Collagen-based Filler for Trapeziometacarpal Osteoarthritis

NCT06881186 | Completed

• 1 other identifier: 3185CESC
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

Intra-articular injection PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata

Verona, ITA, 37121, Italy

Location

Related Publications (1)

• 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.

  PMID: 40590316 DERIVED

MeSH Terms

Interventions

Injections, Intra-Articular

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: March 18, 2025
• Study Start: January 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)