Post Approval Study to Evaluate the Effectiveness and Safety of Cartiva Implant in the Treatment of OA of the Great Toe — MOTION  

Osteoarthritis of First Metatarsalphalangeal Joint Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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 ;

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of First Metatarsalphalangeal Joint

• NCT number: NCT02978573
• Study type: Interventional
• Source: Cartiva, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: October 2016
• Completion date: April 27, 2018