Assessment of the Safety and Performance of a Compression Knee Support in the Prevention of Injuries During Sports Practice

NCT04601168 | Terminated

• 1 other identifier: kneeSOFT100
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

Decathlon has developed kneeSOFT100 product which is medical device designed to reduce pain and joint instability during sport practice. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon kneeSOFT100 product to demonstrate safety and performance of this device in a real-world setting.

Conditions

Chronic Knee Pain; Chronic Instability of Knee Joint

Outcome Measures

Primary Outcomes (1)

• Functional score

  Comparison of the functional result (Lysholm Score: 0-100 points) between the baseline and last follow-up visit

  6 weeks of follow-up

Secondary Outcomes (4)

• Confidence level

  At baseline and 6 weeks of follow-up

• Knee instability

  At 2 weeks and 6 weeks of follow-up

• Knee pain

  At 2 weeks and 6 weeks of follow-up

• Safety (adverse events)

  6 weeks of follow-up

Interventions

kneeSOFT100 DEVICE

During the first two weeks of follow-up, the subject shall not use the device during the sports sessions. The subject shall use the device during the sports sessions for the next 4 weeks (6 weeks of follow-up)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subject with chronic pain AND / OR chronic knee instability whose current condition of his/her knee allows him/her to pursue a usual physical activity.

You may qualify if:

• Subject is aged ≥18 years old
• Subject has chronic pain AND / OR chronic knee instability
• 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 (6 weeks)
• Subject is affiliated to the French social security regime

You may not qualify if:

• 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) during sports sessions during the last month
• 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 (elastodiene, polyester)
• Adult subject to a legal protection measure

Sponsors & Collaborators

• Decathlon SE: lead
• EFOR, France: collaborator

Study Sites (2)

Centre Hospitalier Universitaire de Lille

Lille, 59000, France

Location

KOSS Paris 8

Paris, France

Location

Study Officials

• Valérie WIECZOREK

  Centre Hospitalier Universitaire de Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: October 23, 2020
• Study Start: March 25, 2021
• Primary Completion: July 19, 2022
• Study Completion: July 19, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Locations

FR (2)