Clinical trial NCT06881186: Collagen-based Filler for Trapeziometacarpal Osteoarthritis
Official title: The Use of Collagen-based Filler for Trapeziometacarpal Osteoarthritis. Long-term Follow Up and Future Applications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trapeziometacarpal Osteoarthritis
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: DASH (Disabilities of the Arm, Shoulder, and Hand)
timeFrame: 2 years
measure: VAS (Visual Analogue Scale)
timeFrame: 2 years
measure: Jamar test
timeFrame: 2 years
measure: Pinch tests
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata
state: ITA
Study officials:
References: