NCT02931266终止不适用
Evaluation of the Efficacy and Safety of the PASS MIS® System in the Treatment of Spinal Thoracolumbar Fractures
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Spinal fusion
研究概览
简要总结
Prospective, multicenter non comparative and observational study (post-market clinical follow-up).
详细描述
Patients operated with PASS MIS® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017.
The inclusion period will be 12 months and the follow-up 24 months
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 which need to be operated to treat a fracture at the lumbar and/or thoracic spine with the PASS MIS® device from MEDICREA®
- •Patient > 18years
- •Patient with a mature skeleton
- •Patient able to understand the protocol and the planning visit
- •Patient able to complete a self-administered questionnaire
- •Patient who have signed the informed consent form
排除标准
- •Patient presenting other medical indication than thoracolumbar fracture
- •Patient unable or who refuse to sign an informed consent form
- •Patient unable to complete a self-administered questionnaire
- •Patient judged as non-compliant by the investigator or not able to come back for follow-up visits
- •Patient who need to receive or who received an open procedure
- •Patient who has been not implanted with the PASS MIS® system
- •Pregnant women or intending to get pregnant within the next 2 years after the surgery
- •Patient with contra-indications to do radiographies
- •Local infectious state
- •Allergy or intolerance to the materials, suspected or known
- •Any contra-indications present in the notice of the product
结局指标
主要结局
Spinal fusion
时间窗: 12 months postoperatively
Radiological assessment of bony fusion
Spinal stability
时间窗: 12 months postoperatively
To evaluate though X-rays, the efficacy of the device to promote the stability of the instrumented segments.
次要结局
- Patient satisfaction index(1-6 months, 12 months, 24 months postoperatively)
- Pain(1-6 months, 12 months, 24 months postoperatively)
- Adverse events(During surgery, 1-6 months, 12 months, 24 months postoperatively)
- Disability(1-6 months, 12 months, 24 months postoperatively)
研究者
研究点 (1)
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