Clinical and Radiological Outcomes of a 7-year Follow-up, Multi-center, Prospective, Randomized, Controlled Trial: Two-level Cervical ProDisc-C Vivo Versus Hybrid Construct.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 542
- 主要终点
- Change of overall success rate
研究概览
简要总结
The objective of this study is to investigate the clinical and radiological results of two-level cervical ProDisc-C vivo versus hybrid construct.
详细描述
This is a prospective, randomized, multicenter trial at 7 years of follow-up comparing two level ProDisc-C vivo artificial cervical disc replacement and hybrid construct, i.e., combining ACDF (Anterior cervical discectomy fusion) and ProDisc-C vivo to treat degenerative disc disease (DDD). 542 DDD patients (age from 20 to 70) from several hospitals matching the inclusion criteria will be randomly assigned to two groups (271 patients in each group). One group will be treated with two level ProDisc-C vivo disc replacement. The other group will be treated with hybrid construct. Clinical outcomes and radiological analysis will be done 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
- •A diagnosis of degenerative disc disease with radiculopathy or myeloradiculopathy at 2 contiguous levels from C-3 to C-
- •The symptom is unresponsive to nonoperative treatment for at least 6 weeks.
- •The patient demonstrates progressive symptoms calling for immediate surgery.
排除标准
- •Any prior cervical spine surgery.
研究组 & 干预措施
Two level Prodisc-C vivo
Two level Prodisc-C vivo cervical artificial disc replacement.
干预措施: Two level Prodisc-C vivo (Procedure)
Hybrid
This group of patients will be treated with hybrid construct, i.e., one level of Prodisc-C vivo and one level of anterior cervical discectomy fusion (ACDF).
干预措施: Hybrid (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 radiographs 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 NDI Scores(The NDI scores will be assessed 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(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
guochen
Department of Spine Surgery
Peking University People's Hospital