MedTrace Logo

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

NCT04592471 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2022-09-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • EFOR, France

    collaborator INDUSTRY

  • Decathlon SE

    lead INDUSTRY

Principal Investigators

  • Valérie WIECZOREK · Centre Hospitalier Universitaire de Lille

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04592471 on ClinicalTrials.gov