NCT05625282招募中不适用
Plantar Plate Repair for Treatment of Floating Toe: Must we Associate it to Weil Osteotomy?
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年11月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Manchester-Oxford Foot Questionnaire (MOXFQ) score at the end of follow-up
研究概览
简要总结
The aim of this study is to assess if isolated Weil osteotomy for floating toe grade II or III provides results that are not inferior to those obtained with the Weil osteotomy associated with plantar plate repair.
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
- Double (Participant, 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
- •18 years old, minimum
- •ability to understand treatment and recovery
- •floating toe
排除标准
- •age less than 18 years old at the moment of recruiting
- •patients who are not able to understand treatment and recovery
- •intraoperative diagnosis of plantar plate injury grade 0, I or IV in Nery's classification
- •secondary surgery
结局指标
主要结局
Manchester-Oxford Foot Questionnaire (MOXFQ) score at the end of follow-up
时间窗: 1 year
Score obtained at Manchester-Oxford Foot and Ankle Questionnaire (0-100, where higher scores mean a worse outcome) one year after surgery.
次要结局
- side(moment of recruiting)
- age(moment of recruiting)
- sex(moment of recruiting)
- rate of recurrence(1 month, 3 months, 6 months, 1 year after surgery)
- rate of complications(1 month, 3 months, 6 months, 1 year after surgery)
- Score obtained at Manchester-Oxford Foot and Ankle Questionnaire (0-100, where higher scores mean a worse outcome)(3 months, 6 months after surgery)
研究者
研究点 (1)
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