A Comparison of Two Metal Surface Finishes on Femoral Components in Hip Arthroplasty

Study Overview
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Brief Summary
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The purpose of this study is to compare metal surface finishes (proximal-coated titanium surface versus mid-coated titanium surface) on femoral components in hip arthroplasty.

Detailed Description
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In younger patients femoral components are most often implanted without the use of cement. A direct ingrowth of bone to the implant is crucial to the attainment of good results in those cases where cement is not employed. The construction of a femoral implant, Versys Fiber Metal Taper®, by Zimmer includes a more extensive coating than previous femoral implants. The improved surface coating has been shown to provide these implants with better properties than those demonstrated by implants currently in general use. Theoretically, the greater porous surface of mid-coated implants should: Encourage bone ingrowth through improved osteoconductive properties, however more extensive coating might change the loss of bone due to stress shielding later in time Improve anchorage of the implant due to the higher friction coefficient Result in fewer postoperative complaints measured with the Harris Hip Score and visual analog scale scores The migration of femoral components will be evaluated by RSA, performing radiostereometric analyses at the Orthopaedic Center, Aarhus University Hospital. The follow-up RSA will be scheduled for week 1, as well as 3 months, 12 months and 2 years after surgery. Bone mineral density around the implanted femoral component will be examined by DEXA scan at week 1, as well as 1 year and 2 years after surgery.

Official Title
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A Comparison of Two Metal Surface Finishes (Proximal-Coated Titanium Surface Versus Mid-Coated Titanium Surface) on Femoral Components in Hip Arthroplasty

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Femoral implant (Versys Fiber Metal Taper®)


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-steroid anti-inflammatory drugs (NSAID) 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: 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Femoral implant (Versys Fiber Metal Taper®)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| migration of femoral components evaluated by RSA |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMD in the surrounding bone tissue of femoral components |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RSA, Osteoarthritis, Hip arthroplasty, DEXA