Single-portal Endoscopic Carpal Tunnel Release vs Knifelight for Carpal Tunnel Syndrome. A Randomized Control Trial.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Overall Satisfaction
研究概览
简要总结
The purpose of this study is to determine whether Single-portal Endoscopic Carpal Tunnel Release (Agee technique, SmartRelease™, MicroAire) and mini-open technique (Knifelight®, Stryker) are equally effective and safe surgical options for the treatment of primary Carpal Tunnel Syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary Carpal Tunnel Syndrome
- •no symptoms' relief after 3 months of conservative treatment (NSAIDS, Cast, rest)
- •electrophysiological examination confirms the Carpal Tunnel Syndrome
排除标准
- •Secondary Carpal Tunnel Syndrome
- •Pregnancy
- •Rheumatoid diseases
- •Previous trauma at hand or other condition that may effect the anatomy (eg infections)
结局指标
主要结局
Overall Satisfaction
时间窗: at 1 and 6 months postoperatively
Satisfaction will be assessed by two ways * by answering to the question "are you happy with the result of the surgery?" * with a VAS score (0-100) assessing the satisfaction
Complications
时间窗: up to 6 months postoperatively
Any complication will be reported including remaining numbness, pain in incision, painful scar, complex regional pain syndrome, infection etc
次要结局
- Symptom Severity Scale (SSS)(at 1 and 6 months postoperatively)
- Function Severity Status (FSS)(at 1 and 6 months postoperatively)
- Pain(at 1 and 6 months postoperatively)
- Grip strength(at 1 and 6 months postoperatively)
- key pinch(at 1 and 6 months postoperatively)
- Time to return to Activities of Daily Living (ADL) and return to work(up to the end of the study)
- Recurrences and reoperations(up to the end of study)
研究者
Haris S Vasiliadis, MD, PhD
Lecturer in Orthopaedics
University of Ioannina