Optimization of Peripheral Nerve Reconstruction: A Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- 2-PD
研究概览
简要总结
- To analyse the outcome of different treatment options of peripheral nerve repair with no gap (group 1) and with a critical sized (>5mm) defect (group 2) in order to optimize peripheral nerve repair
- To reduce morbidity with the same outcome
详细描述
Patients planned to undergo peripheral nerve repair after traumatic nerve injury with either no gap (group 1) or with a critical sized defect (>5mm, group 2) of the finger providing written informed consent to this investigation will be randomised in two groups:.
Group 1: nerve repair with no gap Group 1a (standard): Epineural Suture Group 1b (experimental): Epineural Suture and Fibrin Wrap Group 2: Nerve repair with a critical sized (>5mm) defect Group 2a (standard): Epineural suture and autologous nerve transplantation from lateral antebrachial cutaneous nerve (LACN) Group 2b (experimental): Epineural suture and Fibrin Conduit
In all groups an epineural suture will be performed (suture enhancement). The outcome of fibrin enwrapment and fibrin conduit will be compared to the standard treatment option to date (direct nerve repair and autologous nerve graft, respectively). Randomization will be performed using a computer-base algorithm (www.randomizer.at). Ambulatory follow up of patients is carried out by the Department of Plastic, Reconstructive and Aesthetic Surgery, Handsurgery, University Hospital Basel. The outcome-assessor as well as the patient will be blinded for analysis and the outcome-assessor will have no access to the surgery report.
The investigator's aim is to analyse 48 patients within 12 months. Since 100 patients undergo peripheral nerve repair annually in the Department of Plastic, Reconstructive and Aesthetic Surgery, Handsurgery at the University Hospital Basel, patient accrual appears unproblematic.
After completion, statistical analysis focusing on the comparison of the different types of surgery concerning the clinical parameters 2-Point Discrimination (PD), Semmes Weinstein test, and electroneurography will be conducted.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with traumatic peripheral nerve injury of the finger(s) who are to be treated with peripheral nerve repair at the Department of Plastic, Reconstructive and Aesthetic Surgery, Handsurgery, University Hospital of Basel
- •Written informed consent
排除标准
- •Age < 18 years
- •Age > 90 years
- •Pregnancy
结局指标
主要结局
2-PD
时间窗: 2wks, 3mts and 6mts
次要结局
未报告次要终点
