Cartiva® G.R.I.P. Study

Inclusion Criteria:

• ≥18 years of age;
• Refractory to conservative non-operative standard of care for first CMC OA and requires surgical intervention;
• Eaton classification stage II or III OA of the first CMC joint based on X-ray(s) taken within 6 months of the Operative date and/or evidence of first CMC joint OA based on subjective review of associated clinical symptoms;
• Preoperative VAS Pain score of ≥40;
• Presence of good bone stock, without need for bone graft;
• Capable of completing self-administered questionnaires;
• Be willing and able to return for all study-related follow up procedures;
• Have not participated in any other investigational or invasive clinical trial within the last 30 days, and will not participate in any other investigational or invasive clinical trial during this study; and
• Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the REB/Ethics Committee.

Exclusion Criteria:

• <18 years of age;

• Could benefit from conservative non-operative standard of care for first CMC OA and does not require surgical intervention;
• Eaton classification stage I or IV OA of the first CMC joint based on X-ray(s) taken within 6 months of the Operative date;
• Preoperative VAS Pain score <40;
• Active bacterial infection of the hand;
• Previous CMC implant and/or surgery (e.g. trapeziectomy, LRTI) to the affected joint to be treated that would prevent implantation and fixation of Cartiva® SCI for CMC;
• Inflammatory arthropathy and/or diagnosis of gout;
• History of or current diagnosis of rheumatoid arthritis;
• Any significant bone loss, avascular necrosis, and/or subchondral bone cysts of the first carpometacarpal joint to be treated;
• Advanced disease involving MCP hyperextension greater than 30 degrees;
• Physical conditions that would tend to eliminate adequate implant support (g., insufficient quality or quantity of bone resulting from cancer, congenital dislocation, or osteoporosis), systemic and metabolic disorders leading to progressive deterioration of bone (e.g., cortisone therapies or immunosuppressive therapies), and/or tumors and/or cysts >1cm of the supporting bone structures;
• Patient has osteoarthritis of the scaphotrapeziotrapezoidal (STT) joint in the hand to be treated;
• Any disease, including uncontrolled diabetes mellitus, which is clinically known to impact wound healing ability;
• Patient is on chronic anticoagulation due to a bleeding disorder or has taken anticoagulants within 5 days prior to surgery;
• Patient was diagnosed with cancer in the last two (2) years and received treatment with chemotherapy or received radiation to the upper extremity to be treated with Cartiva®;
• Any medical condition that makes the subject unsuitable for inclusion in the study, including, but not limited to patients with a diagnosis of concomitant injury that may interfere with healing; patients with clinically significant renal, hepatic, cardiac, endocrine, hematologic, autoimmune or any systemic disease or systemic infection which may make interpretation of the results difficult; patients who have undergone systemic administration within 30 days prior to implantation of any type of corticosteroid, antineoplastic, immunostimulating or immunosuppressive agents;
• Co-morbidity that reduces life expectancy to less than 12 months;
• If female, be pregnant, planning to become pregnant during the course of the study, breast-feeding, or if childbearing age, is not using contraception;
• Current substance abuser (e.g. recreational drugs, narcotics, or alcohol);
• Is a prisoner or ward of the state;
• Is unable to meet the treatment and follow up protocol requirements; or
• Is being compensated under workers’ compensation or are currently involved in litigation.