Compaction Femur Preparation for Cementless Total Hip Arthroplasty (THA) Unilateral

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 hydroxylapatite (HA) coated titanium cementless femoral stem. Patients who receive a unilateral total hip replacement are randomized to either conventional broaching or compaction. 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 Femur Total Hip Arthroplasty (THA) Uni-lateral

Conditions
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Coxarthrosis

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


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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compaction<br>The bone is pressed very hard together before implantation of femoral component. | Procedure: Bone preparation technique: compaction<br>* The bone is pressed very hard together before implantation of femoral component.<br>* Other names: No other names.;|
| Active Comparator: Conventional technique<br>The bone is broached before implantation of femoral component. | Procedure: Bone preparation technique: conventional technique<br>* Bone is broached before implantation of femoral component.<br>* Other names: No other names.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine a possible difference in density of bones around implantation of femoral component. | A check-up by means of DEXA scanning after 1 week, 1 year, 2 years and 5 years. | 5 years | 

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