Cormet Hip Resurfacing System Post-PMA Study Group (New Enrollment)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Corin
- 入组人数
- 147
- 试验地点
- 12
- 主要终点
- The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24
研究概览
简要总结
The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.
详细描述
This study tracks the performance of the Cormet Hip Resurfacing system in the post-approval environment to see if there are significant changes in device performance from the pre-market IDE setting as compared to the post-approval setting. Specifically this study will compare the proportion of subjects achieving a Month 24 composite clinical success (CCS) criterion and 24 month cumulative revision rate among the newly enrolled post-approval study subjects to the IDE subjects' performance on CCS as reported in the Pre-Market Application (PMA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient who meets eligibility criteria consistent with product labeling
- •skeletally mature
- •mentally capable of completing follow-up forms
- •Will be available for follow-up out to 2 years and annually thereafter until the last patient reaches the two-year evaluation
- •Has been deemed a candidate for hip replacement by diagnosis of the investigator
- •consented to participate in the clinical study
排除标准
- •Patient with active or suspected infection in or around the hip joint;
- •Patient with bone stock inadequate to support the device
- •Patient with severe osteopenia
- •Patient with a family history of severe osteoporosis or severe osteopenia;
- •Patient with osteonecrosis or avascular necrosis (AVN) with >50% involvement of the femoral head (regardless of FICAT Grade)
- •Patient with multiple cysts of the femoral head (>1cm)
- •In cases of questionable bone stock, a DEXA scan may be necessary to assess inadequate bone stock.
- •Patient with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery;
- •Female of child-bearing age due to unknown effects on the fetus of metal ion release.
- •Patient with known moderate or severe renal insufficiency;
- •Patient who is immunosuppressed with diseases such as AIDS or person receiving high doses of corticosteroids;
- •Patient who is severely overweight;
- •Patient with known or suspected metal sensitivity (e.g., jewelry).
研究组 & 干预措施
Cormet Hip Resurfacing Post-PMA Group
hip resurfacing
干预措施: Cormet Hip Resurfacing (Device)
结局指标
主要结局
The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24
时间窗: Month 24+
Composite Clinical Success (CCS) is based upon the following: There has been no revision, removal, or replacement of any device component on or prior to the exact 24 month anniversary (i.e., relative day 730); and Month 24 Harris Hip Total score (HHS) ≥ 80 points.
次要结局
- Number of Procedures (Unilateral & Bilateral) With Any Device Related Adverse Events(Month 24+)
- The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively(Month 24+)
- Survival Rate Using Kaplan-Meier Survival Curves(Month 24+)
- Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+(Month 24+)