Collagen-based Filler for Trapeziometacarpal Osteoarthritis

NCT ID: NCT06881186

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2025-01-01

Brief Summary

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.

Conditions

Trapeziometacarpal Osteoarthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Intra-articular injection

Intra-articular injection of a cell-free collagenic gel matrix into the trapeziometacarpal joint

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patients with rhizarthrosis diagnosed on X-rays performed in the last year;
• patients aged > 18 years;
• enrollment in the study through informed consent;

Exclusion Criteria

• patients who have undergone cortisone and/or hyaluronic acid infiltrations in the last 6 months;
• patients following trauma involving the ATM;
• patients with underlying rheumatological diseases;
• patients under 18 years of age
• ongoing pregnancy;
• patients affected by metabolic disorders (e.g. diabetes)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role: lead

Responsible Party

Massimo Corain

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Azienda Ospedaliera Universitaria Integrata

Verona, ITA, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 40590316 (View on PubMed)

Other Identifiers

3185CESC

Identifier Type: -

Identifier Source: org_study_id