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G.R.I.P 2


Title A Prospective Study to Evaluate the Safety and Effectiveness of the Cartiva® Synthetic Cartilage Implant for CMC in the Treatment of First Carpometacarpal Joint Osteoarthritis as Compared to a Ligament Reconstruction Tendon Interposition (LRTI) Comparator
Therapeutic Area Osteoarthritis
Principal Investigator Charles Cassidy MD
Min Age 22 Years
Gender All
Contact Melissa Stilian
(617) 636-5159
More Information https://clinicaltrials.gov/ct2/show/NCT03247439

Overview

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.

Study Details

Inclusion Criteria

  • 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;

Exclusion Criteria

  • 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;

Study Requirements

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.