Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Hemiarthroplasties

Study Overview
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Brief Summary
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Substudy and continuation of HEMI-SAB-UUS (NCT00491673) Study on radiostereometric measurements of acetabular wear in bipolar hemiarthroplasties and measurements of periprosthetic bone mineral density in cemented and uncemented hemiarthroplasties in patients with femoral neck fractures. Null hypothesis: No difference in acetabular wear or in bone mineral density changes between cemented and uncemented hemiarthroplasties

Detailed Description
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Patients are randomised to treatment with cemented or uncemented bipolar hemiarthroplasty. 1mm tantalum markers are inserted in the pelvis during surgery. RSA X-rays and DEXA measurements conducted postoperatively, after 3 and 12 months. Follow-up visits and clinical examination at 3 and 12 months.

Official Title
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Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Cemented and Uncemented Hemiarthroplasties for Femoral Neck Fractures

Conditions
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Femoral Neck Fractures, Bone Density, Acetabular Wear, Hemiarthroplasty

Intervention / Treatment
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* Procedure: Cemented primary bipolar hemiarthroplasty of the hip
* Procedure: Uncemented primary bipolar hemiarthroplasty of the hip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Femoral neck fracture 65 years or older Able to walk independently Exclusion Criteria: Cognitive dysfunction Infection Fracture caused by malignant disease

Ages Eligible for Study
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Minimum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cemented<br>Cemented primary bipolar hemiarthroplasty of the hip | Procedure: Cemented primary bipolar hemiarthroplasty of the hip<br>* Cemented primary bipolar hemiarthroplasty of the hip<br>* Other names: Spectron, Smith & Nephew, Memphis, TN;|
| Active Comparator: Uncemented<br>Uncemented primary bipolar hemiarthroplasty of the hip | Procedure: Uncemented primary bipolar hemiarthroplasty of the hip<br>* Uncemented primary bipolar hemiarthroplasty of the hip<br>* Other names: Corail, DePuy/Johnson and Johnson, United Kingdom;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acetabular wear in mm |  | 1 year | 
| Loss of bone mineral density (BMD) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome including pain (Harris Hip Score) |  | 1 year | 
| Activities Of Daily Living (Barthels ADL-Index) |  | 1 year | 
| Quality Of Life (EQ-5D) |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fracture, arthroplasty, wear, osteoporosis, bone