E-MAX 2nd Generation Vitamin E Polyethylene On BIOLOX Delta Ceramic Heads
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- E-Max liner wear rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is under 65 years of age
- •Patient's health status qualifies as ASA 1 or ASA 2
- •Patient is willing to commit to long term follow (study duration is 10 yrs)
排除标准
- •Allergy to any materials used in hip implant
- •Unwillingness to participate in long term follow-up
- •Diagnosis of inflammatory arthritis
- •Simultaneous bilateral total hip arthroplasty is recommended.
- •Patient's health status qualifies as ASA 3 or greater.
- •Patient is over the age of 65 of age
结局指标
主要结局
E-Max liner wear rate
时间窗: Change from baseline to 10 years post-operative
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.
次要结局
- Patient Function and Mobility(Change from Pre-operative to 10 years post-operative)