The Use of Collagen-based Filler for Trapeziometacarpal Osteoarthritis. Long-term Follow Up and Future Applications
Sponsor study identifier
observational
64
1 country
1
Study Start
January 1, 2021
Actual (reported)Primary Completion
January 1, 2023
Actual (reported)Study Completion
January 1, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2021
Actual (reported)January 1, 2023
Actual (reported)January 1, 2025
Actual (reported)February 11, 2025
Actual (reported)March 18, 2025
Actual (reported)DASH (Disabilities of the Arm, Shoulder, and Hand)
The DASH is a self-administered questionnaire of over 30 questions designed to measure function and symptoms in patients with any musculoskeletal disorder of the upper limb. MAX 100, MIN 0
2 years
VAS (Visual Analogue Scale)
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. MAX 10, MIN 0
2 years
Jamar test
The Jamar test consists of evaluating grip strength using a hand dynamometer. MIN 0 MAX 100 Kgm.
2 years
Pinch tests
The Pinch tests consist of three tests assessed with a specific dynamometer, evaluating the two-finger grip, three-finger grip, and key grip. MIN 0, MAX 15 Kgm.
2 years
Intra-articular injection of a cell-free collagenic gel matrix into the trapeziometacarpal joint
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All participants were adults with unilateral or bilateral RA, diagnosed via radiographs obtained within the past year. Participation in the study required signing an informed consent form.
Azienda Ospedaliera Universitaria Integrata
Verona, ITA, 37121, Italy
Corain M, Faccioli N, Lavagnolo U. The Use of Collagen-Based Filler for Trapeziometacarpal Osteoarthritis: Long-Term Follow-Up and Future Applications. Cartilage. 2025 Jul 1:19476035251354926. doi: 10.1177/19476035251354926. Online ahead of print.
64 participants (actual enrollment reported by the registry).
First Submitted
February 11, 2025
First Posted
March 18, 2025
Study Start
January 1, 2021
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
January 1, 2023
Actual (reported)Study Completion
January 1, 2025
Actual (reported)Last Updated
March 18, 2025
Record last verified: 2025-02
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Source: ClinicalTrials.gov.
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