NCT02830672已完成2 期
Comparative Clinical Study of Ultrasound-Guided A1 Pulley Release vs Open Surgical Intervention in the Treatment of Trigger Finger
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Resolution of triggering expressed as the "success rate" per digit.
研究概览
简要总结
In this randomized, prospective clinical trial, patients with trigger finger or trigger thumb, will be treated with two different methods; ultrasound-guided release of the first annular pulley or open surgical release of A1 pulley. Results will be compared regarding functional, clinical and cosmetic outcome.
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 (Investigator)
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
- •Patients with resistant -after conservative treatment- trigger finger or trigger thumb, suffering at least for 3 months.
排除标准
- •Patients under 18 years old, these who were treated with a previous operation or a corticosteroid injection for their disease and those who were suffering by inflammatory arthritis, tumor or autoimmune disease.
- •Patients with multiple trigger fingers
研究组 & 干预措施
Open surgical release A1 Pulley
Active Comparator
干预措施: Surgical release A1 pulley for Trigger finger of the hand (Procedure)
Ultrasound guided close release A1 pulley
Active Comparator
干预措施: Surgical release A1 pulley for Trigger finger of the hand (Procedure)
结局指标
主要结局
Resolution of triggering expressed as the "success rate" per digit.
时间窗: 12 weeks
次要结局
- The time for taking postoperative pain killers(12 weeks)
- Range of motion recovery(12 weeks)
- QuickDASH test scores (Greek version)(12 weeks)
- Time to return to normal activities (including work)(12 weeks)
- Cosmetic results(12 weeks)
研究者
Vasileios S. Nikolaou
Assistant Professor Of Orthopedics
National and Kapodistrian University of Athens
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