Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Evaluate the effect of Cartidyss on knee functionality and discomfort after 3 months of supplementation |
Changes from baseline to 3 months of Knee injury and Osteoarthritis Outcome Score (KOOS) global score using a specific self-administered questionnaire Variation of Knee injury and Osteoarthritis Outcome Score using a self-administered questionnaire. The KOOS outcome score is a 42-item self-administrated questionnaire comprising 5 subscales: Pain, Symptoms, Activities of Daily Living, Sports and Recreation function, and Quality Of Life. A separate score ranging from 0 to 100, where 100 represents the best result, will be calculated for each subscale. A global score will be calculated by summing the score of each subscale. |
3 months (Day 0, Month 1 and Month 3) |
|
Secondary |
Evaluate the effect of Cartidyss on knee function after 3 months of supplementation |
Changes from baseline to each time points of knee function using the KOOS questionnaire, a specific self-administered questionnaire Variation of Knee injury and Osteoarthritis Outcome Score. The KOOS outcome score is a 42-item self-administrated questionnaire comprising 5 subscales: Pain, Symptoms, Activities of Daily Living, Sports and Recreation function, and Quality Of Life. A separate score ranging from 0 to 100, where 100 represents the best result, will be calculated for each subscale. A global score will be calculated by summing the score of each subscale. |
3 months (Day 0, Month 1 and Month 3) |
|
Secondary |
Evaluate the effect of Cartidyss on knee pain at rest and while walking after 3 months of supplementation |
Changes from baseline to each time points. Variation of Visual Analogue Scale for the mean knee pain at rest and while walking over the last month The pain Visual Analogue scale (VAS) is a continuous scale comprised of a horizontal line, usually 10 centimeters in length (0-100mm), anchored by 2 verbal descriptors, one for each symptom extreme. |
3 months (Day 0, Month 1 and Month 3) |
|
Secondary |
Evaluate the effect of Cartidyss on patient global assessment after 3 months of supplementation |
Changes from baseline to each time points. Variation of Visual Analogue Scale for patient global assessment of disease activity The Visual Analogue Scale (VAS) is a continuous scale comprised of a horizontal line, usually 10 centimeters in length (0-100mm), anchored by one verbal descriptors for Global Assessment of disease activity. |
3 months (Day 0, Month 1 and Month 3) |
|
Secondary |
Evaluate the effect of Cartidyss on quality of life after 3 months of supplementation |
Changes from baseline to each time points. A global score will be calculated in function of the answers of a Self-administered questionnaire (SF-36). The SF-36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state. |
3 months (Day 0, Month 1 and Month 3) |
|
Secondary |
Evaluate the tolerance of Cartidyss after 3 months of supplementation |
Number of Adverse events (AE or Adverse Device Effect or Device Deficiency; will be coded in terms of System Organ Class (SOC) and Low Level Terms (LLT) using the last version of MedDRA) and drop offs |
Only Month 1 and Month 3 |
|
Secondary |
Evaluate the compliance of Cartidyss after 3 months of supplementation |
Count the capsules in investigation kits brought back by the patient. |
Only Month 1 and Month 3 |
|
Secondary |
Evaluate the satisfaction of Cartidyss after 3 months of supplementation |
Changes after supplementation. Self-administered questionnaire using a 5-Likert scale (extremely unsatisfied- unsatisfied- nor unsatisfied nor satisfied- satisfied- extremely satisfied) to evaluate the product. |
Only Month 1 and Month 3 |
|
Secondary |
Evaluate the pain killer's consumption during the 3 months of supplementation |
Changes after supplementation. Count the number of consumed pain killer |
Only Month 1 and Month 3 |
|
Secondary |
Evaluate the rate of responder to the 3 months supplementation of Cartidyss |
Responder rate to treatment defined as changes in knee pain and/or knee function and/or patients disease activity according to the Outcome Measures in Rheumatology (OMERACT) and the OsteoArthritis Research Society International (OARSI) criteria. Responder criteria for osteoarthritis clinical trials based on the questionnaires describe above. |
Only Month 1 and Month 3 |
|