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Tests treatment safety and results for Trapeziometacarpal Osteoarthritis
Official title 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
ClinicalTrials.gov ID: NCT06781554
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male and female people aged between 18 and 75 years;
- people with clinically diagnosed symptomatic thumb carpometacarpal osteoarthritis confirmed radiographically (stages I and II according to Eaton and...
- [N.B. in case of bilateral symptomatic thumb carpometacarpal osteoarthritis, treatment can be unilateral only, at the level of the thumb...
- people with a VAS score ≥ 5; [The request for pain intensity (VAS) from the patient should refer to moments of hand use, nota t rest!]
- people with joint pain for at least 1 month;
You likely can't join if
- people with rheumatological conditions involving the hands;
- people who have undergone hand surgery for the affected pathology;
- people who have received HA injections in the thumb carpometacarpal joint in the last 3 months;
- people who have taken NSAIDs in the last 7 days and/or corticosteroids in the last 30 days;
- people undergoing physical therapy such as X-ray therapy, Tecar therapy, shock wave therapy, laser therapy, ultrasound therapy in the last 3 months;
- people with neoplastic pathology;
See the full eligibility criteria
- Male and female people aged between 18 and 75 years;
- people 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].
- people with a VAS score ≥ 5; [The request for pain intensity (VAS) from the patient should refer to moments of hand use, nota t rest!]
- people with joint pain for at least 1 month;
- people not using thumb carpometacarpal orthotic devices;
- people agreeing not to take analgesics within 24 hours before the scheduled visits;
- people capable of understanding and signing the Informed Consent.
- people with rheumatological conditions involving the hands;
- people who have undergone hand surgery for the affected pathology;
- people who have received HA injections in the thumb carpometacarpal joint in the last 3 months;
- people who have taken NSAIDs in the last 7 days and/or corticosteroids in the last 30 days;
- people undergoing physical therapy such as X-ray therapy, Tecar therapy, shock wave therapy, laser therapy, ultrasound therapy in the last 3 months;
- people with neoplastic pathology;
- people with systemic infections;
- people with uncontrolled diabetes;
- people with neurological conditions that may affect active participation in the study;
- people with coagulopathies or taking anticoagulants (vitamin K antagonists, heparin);
- people undergoing immunosuppressive treatment;
- people using drugs or abusing alcohol;
- people allergic to porcine collagen;
- Female people who are pregnant or breastfeeding;
- people participating in other clinical studies during the same period;
- people unable to cooperate or for whom poor compliance is expected;
- Any condition that, in the investigator's judgment, recommends the subject's exclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Milan, MI, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, MI, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.