Compaction Total Hip Arthroplasty (THA) Bilateral

Study Overview
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Brief Summary
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This is a prospective, randomized study comparing two different bone preparation techniques for insertion of a porous coated titanium cementless femoral stem. Patients receiving a bilateral total hip replacement are randomized to conventional broaching on one side and compaction on the other side. Hypothesis: Compaction results in significantly less stem migration [evaluated by radiostereometric analysis (RSA)], less peri-prosthetic bone mineral density (BMD) loss [evaluated by dual energy x-ray absorptiometry (DEXA)], and a higher Harris hip score after two years.

Official Title
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Compaction THA Bilateral

Conditions
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Coxarthrosis

Intervention / Treatment
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* Procedure: Bone preparation technique: compaction
* Procedure: Bone preparation technique: broaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with primary arthritis in the hip Patients with sufficient bone density to allow uncemented implantation of a femoral component Informed patient consent in writing Exclusion Criteria: Patients with neuromuscular or vascular disease in the affected leg Patients found upon operation to be unsuited for uncemented acetabulum component Patients who regularly take non-steroidal anti-inflammatory drugs (NSAIDs) and cannot interrupt intake for the postoperative phase of the study Patients with fracture sequelae Female patients of childbearing capacity Hip joint dysplasia Sequelae to previous hip joint disorder in childhood.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compaction<br>Compaction technique for femoral bone preparation prior to cementless femoral stem insertion. | Procedure: Bone preparation technique: compaction<br> <br> * Other names: No other names.;|
| Active Comparator: Broaching<br>Broaching technique for femoral bone preparation prior to cementless femoral stem insertion. | Procedure: Bone preparation technique: broaching<br> <br> * Other names: No other names.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiostereometric analysis | Stem subsidence (change) at 5 and 10 years measured with radiostereometric analysis | 5 and 10 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periprosthetic bone mineral density | Periprosthetic bone mineral density measured with Dual Energy X-ray Absorptiometry (DXA) | 5 years follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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THA