Assessment of the Safety and Performance of Elbow Supports in the Context of Epicondylitis or 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
- 4
- 主要终点
- Functional score
研究概览
简要总结
Decathlon has developed elbowMID500 and elbowSTRAP products which are medical devices that must be positioned around the elbow during sport practice, in order to limit symptoms related to epicondylitis or previous sprains (elbowMID500 only).
The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon elbowMID500 and elbowSTRAP products to demonstrate safety and performance of these devices 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 elbowMID500 and elbowSTRAP devices and support peer-reviewed publications on products performance and safety.
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 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 an acute epicondylitis (stage 1 or 2) OR a recent mild elbow sprain
- •Subject performs regular physical activity (minimum of 2 sessions of 10 minutes per week)
- •The current condition of his/her elbow 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 (elbow brace or articulated orthosis) in the last month during his/her sport practice
- •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, elastodiene) • Adult subject to legal protection measure
结局指标
主要结局
Functional score
时间窗: Change from Baseline functionnal score at 6 weeks
Comparison of the Japanese Elbow Assessment Score System (JOA elbow scale from 0=worst ouctome to 100=best outcome) between the baseline and last follow-up visit in each group (orthosis vs control), for each device model.
次要结局
- Safety (adverse events)(6 weeks of follow-up)
- Confidence level (confidence questionnaire related to physical activity)(Change from Baseline confidence level at 6 weeks)
- Elbow pain(Change from Baseline elbow pain at 6 weeks)