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.
Study Type
OBSERVATIONAL
Enrollment
7
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)
Centre Hospitalier Universitaire de Lille
Lille, France
KOSS Paris 8
Paris, France
Functional score
Comparison of the functional result (Lysholm Score: 0-100 points) between the baseline and last follow-up visit
Time frame: 6 weeks of follow-up
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
Time frame: At baseline and 6 weeks of follow-up
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)
Time frame: At 2 weeks and 6 weeks of follow-up
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)
Time frame: At 2 weeks and 6 weeks of follow-up
Safety (adverse events)
Rate of adverse events occurred during the study
Time frame: 6 weeks of follow-up
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