This study is to evaluate the performance of the Articulinx ICMC (InterCarpoMetacarpalCushion)in the carpometacarpal joint (CMC joint) and to describe the clinical results in patients who have been treated with this device. Expected results include the relief of symptoms and improvement of function in patients with symptomatic osteoarthritis (OA) of the CMC-1 joint. Evaluation of device performance will be achieved through measurements of pain, pain medication use, and joint function in up to 20 subjects. Each subject will be compared to their pre-surgery status for each endpoint.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
The primary endpoint of this study is the Incidence of unanticipated device and procedure related adverse events.
Timeframe: Intra-operatively and through one year follow-up.