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

NCT ID: NCT07322770

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-17

Study Completion Date

2025-08-13

Brief Summary

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

Detailed Description

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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

Conditions

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Knee Osteoarthritis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

CR 500™ SINGLE-DOSE GEL

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Contrad Swiss SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istituto Clinico Mater Domini Casa di Cura Privata - Gruppo Humanitas

Castellanza, VARESE, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type RESULT
PMID: 37573322 (View on PubMed)

Other Identifiers

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CTD-SW CR500™-KOA 2020 - FU 25

Identifier Type: -

Identifier Source: org_study_id

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