A Multi-center Study on Mid-term Effect Observation of Biodegradable Conduit Small Gap Tublization Repairing Peripheral Nerve Injury
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 主要终点
- Nerve function 1
研究概览
简要总结
To observe the Mid-term clinical effect of biodegradable conduit small gap tublization to repair peripheral nerve injury in multi-center．
详细描述
In the study，150 cases of fresh peripheral nerve injury in the upper extremities are recruited in multi-center． After formally informed and obtaining the consent，the biodegradable conduit small gap tublization are used to repair the nerve．Their nerve functional recovery conditions are clinically observed according to the standard score methods provided by SHEN Ning-jiang and British Medical Research Council at 3 years after surgery．The excellent and good rates of the overall nerve functional recovery are calculated．
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fresh peripheral nerve injury in the upper extremities
排除标准
- •acute myocardial infarction history within 6 months,
- •old and pathological peripheral nerve injury,
- •acute and chronic infection,
- •various consumptive diseases
- •unable to tolerate surgery
结局指标
主要结局
Nerve function 1
时间窗: 3 years after surgery
standard score methods provided by British Medical Research Council
次要结局
- Nerve function 2(3 years after surgery)
研究者
Zhang Peixun
Department of orthopaedics and trauma
Peking University People's Hospital