Assessment of the Safety and Performance of an Elbow Brace in the Prevention of Injuries During Sports Practice
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Functionnal score
研究概览
简要总结
Decathlon has developed the Elbow soft300 which is a medical device that must be positioned around the elbow to keep a physical activity on a regular basis in case of chronic epicondylitis, pain associated with tendonitis or chronic instability.
The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Elbow soft 300 product to demonstrate safety and performance of this device in a real-world setting.
Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Decathlon ElbowSoft300 device and support peer-reviewed publications on products performance and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（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 chronic epicondylitis (>3 months) OR elbow pain associated with tendonitis OR chronic elbow instability (>3 months)
- •The current condition of his/her elbow allows the subject to continue 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 (elbow brace or articulated orthosis) in the last month during his/her sport practice
- •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, elastodiene, polyester, elastane)
- •Adult subject to legal protection measure
结局指标
主要结局
Functionnal score
时间窗: Change from Baseline functionnal score at 6 weeks
Comparison of the Patient Rated Elbow Evaluation (20-item questionnaire with a global score from 0=best outcome to 100=worst outcome) between the baseline and last follow-up visit in each group (orthosis vs control)
次要结局
- Confidence level (confidence questionnaire related to physical activity)(Change from Baseline confidence level at 6 weeks)
- Safety (adverse events)(6 weeks of follow-up)
- Elbow pain(Change from Baseline elbow pain at 6 weeks)
- Elbow instability(Change from Baseline elbow instability at 6 weeks)