NCT02931279已完成不适用
Evaluation of the Efficacy and Safety of the Cervical Posterior Fixation System PASS OCT®
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
Prospective, multicenter non comparative and observational study (post-market clinical follow-up).
Patients operated with PASS OCT® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017.
The inclusion period will be 12 months and the follow-up 24 months
详细描述
The primary endpoint is to evaluate the safety of the PASS OCT® system.
The secondary endpoints are to analyze the efficacy of the system with several point of view:
- The quality of fusion and the time of fusion through X rays
- the pain with VAS
- the quality of life thanks to questionnaires: NDI (Neck Disability Index) and JOA for myelopathy
- the daily of the patient: return to work, sport
- the surgeon satisfaction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with
- •degenerative disc disease or,
- •spondylolisthesis, or
- •spinal stenosis, or
- •trauma, or
- •atlanto-axial fractures with instability or
- •cervical tumors.
- •Patient operated with PASS OCT®
- •Patient > 18 years
- •Patient affiliated to health care insurance (social security in France)
- •Patient able to complete a self-administered questionnaire
- •Patient able to understand the protocol and the planning visit
- •Patient able to sign an informed consent form
排除标准
- •Patient unable or unwilling to sign an informed consent form
- •Patient unable to complete a self-administered questionnaire
- •Pregnant patient or intending to get pregnant within the next 3 years
- •Patient judged as non-compliant by the investigator or not able to come back for follow-up visits
结局指标
主要结局
Adverse events
时间窗: 12 months postoperatively
To quantify and describe adverse events
次要结局
- Fusion(1-6 months, 12 months, 24 months postoperatively)
- Quality of life(1-6 months, 12 months, 24 months postoperatively)
- Disability(1-6 months, 12 months, 24 months postoperatively)
- Pain(1-6 months, 12 months, 24 months postoperatively)
研究者
研究点 (1)
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