Sarmiento A

Many assume that the American Joint Replacement Registry (AJRR) is moving forward as originally planned. No one has reported any obstacles that may cast doubt on its continued progress.

Despite the enthusiasm for AJRR, we must be realistic and admit that the project may not in the final analysis bring about its anticipated results. Therefore, periodic sober assessments of its course should be carried out, as they might result in identifying possible flaws and strengths. It is imperative to continue to express doubts regarding the true long-term value of this registry.

Much of the original support for an ongoing registry came from the example provided by the Swedish national registry. The Scandinavian registry had been said to dramatically reduce the number of complications and halve the revision rate for total hip arthroplasties. We need to question the claim that this reduction was solely the result of information produced by the registry. It is hard to believe that the literature had failed to report on those complications long before the registry publicized its findings.

As we take a fresh look at AJRR, it is perhaps wise to keep in mind the history of the AO Swiss Fracture Registry, founded by Maurice Müller and heavily subsidized by industry. Apparently, after gathering millions of pieces of information, primarily about equipment used for fracture fixation, the Swiss registry has failed to produce the greater benefits it had expected. Given the similarities between the Swiss Fracture Registry and AJRR, it is logical to assume that the latter may suffer the same fate.

I base my concerns on factors that, carefully analyzed, might be important in determining the future of AJRR. One major consideration is the difficulty in guaranteeing the veracity of data submitted—a factor shared by all registries.¹ To assume that all participating surgeons adhere to high ethical and professional standards is naïve. Some surgeons who stand to make large profits from their ownership of implants or equipment are submitting false and erroneous information. Other unscrupulous orthopedists are receiving large kickbacks for helping the industry market its implants. These people will be tempted to embellish and falsify information about successes and failures and submit it to the registry.^1-3

Militating against the “guaranteed success” of AJRR is this tainted relationship between the implant manufacturing industry and some members of the orthopedics community. A 2002–2006 investigation by the US Justice Department found egregious unethical transgressions and corrupt relationships between 5 companies and hundreds of orthopedists—representing a widespread loss of professionalism in our ranks.⁴ More recently, the Centers for Medicare & Medicaid Services⁵ disclosed that, in the last 5 months of 2013, $3.5 billion were paid by medical device companies to doctors and leading hospitals. As stated in a newspaper article, “‘Open Payments does not identify which financial relationships … could cause conflicts of interest,’ said Shantanu Agrawal, the agency official overseeing the project. ‘It simply makes the data available to the public.’”⁶ Further, “an initial Associated Press analysis found that orthopedists, cardiologists and adult medicine specialists were among the likeliest to receive payments from drug and device companies. Most of the contributions came in the form of cash payments, followed by in-kind gifts and services, and stock options.”⁶

This official government revelation is disturbing. Although the number of people who are deliberately committing clear infractions may be small, some of these people are likely well-known, and their influence should not be underestimated, particularly with regard to AJRR publications. Some in the orthopedic community do not question the accuracy of these publications but accept their conclusions as fact, and such may be the case with orthopedic guidelines.⁷

Given these concerns and the facts of the situation, can AJRR solve real problems that traditional systems have so far failed to solve? We have enough journals and scientific meetings informing us of the failures and successes of implants. I suspect it is wrong to believe that the AJRR data on 1 million patients’ arthroplasties are necessarily superior to the data from a 20,000-patient registry. Such an erroneous conclusion ignores the fact that, with clinical issues such as the one currently being addressed by AJRR, having a larger registry and more patients does not necessarily imply more meaningful information. In addition, follow-ups longer than those used with traditional methods are not possible—death will continue to intervene. No matter how many patients are included in the system, the maximum follow-up will forever remain the same.

Financing of AJRR is expensive, time-consuming, and likely to be terminated if clear evidence of the true value of the registry is not provided within the next few years. In light of such an outcome, we should replace the current system with a more effective mechanism. For example, we could produce an annual publication that summarizes the peer-reviewed articles published on joint replacement, with an emphasis on controversial topics. Orthopedic fellows, rather than readily accepting AJRR findings and recommendations, will instead be able to decide for themselves what treatment to use for each particular patient and situation, based on information provided by a number of independent investigators.

Meaningful progress in managing clinical conditions, such as the ones we are discussing, is achieved not by expanding the size of a registry but by being committed as individuals to making improvements. A cursory glance at the history of hip arthroplasty easily proves the point. Registries, guidelines, and other popular systems sometimes inadvertently create an environment that inhibits independent thinking. When powerful nonmedical economic and political bodies become involved in medical issues in order to ensure their continued profit, our autonomy is lost or compromised in major ways. Such scenarios must be avoided as forcefully as possible.⁸

Questioning the future of AJRR does not derive from rigid thinking or from a lack of awareness or understanding of the registry’s nature, procedures, benefits, goals, or highly altruistic and noble origins. However, pointing out a lack of evidence of success is not a crime. It is incumbent on us to look at this area and others with open minds while recognizing that honest and sincere scrutiny often helps make a better future a reality. The United States is working to achieve major goals for health care—access for all, lower costs, and fewer abuses of the system. Our involvement is a mandate to be followed enthusiastically.

Many assume that the American Joint Replacement Registry (AJRR) is moving forward as originally planned. No one has reported any obstacles that may cast doubt on its continued progress.

Despite the enthusiasm for AJRR, we must be realistic and admit that the project may not in the final analysis bring about its anticipated results. Therefore, periodic sober assessments of its course should be carried out, as they might result in identifying possible flaws and strengths. It is imperative to continue to express doubts regarding the true long-term value of this registry.

Much of the original support for an ongoing registry came from the example provided by the Swedish national registry. The Scandinavian registry had been said to dramatically reduce the number of complications and halve the revision rate for total hip arthroplasties. We need to question the claim that this reduction was solely the result of information produced by the registry. It is hard to believe that the literature had failed to report on those complications long before the registry publicized its findings.

As we take a fresh look at AJRR, it is perhaps wise to keep in mind the history of the AO Swiss Fracture Registry, founded by Maurice Müller and heavily subsidized by industry. Apparently, after gathering millions of pieces of information, primarily about equipment used for fracture fixation, the Swiss registry has failed to produce the greater benefits it had expected. Given the similarities between the Swiss Fracture Registry and AJRR, it is logical to assume that the latter may suffer the same fate.

I base my concerns on factors that, carefully analyzed, might be important in determining the future of AJRR. One major consideration is the difficulty in guaranteeing the veracity of data submitted—a factor shared by all registries.¹ To assume that all participating surgeons adhere to high ethical and professional standards is naïve. Some surgeons who stand to make large profits from their ownership of implants or equipment are submitting false and erroneous information. Other unscrupulous orthopedists are receiving large kickbacks for helping the industry market its implants. These people will be tempted to embellish and falsify information about successes and failures and submit it to the registry.^1-3

Militating against the “guaranteed success” of AJRR is this tainted relationship between the implant manufacturing industry and some members of the orthopedics community. A 2002–2006 investigation by the US Justice Department found egregious unethical transgressions and corrupt relationships between 5 companies and hundreds of orthopedists—representing a widespread loss of professionalism in our ranks.⁴ More recently, the Centers for Medicare & Medicaid Services⁵ disclosed that, in the last 5 months of 2013, $3.5 billion were paid by medical device companies to doctors and leading hospitals. As stated in a newspaper article, “‘Open Payments does not identify which financial relationships … could cause conflicts of interest,’ said Shantanu Agrawal, the agency official overseeing the project. ‘It simply makes the data available to the public.’”⁶ Further, “an initial Associated Press analysis found that orthopedists, cardiologists and adult medicine specialists were among the likeliest to receive payments from drug and device companies. Most of the contributions came in the form of cash payments, followed by in-kind gifts and services, and stock options.”⁶

This official government revelation is disturbing. Although the number of people who are deliberately committing clear infractions may be small, some of these people are likely well-known, and their influence should not be underestimated, particularly with regard to AJRR publications. Some in the orthopedic community do not question the accuracy of these publications but accept their conclusions as fact, and such may be the case with orthopedic guidelines.⁷

Given these concerns and the facts of the situation, can AJRR solve real problems that traditional systems have so far failed to solve? We have enough journals and scientific meetings informing us of the failures and successes of implants. I suspect it is wrong to believe that the AJRR data on 1 million patients’ arthroplasties are necessarily superior to the data from a 20,000-patient registry. Such an erroneous conclusion ignores the fact that, with clinical issues such as the one currently being addressed by AJRR, having a larger registry and more patients does not necessarily imply more meaningful information. In addition, follow-ups longer than those used with traditional methods are not possible—death will continue to intervene. No matter how many patients are included in the system, the maximum follow-up will forever remain the same.

Financing of AJRR is expensive, time-consuming, and likely to be terminated if clear evidence of the true value of the registry is not provided within the next few years. In light of such an outcome, we should replace the current system with a more effective mechanism. For example, we could produce an annual publication that summarizes the peer-reviewed articles published on joint replacement, with an emphasis on controversial topics. Orthopedic fellows, rather than readily accepting AJRR findings and recommendations, will instead be able to decide for themselves what treatment to use for each particular patient and situation, based on information provided by a number of independent investigators.

Meaningful progress in managing clinical conditions, such as the ones we are discussing, is achieved not by expanding the size of a registry but by being committed as individuals to making improvements. A cursory glance at the history of hip arthroplasty easily proves the point. Registries, guidelines, and other popular systems sometimes inadvertently create an environment that inhibits independent thinking. When powerful nonmedical economic and political bodies become involved in medical issues in order to ensure their continued profit, our autonomy is lost or compromised in major ways. Such scenarios must be avoided as forcefully as possible.⁸

Questioning the future of AJRR does not derive from rigid thinking or from a lack of awareness or understanding of the registry’s nature, procedures, benefits, goals, or highly altruistic and noble origins. However, pointing out a lack of evidence of success is not a crime. It is incumbent on us to look at this area and others with open minds while recognizing that honest and sincere scrutiny often helps make a better future a reality. The United States is working to achieve major goals for health care—access for all, lower costs, and fewer abuses of the system. Our involvement is a mandate to be followed enthusiastically.

Many assume that the American Joint Replacement Registry (AJRR) is moving forward as originally planned. No one has reported any obstacles that may cast doubt on its continued progress.

Despite the enthusiasm for AJRR, we must be realistic and admit that the project may not in the final analysis bring about its anticipated results. Therefore, periodic sober assessments of its course should be carried out, as they might result in identifying possible flaws and strengths. It is imperative to continue to express doubts regarding the true long-term value of this registry.

Much of the original support for an ongoing registry came from the example provided by the Swedish national registry. The Scandinavian registry had been said to dramatically reduce the number of complications and halve the revision rate for total hip arthroplasties. We need to question the claim that this reduction was solely the result of information produced by the registry. It is hard to believe that the literature had failed to report on those complications long before the registry publicized its findings.

As we take a fresh look at AJRR, it is perhaps wise to keep in mind the history of the AO Swiss Fracture Registry, founded by Maurice Müller and heavily subsidized by industry. Apparently, after gathering millions of pieces of information, primarily about equipment used for fracture fixation, the Swiss registry has failed to produce the greater benefits it had expected. Given the similarities between the Swiss Fracture Registry and AJRR, it is logical to assume that the latter may suffer the same fate.

I base my concerns on factors that, carefully analyzed, might be important in determining the future of AJRR. One major consideration is the difficulty in guaranteeing the veracity of data submitted—a factor shared by all registries.¹ To assume that all participating surgeons adhere to high ethical and professional standards is naïve. Some surgeons who stand to make large profits from their ownership of implants or equipment are submitting false and erroneous information. Other unscrupulous orthopedists are receiving large kickbacks for helping the industry market its implants. These people will be tempted to embellish and falsify information about successes and failures and submit it to the registry.^1-3

Militating against the “guaranteed success” of AJRR is this tainted relationship between the implant manufacturing industry and some members of the orthopedics community. A 2002–2006 investigation by the US Justice Department found egregious unethical transgressions and corrupt relationships between 5 companies and hundreds of orthopedists—representing a widespread loss of professionalism in our ranks.⁴ More recently, the Centers for Medicare & Medicaid Services⁵ disclosed that, in the last 5 months of 2013, $3.5 billion were paid by medical device companies to doctors and leading hospitals. As stated in a newspaper article, “‘Open Payments does not identify which financial relationships … could cause conflicts of interest,’ said Shantanu Agrawal, the agency official overseeing the project. ‘It simply makes the data available to the public.’”⁶ Further, “an initial Associated Press analysis found that orthopedists, cardiologists and adult medicine specialists were among the likeliest to receive payments from drug and device companies. Most of the contributions came in the form of cash payments, followed by in-kind gifts and services, and stock options.”⁶

This official government revelation is disturbing. Although the number of people who are deliberately committing clear infractions may be small, some of these people are likely well-known, and their influence should not be underestimated, particularly with regard to AJRR publications. Some in the orthopedic community do not question the accuracy of these publications but accept their conclusions as fact, and such may be the case with orthopedic guidelines.⁷

Given these concerns and the facts of the situation, can AJRR solve real problems that traditional systems have so far failed to solve? We have enough journals and scientific meetings informing us of the failures and successes of implants. I suspect it is wrong to believe that the AJRR data on 1 million patients’ arthroplasties are necessarily superior to the data from a 20,000-patient registry. Such an erroneous conclusion ignores the fact that, with clinical issues such as the one currently being addressed by AJRR, having a larger registry and more patients does not necessarily imply more meaningful information. In addition, follow-ups longer than those used with traditional methods are not possible—death will continue to intervene. No matter how many patients are included in the system, the maximum follow-up will forever remain the same.

Financing of AJRR is expensive, time-consuming, and likely to be terminated if clear evidence of the true value of the registry is not provided within the next few years. In light of such an outcome, we should replace the current system with a more effective mechanism. For example, we could produce an annual publication that summarizes the peer-reviewed articles published on joint replacement, with an emphasis on controversial topics. Orthopedic fellows, rather than readily accepting AJRR findings and recommendations, will instead be able to decide for themselves what treatment to use for each particular patient and situation, based on information provided by a number of independent investigators.

Meaningful progress in managing clinical conditions, such as the ones we are discussing, is achieved not by expanding the size of a registry but by being committed as individuals to making improvements. A cursory glance at the history of hip arthroplasty easily proves the point. Registries, guidelines, and other popular systems sometimes inadvertently create an environment that inhibits independent thinking. When powerful nonmedical economic and political bodies become involved in medical issues in order to ensure their continued profit, our autonomy is lost or compromised in major ways. Such scenarios must be avoided as forcefully as possible.⁸

Questioning the future of AJRR does not derive from rigid thinking or from a lack of awareness or understanding of the registry’s nature, procedures, benefits, goals, or highly altruistic and noble origins. However, pointing out a lack of evidence of success is not a crime. It is incumbent on us to look at this area and others with open minds while recognizing that honest and sincere scrutiny often helps make a better future a reality. The United States is working to achieve major goals for health care—access for all, lower costs, and fewer abuses of the system. Our involvement is a mandate to be followed enthusiastically.