💬In plain words
What the trial is, and whether it could suit you
Collagen is a structural protein biopolymer consisting of three polypeptide chains wrapped around to form a right-handed triple helix. Its structure, characterized by the presence of glycine every third residue, a high content of proline and hydroxyproline, is stabilized by interchain hydrogen bonds and electrostatic interactions, giving the molecules high mechanical resistance, incompressibility, and simultaneously, extensibility, plasticity, and flexibility, making tissues abundant in collagen particularly resistant to stress and load. In humans, collagen is present especially in the skin, subcutaneous tissue, cartilage, bone, joint capsule, tendons, muscles, and ligaments.
Growing evidence supports the infiltrative use of type I collagen in the treatment of musculoskeletal pathologies. In particular, the intra-articular and peri-articular use of collagen has been proposed in the trea
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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