Collagen-based Filler for Trapeziometacarpal Osteoarthritis

Completed

• Conditions: Trapeziometacarpal Osteoarthritis

• Registration Number: NCT06881186
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2023-01-01
• Study Completion: 2025-01-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DASH (Disabilities of the Arm, Shoulder, and Hand)	2 years	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
Pinch tests	2 years	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.
VAS (Visual Analogue Scale)	2 years	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
Jamar test	2 years	The Jamar test consists of evaluating grip strength using a hand dynamometer. MIN 0 MAX 100 Kgm.

Trial Locations

Locations (1)

Azienda Ospedaliera Universitaria Integrata; 🇮🇹 Verona, ITA, Italy