NCT04601168终止不适用
Assessment of the Safety and Performance of a Compression Knee Support in the Prevention of Injuries During Sports Practice
Decathlon SE2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2021年3月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Functional score
研究概览
简要总结
Decathlon has developed kneeSOFT100 product which is medical device designed to reduce pain and joint instability during sport practice. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon kneeSOFT100 product to demonstrate safety and performance of this device in a real-world setting.
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
- 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 chronic pain AND / OR chronic knee instability
- •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 (6 weeks)
- •Subject is affiliated to the French social security regime
排除标准
- •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) during sports sessions during the last month
- •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 (elastodiene, polyester)
- •Adult subject to a legal protection measure
结局指标
主要结局
Functional score
时间窗: 6 weeks of follow-up
Comparison of the functional result (Lysholm Score: 0-100 points) between the baseline and last follow-up visit
次要结局
- Confidence level(At baseline and 6 weeks of follow-up)
- Knee instability(At 2 weeks and 6 weeks of follow-up)
- Knee pain(At 2 weeks and 6 weeks of follow-up)
- Safety (adverse events)(6 weeks of follow-up)
研究者
研究点 (2)
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