The Centers for Arthroplasty Research and Education in Spine (CARES) Lumbar Artificial Disc Registry Protocol
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- DePuy Spine
- 入组人数
- 120
- 主要终点
- Change in Oswestry Disability Index (ODI) Score
研究概览
简要总结
The purpose of the registry is to assess outcomes following treatment with lumbar total disc replacement (TDR) in patients outside the clinical trial setting.
详细描述
The purpose of this study is to capture outcomes associated with use of total disc replacement (TDR) in patients treated with either the CHARITE™ Artificial Disc or the PRODISC®-L Total Disc Replacement may be included in the registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treated with the lumbar TDR.
- •Signed IRB approved consent document.
排除标准
- •None known.
结局指标
主要结局
Change in Oswestry Disability Index (ODI) Score
时间窗: 3, 6, 12, 24, 36, 48, and 60 months post operative
The ODI assesses several domains of function affected by low back pain. A change of 15 points from baseline is considered a clinical meaningful difference for the individual. The change from pre operative baseline to each follow-up assessment will be calculated.
次要结局
未报告次要终点