Trapeziometacarpal Osteoarthritis
Conditions
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.
Interventions
PROCEDUREIntra-articular injection
Intra-articular injection of a cell-free collagenic gel matrix into the trapeziometacarpal joint
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Jamar test | 2 years | The Jamar test consists of evaluating grip strength using a hand dynamometer. MIN 0 MAX 100 Kgm. |
| 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 |
| 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 |
| 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. |
Countries
Italy
Outcome results
None listed