NCT01763619Unknown不适用
Freedom® Cervical Disc Use In The Treatment of Cervical Degenerative Disc Disease
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Safety of FCD
研究概览
简要总结
This study will collect clinical and radiographic data on the Freedom Cervical Disc to monitor the device's safety and performance as part of a post-market evaluation.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature males or females, aged 21 to 65 years old, inclusive.
- •Single, or adjacent, 2-level degenerative disc disease at C3-C7, inclusive.
- •Subject is a surgical candidate for an anterior approach to the cervical spine.
- •Minimum of 6 weeks of unsuccessful conservative treatment.
- •Subject with at least moderate preoperative pain and functional impairment
- •Subject is mentally and physically able to comply with protocol, postoperative compliance instructions, and follow-up schedule through 2-years.
- •Subject must understand and sign the written Informed Consent form.
排除标准
- •Subject with axial neck pain only who does not demonstrate concurrent arm pain or progressive neurological deterioration (specifically numbness or muscle weakness in the arm).
- •An active infection at the operative site or active systemic infection at the time of surgery.
- •Known or suspected allergy to titanium, polyurethane, cobalt, chromium, molybdenum or silicone.
- •Previous spinal fusion at the involved, or adjacent, cervical level(s).
- •Congenital or acquired structural defect at the operative levels (s) or their immediately adjacent level(s).
- •Significant osteoporosis in the cervical spine.
- •The investigator should assess if the subject has any of the following conditions at the index or adjacent level(s) which excludes the subject from study participation:
- •Cervical facet degeneration of the involved C3-C7 levels.
- •Previous trauma to, or fusion in, the C3-C7 levels.
- •Cervical instability at the index level(s) on neutral lateral or flexion/extension x-rays.
- •Radiographic findings of a fused or total collapsed disc.
- •Significant global cervical kyphosis (≥15º on Cobb angle measurement) or significant reversal of lordosis.
- •Female of childbearing potential, pregnant, breast feeding, or interested in becoming pregnant in the next two years
结局指标
主要结局
Safety of FCD
时间窗: 6 months
Monitor the safety (operative and post-operative adverse events through 6-months) of the FCD.
Performance of FCD
时间窗: 6 months
Monitor the performance (radiographic evaluation of segmental non-fusion and device function) of the FCD through 6-months post-operative period.
次要结局
- Incidence of AEs(2 year)
- Neck/Arm Pain(2 years)
- Neurological function(2 years)
- Subject Function(2 years)
- Radiographic Measurements(2 years)
- Examine AEs(2 years)
研究者
研究点 (10)
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