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

Launched by GUNA S.P.A · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new injectable treatment made from type I collagen, called the MD-Small Joints Collagen Medical Device, for people suffering from thumb base osteoarthritis, also known as rhizarthrosis. The goal is to see if this treatment can help reduce pain and improve joint function in patients with this condition. Participants in the trial will be asked to have a specific level of pain and a confirmed diagnosis of thumb osteoarthritis. They should be between 18 and 75 years old and not have certain other medical conditions or treatments that could interfere with the study.

If you choose to participate, you will receive injections of the collagen device in the affected area and will be monitored over several weeks to assess your pain levels and joint function. Researchers will use a pain scale and other tests to measure how well the treatment works. The study aims to determine if participants experience at least a 30% reduction in their pain after six weeks, along with improvements in their ability to use their hands. It’s important to note that you won’t be able to take certain pain medications or undergo other specific treatments during the study period.

Gender

ALL

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.