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Assessment of the Safety and Performance of a Patellofemoral Brace

NCT04653753 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-09-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • EFOR, France

    collaborator INDUSTRY

  • Decathlon SE

    lead INDUSTRY

Principal Investigators

  • Valérie WIECZOREK · Centre Hospitalier Universitaire de Lille

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • France

Study Locations

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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 NCT04653753 on ClinicalTrials.gov