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 .
Use of an Intramedullary Hip-Screw Compared with a Compression Hip-Screw with a Plate for Intertrochanteric Femoral Fractures. A Prospective, Randomized Study of One Hundred Patients*
One hundred elderly patients who had an intertrochanteric femoral fracture were r and omized to treatment with a compression hip-screw with a plate ( fifty patients ) or a  new intramedullary device , the intramedullary hip-screw ( fifty patients ) . All patients were followed prospect ively for one year or until death . A detailed assessment of the functional status and the plain radiographs of the hip was performed one , three , six , and twelve months postoperatively . The two treatment groups were strictly comparable . The operative time needed to insert the intramedullary hip-screw was significantly greater than that needed to insert the compression hip-screw with the plate ( p = 0.02 ) , but use of the intramedullary hip-screw was associated with less estimated intraoperative blood loss ( p = 0.011 ) . The prevalence of perioperative complications , such as bronchopneumonia , cardiac failure , and urinary tract infection , was comparable in the two treatment groups . There were one intraoperative fracture of the femoral shaft and two intraoperative fractures of the greater trochanter in the group managed with the intramedullary hip-screw . One patient had pulling-out of the compression hip-screw on the seventh postoperative day . Four patients had a trochanteric wound hematoma , without infection , after insertion of an intramedullary hip-screw . All but one of the fractures healed . The one non-union , which was in a patient who had a compression hip-screw , was treated with a hemiarthroplasty . The mortality rate was similar in the two treatment groups . The patients who had an intramedullary hip-screw had , on the average , significantly better mobility at one ( p < 0.0001 ) and three months ( p = 0.0013 ) postoperatively . This difference was no longer seen at six and twelve months , although the patients who had an intramedullary hip-screw still had significantly better walking ability outside the home at those time-periods ( p = 0.05 ) . The compression hip-screw was removed from two patients because of pain in the mid-portion of the thigh , which had begun after consolidation of the fracture . Fourteen patients who had an intramedullary hip-screw had cortical hypertrophy at the level of the tip of the nail at twelve months postoperatively . Cortical hypertrophy was significantly related to the use of two interlocking screws ( p = 0.02 ) . Six of these patients also had pain in the mid-portion of the thigh , and the nail had been locked with two screws in five of them . Three of the six patients had the hardware removed because of the pain , and the symptoms resolved . A seventh patient had pain without cortical hypertrophy . The intramedullary hip-screw device was associated with significantly less sliding of the lag-screw and subsequent shortening of the limb in the region of the thigh ( p = 0.012 and 0.019 , respectively ) ; these differences were more pronounced when the unstable fractures in the two treatment groups were compared ( p < 0.001 )
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 .