NCT04592471|Unknown
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Sponsor study identifier
observational
60
1 country
2
Study Start
March 5, 2021
Actual (reported)Primary Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Decathlon has developed kneeMID500-STRONG700 products which are two medical devices designed to be used for sport resumption after mild (kneeMID500) or moderate (KneeSTRONG100) knee sprain or after an Anterior Cruciate Ligament surgery. The difference between these devices is based on the strength of compression and the knee maintain. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon kneeMID500-STRONG700 products to demonstrate safety and performance of these devices in a real-world setting.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 6, 2020
Actual (reported)October 19, 2020
Actual (reported)March 5, 2021
Actual (reported)December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Functional score
Comparison of the functional result (Lysholm Score: 0-100 points ; Tegner Activity Scale: 11-level gradient) between the baseline and last follow-up visit in each group (orthosis vs control), for each device model
At baseline and 18 weeks of follow-up
Confidence level
At baseline and 18 weeks of follow-up
Knee instability
At 6 weeks, 12 weeks and 18 weeks of follow-up
Knee pain
At 6 weeks, 12 weeks and 18 weeks of follow-up
Safety (adverse events)
18 weeks of follow-up
Use of kneeMID500 device
Control Group of the kneeMID500 Orthosis Group - No use of the device
Use of kneeSTRONG700 device
Control Group of the kneeSTRONG700 Orthosis Group - No use of the device
At least 30 patients (15 patients in the orthosis group and 15 patients in the control group) per device type (2 device types: Knee MID 500 and Knee STRONG 700) totalling 60 patients 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Subject with a recent mild (grade I) OR moderate (grade II) knee sprain OR an ACL surgery whose current condition of his/her knee allows the subject to resume usual physical activity.
Centre de rééducation et de balnéothérapie Kinés Faches
Faches-Thumesnil, 59155, France
Centre Hospitalier Universitaire de Lille
Lille, 59000, France
Valérie WIECZOREK
Centre Hospitalier Universitaire de Lille
First Submitted
September 6, 2020
First Posted
October 19, 2020
Study Start
March 5, 2021
Actual (reported)Primary Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 14, 2022
Record last verified: 2022-09
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Source: ClinicalTrials.gov.
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