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 randomized 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 prospectively 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).

RCT Entities:   Population Interventions Outcomes