Treatment of thumb base osteoarthritis using a collagen-based medical device

Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Device) i the Treatment of RHIZOARTROSIS. "SMAGENART PILOT STUDY"

This study is testing a new collagen-based treatment to see if it can help people with painful thumb arthritis feel better and improve their hand function.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guna S.p.a (Industry-sponsored)
• Locations: 1 site (Milan, MI)
• Trial ID: NCT06781554 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the safety and performance of a type I collagen-based medical device for treating symptomatic thumb base osteoarthritis. The study involves a multicenter approach where participants receive a series of infiltrations of the collagen device to assess pain reduction and recovery of joint function. Participants will be monitored at four different time points over a 16-week period to evaluate the effectiveness of the treatment. The goal is to provide a new therapeutic option for individuals suffering from this condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with clinically diagnosed symptomatic thumb carpometacarpal osteoarthritis and a pain score of 5 or higher.

Not a fit: Patients with rheumatological conditions affecting the hands or those who have previously undergone hand surgery may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce pain and improve joint function for patients with thumb base osteoarthritis.

How similar studies have performed: There is growing evidence supporting the use of type I collagen for treating musculoskeletal conditions, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Male and female subjects aged between 18 and 75 years;
* Subjects with clinically diagnosed symptomatic thumb carpometacarpal osteoarthritis confirmed radiographically (stages I and II according to Eaton and Littler's classification);
* \[N.B. in case of bilateral symptomatic thumb carpometacarpal osteoarthritis, treatment can be unilateral only, at the level of the thumb carpometacarpal joint that is more affected at the time of enrollment\].
* Subjects with a VAS score ≥ 5; \[The request for pain intensity (VAS) from the patient should refer to moments of hand use, nota t rest!\]
* Subjects with joint pain for at least 1 month;
* Subjects not using thumb carpometacarpal orthotic devices;
* Subjects agreeing not to take analgesics within 24 hours before the scheduled visits;
* Subjects capable of understanding and signing the Informed Consent.

Exclusion Criteria

* Subjects with rheumatological conditions involving the hands;
* Subjects who have undergone hand surgery for the affected pathology;
* Subjects who have received HA injections in the thumb carpometacarpal joint in the last 3 months;
* Subjects who have taken NSAIDs in the last 7 days and/or corticosteroids in the last 30 days;
* Subjects undergoing physical therapy such as X-ray therapy, Tecar therapy, shock wave therapy, laser therapy, ultrasound therapy in the last 3 months;
* Subjects with neoplastic pathology;
* Subjects with systemic infections;
* Subjects with uncontrolled diabetes;
* Subjects with neurological conditions that may affect active participation in the study;
* Subjects with coagulopathies or taking anticoagulants (vitamin K antagonists, heparin);
* Subjects undergoing immunosuppressive treatment;
* Subjects using drugs or abusing alcohol;
* Subjects allergic to porcine collagen;
* Female subjects who are pregnant or breastfeeding;
* Subjects participating in other clinical studies during the same period;
* Subjects unable to cooperate or for whom poor compliance is expected;
* Any condition that, in the investigator's judgment, recommends the subject's exclusion.

Where this trial is running

Milan, MI

• ASST Grande Ospedale Metropolitano Niguarda Piazza dell'Ospedale Maggiore, — Milan, Mi, Italy (Recruiting)

Conditions Trapeziometacarpal Osteoarthritis; Rhizarthrosis; MEDICAL DEVICE; Infiltrate