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
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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COMPLETED
35 participants
OBSERVATIONAL
2025-02-17
2025-08-13
Brief Summary
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Detailed Description
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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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Study Design
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OTHER
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
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
Eligibility Criteria
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Inclusion Criteria
* Participation in the CTD-SW CR500™-KOA 2020 clinical study.
* Willingness to participate in the survey.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Contrad Swiss SA
INDUSTRY
Responsible Party
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Locations
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Istituto Clinico Mater Domini Casa di Cura Privata - Gruppo Humanitas
Castellanza, VARESE, Italy
Countries
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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.
Other Identifiers
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CTD-SW CR500™-KOA 2020 - FU 25
Identifier Type: -
Identifier Source: org_study_id
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