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NCT06881186

Collagen-based Filler for Trapeziometacarpal Osteoarthritis

Completed Last updated 18 March 2025
What this trial tests

trial testing Intra-articular injection in Trapeziometacarpal Osteoarthritis in 64 participants. Completed in 1 January 2025.

Timeline
1 January 2021
Primary endpoint
1 January 2023
1 January 2025

Quick facts

Lead sponsorAzienda Ospedaliera Universitaria Integrata Verona
StatusCompleted
Study typeOBSERVATIONAL
Enrollment64
Start date1 January 2021
Primary completion1 January 2023
Estimated completion1 January 2025
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona — full company profile →

Who can join

Adults 18 to 99, any sex, with Trapeziometacarpal Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction. Trapeziometacarpal osteoarthritis (TMC OA) is a degenerative condition characterized by pain, stiffness, and reduced hand function, significantly impairing daily activities. Non-surgical management strategies include activity modifications, nonsteroidal anti-inflammatory drugs (NSAIDs), splinting, and corticosteroid injections. When conservative treatments fail, surgical options are considered. The Eaton-Littler classification stratifies TMC OA into four stages based on radiographic joint degeneration. ChondroFiller Liquid®, a cell-free collagen scaffold composed of native type I collagen and chondrostimulating factors, facilitates cartilage regeneration by creating a protective environment for chondrocyte proliferation. It is indicated for treating cartilage lesions up to 3 cm². A prior study demonstrated its efficacy in alleviating pain, improving grip strength (Jamar test and pinch test), and enhancing Patient-Reported Outcome Measures (PROMs) using the Disabilities of the Arm, Shoulder, and Hand (DASH) score. Aims. This study aims to extend the follow-up to 24 months to evaluate the long-term sustainability of clinical improvements following ChondroFiller Liquid® infiltration. Materials and Methods. A total of 40 patients from the initial study were enrolled and categorized into two severity groups based on the Eaton-Littler classification. Clinical evaluations were conducted at 18 months post-infiltration (T1) using the Numeric Rating Scale (NRS) and DASH score. A subsequent assessment at 24 months (T2) included the Jamar test, pinch test, NRS, and DASH score. An additional cohort of 51 patients underwent infiltration with a mean follow-up of 14 months, including 9 patients previously treated in the preliminary study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The Use of Collagen-Based Filler for Trapeziometacarpal Osteoarthritis: Long-Term Follow-Up and Future Applications.
    Corain M, Faccioli N, Lavagnolo U. · · 2025 · PMID 40590316 · DOI 10.1177/19476035251354926

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Other Azienda Ospedaliera Universitaria Integrata Verona trials

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Data sources for this page

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