Knee Osteoarthritis
Conditions
Keywords
Hyaluronic Acid, Algofunctional Scores, Peptides, Knee Osteoarthritis, Topical Treatment, Patient Satisfaction
Brief summary
Evaluate the long-term efficacy of the CR500™ therapy in patients with knee OA.
Detailed description
To assess whether and when the patients enrolled in the CTD-SW CR500™-KOA 2020 clinical study required new orthopaedic treatment for knee osteoarthritis, starting at least 24 months after the conclusion of the clinical study. Evaluate whether, in the long term, despite the potential bias of other therapies, treatment with CR500 has led to a lasting improvement, especially in comparison with infiltrative treatments based on the literature. Collect data on patient satisfaction with the therapy received
Interventions
DEVICECR 500™ SINGLE-DOSE GEL
CR 500™ SINGLE-DOSE GEL is a hydrogel to be applied to intact skin, useful to attenuate the physiological degeneration of cartilage typical of osteoarthritic processes. The presence of sodium hyaluronate facilitates the movement of joints and tendons for greater mobility and flexibility
Sponsors
Contrad Swiss SA
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Oral informed consent from the patient. * Participation in the CTD-SW CR500™-KOA 2020 clinical study. * Willingness to participate in the survey.
Exclusion criteria
* Patients who were excluded following major protocol violations during the CTD-SW CR500™-KOA 2020 clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lequesne Knee Index (LKI) Score | At least after 24 Months from the end of NCT05661162 study visit | The primary efficacy endpoint of the study will be the evaluation of the long-term clinical performance of the CR500™, used as intended in patients affected by KOA, in variation of symptoms related to the physiological degeneration of cartilage typical of osteoarthritic processes, in terms of difference in LKI score between the end of NCT05661162 study visit and follow-up visit. Lequesne Knee Index Score: minimum index score: 0 maximum index score: 24 0 means none OA \>= means extremely severe OA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of pain in the CR500™-treated knee and prosthesis status. | At least after 24 Months from the end of NCT05661162 study visit | To collect, via a questionnaire, information on the health status of the knee treated with CR500™ (presence of pain after treatment) and on prosthesis status (whether undergone or scheduled). After the treatment with CR500, has a similar pain reappeared in the same knee? Yes Yes, but less intense No After the treatment with CR500, have you undergone knee replacement surgery? Yes Waiting list No If Yes, when? |
| Need for additional therapies before and after CR500™. | At least after 24 Months from the end of NCT05661162 study visit. | To collect information, via a questionnaire, on the need for joint injections before and after CR500™ therapy. Did the patients receive HA infiltration before the therapy with CR500? Yes No Had the patients received another treatment for the same pathology after CR500™? Yes No |
| Timing and type of other interventions performed on the same knee with KOA treated with CR500™ in the NCT05661162 study. | At least after 24 Months from the end of NCT05661162 study visit | To collect, via a questionnaire, information on the timing and type of other interventions performed on the same KOA-affected knee treated with CR500™ in the NCT05661162 study, as follows: After the treatment with CR500 have you undergone any other therapies for the treatment of OA? Yes No If yes, which ones? Infiltrative Therapies (HA, PRP, or corticosteroids) Oral anti-inflammatory or pain-relief therapies Topical anti-inflammatory or pain-relief therapies Electromedical therapies Physiotherapy Do you roughly remember when (month/year)? |
| Long-term satisfaction with the CR500™ treatment. | At least after 24 Months from the end of NCT05661162 study visit | To collect, via a questionnaire, information on long-term patient satisfaction at least 24 months after the last application of CR500™. Would you repeat the treatment with CR500™? Yes No Uncertain |
Countries
Italy
Outcome results
None listed