Clinical Trial: Post Approval Study to Evaluate the Effectiveness and Safety of Cartiva Implant in the Treatment of OA of the Great Toe

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Post Approval Study to Evaluate the Safety and Effectiveness of Cartiva Implant in the Treatment of First Metatarsophalangeal Joint Osteoarthritis as Compared to a Control

Brief Summary: Evaluate and confirm the long-term safety and effectiveness of the Cartiva SCI implant established by the pivotal trial.

Detailed Summary: As part of the Conditions of Approval of Cartiva SCI for the treatment of first MTP osteoarthritis, the Food and Drug Administration (FDA) requires additional long term data to evaluate the long term safety and effectiveness of Cartiva including the durability and survivorship of the implant. This Post-Approval Study (PAS) addendum is intended to supplement the initial 24 months follow up period and provide additional long term safety and effectiveness data on Cartiva
Sponsor: Cartiva, Inc.

Current Primary Outcome: Long Term Safety of the Cartiva Implant by demonstrating durability over the long term and no unanticipated safety concerns that arise [ Time Frame: 5 year ]

  1. Durability of the implant over the longer term. This will be addressed using survival analysis starting at Month 24 to determine the rate of implant removals among devices that survived to Month 24. A complementary survival analysis starting at index surgery to end of study will also be performed.
  2. There are no unanticipated safety concerns that arise after Month 24 up to 5 years. This will be addressed by a) determining the incidence of serious device-related adverse events per year and overall from Month 24 to Year 5; and b) summarizing device-related radiographic complications1 over time from Month 24 to Year 5. Note that this analysis will address both device and procedure related complications and serious device-related adverse events whether observed previously in the 24 month follow up portion of the study or encountered for this first time during the extended follow-up period.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain Scale (VAS) [ Time Frame: 5 year ]
    Visual Analog Scale (VAS) Pain
  • Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) [ Time Frame: 5 year ]
    Foot and Ankle Ability Measure (FAAM) Activities of Daily Living scores
  • Foot and Ankle Ability Measure (FAAM) Sports [ Time Frame: 5 year ]
    Foot and Ankle Ability Measure (FAAM) Sports scores


Original Secondary Outcome: Same as current

Information By: Cartiva, Inc.

Dates:
Date Received: November 11, 2016
Date Started: October 2016
Date Completion: February 2018
Last Updated: November 30, 2016
Last Verified: November 2016