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
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
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