A Validated Necrosis Assay to Determine the Need for Revision Surgery in Metal-on-metal Total Hip Arthroplasty

Study Overview
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Brief Summary
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The purpose of the study is to develop a biomarker assay to be used as a diagnostic tool for adverse local tissue reaction, or tissue necrosis, in a metal on metal total hip replacement. A convenience sample of a total of 100 hip patients will be enrolled: 50 metal-on-metal revision hips, 25 metal-on-poly revision hips, and 25 pre-operative total hips (no implant, control group) will be enrolled. Preoperative blood serum samples and intraoperative synovial fluid will be obtained from all hips and used for biomarker testing. Additionally, intraoperative assessment of tissue necrosis will be assessed.

Detailed Description
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Well-functioning MoM implants have shown an increase in serum cobalt and chromium (CoCr) ion levels from the metal debris generated from the implant wear.However, the current evidence suggests that measuring ion levels is unreliable and that increasing ion levels do not correlate with tissue damage. In addition to measuring blood and synovial fluid metal ion levels, ultrasound and MRI with metal artifact reduction sequences (MARS) have been utilized to assess periarticular reactions secondary to metal wear debris. Despite metal reduction software these scans are frequently difficult to interpret. While each of these tests has merit, at the present time there is no single diagnostic test available which delineates the key issue that demands urgent surgical intervention, i.e. tissue necrosis. It is important to have a reliable test to guide surgeons and patients in the shared decision-making process of when surgical intervention is necessary to prevent disabling tissue damage. For this reason, the current study proposes an examination of preoperative serum samples of subjects in addition to synovial fluid collected during revision surgery for biomarkers that may indicate tissue necrosis. To maximize the chance of success of identifying serum biomarkers, all samples will be analyzed using multianalyte assay, biomarker tests. The purpose of the study is to develop a biomarker assay to be used as a diagnostic tool for adverse local tissue reaction, or tissue necrosis, in a metal on metal total hip replacement. A convenience sample of a total of 100 hip patients will be enrolled: 50 metal-on-metal revision hips, 25 metal-on-poly revision hips, and 25 pre-operative total hips (no implant, control group) will be enrolled. Preoperative blood serum samples and intraoperative synovial fluid will be obtained from all hips and used for biomarker testing. Additionally, intraoperative assessment of tissue necrosis will be assessed.

Official Title
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A Validated Necrosis Assay to Determine the Need for Revision Surgery in Metal-on-metal Total Hip Arthroplasty

Conditions
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Arthritis, Failure of Total Hip

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting for a metal on metal hip revision who have cobalt and chromium metal ion levels tested within 6 months of the date of the planned revision surgery. Patients presenting for a metal on poly hip revision Revision hip patients must be greater than one year postoperative The diagnosis at the time of the index, or primary, hip replacement was osteoarthritis. Patients who have hip osteoarthritis but have not had a total hip surgery (control) Exclusion Criteria: Patients presenting for a metal on metal hip revision who have cobalt and chromium metal ion levels tested >6 months of the date of the planned revision Patients with a total hip on the contralateral side. Patients with a prior history of periprosthetic infection Revision cases where the diagnosis at the time of the index, or primary, hip replacement was not osteoarthritis. Prisoners Patients not willing to consent for the proposed treatment Patients with an altered mental status Active, concurrent metastatic infection Active, superficial infection Patients presenting for a metal on poly hip revision to treat trunionosis

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Control<br>pre-operative total hip patients with no existing total hip implant | |
| Metal on polyethylene<br>patients who have a failed metal on polyethylene total hip implant and are presenting for revision surgery | |
| Metal on Metal<br>patients who have a failed metal on metal total hip implant and are presenting for revision surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with serum and synovial fluid biomarkers | Blood Serum and Synovial fluid will be tested using a multi-analyte assay test | participants will be followed for the duration of their hospital stay, an expected average of 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with tissue necrosis | Tissue necrosis will be assessed during total hip surgery. Tissue necrosis will be scored in subsets including: intraoperative tissue damage, histological necrosis score, histologic ALVAL score, inflammatory infiltrate, and tissue organization | participants will be followed for the duration of their hospital stay, an expected average of 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tissue necrosis, metal on metal total hip, biomarker