Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without an Activ-C Cervical Disc Prosthesis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Order of movement
研究概览
简要总结
The purpose of this study is to find out if use of a cervical disc prosthesis in the treatment of a cervical disc herniation preserves or restores normal mobility and movement in the cervical spine.
详细描述
Intractable nerve pain to the arm caused by a cervical disc herniation is typically treated by removal of the protruding disc through an operation. Fusion of the discs follows in about 70% of cases.
Adjacent disc disease (ADD), symptomatic degenerative changes in the levels adjacent to the operated level is regarded as a late complication. Fusion at the operated level is thought to contribute to this process due to compensative increased mobility and stress on the adjacent segments.
Keeping the operated segment mobile through the use of a cervical disc prosthesis possibly prevents ADD.
We hypothesize that use of a cervical disc prosthesis preserves or restores normal mobility to the cervical spine. To test this hypothesis subjects are randomised in a group receiving a standard anterior cervical discectomy, and a group receiving a standard discectomy with placement of a cervical disc prosthesis. Digital X-ray cinematographic videos are made of a flexion/extension movement. The videos will be analyzed manually and through a newly designed automated program, to check for mobility and order of movement.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •indication for anterior cervical discectomy
- •monoradicular syndrome caused by compression at C5-6 or C6-7
- •monosegmental disease on MRI
- •able to actively perform flexion/extension movement
- •segmental mobility on the afflicted level >2 degrees of rotation
- •informed consent
排除标准
- •previous operative interventions on the cervical spine
- •multiple segments afflicted
- •positive L'Hermittes sing
- •Active infection
- •Immature bone
- •Tumorous processes in the cervical region
- •Previous radiation therapy in the cervical region
- •Pregnancy
- •Cervical myelopathy
- •not able to speak Dutch
结局指标
主要结局
Order of movement
时间窗: baseline, 3 months, 12 months
Segmental mobility
时间窗: Baseline, 3 months, 12 months
次要结局
- Treatment of symptoms (pain, neurological assessment)(Baseline, 3 months, 12 months)
- Influence on subjects functioning (social, work)(Baseline, 3 months, 12 months)
研究者
Toon Boselie
MD
Maastricht University Medical Center