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

NCT04592471 | Unknown

• 1 other identifier: kneeMID500-STRONG700
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Sprain (Mild); Knee Sprain (Moderate); Anterior Cruciate Ligament Tear

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Confidence level

  At baseline and 18 weeks of follow-up

• Knee instability

  At 6 weeks, 12 weeks and 18 weeks of follow-up

• Knee pain

  At 6 weeks, 12 weeks and 18 weeks of follow-up

• Safety (adverse events)

  18 weeks of follow-up

Study Arms (4)

Orthosis Group 1

Use of kneeMID500 device

Device: kneeMID500-STRONG700

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

Control Group 2

Control Group of the kneeSTRONG700 Orthosis Group - No use of the device

Interventions

kneeMID500-STRONG700 DEVICE

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.

Orthosis Group 1; Orthosis Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Decathlon SE: lead
• EFOR, France: collaborator

Study Sites (2)

Centre de rééducation et de balnéothérapie Kinés Faches

Faches-Thumesnil, 59155, France

RECRUITING

Centre Hospitalier Universitaire de Lille

Lille, 59000, France

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular; Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Valérie WIECZOREK

  Centre Hospitalier Universitaire de Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean HEE

CONTACT

XX XX XX XX XX; jean.hee@btwin.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: October 19, 2020
• Study Start: March 5, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)