Clinical and Radiographic Analysis of ProDisc-C Vivo to Treat Degenerative Disc Disease: A 7-year Follow-up, Multi-center, Prospective, Randomized, Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 648
- 主要终点
- Change of overall success rate
研究概览
简要总结
The object of this study is to assess the long-term safety and efficacy of cervical disc replacement with the ProDisc-C vivo Cervical Disc in a prospective, randomized, multi-center trial with 7 years of follow-up.
详细描述
This is a prospective, randomized, multicenter trial at 7 years of follow-up comparing ProDisc-C vivo artificial cervical disc replacement and ACDF (Anterior cervical discectomy fusion) to treat degenerative disc disease (DDD). 648 DDD patients (age from 20 to 70) from several hospitals matching the inclusion criteria will be randomly assigned to two groups (324 patients in each group). One group will be treated with ProDisc-C vivo disc replacement. The other group will be treated with ACDF. The clinical outcomes and radiographic measurements will be compared between two groups at 1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single-level cervical disc disease.
- •At least one additional confirmatory neuroradiographic study, such as MRI or CT- enhanced myelography that showed findings consistent with clinical findings and complaints.
排除标准
- •Patients have cervical spinal conditions other than single-level symptomatic degenerative disc disease or evidence of instability.
- •Symptomatic disc disease at level C2 -3 or C7-T
- •A history of discitis.
- •A medical condition that required medication,such as steroids or nonsteroidal antiinflammatory medications that could interfere with fusion.
研究组 & 干预措施
ProDisc-C vivo
This group of patients will be treated with ProDisc-C vivo disc replacement (single segment).
干预措施: ProDisc-C vivo (Procedure)
Anterior cervical discectomy fusion
This group of patients will be treated with anterior cervical discectomy fusion (ACDF) procedure (single segment).
干预措施: Anterior cervical discectomy fusion (Procedure)
结局指标
主要结局
Change of overall success rate
时间窗: The overall success will be assessed at each time point (1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).
A patient's outcome was considered an overall success if all of the following conditions were met: 1) postoperative (Neck Disability Index) NDI score improvement of at least a 15-point increase from preoperative score; 2) maintenance or improvement in neurological status; 3) disc height success; 4) no serious adverse event classified as implant associated or implant/surgical procedure associated; and 5) no additional surgical procedure classified as a "failure".
次要结局
- Change of sagittal angular motion(The radiographic outcomes will be obtained at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).)
- Change of neck disability index scores(The NDI scores will be obtained at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).)
- Change of Arm and Neck pain intensity(Neck and arm pain scores will be measured at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).)
研究者
Zhu Zhenqi
Principal Investigator
Peking University People's Hospital