Investigation of Systemic Metal Ion Concentration Following a Ceramic-on-metal Total Hip Arthroplasty

Study Overview
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Brief Summary
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This is a pilot study to compare systemic concentrations of cobalt and chromium in patients that have previously undergone total hip arthroplasties with ceramic on metal and metal on metal bearing surfaces.

Detailed Description
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This is a pilot study to compare systemic concentrations of cobalt and chromium in patients that have previously undergone total hip arthroplasties with ceramic on metal and metal on metal bearing surfaces. Secondary goals include an assessment of osteolysis on radiographs, potential long term analysis of implant survivability, and cancer rates in the two patient populations. Increased metal ion production has been documented in metal-on-metal arthroplasty articulations. There are several concerns over metal ion production. First, even though there is a decreased histiocytic response to metallic debris, a dose dependent cytotoxic response with Interleukin 6, Prostaglandin E2, and Tumor Necrosis Factor alpha persists and may cause osteolysis in the long term. Second, increased levels of cobalt, chromium and nickel has been shown to correlate with increased cancer rates in several animal models, and the carcinogenic risk in humans has not been fully elucidated as yet. Third, hypersensitivity reactions to metal ion develop in up to 25% of these patients, and 60% of patients with poorly functioning hip. Ceramic on metal avoids many of these problems due to the improved wear characteristics. If the level of metal ion production is significantly reduced and the implant survivability is proven in long term studies, this articulation may become the preferred method.

Official Title
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Investigation of Systemic Metal Ion Concentration Following a Ceramic-on-metal Total Hip Arthroplasty

Conditions
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Hip Replacement, Hip Implant, Total Hip Arthroplasty, Orthopaedic Surgery

Intervention / Treatment
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* Biological: Blood draw
* Radiation: X-Ray of Hip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 40 - 80, who has undergone a top hip arthroplasty with either metal on metal or ceramic on metal articulation for a diagnosis of non-inflammatory degenerative joint disease. We will also include subjects who have had bilateral hip arthroplasties or a second arthroplasty performed since the initial surgery. Patient must be able to provide consent to participate Exclusion Criteria: Diagnosis other than non-inflammatory degenerative joint disease, chronic renal insufficiency, or any systemic inflammatory condition Evidence of active infections Patients whose occupations include welding or metal working A second arthroplasty performed since the initial will not be exclude, but their data will be analyzed as a subpopulation unwillingness to comply with rehabilitation program or inability to return for follow-up visits Any systemic steroid therapy within 3 months of surgery Subjects who are pregnant

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Metal-on-Metal Articulations<br>Subjects will be people who have had metal-on-metal total hip arthroplasties | Biological: Blood draw<br>* Subjects will give blood for analysis of metal ion concentrations<br>Radiation: X-Ray of Hip<br>* Subject will have x-ray of hip to assessment of osteolysis<br>|
| Ceramic-on-Metal Articulations<br>Subjects will be people who have had ceramic-on-metal total hip arthroplasties | Biological: Blood draw<br>* Subjects will give blood for analysis of metal ion concentrations<br>Radiation: X-Ray of Hip<br>* Subject will have x-ray of hip to assessment of osteolysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metal ion concentration in urine |  | 1 year post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metal ion concentration in blood |  | 1 year post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metal Ion Concentration, Osteolysis