Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant

Study Overview
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Brief Summary
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This is a multi-center, randomized study to compare blood and urine cobalt, chromium, and titanium ion levels of a metal-on-metal articular bearing coupled with two different head sizes to that of a conventional metal-on-polyethylene bearing.

Official Title
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Metal Ion Release From an FDA Approved Metal-on-Metal Hip Replacement Implant: A Multi-Center, Randomized Clinical Trial

Conditions
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Non-inflammatory Degenerative Joint Disease

Intervention / Treatment
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* Procedure: Total Hip Replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing cementless primary total hip replacement Receiving acetabular cup of 52mm or greater Preoperative level of function and pain same as for conventional hip replacement Likelihood of obtaining relief of pain and improved function Full skeletal maturity Ability to follow instructions Good general health Willing to return for follow-up evaluations X-ray evaluation confirming the presence of NIDJD Femoral and acetabular bone stock that is sufficient, regarding strength and shape, and suitable to receive the implants Exclusion Criteria: Age less than 40 years or greater than 80 years at time of surgery Patients templated to receive an acetabular component smaller than 52mm in diameter Presence of a previous prosthetic hip replacement device in the hip joint to be operated Previous girdlestone procedure or surgical fusion of the hip to be operated Acute femoral neck fracture Above knee amputation of the contralateral and/or ipsilateral leg Patients with a diagnosis of inflammatory degenerative arthritis Skeletally immature Evidence of active infections that may spread to other areas of the body The presence of a highly communicable disease that may limit follow-up Presence of known active metastatic or neoplastic disease Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weightbearing Any previous hip surgery or conditions that may interfere with the total hip replacement's survival or outcome Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or indicates difficulty to return for follow-up Patient is know to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser Any patient who qualifies for inclusion in the study but refuses consent to participate in the study Any steroid therapy, local or systemic, within three months prior to surgery Patient requiring structural bone grafts in order to support the prosthetic components or to shape the bone to receive the implants Patient has known allergies to metal, e.g., jewelry Any patient not meeting all radiographic and clinical parameters for inclusion

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- |
| Other: Metal-on-Polyethylene<br> | Procedure: Total Hip Replacement<br> <br> |
| Other: Metal-on-Metal, 28mm femoral head<br> | Procedure: Total Hip Replacement<br> <br> |
| Other: Metal-on-Metal, 36mm femoral head<br> | Procedure: Total Hip Replacement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cobalt, chromium, and titanium ion levels in blood and urine |  | Pre-op, 6 months, 1 year, 2 years, 3 years, 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip function |  | Pre-op, 6 months,1 year, 2 years, 3 years, 5 years | 
| Durability |  | 6 months, 1 year, 2 years, 3 years, 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total hip replacement, primary cementless total hip arthroplasty, metal ion, metal-on-metal