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

Phase 1

• Conditions: Femoral Neck Fractures
• Interventions: Procedure: Total hip arthroplasty; Procedure: Hemiarthroplasty

• Registration Number: NCT01109862
• Lead Sponsor: Wolfson Medical Center

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 Description

Not available

Study Timeline

• Status Verified: 2010-04
• Study Start: 2010-04
• Study First Submitted: 2010-04-22
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-23
• Last Update Submitted: 2011-06-16
• Last Update Posted: 2011-06-17
• Primary Completion: 2013-06
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 1. Acute femoral neck fracture.
• 2. Age between 70 and 90 years old.
• 3. Independent community ambulator (more than 0.5km, without the aid of another person. The use of a cane is permitted) prior to fracture.
• 4. Abbreviated mental test score > 6 .

Exclusion Criteria

• 1. Pathological fracture (excluding osteoporosis).
• 2. Rheumatoid arthritis.
• 3. Symptomatic arthrosis of the involved hip.
• 4. Neurological disorder that may significantly influence walking ability and/or tendency to dislocate.
• 5. Chronic corticosteroid use.
• 6. Concomitant other fracture.
• 7. Very high surgical risk.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
THA	Total hip arthroplasty	Total hip arthroplasty
HAP	Hemiarthroplasty	Bipolar Hemiarthroplasty

Primary Outcome Measures

Name	Time	Method
Oxford hip score (OHS)	last followup - 2 years

Secondary Outcome Measures

Name	Time	Method
SF-36 score, walking distance	2 years followup
dislocation rate, mortality rate	within follow up - 2 years

Trial Locations

Locations (1)

Orthopaedic dept., E. Wolfson Medical center; 🇮🇱 Holon, Israel