A Prospective, Randomized, Multi-Center, Post-Approval Clinical Trial Evaluating the Long-Term (7 Year) Safety and Effectiveness of the PCM® Cervical Disc
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 494
- 试验地点
- 36
- 主要终点
- Individual Patient Overall Success
研究概览
简要总结
On October 26, 2012, the FDA granted Premarket Approval (PMA) for the PCM Cervical Disc. PCM Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and manifested by at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels.
The purpose of this post-approval study is to evaluate the long-term (7 year) safety and effectiveness of the PCM Cervical Disc.
详细描述
A prospective, multi-center, post approval study with concurrent control group consisting of those patients that were enrolled and did not fail in the PCM Cervical Disc IDE clinical study and will to give consent to participate.
All of the PCM IDE investigational sites who have active patients will be chosen to participate in this study. All patients who are actively participating in the pivotal IDE study will be asked to participate in this study.
The study consists of follow-up periods only. The follow-up period will last for seven years from each patient's surgery date.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients enrolled in the PCM Cervical Disc IDE clinical study
- •Patients willing and able to give informed consent
排除标准
- •Patients considered failure during the PCM Cervical Disc IDE clinical study
- •Patients who were withdrawn during the PCM Cervical Disc IDE clinical study
结局指标
主要结局
Individual Patient Overall Success
时间窗: 7 years
* Improvement of at least 20% on the Neck Disability Index (NDI) at 7 years compared to baseline * No device failures requiring revision, reoperation, removal or supplemental fixation * No major complications such as vascular or neurological injury * Radiographic success
次要结局
未报告次要终点