NCT04653753招募中不适用
Assessment of the Safety and Performance of a Patellofemoral Brace
Decathlon SE8 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年3月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- Functional score
研究概览
简要总结
Decathlon has developed kneeSOFT500 product, which is a medical device intended to be used on the knee to keep a physical activity on a regular basis in case of patellofemoral pain syndrome or patellar instability. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon kneeSOFT500 product to demonstrate safety and performance of this device in a real-world setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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 patellofemoral syndrome
- •The current condition of his/her knee allows the subject to keep a regular 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) 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, cotton, elastane, elastodiene, polyester)
- •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: 18 weeks of follow-up
Comparison of the functional result (Kujala Anterior Knee Pain Scale, 0-100 points) between the baseline and last follow-up visit in each group (orthosis vs control)
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)
研究者
研究点 (8)
Loading locations...
相似试验
终止
不适用
Assessment of the Safety and Performance of a Compression Knee Support in the Prevention of Injuries During Sports PracticeChronic Knee PainChronic Instability of Knee JointNCT04601168Decathlon SE7
招募中
不适用
Assessment of the Safety and Performance of Knee Ligament Supports in the Context of a Return to Sport After SprainKnee Sprain (Mild)Knee Sprain (Moderate)Anterior Cruciate Ligament TearNCT04592471Decathlon SE60
招募中
不适用
Assessment of the Safety and Performance of a Compression Ankle Support in the Prevention of Injuries During Sports PracticeChronic PainChronic Instability of Ankle JointNCT04742088Decathlon SE30
招募中
不适用
Assessment of the Safety and Performance of a Lumbar BeltLow Back PainNCT05552248Decathlon SE60
Unknown
不适用
Assessment of the Safety and Performance of an Elbow Brace in the Prevention of Injuries During Sports PracticeEpicondylitisTendonitis ElbowElbow InjuryNCT05552235Decathlon SE30