NCT04592471

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Decathlon SE · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-03-05
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2020-10-19
• Last updated: 2022-09-14

Locations

2 sites across 1 country: France