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

NCT07322770 | Completed DMC

• 1 other identifier: CTD-SW CR500™-KOA 2020 - FU 25
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Osteoarthritis

Keywords

Hyaluronic Acid; Algofunctional Scores; Peptides; Knee Osteoarthritis; Topical Treatment; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Need for additional therapies before and after CR500™.

  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.

  At least after 24 Months from the end of NCT05661162 study visit

• Long-term satisfaction with the CR500™ treatment.

  At least after 24 Months from the end of NCT05661162 study visit

• Recurrence of pain in the CR500™-treated knee and prosthesis status.

  At least after 24 Months from the end of NCT05661162 study visit

Study Arms (1)

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

Interventions

CR 500™ SINGLE-DOSE GEL DEVICE

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

CR500 single-dose gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Oral informed consent from the patient.
• Participation in the CTD-SW CR500™-KOA 2020 clinical study.
• Willingness to participate in the survey.

You may not qualify if:

• Patients who were excluded following major protocol violations during the CTD-SW CR500™-KOA 2020 clinical study

Sponsors & Collaborators

• Contrad Swiss SA: lead

Study Sites (1)

Istituto Clinico Mater Domini Casa di Cura Privata - Gruppo Humanitas

Castellanza, VARESE, 21053, Italy

Location

Related Publications (1)

• 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.

  PMID: 37573322 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Patient Satisfaction

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: January 7, 2026
• Study Start: February 17, 2025
• Primary Completion: August 13, 2025
• Study Completion: August 13, 2025
• Last Updated: January 7, 2026

Record last verified: 2025-12

Locations

IT (1)