs high (>30) BMI, smokers vs non-smokers, diabetic vs non-diabetic patients, and those who had previous surgery vs those who did not were compared. A two-tailed t test was used for normally distributed continuous variables and a Mann-Whitney U test, for non-parametric data to compare postoperative radiographic correction, pain scores, and complication rates between each of these groups.

The operative technique for PAO as described by Ganz and colleagues⁵ in 1988 was utilized in all patients. When preoperative imaging showed evidence of labral pathology, a Cam lesion of the femoral head and neck junction, abnormal proximal femoral anatomy, osteonecrosis of the femoral head, or an os acetabulum, a concomitant procedure was performed. Seventeen patients underwent débridement of a Cam lesion noted to be impinging following PAO. Seventeen patients underwent labral débridement and 4 underwent labral repair. Four patients underwent intertrochanteric osteotomy and 1 underwent greater trochanteric slide. Two patients underwent free-vascularized fibular grafting to the ipsilateral femoral head and 5 underwent fixation of an os acetabulum.

Continue to: RESULTS...

RESULTS

A total of 80 hips in 73 patients underwent PAO with adequate perioperative follow-up and records in the inclusion period. Figures A-E represent a patient pre-procedure, immediately post procedure, and 6 months after successful PAO. The average age was 27.5 years (12.8-43.6 years), and the average BMI was 26.8 (18.7-52.2). Four patients had diabetes, 8 were smokers, and 10 had undergone previous surgeries including arthroscopic labral débridement, 3 open reduction with Salter osteotomy, 3 open reduction with internal fixation of a femoral neck fracture, 1 core decompression for femoral head osteonecrosis, 3 subtrochanteric osteotomy and subsequent non-union treated with cephalomedullary nailing, and 1 previous PAO requiring revision.¹

There were 11 perioperative complications in 10 patients (12.5%). The majority of these were infection (n = 10). Overall complications categorized by BMI are summarized in Table 1. Age was similar in patients with complications (27.4 ± 8.8 years) and those without (27.5 ± 8.2 years) (P = .99). Patients with complications had significantly higher BMI than those without (30.9.3 ± 9.5, 26.2 ± 5.6) (P = .03). There was no effect of concomitant procedures on the complication rate. Of the patients who had complications, 60% (6/10) had concomitant procedures, vs 63% (44/70) of those who had no complications (P = .86) Two of 4 patients with diabetes mellitus developed complications, both of which were wound infections. One of these required incision and débridement. There were no perioperative complications in any of the 7 smokers.  

Abbreviation: BMI, body mass index.

Twenty hips were in the high-BMI (>30) and 60 were in the low-BMI (<30) patient groups. There were 6 total perioperative complications in the high-BMI group (30%) and 5 in the low-BMI group (8%). The most common complications in the low-BMI group were superficial infections.⁴ There were 6 total complications in the high-BMI group: 2 deep and 4 superficial infections. There were 3 reoperations (5%) in the low-BMI group during the perioperative period. Two patients underwent successful débridement and irrigation of a superficial wound, and 1 patient required removal of a prominent screw. There were 3 reoperations in the high-BMI group, all of which were débridement and irrigations for wound infections. The rate of wound dehiscence and wound infection was significantly higher in high-BMI patients (30% [6/20]) than in low-BMI patients (8.3% [4/60]) (P = .006). The mean estimated blood loss in the high-BMI group was greater at 923.75 mL vs 779.25 mL in the low-BMI patients; however, this did not reach statistical significance (P = .350). Seventy percent (14/20) of patients who were obese had concomitant procedures vs 60% (36/60) of those who had normal BMI (P = .42 by chi-square analysis). There was no difference in estimated blood loss in patients who underwent concomitant procedures (Table 2).

Abbreviations: BMI, body mass index; EBL, estimated blood loss.

Preoperative pain scores improved from 4.9 (range, 0-10) to 1.9 (range, 0-6) in the high-BMI group and 4.2 (range, 0-10) to 1.2 (range, 0-6) in the low-BMI group (P = .260). The preoperative center-edge angle in the high-BMI group improved from 6.63° ± 6.5° to 28.53° ± 6.7°, and the Tönnis angle from 24.96° ± 6.3° to 10.06° ± 7.7°. In the low-BMI group the center-edge angle improved from 10.53° ± 11.77° to 27.07° ± 13.9°, and the Tönnis angle from 19.00° ± 10.3° to 2.79° ± 8.3°. There was no difference in postoperative center-edge angle between the high-BMI and low-BMI groups (P = .66). There was a trend toward significance in the postoperative Tönnis angle between the high-BMI and low-BMI groups (P = .051).

Continue to: DISCUSSION...

DISCUSSION

There have been 4 previously published articles specifically on complications following PAO. Each of these encompassed follow-up visits including both the perioperative period and at least 2 years of follow-up.^20,22,24,29 Davey and Santore²⁹ reported an overall rate of complications of 10% in a series of 70 patients. These authors classified complications into minor, moderate, and major for purposes of research and discussion, and this classification system has been utilized or modified within the literature to discuss complications in most other articles. Complications within the perioperative period included 2 cases of excessive intraoperative bleeding, 2 cases of reflex sympathetic dystrophy, and 1 case each of unresolved sciatic nerve palsy and deep vein thrombosis.²⁹ Hussell and colleagues²² reported on a large series of 508 PAOs and analyzed the technical complications that occurred during the procedure and caused either immediate or longer-term problems for the patients. Notably, they concluded that 85% of the technical complications occurred with the initial 50 PAOs performed, signifying a steep learning curve for this technically demanding procedure. Perioperative complications reported were intra-articular osteotomy in 2.2%, femoral nerve palsy in 0.6%, sciatic nerve palsy in 1.0%, posterior column insufficiency in 1.2%, and symptomatic hardware in 3.0%.²² Biedermann and colleagues²⁰ found that 47 out of 60 PAOs in their series had at least 1 minor complication. The most common perioperative complications were lateral femoral cutaneous nerve dysesthesia in 33%, delayed wound healing infection in 15%, major blood loss in 8.3%, sciatic or peroneal nerve palsy in 10%, posterior column discontinuity in 6.7%, and intra-articular osteotomy in 1.6%.²⁰ Most recently, complications of PAO in an adolescent population were evaluated.²⁴ The overall rate of complications was 37%. Major perioperative complications included 1 patient with excessive bleeding due to an aberrant artery at the medial wall of the pelvis thought to be due to revascularization following a previous Dega osteotomy. Two patients required immediate revision of the osteotomy due to excessive anterior coverage noted on postoperative radiographs. There were 5% with superficial stitch abscess causing minor infection, 5% with transient lateral femoral cutaneous nerve palsy, and 15 patients with symptomatic hardware.²⁴

At 12.5%, our overall complication rate is slightly lower than that previously reported in the literature. This may be due to the difference in the scope of this study, which reported only perioperative complications. We also chose to utilize the modified Clavien-Dindo classification system for reporting our complications rather than classifying them as minor or major as in the above studies. This classification system has been validated for use in reporting complications of hip preservation surgery. We considered only Grade II complications and higher for statistical analysis as these required a change in postoperative management, which may have artificially lowered our complication rate.

The data in this study indicate that, compared with patients with a BMI of <30, obese patients have a higher rate of perioperative complications and reoperations. Additionally, the proportion of Grade II and higher complications, importantly deep infection, was higher in obese patients. We did not have any reported incidence of deep vein thrombosis or pulmonary embolism, urinary tract infection, intra-articular osteotomy, acetabular or pelvic fracture, femoral or sciatic nerve palsy, or long-term lateral femoral cutaneous nerve palsy in this series of patients. The most common complication in the low-BMI group was symptomatic hardware. Sixteen patients had this complaint; however, this was not considered a Grade II complication as there would be no change in management during the study period, including the perioperative time frame. Two out of 4 patients with diabetes mellitus developed wound infections, both of which required reoperation. However, the number of patients with diabetes mellitus was not large enough to draw any conclusions from this information. There were no perioperative complications in smokers. We hypothesized that there may be a higher rate of wound complications in this population, and although the data in our patients did not support this hypothesis, a larger cohort of smokers is needed to make this determination. Another potential complication in smokers is non-union, which was not reported in this study on perioperative complications. Although it did not reach statistical significance, the intraoperative blood loss was almost 150 mL greater in high-BMI patients (924 mL vs 779 mL). Additionally, there appears to be no effect of concomitant procedure on estimated blood loss in either low- or high-BMI groups. Age was not a risk factor for the development of perioperative complications in this cohort. Pain was reliably improved in both the high- and low-BMI groups at the 12-week follow-up visit. The center-edge angle could be normalized in both groups to 28.53° in the high-BMI group and 27.07° in the low-BMI group, with a similar final correction between groups. The Tönnis angle was also improved in both groups, but the final Tönnis angle strongly trended toward statistical significance (2.79° in the low-BMI group vs 10.06° in the high-BMI group).

This study has limitations in that it is a retrospective review of patient information based on medical records and therefore relied on documentation performed at the time of service. There also may have been a difference in the intraoperative or postoperative protocol for wound monitoring or rehabilitation among patients based on body habitus, which we are not able to detect from the medical records. Although the overall number of patients in this cohort is comparable to other studies on the outcomes of patients after PAO, the number of patients in each BMI group was not evenly matched. Without randomization, selection bias occurred at the time of the procedure as some obese patients were not offered this procedure based on the senior surgeon’s discretion. Additionally, when subgroups such as patients with diabetes mellitus or smokers were analyzed, the number of subjects was too small for statistical analysis; therefore, no conclusions could be made as to the risk of perioperative complications in these populations.

CONCLUSION

Despite the limitations in this study, based on the data from this cohort, we concluded that the goal of PAO of restoring more normal hip joint anatomy can be achieved in both low- and high-BMI patients. However, patients with a BMI >30 should be counseled on their increased risk of major perioperative complications, specifically wound dehiscence and infection, and the higher likelihood of reoperation for treatment of these complications. Diabetic patients can be counseled that they may have a higher risk of infection as well, but future studies with larger numbers will be needed to confirm this. Patients with low BMI should be counseled about the potential for prominent or symptomatic hardware, which may necessitate removal following osteotomy union.

ABSTRACT

Delayed unions and nonunions of the scaphoid are most often treated by open reduction and internal fixation with bone grafting. We sought to evaluate a large consecutive series of nondisplaced or minimally displaced scaphoid nonunions and delayed unions treated by a compression screw without bone grafting by 2 fellowship trained hand surgeons. A total of 23 patients (19 males, 4 females) were identified who had fractures located at the distal third (2), the waist (18), and the proximal third (3). Of the 23 patients, 19 had a complete follow-up (mean follow-up period, 5.2 months) with evidence of radiographic union. There were no radiographic signs of arthrosis, osteonecrosis of the scaphoid, hardware-related complications, or reported revision surgeries. In conclusion, nonunions and delayed unions in nondisplaced or minimally displaced scaphoids without carpal malalignment can be successfully treated using compression screw fixation without bone grafting.

Continued to: Scaphoid nonunions or delayed unions with displacement...

Scaphoid nonunions or delayed unions with displacement, humpback deformities, or dorsal intercalated segmental instability deformities require open exposure with reduction of the fracture and autogenous bone grafting (structural or nonstructural and vascularized or nonvascularized).^1,2 However, in the absence of displacement or deformity, compression and internal fixation without bone grafting may be sufficient to achieve union.

Several reports have described the use of internal fixation alone in the management of scaphoid nonunions with both minimal and extensive bone loss.^3-7 These studies have shown that screw fixation alone affords less morbidity to the patient while allowing high rates of union.

Previous reports of internal fixation alone included limited numbers of patients for review. Therefore, we aim to review a large consecutive series of scaphoid delayed unions and nonunions without osteonecrosis or deformity managed by only internal fixation. Our hypothesis is that drilling combined with compression and rigid stabilization would allow for bony union in these cases

MATERIALS AND METHODS

After Institutional Review Board approval was obtained, a retrospective review of prospectively collected data was performed on consecutive patients with a delayed union or nonunion of the scaphoid. All injuries had failed conservative treatment of casting for at least 12 weeks and ultrasound stimulation, and were subsequently treated by compression screw fixation by 1 of 2 fellowship trained hand surgeons. The database comprised the data of patients who presented to a single, Level 1 trauma center between 2000 and 2012.  

Delayed unions and nonunions were defined as a lack of radiographic trabecular bridging and pain on clinical examination at 3 and 6 months, respectively. All fractures were nondisplaced or minimally displaced (<2 mm), and patients with carpal malalignment or humpback deformity (based on scapholunate angle on plain radiographs) were excluded. Clinical outcome measures included evidence of radiographic union, revision surgery, pain, and reported complications.

Continue to: Inclusion criteria were all patients who sustained...

Inclusion criteria were all patients who sustained a minimally displaced scaphoid fracture and were treated conservatively with casting for at least 12 weeks and ultrasound stimulation, and progressed to delayed unions or nonunions.

Patients younger than age 18 years or with radiographic evidence of arthrosis or humpback deformity were excluded. Any fracture with >2 mm of gapping on original injury radiographs was not considered as minimally displaced and was also excluded. Furthermore, patients with a previous ipsilateral scaphoid injury or hand surgery were also excluded.

Compression screw placement was recorded as being either central or eccentric based on Trumble and colleagues’⁸ criteria. Posteroanterior (PA), lateral, and scaphoid view radiographs were reviewed by the first author (DS) and the treating hand surgeon (AS). Central screw placement was substantiated if the screw was in the middle third of the proximal pole in all 3 views.

The final set of postoperative radiographs was reviewed for unions. Union was defined as bridging trabeculation with near or complete obliteration of the fracture line on PA, lateral, and scaphoid radiographic views. Computerized tomography (CT) was performed at the discretion of the treating surgeon, and its use was not required if there was near obliteration of the fracture line on the 3-view radiographs and in the absence of patient-reported pain. Patients with bone loss or sclerosis were included as long as no deformity existed.

After surgical intervention, a short-arm cast was applied for 6 weeks, followed by a wrist splint for 4 to 8 weeks depending on patient comfort.

Continue to: SURGICAL TECHNIQUE...

SURGICAL TECHNIQUE

Either a 1-cm to 2-cm transverse incision distal to Lister’s tubercle or a longitudinal incision just ulnar was utilized. The extensor pollicis longus was identified and retracted. A longitudinal or an L-shaped capsulotomy was made to identify the proximal pole of the scaphoid. With the wrist flexed, a guide wire was inserted down the central axis of the scaphoid and confirmed by fluoroscopy. The measurement was made off the guidewire and 4 to 6 mm was subtracted. The scaphoid was then drilled, and the variable pitch compression screw (Acutrak Headless Compression Screw, Acumed) was inserted. Compression and position of the screw were confirmed by fluoroscopy before closure.

RESULTS

A total of 23 patients (19 males, 4 females) with acute scaphoid fractures who were treated conservatively with casting for at least 12 weeks and ultrasound stimulation, and progressed to delayed unions or nonunions were identified in this study. The ages of the patients ranged from 19 to 50 years. Of the 23 patients, 6 were smokers. The majority of patients sustained fractures in the scaphoid waist (18 patients) (Figure 1). Two patients had distal third fractures, and 3 had proximal third fractures.

The average time from the sustained injury to the surgical intervention was 8.2 months (range, 3.1-27.6 months). There were no patients with delayed diagnoses. Three fractures were identified as delayed unions with failure of union and pain after 3 months of conservative treatment, whereas the other 20 were identified as nonunions with at least 6 months of failed conservative treatment.

Of the 23 patients, 21 were found to have centrally placed variable compression screws based on Trumble and colleagues’⁸ criteria. Of the 23 patients, 19 had a complete follow-up course with radiographs at 6 months after surgery. All of these 19 patients had evidence of radiographic union defined as bridging trabeculation with near or complete obliteration of the fracture line on PA, lateral, and scaphoid radiographic views (Figure 2). Of the 6 smokers, 5 progressed to radiographic union and 1 patient had <6 months of postoperative return visits and could not be contacted. At the final clinic visit, all of the 19 patients denied wrist pain on direct palpation over the scaphoid tubercle, and no complications were reported. There were no repeat or revision surgical interventions.

Four patients had limited follow-up with <6 months of postoperative return visits. Their final set of radiographs did not demonstrate complete bridging trabeculation. One patient who moved away from the area was lost to follow-up but was contacted. The patient stated that he had a pain-free wrist with no further surgical interventions on his scaphoid. The other 3 patients could not be contacted.

DISCUSSION

The management of scaphoid nonunions and delayed unions has dramatically evolved over the past 20 years.^1,3-8 Historically, semi-rigid stabilization using Kirschner wires and casting afforded a 77% union rate in these cases.⁹ More recently, several authors have reported that stabilization without bone grafting can predictably unite scaphoid nonunions. Treating patients with uncomplicated scaphoid nonunions and delayed unions by internal fixation alone may be all that is required to achieve union.

The definitions of a scaphoid nonunion and delayed union are complex. The exact time when a scaphoid fracture heals varies between patients.^2,5,10 However, the majority of hand surgeons believe that failure to see clear signs of healing (in waist fractures) after 3 months from the injury would suggest a failure to heal and a “delayed” union, whereas failure after 6 months from the injury and without clear signs of healing indicate a nonunion.^5,6,10,11 Any resorption at the fracture site suggests that the fracture will not heal by continued immobilization alone and will require surgery.¹⁰

Continue to: Hand surgeons have several surgical options...

Hand surgeons have several surgical options when managing scaphoid injuries. Mahmoud and Koptan⁴ used a volar approach to percutaneously deliver a headless compression screw into 27 nonunions. Postoperative CT scans demonstrated fracture union in all 27 patients, and no patient underwent revision surgery. Interestingly, 14 of their patients had extensive preoperative resorption (but no deformity) of >5 mm.

Although volar percutaneous approaches for internal fixation have been cited to provide high rates of union and high patient satisfaction in acute scaphoid fracture fixation, this study utilized a dorsal approach. Both Wozasek and Moser¹² and Haddad and Goddard¹³ reported excellent results and high union rates using a volar approach in consecutive acute scaphoid fractures. Despite these results, there are concerns that using a volar approach may damage the scaphotrapezial joint and may be prone to eccentric placement of compression screws.^8,14

Slade and colleagues³ did utilize the dorsal approach with arthroscopic assistance to deliver a compression screw into scaphoid nonunions in 15 consecutive patients without any evidence of deformity, sclerosis, or resorption. Similar to our investigation, they treated patients with both delayed unions and nonunions. CT scans were used to confirm unions in all their patients. Using a dorsal approach, Yassaee and Yang¹⁵ treated 9 consecutive patients using a compression screw without bone grafting for both delayed and nonunion scaphoid injuries. Other authors have used both volar and dorsal approaches in 12 consecutive delayed and nonunion scaphoid injuries and found that 11 of the 12 injuries progressed to unions.⁶

Although these authors and several others advocate the use of CT scans to assess unions, our investigation used bridging trabeculation obliteration of the fracture line on 3 standard radiographic views to confirm unions in addition to the absence of pain clinically.^16,17 CT scans expose the patient to increased radiation that, in our experience, does not alter the postoperative clinical course.¹⁸ If there is clear evidence of bridged callus and no pain on physical examination, a CT scan performed to reconfirm the union affords little benefit to clinical management.¹⁹

Continue to: All these previous studies have demonstrated...

All these previous studies have demonstrated excellent union rates but using a limited series of patients. We reviewed a large number of consecutive patients with scaphoid delayed unions and nonunions treated by screw fixation without bone grafting. Our hospital is a safety net institution for a large urban catchment area and had complete radiographic and clinical data for 19 of our 23 patients. One patient was contacted by telephone and he reported no pain and no revision surgical interventions.

The limitations of this study include not only its retrospective design but also its limited secondary outcome measures. However, our primary outcomes of union, pain, and complications are of utmost importance to clinicians and patients alike. Similar to other authors, we used radiographs to confirm unions. Although bridging trabeculation in radiographs has been demonstrated as soon as 1 month after the injury, there may be problems with interobserver reliability.^{4,13,15,20,21}

Patients being lost to follow-up is not uncommon in the orthopedic trauma literature and can influence results.^22,23 It is speculative to infer that the 3 patients who did not complete a follow-up course did not return because their pain had mitigated.

CONCLUSION 

Like several fractures, the lack of stability and the absence of micro-motion are believed to contribute to fibrous nonunions in scaphoid fractures.¹³ This study provides a large consecutive cohort of patients with minimally displaced scaphoid delayed unions and nonunions that were successfully treated by rigid internal fixation without bone grafting. These results confirm previous reports that bone grafting is not required to provide predictable unions for the majority of scaphoid nonunions.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

Delayed unions and nonunions of the scaphoid are most often treated by open reduction and internal fixation with bone grafting. We sought to evaluate a large consecutive series of nondisplaced or minimally displaced scaphoid nonunions and delayed unions treated by a compression screw without bone grafting by 2 fellowship trained hand surgeons. A total of 23 patients (19 males, 4 females) were identified who had fractures located at the distal third (2), the waist (18), and the proximal third (3). Of the 23 patients, 19 had a complete follow-up (mean follow-up period, 5.2 months) with evidence of radiographic union. There were no radiographic signs of arthrosis, osteonecrosis of the scaphoid, hardware-related complications, or reported revision surgeries. In conclusion, nonunions and delayed unions in nondisplaced or minimally displaced scaphoids without carpal malalignment can be successfully treated using compression screw fixation without bone grafting.

Continued to: Scaphoid nonunions or delayed unions with displacement...

Scaphoid nonunions or delayed unions with displacement, humpback deformities, or dorsal intercalated segmental instability deformities require open exposure with reduction of the fracture and autogenous bone grafting (structural or nonstructural and vascularized or nonvascularized).^1,2 However, in the absence of displacement or deformity, compression and internal fixation without bone grafting may be sufficient to achieve union.

Several reports have described the use of internal fixation alone in the management of scaphoid nonunions with both minimal and extensive bone loss.^3-7 These studies have shown that screw fixation alone affords less morbidity to the patient while allowing high rates of union.

Previous reports of internal fixation alone included limited numbers of patients for review. Therefore, we aim to review a large consecutive series of scaphoid delayed unions and nonunions without osteonecrosis or deformity managed by only internal fixation. Our hypothesis is that drilling combined with compression and rigid stabilization would allow for bony union in these cases

MATERIALS AND METHODS

After Institutional Review Board approval was obtained, a retrospective review of prospectively collected data was performed on consecutive patients with a delayed union or nonunion of the scaphoid. All injuries had failed conservative treatment of casting for at least 12 weeks and ultrasound stimulation, and were subsequently treated by compression screw fixation by 1 of 2 fellowship trained hand surgeons. The database comprised the data of patients who presented to a single, Level 1 trauma center between 2000 and 2012.  

Delayed unions and nonunions were defined as a lack of radiographic trabecular bridging and pain on clinical examination at 3 and 6 months, respectively. All fractures were nondisplaced or minimally displaced (<2 mm), and patients with carpal malalignment or humpback deformity (based on scapholunate angle on plain radiographs) were excluded. Clinical outcome measures included evidence of radiographic union, revision surgery, pain, and reported complications.

Continue to: Inclusion criteria were all patients who sustained...

Inclusion criteria were all patients who sustained a minimally displaced scaphoid fracture and were treated conservatively with casting for at least 12 weeks and ultrasound stimulation, and progressed to delayed unions or nonunions.

Patients younger than age 18 years or with radiographic evidence of arthrosis or humpback deformity were excluded. Any fracture with >2 mm of gapping on original injury radiographs was not considered as minimally displaced and was also excluded. Furthermore, patients with a previous ipsilateral scaphoid injury or hand surgery were also excluded.

Compression screw placement was recorded as being either central or eccentric based on Trumble and colleagues’⁸ criteria. Posteroanterior (PA), lateral, and scaphoid view radiographs were reviewed by the first author (DS) and the treating hand surgeon (AS). Central screw placement was substantiated if the screw was in the middle third of the proximal pole in all 3 views.

The final set of postoperative radiographs was reviewed for unions. Union was defined as bridging trabeculation with near or complete obliteration of the fracture line on PA, lateral, and scaphoid radiographic views. Computerized tomography (CT) was performed at the discretion of the treating surgeon, and its use was not required if there was near obliteration of the fracture line on the 3-view radiographs and in the absence of patient-reported pain. Patients with bone loss or sclerosis were included as long as no deformity existed.

After surgical intervention, a short-arm cast was applied for 6 weeks, followed by a wrist splint for 4 to 8 weeks depending on patient comfort.

Continue to: SURGICAL TECHNIQUE...

SURGICAL TECHNIQUE

Either a 1-cm to 2-cm transverse incision distal to Lister’s tubercle or a longitudinal incision just ulnar was utilized. The extensor pollicis longus was identified and retracted. A longitudinal or an L-shaped capsulotomy was made to identify the proximal pole of the scaphoid. With the wrist flexed, a guide wire was inserted down the central axis of the scaphoid and confirmed by fluoroscopy. The measurement was made off the guidewire and 4 to 6 mm was subtracted. The scaphoid was then drilled, and the variable pitch compression screw (Acutrak Headless Compression Screw, Acumed) was inserted. Compression and position of the screw were confirmed by fluoroscopy before closure.

RESULTS

A total of 23 patients (19 males, 4 females) with acute scaphoid fractures who were treated conservatively with casting for at least 12 weeks and ultrasound stimulation, and progressed to delayed unions or nonunions were identified in this study. The ages of the patients ranged from 19 to 50 years. Of the 23 patients, 6 were smokers. The majority of patients sustained fractures in the scaphoid waist (18 patients) (Figure 1). Two patients had distal third fractures, and 3 had proximal third fractures.

The average time from the sustained injury to the surgical intervention was 8.2 months (range, 3.1-27.6 months). There were no patients with delayed diagnoses. Three fractures were identified as delayed unions with failure of union and pain after 3 months of conservative treatment, whereas the other 20 were identified as nonunions with at least 6 months of failed conservative treatment.

Of the 23 patients, 21 were found to have centrally placed variable compression screws based on Trumble and colleagues’⁸ criteria. Of the 23 patients, 19 had a complete follow-up course with radiographs at 6 months after surgery. All of these 19 patients had evidence of radiographic union defined as bridging trabeculation with near or complete obliteration of the fracture line on PA, lateral, and scaphoid radiographic views (Figure 2). Of the 6 smokers, 5 progressed to radiographic union and 1 patient had <6 months of postoperative return visits and could not be contacted. At the final clinic visit, all of the 19 patients denied wrist pain on direct palpation over the scaphoid tubercle, and no complications were reported. There were no repeat or revision surgical interventions.

Four patients had limited follow-up with <6 months of postoperative return visits. Their final set of radiographs did not demonstrate complete bridging trabeculation. One patient who moved away from the area was lost to follow-up but was contacted. The patient stated that he had a pain-free wrist with no further surgical interventions on his scaphoid. The other 3 patients could not be contacted.

DISCUSSION

The management of scaphoid nonunions and delayed unions has dramatically evolved over the past 20 years.^1,3-8 Historically, semi-rigid stabilization using Kirschner wires and casting afforded a 77% union rate in these cases.⁹ More recently, several authors have reported that stabilization without bone grafting can predictably unite scaphoid nonunions. Treating patients with uncomplicated scaphoid nonunions and delayed unions by internal fixation alone may be all that is required to achieve union.

The definitions of a scaphoid nonunion and delayed union are complex. The exact time when a scaphoid fracture heals varies between patients.^2,5,10 However, the majority of hand surgeons believe that failure to see clear signs of healing (in waist fractures) after 3 months from the injury would suggest a failure to heal and a “delayed” union, whereas failure after 6 months from the injury and without clear signs of healing indicate a nonunion.^5,6,10,11 Any resorption at the fracture site suggests that the fracture will not heal by continued immobilization alone and will require surgery.¹⁰

Continue to: Hand surgeons have several surgical options...

Hand surgeons have several surgical options when managing scaphoid injuries. Mahmoud and Koptan⁴ used a volar approach to percutaneously deliver a headless compression screw into 27 nonunions. Postoperative CT scans demonstrated fracture union in all 27 patients, and no patient underwent revision surgery. Interestingly, 14 of their patients had extensive preoperative resorption (but no deformity) of >5 mm.

Although volar percutaneous approaches for internal fixation have been cited to provide high rates of union and high patient satisfaction in acute scaphoid fracture fixation, this study utilized a dorsal approach. Both Wozasek and Moser¹² and Haddad and Goddard¹³ reported excellent results and high union rates using a volar approach in consecutive acute scaphoid fractures. Despite these results, there are concerns that using a volar approach may damage the scaphotrapezial joint and may be prone to eccentric placement of compression screws.^8,14

Slade and colleagues³ did utilize the dorsal approach with arthroscopic assistance to deliver a compression screw into scaphoid nonunions in 15 consecutive patients without any evidence of deformity, sclerosis, or resorption. Similar to our investigation, they treated patients with both delayed unions and nonunions. CT scans were used to confirm unions in all their patients. Using a dorsal approach, Yassaee and Yang¹⁵ treated 9 consecutive patients using a compression screw without bone grafting for both delayed and nonunion scaphoid injuries. Other authors have used both volar and dorsal approaches in 12 consecutive delayed and nonunion scaphoid injuries and found that 11 of the 12 injuries progressed to unions.⁶

Although these authors and several others advocate the use of CT scans to assess unions, our investigation used bridging trabeculation obliteration of the fracture line on 3 standard radiographic views to confirm unions in addition to the absence of pain clinically.^16,17 CT scans expose the patient to increased radiation that, in our experience, does not alter the postoperative clinical course.¹⁸ If there is clear evidence of bridged callus and no pain on physical examination, a CT scan performed to reconfirm the union affords little benefit to clinical management.¹⁹

Continue to: All these previous studies have demonstrated...

All these previous studies have demonstrated excellent union rates but using a limited series of patients. We reviewed a large number of consecutive patients with scaphoid delayed unions and nonunions treated by screw fixation without bone grafting. Our hospital is a safety net institution for a large urban catchment area and had complete radiographic and clinical data for 19 of our 23 patients. One patient was contacted by telephone and he reported no pain and no revision surgical interventions.

The limitations of this study include not only its retrospective design but also its limited secondary outcome measures. However, our primary outcomes of union, pain, and complications are of utmost importance to clinicians and patients alike. Similar to other authors, we used radiographs to confirm unions. Although bridging trabeculation in radiographs has been demonstrated as soon as 1 month after the injury, there may be problems with interobserver reliability.^{4,13,15,20,21}

Patients being lost to follow-up is not uncommon in the orthopedic trauma literature and can influence results.^22,23 It is speculative to infer that the 3 patients who did not complete a follow-up course did not return because their pain had mitigated.

CONCLUSION 

Like several fractures, the lack of stability and the absence of micro-motion are believed to contribute to fibrous nonunions in scaphoid fractures.¹³ This study provides a large consecutive cohort of patients with minimally displaced scaphoid delayed unions and nonunions that were successfully treated by rigid internal fixation without bone grafting. These results confirm previous reports that bone grafting is not required to provide predictable unions for the majority of scaphoid nonunions.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

Delayed unions and nonunions of the scaphoid are most often treated by open reduction and internal fixation with bone grafting. We sought to evaluate a large consecutive series of nondisplaced or minimally displaced scaphoid nonunions and delayed unions treated by a compression screw without bone grafting by 2 fellowship trained hand surgeons. A total of 23 patients (19 males, 4 females) were identified who had fractures located at the distal third (2), the waist (18), and the proximal third (3). Of the 23 patients, 19 had a complete follow-up (mean follow-up period, 5.2 months) with evidence of radiographic union. There were no radiographic signs of arthrosis, osteonecrosis of the scaphoid, hardware-related complications, or reported revision surgeries. In conclusion, nonunions and delayed unions in nondisplaced or minimally displaced scaphoids without carpal malalignment can be successfully treated using compression screw fixation without bone grafting.

Continued to: Scaphoid nonunions or delayed unions with displacement...

Scaphoid nonunions or delayed unions with displacement, humpback deformities, or dorsal intercalated segmental instability deformities require open exposure with reduction of the fracture and autogenous bone grafting (structural or nonstructural and vascularized or nonvascularized).^1,2 However, in the absence of displacement or deformity, compression and internal fixation without bone grafting may be sufficient to achieve union.

Several reports have described the use of internal fixation alone in the management of scaphoid nonunions with both minimal and extensive bone loss.^3-7 These studies have shown that screw fixation alone affords less morbidity to the patient while allowing high rates of union.

Previous reports of internal fixation alone included limited numbers of patients for review. Therefore, we aim to review a large consecutive series of scaphoid delayed unions and nonunions without osteonecrosis or deformity managed by only internal fixation. Our hypothesis is that drilling combined with compression and rigid stabilization would allow for bony union in these cases

MATERIALS AND METHODS

After Institutional Review Board approval was obtained, a retrospective review of prospectively collected data was performed on consecutive patients with a delayed union or nonunion of the scaphoid. All injuries had failed conservative treatment of casting for at least 12 weeks and ultrasound stimulation, and were subsequently treated by compression screw fixation by 1 of 2 fellowship trained hand surgeons. The database comprised the data of patients who presented to a single, Level 1 trauma center between 2000 and 2012.  

Delayed unions and nonunions were defined as a lack of radiographic trabecular bridging and pain on clinical examination at 3 and 6 months, respectively. All fractures were nondisplaced or minimally displaced (<2 mm), and patients with carpal malalignment or humpback deformity (based on scapholunate angle on plain radiographs) were excluded. Clinical outcome measures included evidence of radiographic union, revision surgery, pain, and reported complications.

Continue to: Inclusion criteria were all patients who sustained...

Inclusion criteria were all patients who sustained a minimally displaced scaphoid fracture and were treated conservatively with casting for at least 12 weeks and ultrasound stimulation, and progressed to delayed unions or nonunions.

Patients younger than age 18 years or with radiographic evidence of arthrosis or humpback deformity were excluded. Any fracture with >2 mm of gapping on original injury radiographs was not considered as minimally displaced and was also excluded. Furthermore, patients with a previous ipsilateral scaphoid injury or hand surgery were also excluded.

Compression screw placement was recorded as being either central or eccentric based on Trumble and colleagues’⁸ criteria. Posteroanterior (PA), lateral, and scaphoid view radiographs were reviewed by the first author (DS) and the treating hand surgeon (AS). Central screw placement was substantiated if the screw was in the middle third of the proximal pole in all 3 views.

The final set of postoperative radiographs was reviewed for unions. Union was defined as bridging trabeculation with near or complete obliteration of the fracture line on PA, lateral, and scaphoid radiographic views. Computerized tomography (CT) was performed at the discretion of the treating surgeon, and its use was not required if there was near obliteration of the fracture line on the 3-view radiographs and in the absence of patient-reported pain. Patients with bone loss or sclerosis were included as long as no deformity existed.

After surgical intervention, a short-arm cast was applied for 6 weeks, followed by a wrist splint for 4 to 8 weeks depending on patient comfort.

Continue to: SURGICAL TECHNIQUE...

SURGICAL TECHNIQUE

Either a 1-cm to 2-cm transverse incision distal to Lister’s tubercle or a longitudinal incision just ulnar was utilized. The extensor pollicis longus was identified and retracted. A longitudinal or an L-shaped capsulotomy was made to identify the proximal pole of the scaphoid. With the wrist flexed, a guide wire was inserted down the central axis of the scaphoid and confirmed by fluoroscopy. The measurement was made off the guidewire and 4 to 6 mm was subtracted. The scaphoid was then drilled, and the variable pitch compression screw (Acutrak Headless Compression Screw, Acumed) was inserted. Compression and position of the screw were confirmed by fluoroscopy before closure.

RESULTS

A total of 23 patients (19 males, 4 females) with acute scaphoid fractures who were treated conservatively with casting for at least 12 weeks and ultrasound stimulation, and progressed to delayed unions or nonunions were identified in this study. The ages of the patients ranged from 19 to 50 years. Of the 23 patients, 6 were smokers. The majority of patients sustained fractures in the scaphoid waist (18 patients) (Figure 1). Two patients had distal third fractures, and 3 had proximal third fractures.

The average time from the sustained injury to the surgical intervention was 8.2 months (range, 3.1-27.6 months). There were no patients with delayed diagnoses. Three fractures were identified as delayed unions with failure of union and pain after 3 months of conservative treatment, whereas the other 20 were identified as nonunions with at least 6 months of failed conservative treatment.

Of the 23 patients, 21 were found to have centrally placed variable compression screws based on Trumble and colleagues’⁸ criteria. Of the 23 patients, 19 had a complete follow-up course with radiographs at 6 months after surgery. All of these 19 patients had evidence of radiographic union defined as bridging trabeculation with near or complete obliteration of the fracture line on PA, lateral, and scaphoid radiographic views (Figure 2). Of the 6 smokers, 5 progressed to radiographic union and 1 patient had <6 months of postoperative return visits and could not be contacted. At the final clinic visit, all of the 19 patients denied wrist pain on direct palpation over the scaphoid tubercle, and no complications were reported. There were no repeat or revision surgical interventions.

Four patients had limited follow-up with <6 months of postoperative return visits. Their final set of radiographs did not demonstrate complete bridging trabeculation. One patient who moved away from the area was lost to follow-up but was contacted. The patient stated that he had a pain-free wrist with no further surgical interventions on his scaphoid. The other 3 patients could not be contacted.

DISCUSSION

The management of scaphoid nonunions and delayed unions has dramatically evolved over the past 20 years.^1,3-8 Historically, semi-rigid stabilization using Kirschner wires and casting afforded a 77% union rate in these cases.⁹ More recently, several authors have reported that stabilization without bone grafting can predictably unite scaphoid nonunions. Treating patients with uncomplicated scaphoid nonunions and delayed unions by internal fixation alone may be all that is required to achieve union.

The definitions of a scaphoid nonunion and delayed union are complex. The exact time when a scaphoid fracture heals varies between patients.^2,5,10 However, the majority of hand surgeons believe that failure to see clear signs of healing (in waist fractures) after 3 months from the injury would suggest a failure to heal and a “delayed” union, whereas failure after 6 months from the injury and without clear signs of healing indicate a nonunion.^5,6,10,11 Any resorption at the fracture site suggests that the fracture will not heal by continued immobilization alone and will require surgery.¹⁰

Continue to: Hand surgeons have several surgical options...

Hand surgeons have several surgical options when managing scaphoid injuries. Mahmoud and Koptan⁴ used a volar approach to percutaneously deliver a headless compression screw into 27 nonunions. Postoperative CT scans demonstrated fracture union in all 27 patients, and no patient underwent revision surgery. Interestingly, 14 of their patients had extensive preoperative resorption (but no deformity) of >5 mm.

Although volar percutaneous approaches for internal fixation have been cited to provide high rates of union and high patient satisfaction in acute scaphoid fracture fixation, this study utilized a dorsal approach. Both Wozasek and Moser¹² and Haddad and Goddard¹³ reported excellent results and high union rates using a volar approach in consecutive acute scaphoid fractures. Despite these results, there are concerns that using a volar approach may damage the scaphotrapezial joint and may be prone to eccentric placement of compression screws.^8,14

Slade and colleagues³ did utilize the dorsal approach with arthroscopic assistance to deliver a compression screw into scaphoid nonunions in 15 consecutive patients without any evidence of deformity, sclerosis, or resorption. Similar to our investigation, they treated patients with both delayed unions and nonunions. CT scans were used to confirm unions in all their patients. Using a dorsal approach, Yassaee and Yang¹⁵ treated 9 consecutive patients using a compression screw without bone grafting for both delayed and nonunion scaphoid injuries. Other authors have used both volar and dorsal approaches in 12 consecutive delayed and nonunion scaphoid injuries and found that 11 of the 12 injuries progressed to unions.⁶

Although these authors and several others advocate the use of CT scans to assess unions, our investigation used bridging trabeculation obliteration of the fracture line on 3 standard radiographic views to confirm unions in addition to the absence of pain clinically.^16,17 CT scans expose the patient to increased radiation that, in our experience, does not alter the postoperative clinical course.¹⁸ If there is clear evidence of bridged callus and no pain on physical examination, a CT scan performed to reconfirm the union affords little benefit to clinical management.¹⁹

Continue to: All these previous studies have demonstrated...

All these previous studies have demonstrated excellent union rates but using a limited series of patients. We reviewed a large number of consecutive patients with scaphoid delayed unions and nonunions treated by screw fixation without bone grafting. Our hospital is a safety net institution for a large urban catchment area and had complete radiographic and clinical data for 19 of our 23 patients. One patient was contacted by telephone and he reported no pain and no revision surgical interventions.

The limitations of this study include not only its retrospective design but also its limited secondary outcome measures. However, our primary outcomes of union, pain, and complications are of utmost importance to clinicians and patients alike. Similar to other authors, we used radiographs to confirm unions. Although bridging trabeculation in radiographs has been demonstrated as soon as 1 month after the injury, there may be problems with interobserver reliability.^{4,13,15,20,21}

Patients being lost to follow-up is not uncommon in the orthopedic trauma literature and can influence results.^22,23 It is speculative to infer that the 3 patients who did not complete a follow-up course did not return because their pain had mitigated.

CONCLUSION 

Like several fractures, the lack of stability and the absence of micro-motion are believed to contribute to fibrous nonunions in scaphoid fractures.¹³ This study provides a large consecutive cohort of patients with minimally displaced scaphoid delayed unions and nonunions that were successfully treated by rigid internal fixation without bone grafting. These results confirm previous reports that bone grafting is not required to provide predictable unions for the majority of scaphoid nonunions.

This paper will be judged for the Resident Writer’s Award.

A score incorporating clinical and biological markers could help predict the risk of death in patients with malignant pleural effusion and their likelihood of responding well to pleurodesis, according to a study published online in The Lancet Oncology.

The researchers used five separate and independent datasets from three previous multicenter randomized controlled trials – TIME-1, TIME-2, and TIME-3 – to identify 17 candidates for biomarkers of survival at 3 months and 7 candidates for biomarkers of pleurodesis success at 3 months.

They combined these with clinical, radiological, and biological variables to develop the clinical PROMISE model, which included relative protein expression of tissue inhibitor of metalloproteinases 1, platelet-derived growth factor, vascular endothelial growth factor, cadherin 1 and interleukin 4. The pleurodesis dataset included tumour necrosis factor alpha, TNF-beta, interleukin 6, and fibroblast growth factor 2.

The model was then externally validated using complete case data from 162 individuals with malignant pleural effusion, just over one-third of whom had died before 3 months.

The researchers also developed a biological model based on prognostic factors for survival, including use of previous chemotherapy and radiotherapy, baseline ECOG performance status, cancer type, hemoglobin, and white blood cell count.

The researchers found that the PROMISE scores showed “good discrimination,” and based on that, they came up with four categories – A, B, C, and D, representing less than 25% risk, 25%-49% risk, 50%-74% risk, and 75% or more risk of death by 3 months. However, none of the biomarkers associated with pleurodesis outcomes could be validated.

“All parameters included in the PROMISE score are independently associated with survival, and thus the identified markers permit some speculation as to their biological role in survival in malignant pleural effusion,” wrote Ioannis Psallidas, MD, of the Oxford Centre for Respiratory Medicine at Oxford (England) University Hospital, and his coauthors.

For example, they noted that patients who had previously been treated with chemotherapy and radiotherapy may have a poorer prognosis because of the development of more aggressive cancer after treatment. Similarly, white blood cell counts and C-reactive protein are markers of inflammation and are linked to poor tumor-specific immunity.

“Evidence suggests that clinical judgment alone is imprecise for estimation of patient survival, highlighted by the fact that physicians are ineffective in excluding study participants with poor prognosis from large clinical trials,” the authors wrote. “Although future confirmatory studies are required, the PROMISE score (either clinical or biological) could potentially be used in everyday clinical practice as a method to improve patient management and reduce associated health-care costs, and as an enrichment strategy for future clinical trials.”

The study was supported by the Oxford Respiratory Trials Unit, Medical Research Funding-University of Oxford, Slater & Gordon Research Fund, and Oxfordshire Health Services Research Committee Research Grants. No conflicts of interest were declared.

SOURCE: Psallidas I et al. Lancet Oncol. 2018 Jun 13. doi: 10.1016/S1470-2045(18)30294-8.

A score incorporating clinical and biological markers could help predict the risk of death in patients with malignant pleural effusion and their likelihood of responding well to pleurodesis, according to a study published online in The Lancet Oncology.

The researchers used five separate and independent datasets from three previous multicenter randomized controlled trials – TIME-1, TIME-2, and TIME-3 – to identify 17 candidates for biomarkers of survival at 3 months and 7 candidates for biomarkers of pleurodesis success at 3 months.

They combined these with clinical, radiological, and biological variables to develop the clinical PROMISE model, which included relative protein expression of tissue inhibitor of metalloproteinases 1, platelet-derived growth factor, vascular endothelial growth factor, cadherin 1 and interleukin 4. The pleurodesis dataset included tumour necrosis factor alpha, TNF-beta, interleukin 6, and fibroblast growth factor 2.

The model was then externally validated using complete case data from 162 individuals with malignant pleural effusion, just over one-third of whom had died before 3 months.

The researchers also developed a biological model based on prognostic factors for survival, including use of previous chemotherapy and radiotherapy, baseline ECOG performance status, cancer type, hemoglobin, and white blood cell count.

The researchers found that the PROMISE scores showed “good discrimination,” and based on that, they came up with four categories – A, B, C, and D, representing less than 25% risk, 25%-49% risk, 50%-74% risk, and 75% or more risk of death by 3 months. However, none of the biomarkers associated with pleurodesis outcomes could be validated.

“All parameters included in the PROMISE score are independently associated with survival, and thus the identified markers permit some speculation as to their biological role in survival in malignant pleural effusion,” wrote Ioannis Psallidas, MD, of the Oxford Centre for Respiratory Medicine at Oxford (England) University Hospital, and his coauthors.

For example, they noted that patients who had previously been treated with chemotherapy and radiotherapy may have a poorer prognosis because of the development of more aggressive cancer after treatment. Similarly, white blood cell counts and C-reactive protein are markers of inflammation and are linked to poor tumor-specific immunity.

“Evidence suggests that clinical judgment alone is imprecise for estimation of patient survival, highlighted by the fact that physicians are ineffective in excluding study participants with poor prognosis from large clinical trials,” the authors wrote. “Although future confirmatory studies are required, the PROMISE score (either clinical or biological) could potentially be used in everyday clinical practice as a method to improve patient management and reduce associated health-care costs, and as an enrichment strategy for future clinical trials.”

The study was supported by the Oxford Respiratory Trials Unit, Medical Research Funding-University of Oxford, Slater & Gordon Research Fund, and Oxfordshire Health Services Research Committee Research Grants. No conflicts of interest were declared.

SOURCE: Psallidas I et al. Lancet Oncol. 2018 Jun 13. doi: 10.1016/S1470-2045(18)30294-8.

A score incorporating clinical and biological markers could help predict the risk of death in patients with malignant pleural effusion and their likelihood of responding well to pleurodesis, according to a study published online in The Lancet Oncology.

The researchers used five separate and independent datasets from three previous multicenter randomized controlled trials – TIME-1, TIME-2, and TIME-3 – to identify 17 candidates for biomarkers of survival at 3 months and 7 candidates for biomarkers of pleurodesis success at 3 months.

They combined these with clinical, radiological, and biological variables to develop the clinical PROMISE model, which included relative protein expression of tissue inhibitor of metalloproteinases 1, platelet-derived growth factor, vascular endothelial growth factor, cadherin 1 and interleukin 4. The pleurodesis dataset included tumour necrosis factor alpha, TNF-beta, interleukin 6, and fibroblast growth factor 2.

The model was then externally validated using complete case data from 162 individuals with malignant pleural effusion, just over one-third of whom had died before 3 months.

The researchers also developed a biological model based on prognostic factors for survival, including use of previous chemotherapy and radiotherapy, baseline ECOG performance status, cancer type, hemoglobin, and white blood cell count.

The researchers found that the PROMISE scores showed “good discrimination,” and based on that, they came up with four categories – A, B, C, and D, representing less than 25% risk, 25%-49% risk, 50%-74% risk, and 75% or more risk of death by 3 months. However, none of the biomarkers associated with pleurodesis outcomes could be validated.

“All parameters included in the PROMISE score are independently associated with survival, and thus the identified markers permit some speculation as to their biological role in survival in malignant pleural effusion,” wrote Ioannis Psallidas, MD, of the Oxford Centre for Respiratory Medicine at Oxford (England) University Hospital, and his coauthors.

For example, they noted that patients who had previously been treated with chemotherapy and radiotherapy may have a poorer prognosis because of the development of more aggressive cancer after treatment. Similarly, white blood cell counts and C-reactive protein are markers of inflammation and are linked to poor tumor-specific immunity.

“Evidence suggests that clinical judgment alone is imprecise for estimation of patient survival, highlighted by the fact that physicians are ineffective in excluding study participants with poor prognosis from large clinical trials,” the authors wrote. “Although future confirmatory studies are required, the PROMISE score (either clinical or biological) could potentially be used in everyday clinical practice as a method to improve patient management and reduce associated health-care costs, and as an enrichment strategy for future clinical trials.”

The study was supported by the Oxford Respiratory Trials Unit, Medical Research Funding-University of Oxford, Slater & Gordon Research Fund, and Oxfordshire Health Services Research Committee Research Grants. No conflicts of interest were declared.

SOURCE: Psallidas I et al. Lancet Oncol. 2018 Jun 13. doi: 10.1016/S1470-2045(18)30294-8.

Fludarabine, cyclophosphamide, and rituximab are recommended as initial therapy for patients with chronic lymphocytic leukemia who do not have TP53 disruption, according to new guidelines from the British Society for Haematology.

The guidelines update the 2012 recommendations on chronic lymphocytic leukemia (CLL) to include “significant” developments in treatment. They were published in the British Journal of Haematology.

Anna H. Schuh, MD, of the department of oncology at the University of Oxford (England), and her coauthors noted that, while these guidelines apply to treatments available outside clinical trials, wherever possible patients with CLL should be treated within the clinical trial setting.

While recommending fludarabine, cyclophosphamide, and rituximab as first-line therapy, the guideline authors acknowledged that the combination of bendamustine and rituximab is an acceptable alternative for patients who could not take the triple therapy because of comorbidities such as advanced age, renal impairment, or issues with marrow capacity.

Similarly, less-fit patients could also be considered for chlorambucil-obinutuzumab or chlorambucil-ofatumumab combinations.

All patients diagnosed with CLL should be tested for TP53 deletions and mutations before each line of therapy, the guideline committee recommended. TP53 disruption makes chemoimmunotherapy ineffective because of either a deletion of chromosome 17p or a mutation in the TP53 gene. However, there is compelling evidence for the efficacy of ibrutinib in these patients, or idelalisib and rituximab for those with cardiac disease or receiving vitamin K antagonists.

With respect to maintenance therapy, the guidelines noted that this was not routinely recommended in CLL as “it is unclear to what extent the progression-free survival benefit is offset by long-term toxicity.”

Patients who are refractory to chemoimmunotherapy, who have relapsed, or who cannot be retreated with chemoimmunotherapy should be treated with idelalisib with rituximab or ibrutinib monotherapy, the guidelines suggested.

“Deciding whether ibrutinib or idelalisib with rituximab is most appropriate for an individual patient depends on a range of factors, including toxicity profile and convenience of delivery,” the authors wrote. However, they noted that the value of adding bendamustine to either option was unclear as research had not shown significant, associated gains in median progression-free survival.

Allogeneic stem cell transplantation should be considered as a treatment option for patients who have either failed chemotherapy, have a TP53 disruption and have not responded to B-cell receptor signaling pathway inhibitors such as ibrutinib, or have a Richter transformation.

The guidelines also addressed the issue of autoimmune cytopenias, which occur in 5%-10% of patients with CLL and can actually precede the diagnosis of CLL in about 9% of cases.

In patients where autoimmune cytopenia is the dominant clinical feature, they should be treated with corticosteroids, intravenous immunoglobulin, or rituximab. However, for patients where the cytopenia is triggered by CLL therapy, the guidelines recommended halting treatment and beginning immunosuppression.

The guideline development was supported by the British Society for Haematology. The UK CLL Forum is a registered charity that receives funding from a number of pharmaceutical companies.

SOURCE: Schuh AH et al. Br J Haematol. 2018 Jul 15. doi: 10.1111/bjh.15460.

Fludarabine, cyclophosphamide, and rituximab are recommended as initial therapy for patients with chronic lymphocytic leukemia who do not have TP53 disruption, according to new guidelines from the British Society for Haematology.

The guidelines update the 2012 recommendations on chronic lymphocytic leukemia (CLL) to include “significant” developments in treatment. They were published in the British Journal of Haematology.

Anna H. Schuh, MD, of the department of oncology at the University of Oxford (England), and her coauthors noted that, while these guidelines apply to treatments available outside clinical trials, wherever possible patients with CLL should be treated within the clinical trial setting.

While recommending fludarabine, cyclophosphamide, and rituximab as first-line therapy, the guideline authors acknowledged that the combination of bendamustine and rituximab is an acceptable alternative for patients who could not take the triple therapy because of comorbidities such as advanced age, renal impairment, or issues with marrow capacity.

Similarly, less-fit patients could also be considered for chlorambucil-obinutuzumab or chlorambucil-ofatumumab combinations.

All patients diagnosed with CLL should be tested for TP53 deletions and mutations before each line of therapy, the guideline committee recommended. TP53 disruption makes chemoimmunotherapy ineffective because of either a deletion of chromosome 17p or a mutation in the TP53 gene. However, there is compelling evidence for the efficacy of ibrutinib in these patients, or idelalisib and rituximab for those with cardiac disease or receiving vitamin K antagonists.

With respect to maintenance therapy, the guidelines noted that this was not routinely recommended in CLL as “it is unclear to what extent the progression-free survival benefit is offset by long-term toxicity.”

Patients who are refractory to chemoimmunotherapy, who have relapsed, or who cannot be retreated with chemoimmunotherapy should be treated with idelalisib with rituximab or ibrutinib monotherapy, the guidelines suggested.

“Deciding whether ibrutinib or idelalisib with rituximab is most appropriate for an individual patient depends on a range of factors, including toxicity profile and convenience of delivery,” the authors wrote. However, they noted that the value of adding bendamustine to either option was unclear as research had not shown significant, associated gains in median progression-free survival.

Allogeneic stem cell transplantation should be considered as a treatment option for patients who have either failed chemotherapy, have a TP53 disruption and have not responded to B-cell receptor signaling pathway inhibitors such as ibrutinib, or have a Richter transformation.

The guidelines also addressed the issue of autoimmune cytopenias, which occur in 5%-10% of patients with CLL and can actually precede the diagnosis of CLL in about 9% of cases.

In patients where autoimmune cytopenia is the dominant clinical feature, they should be treated with corticosteroids, intravenous immunoglobulin, or rituximab. However, for patients where the cytopenia is triggered by CLL therapy, the guidelines recommended halting treatment and beginning immunosuppression.

The guideline development was supported by the British Society for Haematology. The UK CLL Forum is a registered charity that receives funding from a number of pharmaceutical companies.

SOURCE: Schuh AH et al. Br J Haematol. 2018 Jul 15. doi: 10.1111/bjh.15460.

Fludarabine, cyclophosphamide, and rituximab are recommended as initial therapy for patients with chronic lymphocytic leukemia who do not have TP53 disruption, according to new guidelines from the British Society for Haematology.

The guidelines update the 2012 recommendations on chronic lymphocytic leukemia (CLL) to include “significant” developments in treatment. They were published in the British Journal of Haematology.

Anna H. Schuh, MD, of the department of oncology at the University of Oxford (England), and her coauthors noted that, while these guidelines apply to treatments available outside clinical trials, wherever possible patients with CLL should be treated within the clinical trial setting.

While recommending fludarabine, cyclophosphamide, and rituximab as first-line therapy, the guideline authors acknowledged that the combination of bendamustine and rituximab is an acceptable alternative for patients who could not take the triple therapy because of comorbidities such as advanced age, renal impairment, or issues with marrow capacity.

Similarly, less-fit patients could also be considered for chlorambucil-obinutuzumab or chlorambucil-ofatumumab combinations.

All patients diagnosed with CLL should be tested for TP53 deletions and mutations before each line of therapy, the guideline committee recommended. TP53 disruption makes chemoimmunotherapy ineffective because of either a deletion of chromosome 17p or a mutation in the TP53 gene. However, there is compelling evidence for the efficacy of ibrutinib in these patients, or idelalisib and rituximab for those with cardiac disease or receiving vitamin K antagonists.

With respect to maintenance therapy, the guidelines noted that this was not routinely recommended in CLL as “it is unclear to what extent the progression-free survival benefit is offset by long-term toxicity.”

Patients who are refractory to chemoimmunotherapy, who have relapsed, or who cannot be retreated with chemoimmunotherapy should be treated with idelalisib with rituximab or ibrutinib monotherapy, the guidelines suggested.

“Deciding whether ibrutinib or idelalisib with rituximab is most appropriate for an individual patient depends on a range of factors, including toxicity profile and convenience of delivery,” the authors wrote. However, they noted that the value of adding bendamustine to either option was unclear as research had not shown significant, associated gains in median progression-free survival.

Allogeneic stem cell transplantation should be considered as a treatment option for patients who have either failed chemotherapy, have a TP53 disruption and have not responded to B-cell receptor signaling pathway inhibitors such as ibrutinib, or have a Richter transformation.

The guidelines also addressed the issue of autoimmune cytopenias, which occur in 5%-10% of patients with CLL and can actually precede the diagnosis of CLL in about 9% of cases.

In patients where autoimmune cytopenia is the dominant clinical feature, they should be treated with corticosteroids, intravenous immunoglobulin, or rituximab. However, for patients where the cytopenia is triggered by CLL therapy, the guidelines recommended halting treatment and beginning immunosuppression.

The guideline development was supported by the British Society for Haematology. The UK CLL Forum is a registered charity that receives funding from a number of pharmaceutical companies.

SOURCE: Schuh AH et al. Br J Haematol. 2018 Jul 15. doi: 10.1111/bjh.15460.

mycosis fungoides

The US Food and Drug Administration (FDA) has approved mogamulizumab-kpkc (Poteligeo®) for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least 1 prior systemic therapy.

Mogamulizumab is a humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4). It is the first biologic agent targeting CCR4 to be approved for patients in the US.

Mogamulizumab is expected to be commercially available in the fourth quarter of 2018.

The FDA previously granted mogamulizumab breakthrough therapy and orphan drug designations as well as priority review.

The FDA’s approval of mogamulizumab is supported by the phase 3 MAVORIC trial. Results from this trial were presented at the 10th Annual T-cell Lymphoma Forum in February.

MAVORIC enrolled 372 adults with histologically confirmed MF or SS who had failed at least 1 systemic therapy. They were randomized to receive mogamulizumab at 1.0 mg/kg (weekly for the first 4-week cycle and then every 2 weeks) or vorinostat at 400 mg daily.

Patients were treated until disease progression or unacceptable toxicity. Those receiving vorinostat could cross over to mogamulizumab if they progressed or experienced intolerable toxicity.

Baseline characteristics were similar between the treatment arms.

The study’s primary endpoint was progression-free survival. The median progression-free survival was 7.7 months with mogamulizumab and 3.1 months with vorinostat (hazard ratio=0.53, P<0.0001).

The global overall response rate (ORR) was 28% (52/189) in the mogamulizumab arm and 5% (9/186) in the vorinostat arm (P<0.0001).

For patients with MF, the ORR was 21% with mogamulizumab and 7% with vorinostat. For SS patients, the ORR was 37% and 2%, respectively.

After crossover, the ORR in the mogamulizumab arm was 30% (41/136).

The median duration of response (DOR) was 14 months in the mogamulizumab arm and 9 months in the vorinostat arm.

For MF patients, the median DOR was 13 months with mogamulizumab and 9 months with vorinostat. For SS patients, the median DOR was 17 months and 7 months, respectively.

The most common treatment-emergent adverse events (AEs), occurring in at least 20% of patients in either arm (mogamulizumab and vorinostat, respectively), were:

• Infusion-related reactions (33.2% vs 0.5%)
• Drug eruptions (23.9% vs 0.5%)
• Diarrhea (23.4% vs 61.8%)
• Nausea (15.2% vs 42.5%)
• Thrombocytopenia (11.4% vs 30.6%)
• Dysgeusia (3.3% vs 28.0%)
• Increased blood creatinine (3.3% vs 28.0%)
• Decreased appetite (7.6% vs 24.7%).

There were no grade 4 AEs in the mogamulizumab arm. Grade 3 AEs in mogamulizumab recipients included drug eruptions (n=8), infusion-related reactions (n=3), fatigue (n=3), decreased appetite (n=2), nausea (n=1), pyrexia (n=1), and diarrhea (n=1).

mycosis fungoides

The US Food and Drug Administration (FDA) has approved mogamulizumab-kpkc (Poteligeo®) for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least 1 prior systemic therapy.

Mogamulizumab is a humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4). It is the first biologic agent targeting CCR4 to be approved for patients in the US.

Mogamulizumab is expected to be commercially available in the fourth quarter of 2018.

The FDA previously granted mogamulizumab breakthrough therapy and orphan drug designations as well as priority review.

The FDA’s approval of mogamulizumab is supported by the phase 3 MAVORIC trial. Results from this trial were presented at the 10th Annual T-cell Lymphoma Forum in February.

MAVORIC enrolled 372 adults with histologically confirmed MF or SS who had failed at least 1 systemic therapy. They were randomized to receive mogamulizumab at 1.0 mg/kg (weekly for the first 4-week cycle and then every 2 weeks) or vorinostat at 400 mg daily.

Patients were treated until disease progression or unacceptable toxicity. Those receiving vorinostat could cross over to mogamulizumab if they progressed or experienced intolerable toxicity.

Baseline characteristics were similar between the treatment arms.

The study’s primary endpoint was progression-free survival. The median progression-free survival was 7.7 months with mogamulizumab and 3.1 months with vorinostat (hazard ratio=0.53, P<0.0001).

The global overall response rate (ORR) was 28% (52/189) in the mogamulizumab arm and 5% (9/186) in the vorinostat arm (P<0.0001).

For patients with MF, the ORR was 21% with mogamulizumab and 7% with vorinostat. For SS patients, the ORR was 37% and 2%, respectively.

After crossover, the ORR in the mogamulizumab arm was 30% (41/136).

The median duration of response (DOR) was 14 months in the mogamulizumab arm and 9 months in the vorinostat arm.

For MF patients, the median DOR was 13 months with mogamulizumab and 9 months with vorinostat. For SS patients, the median DOR was 17 months and 7 months, respectively.

The most common treatment-emergent adverse events (AEs), occurring in at least 20% of patients in either arm (mogamulizumab and vorinostat, respectively), were:

• Infusion-related reactions (33.2% vs 0.5%)
• Drug eruptions (23.9% vs 0.5%)
• Diarrhea (23.4% vs 61.8%)
• Nausea (15.2% vs 42.5%)
• Thrombocytopenia (11.4% vs 30.6%)
• Dysgeusia (3.3% vs 28.0%)
• Increased blood creatinine (3.3% vs 28.0%)
• Decreased appetite (7.6% vs 24.7%).

There were no grade 4 AEs in the mogamulizumab arm. Grade 3 AEs in mogamulizumab recipients included drug eruptions (n=8), infusion-related reactions (n=3), fatigue (n=3), decreased appetite (n=2), nausea (n=1), pyrexia (n=1), and diarrhea (n=1).

mycosis fungoides

The US Food and Drug Administration (FDA) has approved mogamulizumab-kpkc (Poteligeo®) for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least 1 prior systemic therapy.

Mogamulizumab is a humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4). It is the first biologic agent targeting CCR4 to be approved for patients in the US.

Mogamulizumab is expected to be commercially available in the fourth quarter of 2018.

The FDA previously granted mogamulizumab breakthrough therapy and orphan drug designations as well as priority review.

The FDA’s approval of mogamulizumab is supported by the phase 3 MAVORIC trial. Results from this trial were presented at the 10th Annual T-cell Lymphoma Forum in February.

MAVORIC enrolled 372 adults with histologically confirmed MF or SS who had failed at least 1 systemic therapy. They were randomized to receive mogamulizumab at 1.0 mg/kg (weekly for the first 4-week cycle and then every 2 weeks) or vorinostat at 400 mg daily.

Patients were treated until disease progression or unacceptable toxicity. Those receiving vorinostat could cross over to mogamulizumab if they progressed or experienced intolerable toxicity.

Baseline characteristics were similar between the treatment arms.

The study’s primary endpoint was progression-free survival. The median progression-free survival was 7.7 months with mogamulizumab and 3.1 months with vorinostat (hazard ratio=0.53, P<0.0001).

The global overall response rate (ORR) was 28% (52/189) in the mogamulizumab arm and 5% (9/186) in the vorinostat arm (P<0.0001).

For patients with MF, the ORR was 21% with mogamulizumab and 7% with vorinostat. For SS patients, the ORR was 37% and 2%, respectively.

After crossover, the ORR in the mogamulizumab arm was 30% (41/136).

The median duration of response (DOR) was 14 months in the mogamulizumab arm and 9 months in the vorinostat arm.

For MF patients, the median DOR was 13 months with mogamulizumab and 9 months with vorinostat. For SS patients, the median DOR was 17 months and 7 months, respectively.

The most common treatment-emergent adverse events (AEs), occurring in at least 20% of patients in either arm (mogamulizumab and vorinostat, respectively), were:

• Infusion-related reactions (33.2% vs 0.5%)
• Drug eruptions (23.9% vs 0.5%)
• Diarrhea (23.4% vs 61.8%)
• Nausea (15.2% vs 42.5%)
• Thrombocytopenia (11.4% vs 30.6%)
• Dysgeusia (3.3% vs 28.0%)
• Increased blood creatinine (3.3% vs 28.0%)
• Decreased appetite (7.6% vs 24.7%).

There were no grade 4 AEs in the mogamulizumab arm. Grade 3 AEs in mogamulizumab recipients included drug eruptions (n=8), infusion-related reactions (n=3), fatigue (n=3), decreased appetite (n=2), nausea (n=1), pyrexia (n=1), and diarrhea (n=1).

Florida’s Miami-Dade County reportedly has the largest percentage of residents with serious mental illnesses (SMI) among large U.S. communities. And a Florida judge who helped develop approaches aimed at sparing his state’s residents with mental illness from harmful, avoidable, and expensive bouts of prison time wants to see his strategies replicated.

Courtesy Judge Steve Leifman

“There is something terribly wrong with a society that is willing to spend more money to incarcerate people who are ill than to treat them,” Judge Steve Leifman of the 11th judicial circuit court said at a National Institute of Mental Health conference on mental health services research.

Judge Leifman in 2000 created the Criminal Mental Health Project. It’s been recognized for its success in keeping people with SMI from becoming ensnared in the criminal justice system because of minor offenses. It also helps those who do spend time in jail from returning.

In Miami-Dade County, for example, 97 people were a significant driver of costs in the criminal justice system in a study that was completed in 2010, Judge Leifman said. The members of this group were largely men who suffered from schizophrenia spectrum disorders and were homeless with a co-occurring disorder. Combined, the number of arrests for this group was about 2,200 over a 5-year period, Judge Leifman said. They spent 27,000 days in the Miami-Dade County jail – costing taxpayers about $13.7 million.

“We joke, but it’s true. It would have been cheaper and more effective to send them to Harvard,” Judge Leifman said. “They would have had a shot at an education. They would have had housing. They probably would have done a lot better.”

Through the Criminal Mental Health Project, Judge Leifman and his colleagues seek to both prevent people with mental illness from being arrested and jailed for minor offenses, and to provide a support network for those who have reached jail. The project’s “prebooking diversion” efforts are built on a model developed in Memphis, Tenn., in the late 1980s. Through it, police officers get special training in recognizing mental illness and resolving crises in which people who have these disorders are involved.

The project’s “postbooking diversion” techniques require participants to voluntarily consent to mental health treatment and services. The program is open only to those less serious felonies, which can include drug charges and theft. Through participation in the Criminal Mental Health Project, people can have charges dismissed or reduced. The program provides them with connections to community-based treatment, support, and housing services, according to its website.

Participants in the program who were charged with minor felonies had 75% fewer jail bookings and jail days after enrolling in the Criminal Mental Health Project (N Engl J Med. 2016;374:1701-3).

Judge Leifman said the postbooking jail diversion program has, since 2001, served more than 4,000 individuals. Recidivism rates among participants charged with misdemeanors dropped from roughly 75% to 20%, he said.

Still, Judge Leifman describes his role as a judge as making him a “gatekeeper to the largest psychiatric facility in Florida – the Miami-Dade County Jail.” The jail houses about 1,200 people with serious mental illness on any given day, according to the Criminal Mental Health Project’s website.

Judge Leifman said that, ultimately, he wants more communities to devote more resources to providing medical care for people with mental illness.

Florida’s Miami-Dade County reportedly has the largest percentage of residents with serious mental illnesses (SMI) among large U.S. communities. And a Florida judge who helped develop approaches aimed at sparing his state’s residents with mental illness from harmful, avoidable, and expensive bouts of prison time wants to see his strategies replicated.

Courtesy Judge Steve Leifman

“There is something terribly wrong with a society that is willing to spend more money to incarcerate people who are ill than to treat them,” Judge Steve Leifman of the 11th judicial circuit court said at a National Institute of Mental Health conference on mental health services research.

Judge Leifman in 2000 created the Criminal Mental Health Project. It’s been recognized for its success in keeping people with SMI from becoming ensnared in the criminal justice system because of minor offenses. It also helps those who do spend time in jail from returning.

In Miami-Dade County, for example, 97 people were a significant driver of costs in the criminal justice system in a study that was completed in 2010, Judge Leifman said. The members of this group were largely men who suffered from schizophrenia spectrum disorders and were homeless with a co-occurring disorder. Combined, the number of arrests for this group was about 2,200 over a 5-year period, Judge Leifman said. They spent 27,000 days in the Miami-Dade County jail – costing taxpayers about $13.7 million.

“We joke, but it’s true. It would have been cheaper and more effective to send them to Harvard,” Judge Leifman said. “They would have had a shot at an education. They would have had housing. They probably would have done a lot better.”

Through the Criminal Mental Health Project, Judge Leifman and his colleagues seek to both prevent people with mental illness from being arrested and jailed for minor offenses, and to provide a support network for those who have reached jail. The project’s “prebooking diversion” efforts are built on a model developed in Memphis, Tenn., in the late 1980s. Through it, police officers get special training in recognizing mental illness and resolving crises in which people who have these disorders are involved.

The project’s “postbooking diversion” techniques require participants to voluntarily consent to mental health treatment and services. The program is open only to those less serious felonies, which can include drug charges and theft. Through participation in the Criminal Mental Health Project, people can have charges dismissed or reduced. The program provides them with connections to community-based treatment, support, and housing services, according to its website.

Participants in the program who were charged with minor felonies had 75% fewer jail bookings and jail days after enrolling in the Criminal Mental Health Project (N Engl J Med. 2016;374:1701-3).

Judge Leifman said the postbooking jail diversion program has, since 2001, served more than 4,000 individuals. Recidivism rates among participants charged with misdemeanors dropped from roughly 75% to 20%, he said.

Still, Judge Leifman describes his role as a judge as making him a “gatekeeper to the largest psychiatric facility in Florida – the Miami-Dade County Jail.” The jail houses about 1,200 people with serious mental illness on any given day, according to the Criminal Mental Health Project’s website.

Judge Leifman said that, ultimately, he wants more communities to devote more resources to providing medical care for people with mental illness.

Florida’s Miami-Dade County reportedly has the largest percentage of residents with serious mental illnesses (SMI) among large U.S. communities. And a Florida judge who helped develop approaches aimed at sparing his state’s residents with mental illness from harmful, avoidable, and expensive bouts of prison time wants to see his strategies replicated.

Courtesy Judge Steve Leifman

“There is something terribly wrong with a society that is willing to spend more money to incarcerate people who are ill than to treat them,” Judge Steve Leifman of the 11th judicial circuit court said at a National Institute of Mental Health conference on mental health services research.

Judge Leifman in 2000 created the Criminal Mental Health Project. It’s been recognized for its success in keeping people with SMI from becoming ensnared in the criminal justice system because of minor offenses. It also helps those who do spend time in jail from returning.

In Miami-Dade County, for example, 97 people were a significant driver of costs in the criminal justice system in a study that was completed in 2010, Judge Leifman said. The members of this group were largely men who suffered from schizophrenia spectrum disorders and were homeless with a co-occurring disorder. Combined, the number of arrests for this group was about 2,200 over a 5-year period, Judge Leifman said. They spent 27,000 days in the Miami-Dade County jail – costing taxpayers about $13.7 million.

“We joke, but it’s true. It would have been cheaper and more effective to send them to Harvard,” Judge Leifman said. “They would have had a shot at an education. They would have had housing. They probably would have done a lot better.”

Through the Criminal Mental Health Project, Judge Leifman and his colleagues seek to both prevent people with mental illness from being arrested and jailed for minor offenses, and to provide a support network for those who have reached jail. The project’s “prebooking diversion” efforts are built on a model developed in Memphis, Tenn., in the late 1980s. Through it, police officers get special training in recognizing mental illness and resolving crises in which people who have these disorders are involved.

The project’s “postbooking diversion” techniques require participants to voluntarily consent to mental health treatment and services. The program is open only to those less serious felonies, which can include drug charges and theft. Through participation in the Criminal Mental Health Project, people can have charges dismissed or reduced. The program provides them with connections to community-based treatment, support, and housing services, according to its website.

Participants in the program who were charged with minor felonies had 75% fewer jail bookings and jail days after enrolling in the Criminal Mental Health Project (N Engl J Med. 2016;374:1701-3).

Judge Leifman said the postbooking jail diversion program has, since 2001, served more than 4,000 individuals. Recidivism rates among participants charged with misdemeanors dropped from roughly 75% to 20%, he said.

Still, Judge Leifman describes his role as a judge as making him a “gatekeeper to the largest psychiatric facility in Florida – the Miami-Dade County Jail.” The jail houses about 1,200 people with serious mental illness on any given day, according to the Criminal Mental Health Project’s website.

Judge Leifman said that, ultimately, he wants more communities to devote more resources to providing medical care for people with mental illness.

Background: Prescription opioids play a significant role in the current opioid epidemic. Opioids used for nonmedical purposes often are obtained from the prescription of friends and family members, and a majority of heroin users report that their first opioid exposure was via a prescription opioid. Prescription of opioids following low-risk surgical procedures has increased over the past decade.

Dr. Salber is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.

Background: Prescription opioids play a significant role in the current opioid epidemic. Opioids used for nonmedical purposes often are obtained from the prescription of friends and family members, and a majority of heroin users report that their first opioid exposure was via a prescription opioid. Prescription of opioids following low-risk surgical procedures has increased over the past decade.

Dr. Salber is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.

Background: Prescription opioids play a significant role in the current opioid epidemic. Opioids used for nonmedical purposes often are obtained from the prescription of friends and family members, and a majority of heroin users report that their first opioid exposure was via a prescription opioid. Prescription of opioids following low-risk surgical procedures has increased over the past decade.

Dr. Salber is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.

Conversation surrounding the drug crisis in the United States tends to focus on OxyContin, methamphetamine, fentanyl, and heroin. They are trouble for sure and are ruining the lives of many. But, as argued by Nicole Fisher in an article in Forbes, the discussion needs to be broadened to consider the purity and potency of the drugs being consumed.

Artfoliophoto/Thinkstock

“At face value, one might think that OxyContin is OxyContin or heroin is heroin. But that couldn’t be further from the truth,” writes Ms. Fisher.

Illicit drugs can contain other compounds, like methamphetamine and other addictive substances, or even rat poison. The result can be a lethal brew. Only a decade ago, when methamphetamine was cooked up in basement labs, the purity was nowhere near that of the nearly pure product made now by drug cartels.

The purity of meth has skyrocketed from 39% in 2008 to more than 93% now.

Just fighting opioid prescription abuse may be a simplistic response to a more complex problem. The variations in the composition and potency of illicit drugs is important but is being overlooked.

“As we craft ways to fight the opioid crisis in the U.S., it is necessary to ensure that we understand exactly what chemical compositions we are battling against,” Ms. Fisher writes.

Recent data on the purity of drugs seized by the U.S. Drug Enforcement Agency hammer home this point. The data reveal a varied picture across the country. On average, drugs seized west of the Mississippi River are about 40% more pure than those seized east of the river. Whatever the reason – the origin of the product, the distribution network, the dealers involved in the preparation and sale, and more – the result can be a more lethal drug, especially in a user from an area where less pure drugs are the norm.

Click here to read the Forbes article.

Conversation surrounding the drug crisis in the United States tends to focus on OxyContin, methamphetamine, fentanyl, and heroin. They are trouble for sure and are ruining the lives of many. But, as argued by Nicole Fisher in an article in Forbes, the discussion needs to be broadened to consider the purity and potency of the drugs being consumed.

Artfoliophoto/Thinkstock

“At face value, one might think that OxyContin is OxyContin or heroin is heroin. But that couldn’t be further from the truth,” writes Ms. Fisher.

Illicit drugs can contain other compounds, like methamphetamine and other addictive substances, or even rat poison. The result can be a lethal brew. Only a decade ago, when methamphetamine was cooked up in basement labs, the purity was nowhere near that of the nearly pure product made now by drug cartels.

The purity of meth has skyrocketed from 39% in 2008 to more than 93% now.

Just fighting opioid prescription abuse may be a simplistic response to a more complex problem. The variations in the composition and potency of illicit drugs is important but is being overlooked.

“As we craft ways to fight the opioid crisis in the U.S., it is necessary to ensure that we understand exactly what chemical compositions we are battling against,” Ms. Fisher writes.

Recent data on the purity of drugs seized by the U.S. Drug Enforcement Agency hammer home this point. The data reveal a varied picture across the country. On average, drugs seized west of the Mississippi River are about 40% more pure than those seized east of the river. Whatever the reason – the origin of the product, the distribution network, the dealers involved in the preparation and sale, and more – the result can be a more lethal drug, especially in a user from an area where less pure drugs are the norm.

Click here to read the Forbes article.

Conversation surrounding the drug crisis in the United States tends to focus on OxyContin, methamphetamine, fentanyl, and heroin. They are trouble for sure and are ruining the lives of many. But, as argued by Nicole Fisher in an article in Forbes, the discussion needs to be broadened to consider the purity and potency of the drugs being consumed.

Artfoliophoto/Thinkstock

“At face value, one might think that OxyContin is OxyContin or heroin is heroin. But that couldn’t be further from the truth,” writes Ms. Fisher.

Illicit drugs can contain other compounds, like methamphetamine and other addictive substances, or even rat poison. The result can be a lethal brew. Only a decade ago, when methamphetamine was cooked up in basement labs, the purity was nowhere near that of the nearly pure product made now by drug cartels.

The purity of meth has skyrocketed from 39% in 2008 to more than 93% now.

Just fighting opioid prescription abuse may be a simplistic response to a more complex problem. The variations in the composition and potency of illicit drugs is important but is being overlooked.

“As we craft ways to fight the opioid crisis in the U.S., it is necessary to ensure that we understand exactly what chemical compositions we are battling against,” Ms. Fisher writes.

Recent data on the purity of drugs seized by the U.S. Drug Enforcement Agency hammer home this point. The data reveal a varied picture across the country. On average, drugs seized west of the Mississippi River are about 40% more pure than those seized east of the river. Whatever the reason – the origin of the product, the distribution network, the dealers involved in the preparation and sale, and more – the result can be a more lethal drug, especially in a user from an area where less pure drugs are the norm.

Click here to read the Forbes article.

WASHINGTON – The National Eczema Association (NEA) has established the Coalition United for Better Eczema Care (CUBE-C) to provide practitioners with a resource for “trustworthy, up-to-date, state of the art” information on atopic dermatitis, with the goal of improving health outcomes, according to Julie Block, president and chief executive officer of the NEA.

In an interview at a symposium presented by CUBE-C, Ms. Block provided more information on CUBE-C, including how and why it started and what it can offer to dermatologists, as well as primary care physicians, who care for patients with atopic dermatitis. She said that the NEA convened dermatologists, allergists, immunologists, psychologists, nurse practitioners, physician assistants, and patients “to design a curriculum that provided an entire picture of the patient experience, so that we could go out and educate not only on the basics of eczema and atopic dermatitis for a variety of practitioners ... but also for the specialists who are now going to be engaging in new innovations and new therapies for their patients.”

She was joined by Adam Friedman, MD, professor of dermatology and residency program director at George Washington University, Washington, where the symposium, a resident’s boot camp, was held. The boot camp was somewhat unique in that it was geared more towards trainees; typically, the CUBE-C program is a CME program for practitioners, but this reflects the flexibility of the program, which can be tailored to the audience, Dr. Friedman pointed out. “The hope is that programs like these pop up all over the place ... anywhere you have a critical mass of individuals who want to learn about this,” where planners can choose from a menu of topics provided by CUBE-C – which include therapeutics, infections, pathogenesis, and access to care – and “easily formulate a conference like we held here today for the right audience.”

Topics covered at the George Washington University symposium included the impact of climate on the prevalence of childhood eczema, the diagnosis and differential diagnosis in children, infections in atopic dermatitis patients, and itch treatment.

More information on CUBE-C is available on the NEA website.

The symposium was supported by an educational grant from Sanofi Genzyme, Regeneron Pharmaceuticals, and Pfizer. Dr. Friedman reported serving as a speaker for Regeneron, Pfizer, and other companies. He also consults and serves on the advisory board for Pfizer and multiple other companies developing and marketing atopic dermatitis therapies and products.
 

[email protected]

WASHINGTON – The National Eczema Association (NEA) has established the Coalition United for Better Eczema Care (CUBE-C) to provide practitioners with a resource for “trustworthy, up-to-date, state of the art” information on atopic dermatitis, with the goal of improving health outcomes, according to Julie Block, president and chief executive officer of the NEA.

In an interview at a symposium presented by CUBE-C, Ms. Block provided more information on CUBE-C, including how and why it started and what it can offer to dermatologists, as well as primary care physicians, who care for patients with atopic dermatitis. She said that the NEA convened dermatologists, allergists, immunologists, psychologists, nurse practitioners, physician assistants, and patients “to design a curriculum that provided an entire picture of the patient experience, so that we could go out and educate not only on the basics of eczema and atopic dermatitis for a variety of practitioners ... but also for the specialists who are now going to be engaging in new innovations and new therapies for their patients.”

She was joined by Adam Friedman, MD, professor of dermatology and residency program director at George Washington University, Washington, where the symposium, a resident’s boot camp, was held. The boot camp was somewhat unique in that it was geared more towards trainees; typically, the CUBE-C program is a CME program for practitioners, but this reflects the flexibility of the program, which can be tailored to the audience, Dr. Friedman pointed out. “The hope is that programs like these pop up all over the place ... anywhere you have a critical mass of individuals who want to learn about this,” where planners can choose from a menu of topics provided by CUBE-C – which include therapeutics, infections, pathogenesis, and access to care – and “easily formulate a conference like we held here today for the right audience.”

Topics covered at the George Washington University symposium included the impact of climate on the prevalence of childhood eczema, the diagnosis and differential diagnosis in children, infections in atopic dermatitis patients, and itch treatment.

More information on CUBE-C is available on the NEA website.

The symposium was supported by an educational grant from Sanofi Genzyme, Regeneron Pharmaceuticals, and Pfizer. Dr. Friedman reported serving as a speaker for Regeneron, Pfizer, and other companies. He also consults and serves on the advisory board for Pfizer and multiple other companies developing and marketing atopic dermatitis therapies and products.
 

[email protected]

WASHINGTON – The National Eczema Association (NEA) has established the Coalition United for Better Eczema Care (CUBE-C) to provide practitioners with a resource for “trustworthy, up-to-date, state of the art” information on atopic dermatitis, with the goal of improving health outcomes, according to Julie Block, president and chief executive officer of the NEA.

In an interview at a symposium presented by CUBE-C, Ms. Block provided more information on CUBE-C, including how and why it started and what it can offer to dermatologists, as well as primary care physicians, who care for patients with atopic dermatitis. She said that the NEA convened dermatologists, allergists, immunologists, psychologists, nurse practitioners, physician assistants, and patients “to design a curriculum that provided an entire picture of the patient experience, so that we could go out and educate not only on the basics of eczema and atopic dermatitis for a variety of practitioners ... but also for the specialists who are now going to be engaging in new innovations and new therapies for their patients.”

She was joined by Adam Friedman, MD, professor of dermatology and residency program director at George Washington University, Washington, where the symposium, a resident’s boot camp, was held. The boot camp was somewhat unique in that it was geared more towards trainees; typically, the CUBE-C program is a CME program for practitioners, but this reflects the flexibility of the program, which can be tailored to the audience, Dr. Friedman pointed out. “The hope is that programs like these pop up all over the place ... anywhere you have a critical mass of individuals who want to learn about this,” where planners can choose from a menu of topics provided by CUBE-C – which include therapeutics, infections, pathogenesis, and access to care – and “easily formulate a conference like we held here today for the right audience.”

Topics covered at the George Washington University symposium included the impact of climate on the prevalence of childhood eczema, the diagnosis and differential diagnosis in children, infections in atopic dermatitis patients, and itch treatment.

More information on CUBE-C is available on the NEA website.

The symposium was supported by an educational grant from Sanofi Genzyme, Regeneron Pharmaceuticals, and Pfizer. Dr. Friedman reported serving as a speaker for Regeneron, Pfizer, and other companies. He also consults and serves on the advisory board for Pfizer and multiple other companies developing and marketing atopic dermatitis therapies and products.
 

[email protected]

Girls with parents who considered religion important in their lives were less likely to consider or attempt suicide, according to Connie Svob, PhD, of Columbia University, New York, and her associates.

Data were collected from an ongoing, 30-year, three-generational, observational study at the New York State Psychiatric Institute and Columbia University. In the study, the second and third generations were determined to be at high or low risk for major depressive disorder because of either the presence or absence of MDD in the first generation.

The study included 214 children aged 6-18 years from 112 unique families, who had undergone at least one assessment of religiosity, and a parent from each included family. Among the children, religious importance was associated with reduced suicide risk in girls (OR, 0.48; 95% CI, 0.33-0.70) but not in boys (OR, 1.15; 95% CI, 0.74-1.80).

A similar association was found for religious attendance, where girls saw a reduced risk (OR, 0.64; 95% CI, 0.49-0.84) and boys did not (OR, 0.94; 95% CI, 0.69-1.27), Dr. Svob and her associates reported in JAMA Psychiatry.

“These findings suggest that a parent’s belief in the importance of religion may be a more robust factor than a parent’s attendance at religious services and make one wonder whether religious importance might be more strongly associated with teaching and beliefs about suicide within the home than is service attendance, or whether some other mechanism might be responsible,” the authors noted.

Study limitations included a homogeneous population who were all white and predominantly Roman Catholic or Protestant, as well as a small sample size of children with suicidal behavior or ideation.

“Our data suggest there may be alternative and additional ways to help children and adolescents at highest risk for suicidal behavior,” Dr. Svob and her associates wrote. “These include conducting a brief spiritual history with parents of offspring being brought in for psychiatric consultations, as well as assessing an offspring’s own beliefs (religious importance) and behaviors (religious service attendance), particularly with girls.”

Dr. Svob reported no disclosures. The study was supported partly by the John Templeton Foundation and the National Institute of Mental Health.
 

[email protected]

SOURCE: Svob C et al. JAMA Psychiatry. 2018 Aug 8. doi: 10.1001/jamapsychiatry.2018.2060.

Girls with parents who considered religion important in their lives were less likely to consider or attempt suicide, according to Connie Svob, PhD, of Columbia University, New York, and her associates.

Data were collected from an ongoing, 30-year, three-generational, observational study at the New York State Psychiatric Institute and Columbia University. In the study, the second and third generations were determined to be at high or low risk for major depressive disorder because of either the presence or absence of MDD in the first generation.

The study included 214 children aged 6-18 years from 112 unique families, who had undergone at least one assessment of religiosity, and a parent from each included family. Among the children, religious importance was associated with reduced suicide risk in girls (OR, 0.48; 95% CI, 0.33-0.70) but not in boys (OR, 1.15; 95% CI, 0.74-1.80).

A similar association was found for religious attendance, where girls saw a reduced risk (OR, 0.64; 95% CI, 0.49-0.84) and boys did not (OR, 0.94; 95% CI, 0.69-1.27), Dr. Svob and her associates reported in JAMA Psychiatry.

“These findings suggest that a parent’s belief in the importance of religion may be a more robust factor than a parent’s attendance at religious services and make one wonder whether religious importance might be more strongly associated with teaching and beliefs about suicide within the home than is service attendance, or whether some other mechanism might be responsible,” the authors noted.

Study limitations included a homogeneous population who were all white and predominantly Roman Catholic or Protestant, as well as a small sample size of children with suicidal behavior or ideation.

“Our data suggest there may be alternative and additional ways to help children and adolescents at highest risk for suicidal behavior,” Dr. Svob and her associates wrote. “These include conducting a brief spiritual history with parents of offspring being brought in for psychiatric consultations, as well as assessing an offspring’s own beliefs (religious importance) and behaviors (religious service attendance), particularly with girls.”

Dr. Svob reported no disclosures. The study was supported partly by the John Templeton Foundation and the National Institute of Mental Health.
 

[email protected]

SOURCE: Svob C et al. JAMA Psychiatry. 2018 Aug 8. doi: 10.1001/jamapsychiatry.2018.2060.

Girls with parents who considered religion important in their lives were less likely to consider or attempt suicide, according to Connie Svob, PhD, of Columbia University, New York, and her associates.

Data were collected from an ongoing, 30-year, three-generational, observational study at the New York State Psychiatric Institute and Columbia University. In the study, the second and third generations were determined to be at high or low risk for major depressive disorder because of either the presence or absence of MDD in the first generation.

The study included 214 children aged 6-18 years from 112 unique families, who had undergone at least one assessment of religiosity, and a parent from each included family. Among the children, religious importance was associated with reduced suicide risk in girls (OR, 0.48; 95% CI, 0.33-0.70) but not in boys (OR, 1.15; 95% CI, 0.74-1.80).

A similar association was found for religious attendance, where girls saw a reduced risk (OR, 0.64; 95% CI, 0.49-0.84) and boys did not (OR, 0.94; 95% CI, 0.69-1.27), Dr. Svob and her associates reported in JAMA Psychiatry.

“These findings suggest that a parent’s belief in the importance of religion may be a more robust factor than a parent’s attendance at religious services and make one wonder whether religious importance might be more strongly associated with teaching and beliefs about suicide within the home than is service attendance, or whether some other mechanism might be responsible,” the authors noted.

Study limitations included a homogeneous population who were all white and predominantly Roman Catholic or Protestant, as well as a small sample size of children with suicidal behavior or ideation.

“Our data suggest there may be alternative and additional ways to help children and adolescents at highest risk for suicidal behavior,” Dr. Svob and her associates wrote. “These include conducting a brief spiritual history with parents of offspring being brought in for psychiatric consultations, as well as assessing an offspring’s own beliefs (religious importance) and behaviors (religious service attendance), particularly with girls.”

Dr. Svob reported no disclosures. The study was supported partly by the John Templeton Foundation and the National Institute of Mental Health.
 

[email protected]

SOURCE: Svob C et al. JAMA Psychiatry. 2018 Aug 8. doi: 10.1001/jamapsychiatry.2018.2060.