Retrospective Evaluation of the Long-term Effectiveness of the CR500™ SINGLE-DOSE GEL Medical Device in Patients With Knee Osteoarthritis (KOA)

Contrad Swiss

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Device: CR 500™ SINGLE-DOSE GEL

Study type: Observational

Funder types: Industry

Identifiers

NCT07322770

CTD-SW CR500™-KOA 2020 - FU 25

Details and patient eligibility

About

Evaluate the long-term efficacy of the CR500™ therapy in patients with knee OA.

Full 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

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

35 participants in 1 patient group

CR500 single-dose gel

Description:

This retrospective phone follow-up involves the 35 patients who completed the CTD-SW CR500™-KOA 2020 study. After obtaining consent, patients will be asked whether and when they required further therapeutic interventions for KOA after the trial. This information will describe the long-term course of each arm by identifying subsequent treatments needed beyond the interventions originally administered during the study.

Treatment:

Device: CR 500™ SINGLE-DOSE GEL