Cartiva® GRIP Study, PTC-0116
Research type
Research Study
Full 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 (Cartiva® GRIP Study)
IRAS ID
183219
Contact name
Katie Strother
Contact email
Sponsor organisation
Cartiva, Inc.
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NIHR CRN MUSC 4231, NIHR CRN Portfolio
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The Cartiva® Synthetic Cartilage Implant (SCI) for carpometacarpal (CMC) is intended to treat diseased or damaged articular surfaces of the first CMC (or thumb) joint associated with joint pain or decreased range of motion. The implant, a cylindrical device made from an elastic biomaterial, may be used as a replacement for damaged cartilage and bone without requiring the destruction or removal of a patient’s healthy tissue. It is intended for use during a single surgical procedure. The device, which is classified as a hydrated polymer, consists of water in similar proportion to human tissue. This organic polymer-based biomaterial is capable of withstanding repetitive loading typical of normal hand use, and its mechanical properties are similar to articular cartilage.
The objectives of this clinical study are to evaluate the safety and effectiveness of Cartiva® SCI for CMC in terms of pain relief and functional improvement in the treatment of first carpometacarpal (CMC) joint osteoarthritis and to evaluate Cartiva® SCI for CMC device performance in order to establish the parameters for a pivotal trial. This is a prospective traditional feasibility multi-centre study using primary and secondary outcome measures to evaluate symptom resolution and functional improvements following device implantation. Approximately 50 subjects will be enrolled and treated in the study at approximately 6 study sites. The study will last for 1 year following each subject’s surgical procedure, until the last subject is seen at the 1 year follow up visit, or is withdrawn from the study.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
15/YH/0379
Date of REC Opinion
23 Oct 2015
REC opinion
Further Information Favourable Opinion