NCT01109862

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Wolfson Medical Center · Other Government
• Sex: All
• Age: 70 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Femoral Neck Fractures

Interventions

Type	Name	Description
PROCEDURE	Total hip arthroplasty	All cemented THA
PROCEDURE	Hemiarthroplasty	Cemented bipolar HAP

Timeline

• Start date: 2010-04-01
• Primary completion: 2013-06-01
• Completion: 2013-12-01
• First posted: 2010-04-23
• Last updated: 2011-06-17

Locations

1 site across 1 country: Israel