Femoral Neck Fractures Clinical Trial
Official title:
Prospective Randomized Comparison of Bipolar Hemiarthroplasty and Total Hip Arthroplasty With Large Femoral Heads for the Treatment of Displaced Intracapsular Femoral Neck Fractures in the Elderly
The purpose of this study is to compare hemiarthroplasty (HAP) with total hip arthroplasty
(THA), performed by trained arthroplasty surgeons with the use of large femoral heads for
the treatment of displaced femoral neck fractures in mobile independent elderly patients, to
determine the impact of these surgical options on the short term functional outcomes and
complication rates, namely dislocation and the need for further surgery.
This is a single-blinded prospective randomized clinical trial comparing functional outcome
and complication rates of 40 patients treated with all cemented THA to a control group of 40
patients treated with cemented bipolar HAP, in a 2 years followup.
The primary endpoint is the Oxford hip score (OHS) at last followup as a measure of
functional outcome. Secondary endpoints include the SF-36 score, walking distance and rates
of postoperative dislocation, component loosening, need for revision and postoperative
mortality.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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