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
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|ClinicalTrials.gov Identifier: NCT01109862|
Recruitment Status : Unknown
Verified April 2010 by Wolfson Medical Center.
Recruitment status was: Recruiting
First Posted : April 23, 2010
Last Update Posted : June 17, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Femoral Neck Fractures||Procedure: Total hip arthroplasty Procedure: Hemiarthroplasty||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||December 2013|
Total hip arthroplasty
Procedure: Total hip arthroplasty
All cemented THA
Active Comparator: HAP
Cemented bipolar HAP
- Oxford hip score (OHS) [ Time Frame: last followup - 2 years ]
- SF-36 score, walking distance [ Time Frame: 2 years followup ]
- dislocation rate, mortality rate [ Time Frame: within follow up - 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109862
|Contact: Dror Lakstein, MDfirstname.lastname@example.org|
|Orthopaedic dept., E. Wolfson Medical center||Recruiting|
|Holon, Israel, 58100|
|Contact: Dror Lakstein, MD ++972-3-5028383 email@example.com|
|Principal Investigator:||Dror Lakstein, MD||E. Wolfson medical center|