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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04592471
Other study ID # kneeMID500-STRONG700
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 5, 2021
Est. completion date December 2023

Study information

Verified date September 2022
Source Decathlon SE
Contact Jean HEE
Phone XX XX XX XX XX
Email jean.hee@btwin.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
kneeMID500-STRONG700
At least 30 patients (15 patients in the orthosis group and 15 patients in the control group) per device type (2 device types: Knee MID 500 and Knee STRONG 700) totalling 60 patients will be included. Patients included in the orthosis group will use the device during sports sessions while patients included in the control group will not use a knee support device.

Locations

Country Name City State
France Centre de rééducation et de balnéothérapie Kinés Faches Faches-Thumesnil
France Centre Hospitalier Universitaire de Lille Lille

Sponsors (2)

Lead Sponsor Collaborator
Decathlon SE EFOR, France

Country where clinical trial is conducted

France, 

Outcome

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
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