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The purpose of this study is to monitor outcomes of total hip arthroplasties performed with E-MAX polyethylene and BIOLOX Delta Ceramic head. Polyethylene has been used as a bearing surface in total joint replacements for half of a century. Radiation, the most common form of sterilization, unfortunately it results in the creation of free radicals (atoms or molecules that cause chemical reactions with other substances) within the materials which cause the breakdown of the polyethylene. Second generation antioxidant polyethylene, Renovis E-MAX, mechanically blends in Vitamin E as an antioxidant. This helps eliminate free radicals while maintaining mechanical strength. The theory is that E-MAX will be a safe and long lasting bearing surface in total hip arthroplasty that meets or exceeds current wear rates after being placed in a patient.
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| Measure | Description | Time Frame |
|---|---|---|
| E-Max liner wear rate | This measure's purpose it to look at the longevity of our product. Radiographs will be taken at standard checkpoints over the course of 10 years. Radiographic analysis will be done to assess wear rates of the E-Max liner over the course of the 10 year study. Wear rates will then be compared to other products that have already been studied and published in hopes of finding that E-Max's wear rates are at least as good if not better than comparative products on the market. | Change from baseline to 10 years post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Function and Mobility | This measure will assess patient function and mobility preoperatively and compare this at standard checkpoints over 10 years post-operatively. This will be done through use of the Harris Hip Score and UCLA Functional Assessment with the hope of seeing improvement in both over the course of time. | Change from Pre-operative to 10 years post-operative |
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Subjects will be patients of specified doctors specialized in orthopedic medicine with a specialty in joint replacement.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornerstone Orthopedics | Louisville | Colorado | 80027 | United States |
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