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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.