Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures.

Study Overview
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Brief Summary
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Hemiarthroplasty of the hip is standard treatment of femoral neck fractures (hip fractures). Hemiarthroplasty means replacing the hip joint with a metal prosthesis. Unipolar prostheses has a one-piece design where the hip movement occurs between the prosthesis and the acetabulum (hip socket). A bipolar prosthesis has an additional artificial joint between the two components of the prosthesis. Both treatments are clinically proven and common around the world. No clinical trial has proven benefits of one or the other prosthesis design. The investigators want to measure the differences in acetabular wear using these two prostheses, using radiostereometric measurements.

Detailed Description
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Patients 70 years or older presenting to our hospital with an acute femoral neck fracture are eligible for inclusion. 15 patients in each group will be recruited. One group receives a unipolar hemiarthroplasty and 15 receives a bipolar arthroplasty. Tantalum markers are placed around the acetabulum during surgery. Follow-up intervals are at 3, 12 and 24 months with radiostereometric evaluation (radiographs) and clinical evaluation.

Official Title
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Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. A Randomized Trial of RSA Measurements of Acetabular Wear.

Conditions
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Hip Fractures

Intervention / Treatment
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* Device: Unipolar hip hemiarthroplasty
* Device: Bipolar hip hemiarthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Displaced femoral neck fracture 70 years or older Ambulatory status: No walking aids No mental illness or impaired cognitive function Exclusion Criteria: Pathological fracture (malignant disease) Ongoing systemic or local infection Radiologically presence of acetabular wear (osteoarthrosis)

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Unipolar<br>15 patients randomized for treatment with a unipolar hip hemiarthroplasty | Device: Unipolar hip hemiarthroplasty<br>* Unipolar hip hemiarthroplasty for the treatment of femoral neck fractures<br>* Other names: Modular Cathcart Unipolar, DePuy/Johnson and Johnson;|
| Active Comparator: Bipolar<br>15 patients randomized for treatment with a bipolar hip hemiarthroplasty | Device: Bipolar hip hemiarthroplasty<br>* Bipolar hip hemiarthroplasty for the treatment of femoral neck fractures<br>* Other names: Celf-Centering Bipolar, DePuy/Johnson and Johnson;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acetabular wear measured with radiostereometry |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris hip score |  | 24 months | 
| Health-related quality of life (eq-5d) |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip, Fracture, Femoral neck, Hemiarthroplasty, Bipolar, Unipolar, Displaced femoral neck fractures