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

NCT02978573 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2019-03-22

No results posted yet for this study

Summary

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

Conditions

  • Osteoarthritis of First Metatarsalphalangeal Joint

Interventions

DEVICE

Cartiva

Cartiva Synthetic Cartilage Implant

Sponsors & Collaborators

  • Cartiva, Inc.

    lead INDUSTRY

Principal Investigators

  • Judith Baumhauer, MD · University of Rochester

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-04-27
Completion
2018-04-27

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02978573 on ClinicalTrials.gov