- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Holon, Israel, 58100
- Recruiting
- Orthopaedic dept., E. Wolfson Medical center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: THA
Total hip arthroplasty
|
All cemented THA
|
Active Comparator: HAP
Bipolar Hemiarthroplasty
|
Cemented bipolar HAP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Oxford hip score (OHS)
Time Frame: last followup - 2 years
|
last followup - 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
SF-36 score, walking distance
Time Frame: 2 years followup
|
2 years followup
|
dislocation rate, mortality rate
Time Frame: within follow up - 2 years
|
within follow up - 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dror Lakstein, MD, E. Wolfson Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0019-10-WOMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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