The purpose of this research study is to determine the safety and effectiveness of a new treatment for osteoarthritis of the first carpometacarpal joint (the base of your thumb). The new treatment uses the Cartiva Synthetic Cartilage Implant (Cartiva implant) to replace the damaged cartilage in your thumb joint. The most common treatment is called ligament reconstruction tendon interposition (LRTI), where the bone is surgically removed and the joint is stabilized using surrounding tendons.
You will need to have the following exam, tests, and procedures to find out if you can be in the study. The exam, tests, and procedures are part of your regular thumb arthritis care and may be done even if you do not join the study. If you have had some of these done recently, they may not need to be repeated. This will be up to your study doctor.
After surgery you will need to come back for follow up visits. These visits will happen at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and each year up to 5 years after your hand surgery. The procedures performed during these visits are part of regular thumb arthritis care.
- Refractory to conservative non-operative standard of care treatment for first CMC OA lasting for at least 6 months that requires surgical intervention;
- Preoperative VAS Pain score of ≥40 in the treated hand;
- Preoperative QuickDASH score of ≥20;
- Active bacterial infection of the hand;
- Previous CMC implant, trapeziectomy, or LRTI to the affected joint to be treated;
- Inflammatory arthropathy and/or diagnosis of gout;
Standard screening visit and operation will follow Standard of Care of this type of procedure
Follow up visits will occur at the following time points after the surgical procedure: 2 weeks, 6 weeks, 3 months, 6 months, and 1 year, 2 year, 3 year, 4 year and 5 year. With X-Rays performed every visit except at 6 weeks and 6 months.