Five-year Follow-up of the CHARITÉ™ Artificial Disc Compared to Anterior Lumbar Interbody Fusion With the BAK Cage.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- DePuy Spine
- 入组人数
- 367
- 试验地点
- 10
- 主要终点
- Overall Success
研究概览
简要总结
To assess the clinical and radiographic outcomes through 5-years following treatment with CHARITÉ™ Artificial Disc vs. the BAK Cage for treatment of degenerative disc disease at one level (L4-S1).
详细描述
This study is an extension out to 5 year follow-up of a randomized comparative IDE trial of the CHARITÉ™ Artificial Disc vs. ALIF with the BAK cage for treatment of degenerative disc disease. The original 2-year trial demonstrated non-inferiority of the CHARITÉ™ compared to ALIF.
This extension will continue to follow-up the original outcome measures and will also examine adjacent segment progression.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participated in either the training or randomized arm of the CHARITÉ Artificial Disc IDE study,
- •Still have the original implant they received in their index surgery.
排除标准
- 未提供
结局指标
主要结局
Overall Success
时间窗: 5 Years
ODI Improvement greater than or equal to 15 points from baseline No device failures (i.e., revision, re-operation, supplemental fixation, or removal) No major complications Maintenance or improvement in neurological status compared to baseline.
次要结局
- Secondary Endpoints(5 Years)