Quantification and Characterization of Foot Postoperative Edema - Bicentric Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Evaluate the change of volume of an operated foot to evaluate the edema.
研究概览
简要总结
In foot surgery, postoperative edema is a complication making the postoperative outcome quite uncertain as to the rehabilitation of the patient. The evolution of this edema is unknown ... The means of "mastering" this edema are empirical, with little study other than cryotherapy and restraint. This study aims to study postoperative edema in a cohort of patients undergoing forefoot surgery. The follow-up will be prospective with measurement of the volume of the foot using an optical technique, during the various follow-up consultations between Day 8 and Month 6 postoperative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Major patient
- •Patient operated on forefoot surgery
- •Patient having given informed consent
- •For female patients of childbearing age, not to be pregnant or likely to be during the study, not to be breastfeeding
排除标准
- •Minor patient
- •Patient deprived of his liberty or under guardianship
- •Patient operated on for surgery of the forefoot other than hallux and lateral toes
- •Patient unable to undergo protocol monitoring for psychological, social, family, geographic or linguistic reasons
- •Patient with an underlying or concomitant pathology incompatible with inclusion in the trial, whether psychiatric or somatic
- •Vulnerable people according to article L1121-6 of the CSP
研究组 & 干预措施
Hallux surgery
These are patients operated on for hallux without change of strategy compared to current care
干预措施: Optical scanner (Device)
Metatarsal paddle surgery
These are patients operated on for metatarsal paddle without change of strategy compared to current care
干预措施: Optical scanner (Device)
Hallux and metatarsal pallet surgery
These are patients operated on for hallux and metatarsal paddle without change of strategy compared to current care
干预措施: Optical scanner (Device)
结局指标
主要结局
Evaluate the change of volume of an operated foot to evaluate the edema.
时间窗: Day 0 before surgery, Day 8 after surgery
Change of volume of the foot from Day 0
Evaluate the change of volume of the edema of an operated foot during the 6 months after surgery
时间窗: Day 21, Day 45, Month 3 and Month 6 after surgery
次要结局
未报告次要终点