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NCT06881186
Collagen-based Filler for Trapeziometacarpal Osteoarthritis
trial testing Intra-articular injection in Trapeziometacarpal Osteoarthritis in 64 participants. Completed in 1 January 2025.
1 January 2023
Quick facts
| Lead sponsor | Azienda Ospedaliera Universitaria Integrata Verona |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 64 |
| Start date | 1 January 2021 |
| Primary completion | 1 January 2023 |
| Estimated completion | 1 January 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Intra-articular injection — full drug profile →
Conditions studied
- Trapeziometacarpal Osteoarthritis — all drugs for Trapeziometacarpal Osteoarthritis →
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):
-
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
Verify or expand the search:
- PubMed search for NCT06881186
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Trapeziometacarpal Osteoarthritis
Currently open trials in the same condition.
- NCT06401317 — Corticosteroid Against Saline Injections for Thumb Osteoarthritis (CASITOA) · Phase 2 · recruiting
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- NCT06781554 — Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Dev · NA · recruiting
Other Azienda Ospedaliera Universitaria Integrata Verona trials
Trials by the same sponsor.
- NCT07325877 — Supra-papillary Versus Trans-papillary Biliary Stenting in Malignant Peri-hilar Stenosis · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06881186 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Azienda Ospedaliera Universitaria Integrata Verona
- Last refreshed: 18 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06881186.
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