Frede Frihagen1, Lars Nordsletten, Jan Erik Madsen. 1. Orthopaedic Centre, Ulleval University Hospital, Oslo, Norway, and Faculty of Medicine, University of Oslo, Norway. j.f.frihagen@medisin.uio.no
Abstract
OBJECTIVE: To compare the functional results after displaced fractures of the femoral neck treated with internal fixation or hemiarthroplasty. DESIGN: Randomised trial with blinding of assessments of functional results. SETTING:University hospital. PARTICIPANTS: 222 patients; 165 (74%) women, mean age 83 years. Inclusion criteria were age above 60, ability to walk before the fracture, and no major hip pathology, regardless of cognitive function. INTERVENTIONS:Closed reduction and two parallel screws (112 patients) and bipolar cemented hemiarthroplasty (110 patients). Follow-up at 4, 12, and 24 months. MAIN OUTCOME MEASURES: Hip function (Harris hip score), health related quality of life (Eq-5d), activities of daily living (Barthel index). In all cases high scores indicate better function. RESULTS:Mean Harris hip score in the hemiarthroplasty group was 8.2 points higher (95% confidence interval 2.8 to 13.5 points, P=0.003) at four months and 6.7 points (1.5 to 11.9 points, P=0.01) higher at 12 months. Mean Eq-5d index score at 24 months was 0.13 higher in the hemiarthroplasty group (0.01 to 0.25, P=0.03). The Eq-5d visual analogue scale was 8.7 points higher in the hemiarthroplasty group after 4 months (1.9 to 15.6, P=0.01). After 12 and 24 months the percentage scoring 95 or 100 on the Barthel index was higher in the hemiarthroplasty group (relative risk 0.67, 0.47 to 0.95, P=0.02. and 0.63, 0.42 to 0.94, P=0.02, respectively). Complications occurred in 56 (50%) patients in the internal fixation group and 16 (15%) in the hemiarthroplasty group (3.44, 2.11 to 5.60, P<0.001). In each group 39 patients (35%) died within 24 months (0.98, 0.69 to 1.40, P=0.92) CONCLUSIONS:Hemiarthroplasty is associated with better functional outcome than internal fixation in treatment of displaced fractures of the femoral neck in elderly patients. TRIAL REGISTRATION: NCT00464230.
RCT Entities:
OBJECTIVE: To compare the functional results after displaced fractures of the femoral neck treated with internal fixation or hemiarthroplasty. DESIGN: Randomised trial with blinding of assessments of functional results. SETTING: University hospital. PARTICIPANTS: 222 patients; 165 (74%) women, mean age 83 years. Inclusion criteria were age above 60, ability to walk before the fracture, and no major hip pathology, regardless of cognitive function. INTERVENTIONS: Closed reduction and two parallel screws (112 patients) and bipolar cemented hemiarthroplasty (110 patients). Follow-up at 4, 12, and 24 months. MAIN OUTCOME MEASURES: Hip function (Harris hip score), health related quality of life (Eq-5d), activities of daily living (Barthel index). In all cases high scores indicate better function. RESULTS: Mean Harris hip score in the hemiarthroplasty group was 8.2 points higher (95% confidence interval 2.8 to 13.5 points, P=0.003) at four months and 6.7 points (1.5 to 11.9 points, P=0.01) higher at 12 months. Mean Eq-5d index score at 24 months was 0.13 higher in the hemiarthroplasty group (0.01 to 0.25, P=0.03). The Eq-5d visual analogue scale was 8.7 points higher in the hemiarthroplasty group after 4 months (1.9 to 15.6, P=0.01). After 12 and 24 months the percentage scoring 95 or 100 on the Barthel index was higher in the hemiarthroplasty group (relative risk 0.67, 0.47 to 0.95, P=0.02. and 0.63, 0.42 to 0.94, P=0.02, respectively). Complications occurred in 56 (50%) patients in the internal fixation group and 16 (15%) in the hemiarthroplasty group (3.44, 2.11 to 5.60, P<0.001). In each group 39 patients (35%) died within 24 months (0.98, 0.69 to 1.40, P=0.92) CONCLUSIONS: Hemiarthroplasty is associated with better functional outcome than internal fixation in treatment of displaced fractures of the femoral neck in elderly patients. TRIAL REGISTRATION: NCT00464230.
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