Assessment of the Safety and Performance of Knee Ligament Supports in the Context of a Return to Sport After Sprain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Functional score
研究概览
简要总结
Decathlon has developed kneeMID500-STRONG700 products which are two medical devices designed to be used for sport resumption after mild (kneeMID500) or moderate (KneeSTRONG100) knee sprain or after an Anterior Cruciate Ligament surgery.
The difference between these devices is based on the strength of compression and the knee maintain.
The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon kneeMID500-STRONG700 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 (grade I) OR moderate (grade II) knee sprain OR an ACL surgery
- •The current condition of his/her knee 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 (18 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 (knee 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, elastodiene)
- •Adult subject to a legal protection measure
排除标准
- 未提供
结局指标
主要结局
Functional score
时间窗: At baseline and 18 weeks of follow-up
Comparison of the functional result (Lysholm Score: 0-100 points ; Tegner Activity Scale: 11-level gradient) 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 18 weeks of follow-up)
- Knee instability(At 6 weeks, 12 weeks and 18 weeks of follow-up)
- Knee pain(At 6 weeks, 12 weeks and 18 weeks of follow-up)
- Safety (adverse events)(18 weeks of follow-up)