Clinical Trial: 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
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Prospective Randomized Comparison of Bipolar Hemiarthroplasty and Total Hip Arthroplasty With Large Femoral Heads for the Treatment of Displaced Intracapsular Femoral Neck Fractu
Brief Summary:
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.
Detailed Summary:
Sponsor: Wolfson Medical Center
Current Primary Outcome: Oxford hip score (OHS) [ Time Frame: last followup - 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- SF-36 score, walking distance [ Time Frame: 2 years followup ]
- dislocation rate, mortality rate [ Time Frame: within follow up - 2 years ]
Original Secondary Outcome: Same as current
Information By: Wolfson Medical Center
Dates:
Date Received: April 22, 2010
Date Started: April 2010
Date Completion: December 2013
Last Updated: June 16, 2011
Last Verified: April 2010
