NCT01017471Unknown3 期
Comparison Results of Carpal Tunnel Release Between Standard Incision and Limited Incision Using PSU Retractor: A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- CTS score
研究概览
简要总结
The investigators study aims to evaluate both efficacy and safety of carpal tunnel release using limited incision with the PSU retractor compared to standard incision.
The investigators will do a randomized controlled trial in 60 patients with carpal tunnel release and evaluate for outcome regarding pain, VAS score, return to work time, CTS score and complications at 6 months.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as carpal tunnel syndrome who failed to conservative treatment 3 months
排除标准
- •Underlying disease such as : DM, neuropathy
- •Previous wrist or hand surgery in the same side
- •Previous wrist and hand trauma
- •Pregnancy
研究组 & 干预措施
control
Experimental
carpal tunnel release using standard incision
干预措施: Limited incision using PSU retractor (Procedure)
结局指标
主要结局
CTS score
时间窗: 1 year
次要结局
- VAS score(1 year)
- return to work time(1 year)
- satisfaction score(1 year)
- complication rate(1 year)
研究者
Boonsin Tangtrakulwanich
Department of Orthopaedic surgery
Prince of Songkla University
研究点 (1)
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