Clinical trial · Observational
Assessment of the Safety and Performance of Knee Ligament Supports in the Context of a Return to Sport After Sprain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anterior Cruciate Ligament Tear | — | UNRESOLVED | — |
| Knee Sprain (Mild) | — | UNRESOLVED | — |
| Knee Sprain (Moderate) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| kneeMID500-STRONG700 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Orthosis Group 1
- description
- Use of kneeMID500 device
- interventionNames
- Device: kneeMID500-STRONG700
- label
- Control Group 1
- description
- Control Group of the kneeMID500 Orthosis Group - No use of the device
- label
- Orthosis Group 2
- description
- Use of kneeSTRONG700 device
- interventionNames
- Device: kneeMID500-STRONG700
- label
- Control Group 2
- description
- Control Group of the kneeSTRONG700 Orthosis Group - No use of the device
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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
References
Publications (0)
Data not yet available