Anterior Cruciate Ligament Tear Clinical Trial
Official title:
Assessment of the Safety and Performance of Knee Ligament Supports in the Context of a Return to Sport After Sprain
Verified date | September 2022 |
Source | Decathlon SE |
Contact | Jean HEE |
Phone | XX XX XX XX XX |
jean.hee[@]btwin.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre de rééducation et de balnéothérapie Kinés Faches | Faches-Thumesnil | |
France | Centre Hospitalier Universitaire de Lille | Lille |
Lead Sponsor | Collaborator |
---|---|
Decathlon SE | EFOR, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional score | 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 | At baseline and 18 weeks of follow-up | |
Secondary | Confidence level | 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 | At baseline and 18 weeks of follow-up | |
Secondary | Knee instability | 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 | At 6 weeks, 12 weeks and 18 weeks of follow-up | |
Secondary | Knee pain | Comparison of knee pain, assessed through NRS (ranging from 0 to 10), between the groups (orthosis vs control), for each device model | At 6 weeks, 12 weeks and 18 weeks of follow-up | |
Secondary | Safety (adverse events) | Comparison of adverse events rates between the groups (orthosis vs control), for each device model | 18 weeks of follow-up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05109871 -
Reliability and Validity of Inline Dynamometry Study for Measuring Knee Extensor Torque
|
N/A | |
Recruiting |
NCT04088227 -
Effects of Platelet Rich Plasma Injections on Biomarkers After Anterior Cruciate Ligament Tears
|
Phase 2 | |
Completed |
NCT04956393 -
The SOAR (Stop OsteoARthritis) Program Proof-of-Concept Study
|
N/A | |
Recruiting |
NCT05574946 -
Comparison of Two ACL Reconstruction Techniques: All-inside Versus Complete Tibial Tunnel Technique
|
N/A | |
Completed |
NCT01447277 -
Prospective Femoral Versus Femoral and Sciatic Nerve Block for Anterior Cruciate Ligament (ACL) Reconstruction
|
N/A | |
Recruiting |
NCT06430775 -
Exploring Prolonged AMR in ACL Reconstructed Patients
|
||
Terminated |
NCT02911909 -
Moderated Blood Flow Restriction After Anterior Cruciate Ligament Reconstruction
|
N/A | |
Completed |
NCT02760589 -
Magnetic Resonance Imaging and Functional Performance Outcome After ACL Repair With Internal Brace Technique
|
||
Completed |
NCT02787096 -
Dynamic Knee Laxity Measurement Coupled to MRI in Cases of Suspected Partial Anterior Cruciate Ligament Tear
|
N/A | |
Completed |
NCT04635579 -
Personalized Blood Flow Restriction for Anterior Cruciate Ligament Rehabilitation
|
N/A | |
Completed |
NCT01850758 -
Regenexx™ SD Versus Exercise Therapy for ACL Tears
|
N/A | |
Recruiting |
NCT05204836 -
Altering Bone Microarchitecture and Mechanics by Off-label Pharmaceutical Intervention Following an Acute Knee Injury
|
Phase 1 | |
Completed |
NCT01580722 -
Comparison of Early Versus Delay Reconstruction in Anterior Cruciate Ligament Tearing
|
Phase 2 | |
Recruiting |
NCT05174611 -
Vitamin D to Improve Quadricep Muscle Strength
|
Phase 2 | |
Recruiting |
NCT05501210 -
Vibration on Patellofemoral Joint Pain After ACLR
|
N/A | |
Recruiting |
NCT05682820 -
Analysis of Radiological Features of Lateral Femoral Impaction Fracture / Lateral Femoral Notch Sign
|
||
Terminated |
NCT02930122 -
IL-1RA Treatment in Patients With Acute ACL Tear and Painful Effusions
|
Phase 2 | |
Recruiting |
NCT05306054 -
Physical Activity, Knee Joint Loading and Joint Health
|
||
Completed |
NCT04374968 -
Use of Blood Flow Restriction Therapy Following ACL Tear
|
N/A | |
Recruiting |
NCT04998656 -
Werewolf Flow 50 During ACL Reconstruction
|
N/A |