Clinical trial NCT04592471: Assessment of the Safety and Performance of Knee Ligament Supports in the Context of a Return to Sport After Sprain
Official title: Assessment of the Safety and Performance of Knee Ligament Supports in the Context of a Return to Sport After Sprain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Sprain (Mild)
Knee Sprain (Moderate)
Anterior Cruciate Ligament Tear
Lead sponsor: Decathlon SE
Sponsor class: INDUSTRY
Collaborators: name: EFOR, France
First posted: 2020-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Functional score
timeFrame: At baseline and 18 weeks of follow-up
Secondary outcomes:
measure: Confidence level
timeFrame: At baseline and 18 weeks of follow-up
measure: Knee instability
timeFrame: At 6 weeks, 12 weeks and 18 weeks of follow-up
measure: Knee pain
timeFrame: At 6 weeks, 12 weeks and 18 weeks of follow-up
measure: Safety (adverse events)
timeFrame: 18 weeks of follow-up
Other outcomes:
Locations:
city: Faches-Thumesnil
country: France
facility: Centre de rééducation et de balnéothérapie Kinés Faches
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
Study officials:
affiliation: Centre Hospitalier Universitaire de Lille
name: Valérie WIECZOREK
role: PRINCIPAL_INVESTIGATOR
References: