Collagen-based Filler for Trapeziometacarpal Osteoarthritis

Integrated University Hospital Trust of Verona

Status: Completed

Conditions: Trapeziometacarpal Osteoarthritis

Treatments: Procedure: Intra-articular injection

Study type: Observational

Funder types: Other

Identifiers

NCT06881186

3185CESC

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)