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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04592471
• Other study ID #: kneeMID500-STRONG700
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Tear
• Knee Sprain (Mild)
• Knee Sprain (Moderate)
• Sprains and Strains

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