A Prospective, Feasibility, Multi-Center Nonrandomized Clinical Trial Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Neck Disability Index (NDI) Score Improvement of at Least 15 Points
研究概览
简要总结
The objective of this study is to evaluate long-term safety and effectiveness of the NuNec® Cervical Arthroplasty System in a small patient population. The NuNec device is currently CE marked and commercially available in Europe.
详细描述
The NuNec® feasibility study is a prospective, multi-centered, non-randomized clinical trial. Only patients who have been diagnosed with single level, C3 to C7, symptomatic cervical degenerative disc disease and have failed at least 6 weeks of conservative treatment or present signs of progression of spinal cord/nerve root compression with continued non-operative care will be enrolled.
Patients will be evaluated preoperatively and postoperatively at discharge, 6 weeks, 3, 6, 12 and 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •is at least 21 years of age and skeletally mature
- •must have symptomatic degenerative disc disease at one level in the cervical spine, C3 to C7, demonstrated by herniated disc and/or spondylosis;
- •must have completed a minimum of six weeks of unsuccessful conservative, non-operative care or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment
- •must score at least 15/50 (30%) on the Neck Disability Index
- •is willing and able to follow the post-operative management program
- •must understand and sign the informed consent document
排除标准
- •symptomatic cervical DDD at more than one level
- •axial neck pain as the primary diagnosis without evidence of neural compression
- •neck or arm pain of unknown etiology
- •any significant anatomical consideration which would make the anterior cervical approach excessively risky or impossible
- •severe spondylosis at the target level
- •prior surgery at the target level
- •fused level adjacent to the target level
- •osteoporosis, osteopenia, osteomalacia, Paget's disease or metabolic bone disease
- •active infection or surgical site infection
- •is using any medication known to interfere with bone/soft tissue healing
- •diabetes mellitus requiring daily insulin management
- •any terminal, systemic, or autoimmune disease
- •medical conditions or mental incompetence which may interfere with study requirements
- •BMI >40 or a weight more than 100 lbs over ideal body weight
- •chemical dependency problem that may interfere with study requirements
- •current smokers
- •history of any invasive malignancy unless treated and in remission for at least two years
- •documented allergies to metal or plastic
- •currently pregnant, or interested in becoming pregnant during the study follow-up
研究组 & 干预措施
NuNec Cervical Disc
Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months.
干预措施: NuNec Cervical Disc (Device)
结局指标
主要结局
Neck Disability Index (NDI) Score Improvement of at Least 15 Points
时间窗: At 24 months
The Neck Disability Index is a patient reported outcome measure for self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. A higher score would indicate that the patient did not improve.
Visual Analog Scale (VAS) Improvement of 2.0 cm for Neck Pain
时间窗: At 24 months
The pain Visual Analog Scale is a uni-dimensional measure of pain intensity, represented by a 100 mm line, anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\]). A higher score would indicate that the patient had a worse outcome.
Serious Adverse Events Related to the Device
时间窗: Up to 24 months
The number of serious adverse events have been recorded
Device Failures or Removals, Revisions, Re-operations
时间窗: Up to 24 months
The failures or re-operations or supplemental fixation at the treated level
次要结局
- Patient Satisfaction(At 24 months)
- Absence of Device Migration or Subsidence(Up to 24 months)