Randomized Study on Akin Osteotomy: Fixation Versus Non-fixation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Overall mobility of the metatarsophalangeal hallux joint in degre
研究概览
简要总结
We hypothesize that the Akin screw fixation osteotomy technique provides better postoperative mobility of the metatarsophalangeal hallux joint compared to the non-fixation technique.
详细描述
Compare the screw fixation technique of Akin's osteotomy, compared to the technique without fixation, on the postoperative mobility of the metatarsophalangeal joint of the hallux at one year postoperatively in patients ( patients operated on for an isolated hallux valgus, that is to say without any associated lateral movement, by percutaneous technique (MICA or PERC).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years-old
- •Patient undergoing percutaneous surgery for Hallux valgus with first hybrid and / or percutaneous ray procedure without rotation disorder,
- •First line surgery,
- •Absence of metatarsophalangeal osteoarthritis,
- •Persistence of mobility of the hallux metatarsophalangeal gland,
- •Subject benefiting from a social protection insurance
- •Patient having signed the free and informed consent / Patient having given his express consent / Patient having been informed and not opposing this research.
排除标准
- •Rotation disorder,
- •Rheumatoid foot,
- •Hallux rigidus.
- •Patient participating in another clinical study
- •Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision;
- •Pregnant, breastfeeding or parturient woman;
- •Hospitalized without consent.
研究组 & 干预措施
AKIN osteotomy with screw fixation
干预措施: AKIN osteotomy with screw fixation (Procedure)
AKIN osteotomy without screw fixation
干预措施: AKIN osteotomy without screw fixation (Procedure)
结局指标
主要结局
Overall mobility of the metatarsophalangeal hallux joint in degre
时间窗: 1 year
Overall mobility of the metatarsophalangeal hallux joint in degree, one year after surgery, measured by a goniometer, as the amplitude between plantar flexion and dorsiflexion.
次要结局
未报告次要终点