Summary

for people ages 22 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

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.

Official 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

Details

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.

Keywords

Osteoarthritis CMC Joint Cartilage Replacement First CMC Joint Osteoarthritis Damaged Articular Surface LRTI Ligament Reconstruction Tendon Interposition Cartiva

Eligibility

You can join if…

Open to people ages 22 years and up

  • ≥ 22 years of age
  • Refractory to conservative non-operative standard of care treatment for first CMC OA lasting for at least 6 months that requires surgical intervention
  • Eaton classification stage II or III OA of the first CMC joint based on X-rays taken within 6 months of the Operative date and evidence of first CMC joint OA based on subjective review of associated clinical symptoms
  • Be willing and able to return for all study-related follow up procedures

You CAN'T join if...

  • Previous CMC implant, trapeziectomy, or LRTI to the affected joint to be treated
  • History of or current diagnosis of rheumatoid arthritis
  • OA of the scaphotrapeziotrapezoidal (STT) joint based on radiographic assessment in the hand to be treated
  • Any disease, including uncontrolled diabetes mellitus, which is clinically known to impact wound healing ability
  • Known or suspected allergic reaction to polyvinyl alcohol

Locations

  • University of California, San Diego accepting new patients
    San Diego California 92093 United States
  • Indiana Hand to Shoulder Center accepting new patients
    Indianapolis Indiana 46202 United States
  • Georgia Hand, Shoulder & Elbow not yet accepting patients
    Atlanta Georgia 30309 United States
  • University of Rochester accepting new patients
    Rochester New York 14642 United States
  • Hospital for Specialty Surgery accepting new patients
    New York New York 10021 United States
  • Tufts Medical Center accepting new patients
    Boston Massachusetts 02111 United States
  • Royal Derby Hospital accepting new patients
    Derby Derbyshire DE22 3NE United Kingdom
  • Dorset County Hospital accepting new patients
    Dorchester Dorset DT2 8DH United Kingdom
  • Queen Alexandra Hospital accepting new patients
    Portsmouth Hampshire PO6 3LY United Kingdom
  • South Tees Hospitals accepting new patients
    Middlesborough North Yorkshire TS4 3BW United Kingdom

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cartiva, Inc.
ID
NCT03247439
Study Type
Interventional
Last Updated
August 14, 2018