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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01109862
• Other study ID #: 0019-10-WOMC
• Status: Recruiting
• Phase: Phase 1
• First received: April 22, 2010
• Last updated: June 16, 2011
• Start date: April 2010
• Est. completion date: December 2013

Study information

• Verified date: April 2010
• Source: Wolfson Medical Center
• Contact: Dror Lakstein, MD
• Phone: ++972-3-5028383
• Email: drorale[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone

Intervention

Procedure:
• Total hip arthroplasty
All cemented THA
• Hemiarthroplasty
Cemented bipolar HAP

Locations

Country	Name	City	State
Israel	Orthopaedic dept., E. Wolfson Medical center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxford hip score (OHS)		last followup - 2 years	No
Secondary	SF-36 score, walking distance		2 years followup	No
Secondary	dislocation rate, mortality rate		within follow up - 2 years	Yes

External Links

•   Institutional web site