NCT03247439

Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis Compared to LRTI (GRIP 2)

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Cartiva, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the first CMC joint in the hand compared to LRTI.

Detailed description

This is a prospective, multicenter study with one treatment arm. Comparisons will be made to a performance target defined by subtracting a non-inferiority margin of 0.05 from an expected standard of care success rate of 0.55. The active treatment arm will receive a Cartiva® SCI for CMC. A total of 74 subjects will be enrolled into the pivotal study. Follow up visits will occur at the following time points after the surgical procedure: 2 week, 6 week, 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Cartiva	Synthetic Cartilage Implant

Timeline

• Start date: 2017-12-22
• Primary completion: 2020-10-30
• Completion: 2024-03-01
• First posted: 2017-08-11
• Last updated: 2020-12-03

Locations

9 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated device study