Clinical Evaluation of the Articulinx InterCarpoMetacarpal Cushion (ICMC) for Osteoarthritis of the First Metacarpal Joint

Inclusion Criteria: * Patient is diagnosed by the investigator to be medically acceptable for a surgical procedure * Patient is aged 40 to 75 inclusive * Patient has symptomatic osteoarthritis of the carpometacarpal (CMC-1) joint as demonstrated by a minimum DASH score of 40 at baseline * Patient has pain in the target CMC joint as demonstrated by an average VAS pain score greater than or equal to 40 at baseline on a 100mm VAS * Patient has radiographic evidence of Stage II OA with no free-floating bodies in the CMC-1 joint * Patient has subluxation of less than one-third of the target CMC joint * Patient agrees to return to the clinic for follow-up visits at the required times per protocol and follow the requirements of this protocol * Patient is able and willing to provide voluntary consent to participate Exclusion Criteria: * Patient has non-symptomatic osteoarthritis of the first CMC joint * Patient has small bone or calcific fragments (spurs, osteophytes) in the target CMC joint greater than two millimeters (\>2mm) in diameter * Patient has free floating bodies of any size within the target CMC joint * Patient has radiographic/imaging evidence of significant osteoarthritic changes within the first metacarpal, or scaphotrapezotrapezoidal (STT) joint of the target wrist consistent with Stage III/IV OA, according to Eaton-Glickel * Patient has concomitant musculoskeletal pathology of the target hand, such as carpal tunnel syndrome, palmar tenosynovitis, schaphoulnate lig…