Assessment of the Safety and Performance of Ankle Ligament Supports in the Context of a Return to Sport After Sprain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Functional score
研究概览
简要总结
Decathlon has developed Ankle STRONG products which are medical devices that must be positioned around the ankle to limit ankle sprain occurrence.
The Ankle STRONG devices cover a range of 3 products (Ankle STRONG 100/500/900). The differences between the devices is based on the strength of compression and the ankle maintain.
The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Ankle STRONG products to demonstrate safety and performance of these devices in a real-world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Subject is aged ≥ 18 years old
- •Subject has a recent mild OR moderate OR serious ankle sprain
- •The current condition of his/her ankle allows the subject to resume usual physical activity
- •Subject has been informed and is willing to sign an informed consent form
- •Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (12 weeks)
- •Subject is affiliated to the French social security regime
- •Non-inclusion Criteria:
- •Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
- •Subject has worn a support (ankle brace or articulated orthosis) since his/her recent injury
- •Subject has resumed regular physical activity since his/her recent injury
- •Subject has any medical condition that could impact the study at investigator's discretion
- •Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastane, polyester, cotton)
- •Adult subject to legal protection measure
排除标准
- 未提供
结局指标
主要结局
Functional score
时间窗: 12 weeks of follow-up
Comparison of the functional result (Karlsson Ankle Function Score, 0-100 points) between the baseline and last follow-up visit in each group (orthosis vs control), for each device model
次要结局
- Confidence level(At baseline and 12 weeks of follow-up)
- Ankle instability(At 4 weeks, 8 weeks and 12 weeks of follow-up)
- Ankle pain(At 4 weeks, 8 weeks and 12 weeks of follow-up)
- Safety (adverse events)(12 weeks of follow-up)