The clinical evidence behind the current implants used for proximal femoral fractures is weak considering the number of implants used worldwide .
Sporadic evaluation is not sufficient to identify long term problems .
INTRODUCTION Evaluation of the long-term performance of  implants used in trauma surgery relies on post-marked clinical studies since no registry based implant assessment exists .
The purpose of this study was to evaluate the evidence of performance of implants  currently used for treating proximal femoral fractures ( PFF ) in Denmark .
The next critical role of orthopedic registries
There is an urgent need for the introduction of new implant technology in orthopedic surgery to be conducted in a more controlled manner than in the past . Inadequate regulation and lack of effective post-market surveillance have meant that patients have not been protected from potentially harmful implants and procedures . Compounding the problem is a lack of question ing , a lack of critical appraisal , and lack of a requirement for clinical evidence by both surgeons and manufacturers before large-scale introduction of new technology to the market . There is a long and growing history of failed innovation , demonstrated by the failure or recall of individual products such as Boneloc ( bone cement ) , The Capital Hip ( total hip arthroplasty ) , and the ASR hip system ( total hip arthroplasty ) among others , as well as whole classes of devices such as large-head metal-on-metal bearings . This demonstrates simple , yet severe flaws in the mechanisms that should protect patients from increased risk associated with introduction of new technology . Insufficient or inadequate pre clinical data , a lack of clinical data from timely RSA ( radiostereometric analysis ) studies , and limited larger , multicenter cohort studies prior to general release all increase the risk to patients . The 510k process , where the majority of so-called innovative new design s have been cleared or approved by FDA - or CE-notified bodies for clinical use , is based on similarities to previously used implants . In the 510k process , there is no requirement for specific clinical evidence , so manufactures have not obtained clinical data . Registry post-market surveillance has proven to be a powerful method for detection of increased risk of implant failure , but this is not available in all countries . When registries do identify poor-performing devices , regulators and manufacturers are often slow to respond . The main problem with the current approach to the introduction of new technology is the inability to identify unanticipated failures before wider release ( Bauer 1992 ) . It is 20 years since the stepwise introduction of new implants was first described ( Malchau 1995 ) . The basic concept of this approach is that the smallest possible numbers of patients ( after sufficient pre clinical testing ) are exposed to the implant prior to general release . Stepwise introduction uses a combination of ( 1 ) outcome measurements with high-precision metrics in small cohorts , such as RSA , and ( 2 ) limited clinical introduction in a larger cohort , prospect ively monitoring outcomes and revisions . Adoption of this concept would certainly have reduced the large number of poor-performing new implants introduced in recent years . The concept has , however , never been implemented due to lack of support from surgeons , manufacturers , and regulatory authorities . Now trends have changed , with increasing focus on implementing an effective approach to pre-release clinical assessment . The ongoing work and discussion s in the International Society of Arthroplasty Registries ( ISAR ) , the reports from the Australian Orthopaedic Association total joint registry , and the actions taken in the UK to put a “ beyond compliance ” program into action will facilitate a more cautious market introduction . In addition , the Arthroplastywatch project ( www.arthroplastywatch.com ) is in action : data are collected on the web through a specially developed search routine . Based on examination in several steps using medical and statistical expertise , a caution could be warranted or a warning declared . These combined initiatives say one thing : that close monitoring of new implants by well-established registries during a phase of controlled introduction must be a universal requirement . We propose a structured model for clinical trials involving 4 levels : ( 1 ) a pure observational study using reoperation data from multiple registries , as shown in several papers by the Nordic Arthroplasty Register Association ( NARA ) ; ( 2 ) patient-reported outcome measures , either from national implant registries or from other registries for specific studies ; ( 3 ) radiographic data plus other parameters such as blood levels of metal ions , based on specific needs for a new technology ; and ( 4 ) options for r and omized studies with use of , for example , RSA in the evaluation . The cornerstone in this structural model should be the exp and ed use of existing and future registries with a high degree of coverage and completeness . While registries have a strong tradition in arthroplasty surgery , this is not as well developed in other areas of orthopedic surgery . It is the responsibility of orthopedic surgeons and their professional bodies to support and implement registries where they can be of benefit . The arthroplasty registry experience has shown that it is possible to use registries to effectively monitor the introduction of new technology . Without this registry-based surveillance , identification of many of the failed innovations would have been delayed or might even have gone unrecognized . It is encouraging that registries in fracture surgery are now emerging , where implants are inserted in large and increasing numbers . Finally , implant performance is potentially confounded by the technical difficulty of inserting the implant , the knowledge and abilities of the surgeon inserting them , and the complexity of the cases . Many registries monitor performance at the surgeon level . This together with continuous education and training in how to use new implants should be an integral part of the process of a more cautious market introduction . If training is linked in with the stepwise introduction , it will be possible to identify the need for and the extent of training . Our proposed regulatory change to require registry-based monitoring of new implants during the phase of limited introduction must be accompanied by a change in the way we think and act as orthopedic surgeons . In the training of future orthopedic surgeons , emphasis must be placed on developing a healthy skepticism to innovation , on recognizing the need for evidence -based introduction , and on building a culture holding the view that reporting to a registry is imperative . The registries will then be able to offer back data to enable surgeons to choose the best clinical practice . To increase innovation and to ensure that innovation is effective and beneficial , the role of registries should be exp and ed . The registries should not undertake the role of a regulatory authority , but in compliance with the industry and the orthopedic community they should ensure that a more cautious approach is used when new technology is introduced . This could lead to a better balance between the inborn conservatism that a registry represents and the continuous need for innovation . The independence , infrastructure , and expertise of the registries can be used more fully to optimize how new implants are introduced . All stakeholders need to join to ensure that first and foremost , we do no harm
The clinical evidence behind the current implants used for proximal femoral fractures is weak considering the number of implants used worldwide .
Sporadic evaluation is not sufficient to identify long term problems .
INTRODUCTION Evaluation of the long-term performance of  implants used in trauma surgery relies on post-marked clinical studies since no registry based implant assessment exists .
The purpose of this study was to evaluate the evidence of performance of implants  currently used for treating proximal femoral fractures ( PFF ) in Denmark .