Trapeziometacarpal OsteoarthritisNCT06881186
Collagen-based Filler for Trapeziometacarpal Osteoarthritis
An observational study of Trapeziometacarpal Osteoarthritis, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
Introduction. Trapeziometacarpal osteoarthritis (TMC OA) is a degenerative condition characterized by pain, stiffness, and reduced hand function, significantly impairing daily activities. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Trapeziometacarpal Osteoarthritis
- What is being tested?
- Intra-articular injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients with rhizarthrosis diagnosed on X-rays performed in the last year;
- patients aged > 18 years;
- enrollment in the study through informed consent;
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Intra-articular injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular injectionProcedure or surgery
Intra-articular injection of a cell-free collagenic gel matrix into the trapeziometacarpal joint
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2 years
Jamar test
The Jamar test consists of evaluating grip strength using a hand dynamometer. MIN 0 MAX 100 Kgm.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Jan 2021
- Primary completion1 Jan 2023
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trapeziometacarpal OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Corain, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881186
- Sponsor's protocol ID
- 3185CESC
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40590316
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Collagen-based Filler for Trapeziometacarpal Osteoarthritis. Long-term Follow Up and Future Applications
- ClinicalTrials.gov ID
- NCT06881186
- Acronym / sponsor ID
- 3185CESC
- Conditions
- Trapeziometacarpal Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- patients with rhizarthrosis diagnosed on X-rays performed in the last year;
- patients aged > 18 years;
- enrollment in the study through informed consent;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-articular injectionIntra-articular injection of a cell-free collagenic gel matrix into the trapeziometacarpal joint | Procedure or surgery | – |
Primary outcome
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
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
Jamar test
Time frame: 2 years
The Jamar test consists of evaluating grip strength using a hand dynamometer. MIN 0 MAX 100 Kgm.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Derived from this study: PubMed 40590316Corain 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.
- Individual participant dataSharing planned: No
Related trials for Trapeziometacarpal Osteoarthritis
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Not yet recruitingObservational study
Thumb Muscle Activation During Different Activities of Daily Living in Thumb Base Osteoarthritis and Healthy Controls
Trapeziometacarpal Osteoarthritis
RecruitingPhase 2
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of Trapeziometacarpal Osteoarthritis
Trapeziometacarpal Osteoarthritis
RecruitingObservational study
ICF-Based Biopsychosocial Assessment With AI-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model
Trapeziometacarpal Osteoarthritis, Thumb Osteoarthritis
RecruitingPhase 2
Corticosteroid Against Saline Injections for Thumb Osteoarthritis (CASITOA)
Trapeziometacarpal Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trapeziometacarpal Osteoarthritis, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DASH (Disabilities of the Arm, Shoulder, and Hand) (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06881186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.