Cartiva® GRIP 2 Study, PTC-0290

• 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 as Compared to a Ligament Reconstruction Tendon Interposition (LRTI) Comparator (Cartiva® GRIP 2 Study)

• IRAS ID

  233671

• Contact name

  Robert Townsend

• Contact email

  rtownsend@cartiva.net

• Sponsor organisation

  Cartiva, Inc.

• Clinicaltrials.gov Identifier

  NCT03247439

• Clinicaltrials.gov Identifier

  NIHR CRN MUSC, NIHR CRN Portfolio

• Duration of Study in the UK

  6 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 as compared to Ligament Reconstruction Tendon Interposition (LRTI). This is a prospective study using multiple outcome measures to evaluate symptom resolution and functional improvements following device implantation. Approximately 74 subjects will be enrolled and treated in the study at approximately 12 study sites. The study will last for 5 years following each subject’s surgical procedure, until the last subject is seen at the 5 year follow up visit, or is withdrawn from the study.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  17/EM/0403

• Date of REC Opinion

  1 Dec 2017

• REC opinion

  Further Information Favourable Opinion