NCT06680518招募中不适用
Prospective, Randomized Study of Tourniquet Use in Hallux Valgus Surgery
Clinique Saint Jean, France2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年10月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Average pain in the first week after surgery
研究概览
简要总结
Prospective, single-center, randomized interventional clinical trial of tourniquet use in hallux valgus surgery. Patients will be their own controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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 over 18 who has been informed and has signed the consent form
- •Patient to be operated on for bilateral hallux valgus with no difference in the procedure performed between the 2 feet, the deformity must not differ by more than 10° (angle M1P1) between the 2 sides.
- •Surgery planned on the same day for both feet
排除标准
- •Arthritic hallux valgus requiring arthrodesis
- •Inflammatory pathology (rheumatoid arthritis, etc.)
研究组 & 干预措施
Arm with tourniquet
Active Comparator
The surgeon will use the tourniquet as usual.
干预措施: tourniquet (Other)
Arm without tourniquet
Experimental
The surgeon will operate without the aid of a tourniquet
干预措施: No tourniquet (Other)
结局指标
主要结局
Average pain in the first week after surgery
时间窗: first week after surgery
Comparison between the 2 groups of the average VAS over the first week following surgery, from 0 to 100 points, 0 being the value where the patient has no pain and 100 the maximum pain value.
次要结局
- Edema(Day 10 after surgery)
- Complications(first week after surgery)
研究者
Wayan HEBRARD
Doctor
Clinique Saint Jean, France
研究点 (2)
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