NCT04653753

Assessment of the Safety and Performance of a Patellofemoral Brace

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Decathlon SE · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Decathlon has developed kneeSOFT500 product, which is a medical device intended to be used on the knee to keep a physical activity on a regular basis in case of patellofemoral pain syndrome or patellar instability. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon kneeSOFT500 product to demonstrate safety and performance of this device in a real-world setting.

Conditions

• Patellofemoral Pain Syndrome
• Patellar Instability

Interventions

Type	Name	Description
DEVICE	kneeSOFT500	At least 30 patients (15 patients in the orthosis group and 15 patients in the control group) 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: 2021-03-02
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2020-12-04
• Last updated: 2022-09-14

Locations

4 sites across 1 country: France