Assessment of Orthopedic Care of the Z-shaped Foot in Children From 6 Months to 2 Years Old
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- The main criterion of the study is the success rate of orthopedic management of the Z-foot.
研究概览
简要总结
Real-life, observational, monocentric, ambispective study, carried out in France. The aim of the study is to evaluate the success rate of orthopedic management of the Z-foot after at least 9 months of follow-up.
详细描述
The study will include a single prospective data collection, which will make it possible to obtain prospective clinical data at the longest follow-up after treatment, with a minimum follow-up of 9 months. This collection will be done during a visit to the office or a phone call, depending on the preference of patients and their parents.
Early data (before the intervention, immediately after, and at 3 months of follow-up) will be collected retrospectively in medical records.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 6 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child having presented a congenital idiopathic malformation uni- or bilateral of foot in Z, defined by the presence of an angular adduction of the mid-forefoot and a dorsolateral hump;
- •Orthopedic treatment with femoropedic plasters and slotted splints in 1st intention, having started at least 9 months before inclusion;
- •Child aged 6 months to 2 years at the start of care;
- •Authorization of the parents or the legal representative of the child to collect personal information about their child.
排除标准
- •Child having presented a secondary Z foot;
- •History of foot surgery;
- •Lack of retrospective data to assess the convexity of the external edge of the foot before orthopedic care;
- •Inability of the parents or the child's legal representative to understand the study protocol.
结局指标
主要结局
The main criterion of the study is the success rate of orthopedic management of the Z-foot.
时间窗: 9 months
Success is a composite criterion, measured at the last follow-up, defined by: * Outer edge of the straight foot; AND * Absence of dorsolateral hump OR possibility of putting on shoes without difficulty AND * Absence of recurrence of the malformation OR resumption of surgery OR resumption of orthopedic treatment.
次要结局
- Moderate success rate of the procedure(9 months)
- Partial and total success rate (relative to the number of patients treated)(9 months)
- Convex angle of the outer edge of the foot during follow-up(9 months)