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NCT Number: NCT06881186

Collagen-based Filler for Trapeziometacarpal Osteoarthritis

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.

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Key information

Conditions

Trapeziometacarpal Osteoarthritis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Universitaria Integrata

Verona, ITA, 37121, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

intra-articular injection

Procedure

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

Primary outcomes

  1. DASH (Disabilities of the Arm, Shoulder, and Hand)

    Time frame: 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

  2. VAS (Visual Analogue Scale)

    Time frame: 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

  3. Jamar test

    Time frame: 2 years

    The Jamar test consists of evaluating grip strength using a hand dynamometer. MIN 0 MAX 100 Kgm.

  4. Pinch tests

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Mar 18, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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