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 ligament instability/degeneration, ulnocarpal impaction syndrome, or trigger finger * Patient has concomitant rheumatic disease (e.g., inflammatory rheumatoid arthritis, cutaneous psoriasis, polyarticular chondrocalcinosis, gout, fibromyalgia) or exhibits signs of metabolic disorders affecting the bone or joint (e.g., osteoporosis,osteomalacia, hyper- or hypo-parathyroidism,Paget's disease) * Patient has an active infection, sepsis or osteomyelitis * Patient has skin disease or eruption at the CMC target site * Patient had previous surgery on the target CMC joint or; prior surgery within the previous 12 months on the wrist of the target hand that could alter the biomechanics of the wrist or CMC-1 joint or; prior surgery on the wrist of the target hand more than 12 months previously fro which there are existing sequelae * Patient had significant injury to the target CMC joint within the 6 months prior to study enrollment or a significant permanent injury at any time prior to study enrollment * Patient has a significant comorbid medical condition that could exacerbate pain symptoms or adversely affect physical functioning or healing of the thumb CMC joint (e.g. de Quervains disease, Ehler-Danlos Syndrome, Complex Regional Pain Syndrome) * Patient has had corticosteroid injections in the target CMC joint within 6 months prior to study enrollment * Patient takes concomitant immunosuppressive therapy (e.g., oral/injectable glucocorticoids, alkylating agents, antimetabolites, antibodies, drugs acting on immunophilins \[Ciclosporin, Sirolimus\], interferons, opioids) that could adversely affect healing * Patient has uncontrolled diabetes mellitus * Patient takes anticoagulation and or antiplatelet therapy that cannot be stopped prior to surgery * Patient is planning a pregnancy, or patient is pregnant and/or lactating * Patient is participating in any other clinical investigation that could impact the outcome of this study * Patient has a known history of drug or alcohol abuse in the previous 12 months * Patient has a history of, or is currently engaged in, litigation for musculoskeletal injuries or disorders or medical malpractice * Patient has other life circumstances that the Investigator feels would interfere with study participation such as planned relocation, difficulty complying with schedule of study follow-up visits, is generally uncooperative