NCT00374413终止不适用
Clinical Study Protocol for the Investigation of the Kineflex|C Spinal System - a Pivotal Study in Continued Access Stage
SpinalMotion41 个研究点 分布在 1 个国家目标入组 343 人开始时间: 2005年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 343
- 试验地点
- 41
- 主要终点
- Improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline
研究概览
简要总结
The purpose of this study is to show that the Kineflex|C Spinal System is no worse than conventional Anterior Cervical Diskectomy with Fusion (ACDF) in patients with single level degenerative disc disease at any cervical level from C3 to C7.
详细描述
The Kineflex|C disc is a 3-piece modular design consisting of two cobalt chrome molybdenum (CCM) end-plates and a fully articulating CCM core. The system is available in two foot print sizes.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have symptoms of cervical degenerative disc disease (DDD) at only one cervical level from C3 to C7, disc herniation on CT or MRI;
- •have radiculopathy symptoms in neck, one or both shoulders, and/or one or both arms;
- •have at least six months of prior conservative treatment (e.g., physical therapy and/or use of anti-inflammatory medications and muscle relaxants at the manufacturer's recommended therapeutic dose), the presence of progressive symptoms (e.g., increasing numbness or tingling), or signs of nerve root compression;
- •have moderate disability neck disability index (NDI) score; AND
- •be likely to return for all follow-up visits and be willing and able to provide informed consent for study participation
排除标准
- •marked cervical instability;
- •non discogenic neck pain or non discogenic source of symptoms;
- •radiographic confirmation of severe facet disease or facet degeneration;
- •bridging osteophytes;
- •prior surgery at the level to be treated;
- •prior fusion at any cervical level;
- •more than one neck surgery via anterior approach;
- •previous trauma to the C3-C7 levels resulting in compression or bursting;
- •documented presence of free nuclear fragment at any cervical level;
- •severe myelopathy;
- •any paralysis;
- •history of chemical or alcohol dependence;
- •active systemic infection;
- •infection at the site of surgery;
- •prior disc space infection or osteomyelitis in the cervical spine;
- •any terminal, systemic or autoimmune disease;
- •metabolic bone disease (e.g., osteoporosis, gout, osteomalacia, Paget's disease);
- •any disease, condition or surgery which might impair healing;
- •known metal allergy;
- •arachnoiditis;
- •currently experiencing an episode of major mental illness;
- •pregnancy at time of enrollment, or planning to become pregnant, since this would contraindicate surgery;
- •morbid obesity; use of spinal stimulator at any cervical level prior to surgery;
- •currently a prisoner;
- •currently involved in spinal litigation which may influence the subjects reporting of symptoms; OR
- •lives more than 300 miles from study center or participation in any other investigational drug, biologic, or medical device study within the last 30 days prior to study surgery
研究组 & 干预措施
Kineflex-C
Experimental
干预措施: Artificial disk (Device)
Kineflex-C
Experimental
干预措施: Artificial disc (Device)
ACDF
Active Comparator
干预措施: Artificial disk (Device)
ACDF
Active Comparator
干预措施: Artificial disc (Device)
结局指标
主要结局
Improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline
时间窗: 24 months
No major device related adverse events
时间窗: 24 months
次要结局
- Disc height at 24 months compared to baseline(24 months)
- Clinically significant improvement in one or more radicular symptoms at 24 months compared to baseline(24 months)
- Displacement or migration of the device(24 months)
- Time to recovery(24 months)
- Adjacent level deterioration at 24 months compared to baseline(24 months)
- Odom's Criteria(24 months)
- Progressive facet disease at 24 months compared to baseline(24months)
研究者
研究点 (41)
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