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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
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.
Centre de rééducation et de balnéothérapie Kinés Faches
Faches-Thumesnil, France
RECRUITINGPhysio Sport Levallois
Levallois-Perret, France
RECRUITINGCentre Hospitalier Universitaire de Lille
Lille, France
RECRUITINGFunctional score
Comparison of the functional result (Kujala Anterior Knee Pain Scale, 0-100 points) between the baseline and last follow-up visit in each group (orthosis vs control)
Time frame: 18 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 in each group (orthosis vs control)
Time frame: At baseline and 18 weeks of follow-up
Knee instability
Comparison of knee instability, assessed through a numerical rating scale (NRS, ranging from 0 to 10), between the groups (orthosis vs control)
Time frame: At 6 weeks, 12 weeks and 18 weeks of follow-up
Knee pain
Comparison of knee pain, assessed through NRS (ranging from 0 to 10), between the groups (orthosis vs control)
Time frame: At 6 weeks, 12 weeks and 18 weeks of follow-up
Safety (adverse events)
Comparison of adverse events rates between the groups (orthosis vs control)
Time frame: 18 weeks of follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cabinet de kinésithérapie du Belvédère
Paris, France
NOT_YET_RECRUITING