Collagen-based Filler for Trapeziometacarpal Osteoarthritis

The Use of Collagen-based Filler for Trapeziometacarpal Osteoarthritis. Long-term Follow Up and Future Applications

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.

Study Overview

• Status: Completed
• Conditions: Trapeziometacarpal Osteoarthritis
• Intervention / Treatment: Procedure: Intra-articular injection

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• Italy
  • ITA
    • Verona, ITA, Italy, 37121
      • Azienda Ospedaliera Universitaria Integrata

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: 3185CESC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No