NCT04726566已完成不适用
Return to Sport and Functional Assessment After Surgery for Chronic Lateral Ankle Instability
GCS Ramsay Santé pour l'Enseignement et la Recherche1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2021年1月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Rate of return to main sport at the expected level in both groups
研究概览
简要总结
Real-life, observational, monocentric, prospective, longitudinal study, carried out at the European Center for Sports Rehabilitation (CERS), France.
详细描述
The data will be collected through an electronic Case Report Form completed by the physician, and some auto-questionnaire completed by the patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 15 years;
- •Patient treated at the European Sports Rehabilitation Center after a first arthroscopic surgery on the external lateral ligament of the ankle for chronic instability by anatomical reconstruction:
- •With tendon graft;
- •By suture with biological reinforcement;
- •Non-opposition of the patient and his/her parents (if minor) to the collection of his/her personal data.
排除标准
- •- Minor patient (age <18 years) not accompanied by one of his/her parents or legal representative during the inclusion visit;
- •History of surgery on the same ankle;
- •Associated complex osteochondral or internal ligament damage, syndesmosis, fracture;
- •Non-anatomical reconstruction;
- •Inability of the patient to understand the study protocol;
- •Vulnerable person whose inclusion is not justified by the purposes of the research: pregnant woman, person undergoing psychiatric care, or adult person subject to legal protection.
结局指标
主要结局
Rate of return to main sport at the expected level in both groups
时间窗: 10 months
The main objective is to evaluate the rate of patients who returned to sport at the level before the injury, according to their evaluation, 10 months after arthroscopic stabilization according to the surgical technique used (repair by suture or reconstruction by tendon graft).
次要结局
- Time taken to resume sport after arthroscopic stabilization(10 months)
- Factors associated with the lack of resumption of sport at the level before the injury(10 months)
- Functional state of the ankle(10 months)
研究者
研究点 (1)
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