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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THA | Experimental | Total hip arthroplasty |
|
| HAP | Active Comparator | Bipolar Hemiarthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total hip arthroplasty | Procedure | All cemented THA |
| |
| Hemiarthroplasty |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford hip score (OHS) | last followup - 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| SF-36 score, walking distance | 2 years followup | |
| dislocation rate, mortality rate | within follow up - 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dror Lakstein, MD | Contact | ++972-3-5028383 | drorale@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dror Lakstein, MD | E. Wolfson medical center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic dept., E. Wolfson Medical center | Recruiting | Holon | 58100 | Israel |
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| Procedure |
Cemented bipolar HAP |
|
| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| D062785 | Hemiarthroplasty |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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