Assessment of the Safety and Performance of Knee Ligament Supports in the Context of a Return to Sport After Sprain

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Tear; Knee Sprain (Mild); Knee Sprain (Moderate)
• Intervention / Treatment: Device: kneeMID500-STRONG700

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Jean HEE; Phone Number: XX XX XX XX XX; Email: jean.hee@btwin.com

Study Locations

• France
  • Faches-Thumesnil, France, 59155
    • Recruiting
    • Centre de rééducation et de balnéothérapie Kinés Faches
    • Contact: Loïc RAUSENBERGER
    • Principal Investigator: Loïc RAUSENBERGER
  • Lille, France, 59000
    • Recruiting
    • Centre Hospitalier Universitaire de Lille
    • Contact: Valérie WIECZOREK
    • Principal Investigator: Valérie WIECZOREK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subject with a recent mild (grade I) OR moderate (grade II) knee sprain OR an ACL surgery whose current condition of his/her knee allows the subject to resume usual physical activity.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Orthosis Group 1; Use of kneeMID500 device	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.
Control Group 1; Control Group of the kneeMID500 Orthosis Group - No use of the device
Orthosis Group 2; Use of kneeSTRONG700 device	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.
Control Group 2; Control Group of the kneeSTRONG700 Orthosis Group - No use of the device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Safety (adverse events)	Comparison of adverse events rates between the groups (orthosis vs control), for each device model	18 weeks of follow-up

Collaborators and Investigators

• Sponsor: Decathlon SE
• Collaborators: EFOR, France
• Investigators: Principal Investigator: Valérie WIECZOREK, Centre Hospitalier Universitaire de Lille

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: September 6, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Sprains and Strains
• Other Study ID Numbers: kneeMID500-STRONG700

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No