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

The purpose of this research project is to understand through a multicenter Clinical Investigation, the performance and safety of an intra-articular and peri-articular treatment with a medical device (MD-Small Joints Collagen Medical Device) based on type I collagen in terms of pain reduction and joint function recovery in subjects with symptomatic thumb base osteoarthritis.

STUDY DESIGN:

This multicenter pilot Clinical Investigation will be based on a One-sample design. Variables will be assessed at 4 different time points: baseline (T0), after 3 weeks (T3w), after 6 weeks (T6 weeks), and after 16 weeks (T16w/FU), which is 12 weeks after the end of the infiltrative treatment.

Subjects will be treated with one infiltration of 2ml volume at the time of enrollment (T0) and weekly for a total of 5 infiltrations.

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.