Taperloc Versus Taplerloc Microplasty

Study Overview
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Brief Summary
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This evaluation is conducted to evaluate the safety and performance of two different stem lengths of the Taperloc Total Hip System. Per implant bone loss and migration of the stem are compared between the two groups with Dual-energy X-ray absorptiometry (DEXA) and radiostereomektric analysis

Detailed Description
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Consecutive patients between 50 - 70 years diagnosed with primary osteoarthritis of the hip and eligible for total hip arthroplasty will be asked to participate in the study. Periprosthetic bone loss, migration of the components and clinical scores will be recorded prospectively at 3,6,12 and 24 months.

Official Title
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Clinical Evaluation of Taperloc Total Hip System With Two Different Stem Lengths

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Taperloc Microplasty
* Device: Taperloc standard


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients with primary osteoarthritis of the hip scheduled for THA. Suitable anatomy for both stems Willingness and ability to follow study-protocol Exclusion Criteria Malignancy or metastatic bone disease. Any other disease severely affecting bone and mineral metabolism Ongoing or previous treatment (within 5 years prior to inclusion) with steroids Ongoing or previous treatment (within 5 years prior to inclusion) with antiresorptives. Ongoing or previous treatment (within 5 years prior to inclusion) with immunosuppressive drugs. Ongoing or previous treatment (within 5 years prior to inclusion) with anticonvulsive therapy. Ongoing or previous treatment (within 5 years prior to inclusion) with hormonal therapy.

Ages Eligible for Study
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Minimum Age: 50 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: Taperloc Microplasty<br>Patients with primary osteoarthritis with Taperloc microplasty non inferiority | Device: Taperloc Microplasty<br>* primary total hip arthroplasty<br>|
| Active Comparator: Taperloc Standard<br>Patients with primary osteoarthritis Taperloc standard | Device: Taperloc standard<br>* primary total hip arthroplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA) [ Time Frame: |  | bone mineral density (BMD) measured postoperatively at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Short femoral stem, Stress shielding, Stem migration, Implant Survival, DEXA, Radiostereometric analysis