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

Retrospective Evaluation of the Long-term Effectiveness of the CR500™ SINGLE-DOSE GEL Medical Device in Patients With Knee Osteoarthritis (KOA) Enrolled in the Clinical Study CTD-SW CR500™-KOA 2020

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

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: CR 500™ SINGLE-DOSE GEL

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

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Italy
  • VARESE
    • Castellanza, VARESE, Italy, 21053
      • Istituto Clinico Mater Domini Casa di Cura Privata - Gruppo Humanitas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants in the CTD-SW CR500™-KOA 2020 clinical study

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

CR500 single-dose gel; 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.

Device: CR 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lequesne Knee Index (LKI) Score	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	At least after 24 Months from the end of NCT05661162 study visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for additional therapies before and after CR500™.	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	At least after 24 Months from the end of NCT05661162 study visit.
Timing and type of other interventions performed on the same knee with KOA treated with CR500™ in the NCT05661162 study.	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)?	At least after 24 Months from the end of NCT05661162 study visit
Long-term satisfaction with the CR500™ treatment.	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	At least after 24 Months from the end of NCT05661162 study visit
Recurrence of pain in the CR500™-treated knee and prosthesis status.	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?	At least after 24 Months from the end of NCT05661162 study visit

Collaborators and Investigators

• Sponsor: Contrad Swiss SA

Publications and helpful links

General Publications

• Colombini A, Doro G, Ragni E, Forte L, de Girolamo L, Zerbinati F. Treatment with CR500(R) improves algofunctional scores in patients with knee osteoarthritis: a post-market confirmatory interventional, single arm clinical investigation. BMC Musculoskelet Disord. 2023 Aug 12;24(1):647. doi: 10.1186/s12891-023-06754-7.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2025
• Primary Completion (Actual): August 13, 2025
• Study Completion (Actual): August 13, 2025

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Knee Osteoarthritis; Peptides; Hyaluronic Acid; Patient Satisfaction; Topical Treatment; Algofunctional Scores
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Behavior; Treatment Adherence and Compliance; Health Behavior; Osteoarthritis, Knee; Patient Satisfaction
• Other Study ID Numbers: CTD-SW CR500™-KOA 2020 - FU 25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No