Assessment of the Safety and Performance of Knee Ligament Supports in the Context of a Return to Sport After Sprain
- Conditions
- Anterior Cruciate Ligament TearKnee Sprain (Mild)Knee Sprain (Moderate)
- Interventions
- Device: kneeMID500-STRONG700
- Registration Number
- NCT04592471
- Lead Sponsor
- Decathlon SE
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Orthosis Group 2 kneeMID500-STRONG700 Use of kneeSTRONG700 device Orthosis Group 1 kneeMID500-STRONG700 Use of kneeMID500 device
- Primary Outcome Measures
Name Time Method Functional score 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
- Secondary Outcome Measures
Name Time Method Confidence level At baseline and 18 weeks of follow-up Gap in the confidence level (patient rated outcome with 6 questions, ranging from 0 to 100) related to physical activity, between the baseline and last follow-up visit in each group (orthosis vs control), for each device model
Knee instability At 6 weeks, 12 weeks and 18 weeks of follow-up Comparison of knee instability, assessed through a numerical rating scale (NRS, ranging from 0 to 10), between the groups (orthosis vs control), for each device model
Knee pain At 6 weeks, 12 weeks and 18 weeks of follow-up Comparison of knee pain, assessed through NRS (ranging from 0 to 10), between the groups (orthosis vs control), for each device model
Safety (adverse events) 18 weeks of follow-up Comparison of adverse events rates between the groups (orthosis vs control), for each device model
Trial Locations
- Locations (2)
Centre Hospitalier Universitaire de Lille
🇫🇷Lille, France
Centre de rééducation et de balnéothérapie Kinés Faches
🇫🇷Faches-Thumesnil, France