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

Chronic Knee Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04601168
• Other study ID #: kneeSOFT100
• Status: Terminated
• Start date: March 25, 2021
• Est. completion date: July 19, 2022

Study information

• Verified date: September 2022
• Source: Decathlon SE
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: July 19, 2022
• Est. primary completion date: July 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Instability of Knee Joint
• Chronic Knee Pain

Intervention

Device:
• kneeSOFT100
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)

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Lille	Lille
France	KOSS Paris 8	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Decathlon SE	EFOR, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Confidence level	Gap in the confidence level (patient rated outcome with 6 questions, ranging from 0 to 100) related to physical activity, between the baseline and last follow-up visit	At baseline and 6 weeks of follow-up
Secondary	Knee instability	Comparison of knee instability between the first two weeks of follow-up (without use of the device during sports sessions) and the following four weeks (with use of the device during sports sessions), measured through a numerical rating scale (NRS, ranging from 0 to 10)	At 2 weeks and 6 weeks of follow-up
Secondary	Knee pain	Comparison of knee pain between the first two weeks of follow-up (without use of the device during sports sessions) and the following four weeks (with use of the device during sports sessions), measured through a NRS (ranging from 0 to 10)	At 2 weeks and 6 weeks of follow-up
Secondary	Safety (adverse events)	Rate of adverse events occurred during the study	6 weeks of follow-up