The next critical role of orthopedic registries The Scandinavian ACL registries 2004–2007: baseline epidemiology Cement augmentation of the Proximal Femoral Nail Antirotation (PFNA) - A multicentre randomized controlled trial. Implant-Related Fractures of the Femur Following Hip Fracture Surgery A new short uncemented, proximally fixed anatomic femoral implant with a prominent lateral flare: design rationals and study design of an international clinical trial [Two-year results of a modular short hip stem prosthesis--a prospective study]. A randomized study on migration of the Spectron EF and the Charnley flanged 40 cemented femoral components using radiostereometric analysis at 2 years Which Implant Is Better for Treating Reverse Obliquity Fractures of the Proximal Femur: A Standard or Long Nail? Is the Proximal Femoral Nail a Suitable Implant for Treatment of All Trochanteric Fractures? Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. Bone remodelling after femoral short stem implantation in total hip arthroplasty: 1-year results from a randomized DEXA study Locking intramedullary nails and locking plates in the treatment of two-part proximal humeral surgical neck fractures: a prospective randomized trial with a minimum of three years of follow-up. A comparative study of screw and helical proximal femoral nails for the treatment of intertrochanteric fractures. A comparison of the long gamma nail with the sliding hip screw for the treatment of AO/OTA 31-A2 fractures of the proximal part of the femur: a prospective randomized trial. Maintenance of bone mineral density after implantation of a femoral neck hip prosthesis Early functional results after Hemiarthroplasty for femoral neck fracture: a randomized comparison between a minimal invasive and a conventional approach Comparative study of the proximal femoral nail antirotation versus the reconstruction nail in the treatment of comminuted proximal femoral fracture. Expandable Proximal Femoral Nails (EPFNs) in Elderly Patients Retracted: Outcome of Short Proximal Femoral Nail Antirotation and Dynamic Hip Screw for Fixation of Unstable Trochanteric Fractures. A Randomised Prospective Comparative Trial Conventional versus computer-navigated TKA: a prospective randomized study Treatment of unstable trochanteric fractures. Randomised comparison of the gamma nail and the proximal femoral nail. A Comparative study of the Dynamic Hip Screw, the Cemented Bipolar Hemiarthroplasty and the Proximal Femoral Nail for the Treatment of Unstable Intertrochanteric Fractures. [Proximal femoral intramedullary nail versus DHS plate for the treatment of intertrochanteric fractures. A prospective analysis].
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 Background and purpose No prospect i ve surveillance systems have been available for monitoring the outcome of  cruciate ligament surgery in Sc and inavia ( Denmark , Norway , and Sweden ) . In the present paper we describe the Sc and inavian ACL registries including their main function , similarities , and preliminary baseline results . Methods The Sc and inavian registries were established in 2004 ( Norway ) and 2005 ( Denmark and Sweden ) . The Danish and Swedish registries were originally based on the Norwegian registry , and there is no overriding difference between the three . In Denmark , all hospitals and clinics are legally bound to report to an approved national data base . In Norway and Sweden , the registries are based on voluntarily reporting by surgeons . Results The annual incidence of primary ACL reconstructions  is higher in Denmark than in Norway , except in females younger than 20 years . Among Sc and inavian surgeons , there is a similar approach to the patients . Differences do , however , exist regarding choice of grafts , choice of implants , and choice of treatment of simultaneous meniscal and cartilage injuries ; the proportion of ACL reconstructions performed as outpatient surgery ; and the use of prophylactic anticoagulation . Clinical ly , the preoperative KOOS scores are not significantly different between the Sc and inavian registries , except that Denmark reports more symptoms both pre- and postoperatively . Interpretation The Sc and inavian national ACL registries will generate new data about ACL reconstructions . They will contribute important knowledge regarding ACL epidemiology . They will be the only source of data on the performance of a wide range of different implants and techniques . In addition , they will hopefully have an impact on the selection of methods for ACL reconstructions in Sc and inavia and elsewhere INTRODUCTION New implant design s like the Proximal Femoral Nail Antirotation ( PFNA ) were developed to reduce failure rates in unstable pertrochanteric fractures in the elderly . St and ardized implant augmentation with up to 6 mL of polymethylmethacrylate ( PMMA ) cement has been introduced to enhance implant anchorage by increasing the implant-bone interface in osteoporotic bone conditions . Biomechanically , loads to failure were significantly higher with augmentation . The primary objective of this study was to compare the mobility of patients with closed unstable trochanteric fractures treated by PFNA  either with or without cement augmentation . PATIENTS AND METHODS A prospect i ve multicentre , r and omized , patient-blinded trial was conducted with ambulatory patients aged 75 or older who sustained a closed , unstable trochanteric fracture . Surgical fixation had to be performed within 72 h after admission . Outcomes were evaluated at baseline , during surgery , 3 to 14 days after surgery , 3 months , 6 months , and 12 months after surgery . To evaluate the primary objective , patients ' walking speed was assessed by the Timed Up and Go ( TUG ) test . Secondary objectives included the analysis of implant migration assessed on radiographs , quality of life measured by the Barthel Index , mobility measured by the Parker Mobility Score , and complications . RESULTS Of 253 r and omized patients , 223 patients were eligible : 105 patients were allocated to the  PFNA Augmentation group and 118 to  PFNA group .  At 3 to 14 days after surgery , there was no statistical significant difference in mean walking speed between the treatment groups . For the secondary objectives , also no statistical significant differences were found . However , no patient in the PFNA Augmentation group had a reoperation due to mechanical failure or symptomatic implant migration compared to 6 patients in the PFNA group . CONCLUSIONS Augmentation of the PFNA blade did not improve patients ' walking ability compared to the use of a non-augmented PFNA but might have the potential to prevent reoperations by strengthening the osteo synthesis construct Background : Most hip fractures are treated surgically , with use of either internal fixation or prosthetic replacement of the femoral head . The presence of these implants increases the risk of a later femoral fracture in susceptible osteoporotic patients . The purpose of this study was to analyze the incidence of and risk factors for implant-related fractures of the femur after previous hip fracture surgery . Methods : Over a ten-year period from January 1988 to December 1997 , 6230 patients ( median age , eighty-two years ; male : female ratio , 1247:4983 ) who sustained a total of 6696 hip fractures were admitted to the Edinburgh Orthopaedic Trauma Unit . Demographic information on the patients and details of the original treatment of the hip fracture were prospect ively coded and entered into a trauma data base . All subsequent readmissions due to a femoral fracture related to the implant were prospect ively audited and extracted for the purpose s of this study . Results : One hundred and forty-one patients sustained an ipsilateral fracture of the femur at a median of twenty-four weeks following the original hip fracture surgery . Survivorship analysis of the hip fracture population revealed an overall rate of subsequent femoral fracture of 2.9 % at five years , which increased to 5.1 % at ten years . The median age and gender distribution of the patients who sustained a subsequent femoral fracture were similar to those of the hip fracture population as a whole . Two-thirds of the fractures propagated from the tip of the implant . Analysis of the subsequent fractures according to the type of implant used to treat the original fracture revealed considerable differences in incidence . The incidence was relatively high in the patients initially treated with a Gamma nail ( 18.74 fractures per 1000 person-years ) or a cementless hemiarthroplasty ( 11.72 per 1000 person-years ) and was relatively low in those treated with a compression hip screw ( 4.46 per 1000 person-years ) , cannulated screws ( 4.50 per 1000 person-years ) , or a primary arthroplasty with cement ( 6.2 per 1000 person-years ) . The highest incidence of fracture was seen in the patients who had required an arthroplasty with cement as a revision procedure following failure of a primary implant ( 22.39 per 1000 person-years ) . Conclusions : Implant-related fractures following hip fracture surgery are more common than has previously been appreciated . The risk of later ipsilateral femoral fracture is increased by the use of a Gamma nail or a cementless hemiarthroplasty to treat the original hip fracture Background Anatomic short femoral prostheses with a prominent lateral flare have the potential to reduce stress-shielding in the femur through a more physiological stress distribution to the proximal femur . We present the design rationale of a new short uncemented , proximally fixed anatomic femoral implant and the study design of a prospect i ve multi-centre trial to collect long-term patient outcome and radiographic follow up data . Methods A prospect i ve surveillance study ( trial registry NCT00208555 ) in four European centres ( UK , Italy , Spain and Germany ) with a follow up period of 15 years will be executed . The recruitment target is 200 subjects , patients between the ages of 18 and 70 admitted for primary cementless unilateral THA will be included . The primary objective is to evaluate the five-year survivorship of the new cementless short stem .  The secondary objectives of this investigation are to evaluate the long term survivorship and the clinical performance of the implant , the impact on the subjects health related Quality of Life and the affect of the prosthesis on bone mineral density . Peri- and postoperative complications will be registered . Clinical and radiographic evaluation of prosthesis positioning will be done post-operatively and at 3 , 6 , 12 , 24 , 60 , 120 and 180 months follow up . Discussion Shortening of the distal stem can maximise bone and soft tissue conservation . New stem types have been design ed to improve the limitations of traditional implants in primary THA . A new , uncemented femoral short stem is introduced in this paper . A long-term follow up study has been design ed to verify stable fixation and to research into the clinical outcome . The results of this trial will be presented as soon as they become available AIM The short-term results of a prospect i ve , consecutive series of 50 cementless modular short hip stem endoprostheses  are reported . METHOD 48 cases were available for clinical and radiological follow-up at an average time of 2.4 years post-op . One patient did not consent to a follow-up investigation , 1 early revision was necessary 4 weeks post-op after a fall precipitating a periprosthetic fracture . RESULTS The average age at the time of THA was 54 years and the Harris hip score reached 95 points at the time of follow-up . One implant had aseptic loosening and 1 implant was revised due to a failure of the modular titanium neck adapter . An equal number of patients received modular neck adapters with neutral or 7.5 degrees retroversion . No 140 degrees neck and no anteverted neck adapters were used . Radiological results of the 2/3 porous coated hip stem showed a metaphyseal bone remodelling with hypertrophies in coated Gruen zones 3 ( 17 % ) and 6 ( 46 % ) and marked spot welds and increased bone density ( 86 % ) in the distal area of the coating . Primary implant migration between 2 and 10 mm was present in 7 cases due to a low osteotomy and implant position combined with an implant undersizing and lack of proximal-lateral support . At the time of the last follow-up these cases had no clinical symptoms with an average HHS of 96 points and with full bony integration . CONCLUSION Our results support the use of the investigated short hip stem for THA when the femoral bone quality and morphology support the metaphyseal anchoring concept . The surgical technique must avoid a stem position without proximal-lateral cortical contact to the femoral osteotomy , as this reduces primary implant stability . Further follow-up is necessary to vali date the long-term success of this procedure Background and purpose We performed a r and omized study to determine the migration patterns of the Spectron EF femoral stem and to compare them with those of the Charnley stem , which is regarded by many as the gold st and ard for comparison of implants due to its extensive documentation . Patients and methods 150 patients with a mean age of 70 years were r and omized , single-blinded , to receive either a cemented Charnley flanged 40 monoblock , stainless steel , vaquasheen surface femoral stem with a 22.2-mm head ( n = 30 ) or a cemented Spectron EF modular , matte , straight , collared , cobalt-chrome femoral stem with a 28-mm femoral head and a roughened proximal third of the stem ( n = 120 ) . The patients were followed with repeated radiostereometric analysis for 2 years to assess migration . Results At 2 years , stem retroversion was 2.3 ° and 0.7 ° ( p < 0.001 ) and posterior translation was 0.44 mm and 0.17 mm ( p = 0.002 ) for the Charnley group ( n = 26 ) and the Spectron EF group ( n = 74 ) , respectively . Subsidence was 0.26 mm for the Charnley and 0.20 mm for the Spectron EF ( p = 0.5 ) . Interpretation The Spectron EF femoral stem was more stable than the Charnley flanged 40 stem in our study when evaluated at 2 years . In a report from the Norwegian arthroplasty register , the Spectron EF stem had a higher revision rate due to aseptic loosening beyond 5 years than the Charnley . Initial stability is not invariably related to good long-term results . Our results emphasize the importance of prospect i ve long-term follow-up of prosthetic implants in clinical trials and national registries and a stepwise introduction of implants Background Reverse obliquity fractures of the proximal femur have biomechanical characteristics distinct from other intertrochanteric fractures and high implant failure rate when treated with sliding hip screws . Intramedullary hip nailing for these fractures reportedly has less potential for cut-out of the lag screw because of their loadbearing capacity when compared with extramedullary implants . However , it is unclear whether nail length influences healing . Questions / purpose sWe compared st and ard and long types of intramedullary hip nails in terms of ( 1 ) reoperation ( fixation failure ) , ( 2 ) 1-year mortality rate , ( 3 ) function and mobility , and ( 4 ) union rate . Methods We conducted a pilot prospect i ve r and omized controlled trial comparing st and ard versus long ( ≥ 34 cm ) intramedullary hip nails for reverse obliquity fractures of the proximal femur from January 2009 to December 2009 . There were 15 patients with st and ard nails and 18 with long nails . Mean age was 79 years ( range , 67–95 years ) . We determined 1-year mortality rates , reoperation rates , Parker-Palmer mobility and Harris hip scores , and radiographic findings ( fracture union , blade cut-out , tip-apex distance , implant failure ) . Minimum followup was 12 months ( mean , 14 months ; range , 12–20 months ) . Results We found no difference in reoperation rates between groups . Two patients ( both from the long-nail group ) underwent revision surgery because of implant failure in one and deep infection in the other . There was no difference between the st and ard- and long-nail groups in mortality rate ( 17 % versus 18 % ) , Parker-Palmer mobility score ( five versus six ) , Harris hip score ( 74 versus 79 ) , union rate ( 100 % in both groups ) , blade cut-out ( zero versus one ) , and tip-apex distance ( 22 versus 24 mm ) . Conclusions Our preliminary data suggest reverse obliquity fractures of the trochanteric region of the femur can be treated with either st and ard or long intramedullary nails . Level of Evidence Level II , therapeutic study . See Instructions for Authors for a complete description of levels of evidence We review ed 155 consecutive patients who were treated with a proximal femoral nail from 1997 to 2001 to determine the rate of implant specific complications . Results were stratified according to fracture type and surgeon experience to determine which problems occurred in these groups . One year postoperative followup was available for 129 of 132 surviving patients ( 98 % ) . Failure of fixation occurred in three patients ( 2 % ) , and a femoral shaft fracture occurred in one patient ( 0.7 % ) . Fixation failures included one cutout , one delayed fracture healing , and one lateral displacement of the antirotation screw . The total reoperation rate was high ( 12 % ) mainly because of hardware removals , which occurred in 13 patients ( 8.6 % ) . Stratification of results showed that hematomas and iliotibial tract irritation occurred more commonly with lesser surgical experience . General complications and intraoperative problems were seen more often with subtrochanteric fractures . Because the high reoperation rate with the proximal femoral nail is a concern , extramedullary devices continue to be the preferred implants for treatment of stable trochanteric fractures . The low rates of femoral shaft fractures and failure of fixation suggest the proximal femoral nail is useful for treatment of unstable trochanteric and subtrochanteric fractures . Level of Evidence : Therapeutic study , Level IV ( case series ) . See the Guidelines for Authors for a complete description of levels of evidence OBJECTIVES The objective was to define the characteristics of a real-world patient population treated with transcatheter aortic valve implantation ( TAVI )  , regardless of technology or access route , and to evaluate their clinical outcome over the mid to long term . BACKGROUND Although a substantial body of data exists in relation to early clinical outcomes after TAVI , there are few data on outcomes beyond 1 year in any notable number of patients . METHODS The U.K. TAVI ( United Kingdom Transcatheter Aortic Valve Implantation ) Registry was established to report outcomes of all TAVI procedures performed within the United Kingdom . Data were collected prospect ively on 870 patients undergoing 877 TAVI procedures up until December 31 , 2009 . Mortality tracking was achieved in 100 % of patients with mortality status reported as of December 2010 . RESULTS Survival at 30 days was 92.9 % , and it was 78.6 % and 73.7 % at 1 year and 2 years , respectively . There was a marked attrition in survival between 30 days and 1 year . In a univariate model , survival was significantly adversely affected by renal dysfunction , the presence of coronary artery disease , and a nontransfemoral approach ; whereas left ventricular function ( ejection fraction < 30 % ) , the presence of moderate/severe aortic regurgitation , and chronic obstructive pulmonary disease remained the only independent predictors of mortality in the multivariate model . CONCLUSIONS Midterm to long-term survival after TAVI was encouraging in this high-risk patient population , although a substantial proportion of patients died within the first year Introduction Short stem prostheses have been developed to preserve proximal femoral bone stock . This prospect i ve , r and omized study compared periprosthetic bone remodelling following short and straight stem implantation 1 year after surgery . Material s and methods One hundred and forty-four consecutive patients undergoing total hip arthroplasty were r and omized to either a Fitmore short or a cementless straight stem ( both Zimmer , Winterthur , Switzerl and ) . Periprosthetic bone mineral density ( BMD ) was measured using dual-energy X-ray absorptiometry performed the day before surgery and at 7 days , 3 months and 1 year postoperatively . Furthermore , the HHS and the WOMAC were obtained . Results One hundred and thirty-eight patients completed 1-year follow-up . Periprosthetic BMD changes at 1 year were most pronounced in the proximal medial region of interest ( ROI ) 7 with −17.2 % after short stem and −16.7 % after straight implantation ( p = 0.67 ) . However , there was significantly less BMD reduction in ROI 6 following short ( −4.7 % ) versus straight stem ( −10.8 % ) implantation ( p = 0.01 ) . There were no significant differences between the two groups in terms of the HHS and the WOMAC either before or after surgery . Conclusion One year after surgery , both stems showed an implant-specific periprosthetic bone remodelling . Nevertheless , proximal load transfer was more pronounced after short stem implantation than with a straight stem BACKGROUND locking intramedullary nails and locking plates specially design ed for proximal humeral fractures are widely used . The purpose of our study was to compare the outcomes between these two types of implants in patients with a two-part surgical neck fracture . The advantages and shortcomings of each method were analyzed . METHODS a prospect i ve r and omized study was performed . Fifty-one consecutive patients with a fresh two-part surgical neck fracture were r and omized to be treated with a locking intramedullary nail ( n = 25 ) or a locking plate ( n = 26 ) . Clinical and radiographic assessment s were conducted at one year and three years after the surgery . A visual analog scale ( VAS ) was used to assess shoulder pain . The American Shoulder and Elbow Surgeons ( ASES ) scores and Constant-Murley scores were recorded to evaluate shoulder function . RESULTS fracture union was achieved in all patients within three months after the surgery . At one year postoperatively , a significant difference ( p = 0.024 ) was found with regard to the complication rate between the locking plate group ( 31 % ) and the locking nail group ( 4 % ) . The average ASES score , median VAS score , and average strength of the supraspinatus were significantly better in the locking plate group ( 90.8 compared with 83.6 points [ p = 0.021 ] , 1.0 compared with 0.5 point [ p = 0.042 ] , and 77.4 % compared with 64.3 % [ p = 0.032 ] ) . At three years postoperatively , no significant difference could be found in terms of any parameter between the two groups . Significant improvement in the VAS pain scores , ASES scores , and Constant-Murley scores were found between the one-year and three-year follow-up examinations in each group . CONCLUSIONS satisfactory results can be achieved with either implant in the treatment of two-part proximal humeral surgical neck fractures . There was no difference regarding the ASES scores between these two implants at the time of the final , three-year follow-up . The complication rate was lower in the locking intramedullary nail group , while fixation with a locking plate had the advantage of a better one-year outcome . LEVEL OF EVIDENCE therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence The goal of this study was to compare treatment outcomes of screw proximal femoral nails and helical proximal femoral nails and to investigate the effectiveness of helical proximal femoral nails for the treatment of intertrochanteric fractures . Forty patients with intertrochanteric fractures were treated at our institution between January 2005 and January 2007 , with a minimum follow-up of 1.5 years . Seventeen patients were treated with screw proximal femoral nails ( mean patient age , 67 years ; age range , 45 - 89 years ; men : women ratio , 3:14 ) , and 23 were treated with helical proximal femoral nails ( mean patient age , 74 years ; age range , 64 - 91 years ; men : women ratio , 6:17 ) . We evaluated mean operation time , amount of bleeding , time to ambulation , average union period , changes in neck shaft angle , and complications , and performed radiographic review s , telephone interviews  , and direct  contact interviews  at an outpatient clinic . We evaluated postoperative function and mobility using social function scores and mobility scores .  Helical proximal femoral nails produced better results in terms of social function scores , mobility scores , and complication rates with statistical significance . No significant differences were found between the 2 nails in terms of mean operation time , amount of bleeding , average union period , time to ambulation , or neck shaft angle changes .  Screw proximal femoral nails and helical proximal femoral nails are suitable implants for intertrochanteric fractures , but helical proximal femoral nails are better in terms of functional aspects and complication rates BACKGROUND Controversy exists with regard to whether to treat AO/OTA 31-A2 fractures of the proximal part of the femur with an intramedullary device or an extramedullary device . A prospect i ve , r and omized , controlled trial was performed to compare the outcome of treatment of these unstable fractures of the proximal part of the femur with either a sliding hip screw or a long gamma nail . METHODS Two hundred and ten patients presenting with an AO/OTA 31-A2 fracture of the proximal part of the femur were r and omized , at the time of admission , to fixation with use of either a long gamma nail or a sliding hip screw .  The primary outcome measure was reoperation within the first postoperative year . Secondary measures included mortality , length of hospital stay , transfusion rate , change in mobility and residence , and quality of life as measured with the EuroQol 5D outcome score . RESULTS There was no significant difference between the reoperation rates for the two groups . In total , five patients ( three from the long-gamma-nail group and two from the sliding-hip-screw group ) underwent revision surgery because of cut-out . Tip-apex distance was found to correlate with the implant cut-out rate . There was no significant difference between the two groups in terms of the EuroQol 5D outcome scores , the mortality rates after correction for the mini-mental score , or any of the secondary outcome measures . CONCLUSIONS When compared with the long gamma nail , the sliding hip screw should remain the gold st and ard for the treatment of AO/OTA 31-A2 fractures of the proximal part of the femur because it is associated with similar outcomes with less expense Background Stress shielding of the proximal femur has been observed in a number of conventional cementless implants used in total hip arthroplasty .  Short femoral-neck implants are cl aim ing less interference with the biomechanics of the proximal femur . The goal of this study was to investigate the changes of bone-mineral density in the proximal femur and the clinical outcome after implantation of a short femoral-neck prosthesis . Methods We prospect ively assessed the clinical outcome and the changes of bone mineral density of the proximal femur up to one year after implantation of a short femoral neck prosthesis in 20 patients with a mean age of 47 years ( range 17 to 65 ) . Clinical outcome was assessed using the Harris Hip Score . The WOMAC was used as a patient-relevant outcome -measure . The bone mineral density was determined using dual energy x-ray absorptiometry , performed 10 days , three months and 12 months after surgery . Results The Harris Hip Score improved from an average preoperative score of 46 to a postoperative score at 12 months of 89 points , the global WOMAC index from 5,3 preoperatively to 0,8 at 12 months postoperatively . In contrast to conventional implants , the DEXA-scans overall revealed a slight increase of bone mineral density in the proximal femur in the 12 months following the implantation . Conclusion The short femoral neck stem lead to a distinct bone reaction . This was significantly different when compared to the changes in bone mineral density reported after implantation of conventional implants Background A minimal invasive approach for elective hip surgery has been implemented in our institution in the past . It is widely hypothesized that implanting artificial hips in a minimal invasive fashion decreases surgical trauma and is helpful in the rehabilitation process in elective hip surgery . Thereby geriatric patients requiring emergency hip surgery also could theoretically benefit from a procedure that involves less tissue trauma . Methods Sixty patients who sustained a fractured neck of femur were r and omly assigned into two groups . In the minimal invasive arm , the so called “ direct anterior approach ” ( DAA ) was chosen , in the conventional arm the Watson-Jones-Approach was used for implantation of a bipolar hemi-arthroplasty . Primary outcome parameter was the mobility as measured by the four-item-Barthel index . Secondary outcome parameters included pain , haemoglobin-levels , complications , duration of surgery , administration of blood transfusion and external length of incision . Radiographs were evaluated . Results A statistically significant difference ( p = 0,009 ) regarding the mobility as measured with the four-item Barthel index was found at the 5th postoperative day , favouring the DAA . Evaluation of the intensity of pain with a visual analogue scale ( VAS ) showed a statistically significant difference ( p = 0,035 ) at day 16 . No difference was evident in the comparison of radiographic results . Conclusions Comparing two different approaches to the hip joint for the implantation of a bipolar hemi-arthroplasty after fractured neck of femur , it can be stated that mobilization status is improved for the DAA compared to the WJA when measured by the four-item Barthel index , there is less pain as measured using the VAS . There is no radiographic evidence that a minimal invasive technique leads to inferior implant position . Level of Evidence : Level II therapeutic study The purpose of our study was to compare the proximal femoral nail antirotation ( PFNA ; Synthes , Paoli , Pennsylvania ) with a reconstruction nail ( Recon ; Zimmer , Warsaw , Indiana ) in the treatment of comminuted proximal femoral fractures . Between 2003 and 2010 , twenty-three consecutive patients with AO/Orthopaedic Trauma Association 31-A3 fractures combined with proximal 32 fractures who had a minimum 18-month follow-up were evaluated retrospectively . There were 10 patients ( age range , 18 - 74 years ) in the Recon nail group and 13 patients ( age range , 22 - 90 years ) in the PFNA nail group . Patients treated with Recon nails experienced a longer operation time ( P=.006 ) and more blood loss ( P=.012 ) than patients treated with the PFNA nail . On postoperative radiographs , the change in the neck-shaft angle was 8.8 ° in the Recon nail group and 4.7 ° in the PFNA nail group ( P=.048 ) . The fracture union time averaged 31.8 weeks in the Recon nail group and 21.5 weeks in the PFNA nail group ( P=.148 ) . More patients in the Recon nail group underwent major or minor reoperation ( P=.038 ) compared with the PFNA nail group . No implant failure occurred in either group . The functional results were similar in the 2 groups . For the treatment of comminuted proximal femoral fractures , use of either the PFNA and Recon nail is clinical ly effective . However , the PFNA nail provides a shorter operation time , less blood loss , and better realignment ability and reduces the incidence of reoperation . Therefore , the PFNA nail can be considered a better device than the Recon nail ABSTRACT Purpose : The purpose was to study the performance of exp and able proximal femoral nails ( EPFNs ) for the treatment of unstable intertrochanteric fractures in elderly patients . Patients and methods : Eighty-four patients were treated with a newly design ed EPFN and followed up for one year . Results : The mean operating time was 50.1 ± 3.2 min and the mean blood loss was 112.3 ± 5.3 ml . Patients were treated with EPFNs of 220 mm ( n = 24 ) , 240 mm ( n = 59 ) , and 340 mm ( n = 1 ) length . At six months postoperatively , the Harris Hip Score was 74.5 ± 5.3 . At the end of follow up , 75 % of patients completely recovered their preoperative function and resumed their normal activities . Seven patients died within one year postoperatively . During the operation , one patient experienced proximal femoral diaphyseal slight crack fracture . This crack fracture was treated by using a long EPFN ( 340 mm ) . Two patient developed screw cut-outs , which were solved by reoperation . And one developed deep infection resolved favorably by the appropriate antibiotic treatment . Implant failure , deep venous thrombosis , fat embolism , secondary fracture , and nonunion were not encountered . Conclusions : In conclusion , the results of the EPFNs were satisfactory in most elderly patients with unstable intertrochanteric fracture . However , during the inflation period , the pressure on the nail must be monitored carefully in order to prevent a crack fracture A prospect i ve , r and omised , controlled trial was performed to compare the outcome of treatment of unstable trochanteric fractures with either a short proximal femoral nail antirotation ( PFNA ) or dynamic hip screw ( DHS ) .  Eighty one patients with unstable fracture of the proximal part of the femur were r and omised , at the time of admission , for fixation with either a short PFNA ( n=42 ) or DHS ( n= 39 ) . The primary outcome measure was reoperation within the first postoperative year and mortality at the end of one year . Operative time , fluoroscopy time , blood loss , and any intra-operative complication were recorded for each patient . Clinical and radiological follow-up was undertaken for a minimum of 36 months . Any changes in the position of the implant or fixation failure were recorded . Hip range of motion , pain in the hip or thigh and return to work were used to compare the outcomes . There was no significant difference between 1 year mortality rates for the two groups . The mean operative time was significantly less in PFNA group ( 25 min ) than in the DHS group ( 38 min ) . Patients treated with a PFNA experienced a shorter fluoroscopy time and less blood loss . Six patients in DHS group had implant failure while none experienced this in PFNA group . The PFNA group had a better functional outcome than the DHS group Purpose The purpose of this study was to assess the midterm results of total knee arthroplasty ( TKA ) implanted with  a specific computer navigation system in a group of patients ( NAV ) and to assess the same prosthesis implanted with the conventional technique in another group ( CON ) ; we hypothesized that computer navigation surgery would improve implant alignment , functional scores and survival of the implant compared to the conventional technique . Methods From 2008 to 2009 , 225 patients were enrolled in the study and r and omly assigned in CON and NAV groups ; 240 consecutive mobile-bearing ultra-congruent score ( Amplitude , Valence , France ) TKAs were performed by a single surgeon , 117 using the conventional method and 123 using the computer-navigated approach .  Clinical outcome assessment was based on the Knee Society Score ( KSS ) , the Hospital for Special Surgery Knee Score and the Western Ontario Mac Master University Index score . Component survival was calculated by Kaplan – Meier analysis . Results Median follow-up was 6.4 years ( range 6–7 years ) . Two patients were lost to follow-up . No differences were seen between the two groups in age , sex , BMI and side of implantation . Three patients of CON group referred feelings of instability during walking , but clinical tests were all negative . NAV group showed statistical significant better KSS Score and wider ROM and fewer outliers from neutral mechanical axis , lateral distal femoral angle , medial proximal tibial angle and tibial slope in post-operative radiographic assessment . There was one case of early post-operative superficial infection ( caused by Staph . Aureus ) successfully treated with antibiotics . No mechanical loosening , mobile-bearing dislocation or patellofemoral complication was seen . At 7 years of follow-up , component survival in relation to the risk of aseptic loosening or other complications was 100 % . There were no implant revisions . Conclusion This study demonstrates superior accuracy in implant positioning and statistical significant better functional outcomes of computer-navigated TKA . Computer navigation for TKAs should be used routinely in primary implants . Level of evidence II The proximal femoral nail ( PFN ) is a recently introduced intramedullary system , design ed to improve treatment of unstable trochanteric fractures of the hip . In a multicentre prospect i ve clinical study , the intra-operative use , complications and outcome of treatment using the  PFN ( n = 211 ) were compared with those using the gamma nail ( GN ) ( n = 213 ) . The intra-operative blood loss was lower with the PFN ( 220 ml v 287 ml , p = 0.001 ) . Post-operatively , more lateral protrusion of the hip screws of the PFN ( 7.6 % ) was documented , compared with the gamma nail ( 1.6 % , p = 0.02 ) . Most local complications were related to suboptimal reduction of the fracture and /or positioning of the implant . Functional outcome and consolidation were equal for both implants . Generally , the results of treatment of unstable trochanteric fractures were comparable for the PFN and GN . The pitfalls and complications were similar , and mainly surgeon- or fracture-related , rather than implant-related INTRODUCTION Fractures of the Intertrochanteric ( IT ) region are some of the most common fractures encountered by an orthopedic surgeon in his lifetime . With increase in life expectancy , the incidence of these fractures is also increasing . By 2040 , the incidence of these fractures is expected to double . Unstable IT fractures are a major cause of concern in the elderly due to the associated increase in morbidity and mortality . AIM The purpose of this study was to compare the intraoperative and postoperative parameters using the Dynamic Hip Screw ( DHS ) , the Cemented Bipolar Hemiarthroplasty ( BH ) and the Proximal Femoral Nail ( PFN ) for the management of unstable IT fractures . MATERIAL S AND METHODS Fifty patients , having unstable IT fractures with age more than 60 years were r and omly selected and were followed up averagely for 19 months ( 12- 30 months ) . The type of implant for a particular patient and a particular type of fracture was r and omly selected and the same surgical team treated all patients . Total number of 19 patients were operated using the DHS ( Group-1 ) , 13 using the BH ( Group-2 ) and 18 using the PFN ( Group-3 ) . All patients in the three groups were compared in terms of preoperative , intraoperative and postoperative parameters and functionally assessed using the Harris hip score and the mobility score of Parker and Palmer . RESULTS Patients operated using the PFN had significantly lower mean blood loss as compared to the other two groups . The mean days to unaided Full Weight Bearing ( FWB ) was significantly higher in patients treated by the DHS as compared to the other two groups . All three groups were comparable in terms of functional assessment . CONCLUSION Treatment of unstable IT fracture of femur is a matter open to debate . IT fractures of elderly must be treated with considering the age of the patient , mental status , bone quality , and the type of fracture . Level of Evidence according to OCEBM Levels of Evidence Working Group - Level 2 OBJECTIVE To show that patients with intertrochanteric fractures treated with a proximal femoral nail  have a better postoperative course than those treated with a DHS plate ( dynamic hip screw ) . METHODS Patients with a Boyd & Griffin type II intertrochanteric fracture were r and omly divided into two groups : a group of patients treated with a PFN and another one treated with a DHS plate . All patients were assessed at 2 , 4 , 8 and 16 weeks using the Harris scale and the visual analog scale pre- and postoperatively , as well as the operative time , incision size , intraoperative bleeding , onset of partial and /or total weight bearing , healing time , time to attain prior physical activity level , and radiographic result . RESULTS 32 patients met our criteria . The variables that had a significant reduction were : incision , operative time , postoperative pain according to the visual analog scale , onset of mobility , partial weight bearing and pain at 2 weeks . CONCLUSIONS The proximal femoral nail has better short-term outcomes than the DHS plate ; however , in the medium term both implants have the same outcomes
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 .