Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study"
NCT03060057 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2023-06-05
Summary
The purpose of this study is to evaluate both short and long term clinical performance and safety of the commercially available U2 Knee™ System.
Conditions
- Osteo Arthritis Knee
Interventions
- DEVICE
-
U2 Knee™ System
The United U2 Knee™ System consists of several components and for this clinical evaluation it includes the (1) Femoral Component, (2) Tibial Insert, 3) Tibial Baseplate, and the 4) Patella.
Sponsors & Collaborators
-
United Orthopedic Corporation
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-30
- Primary Completion
- 2024-03-30
- Completion
- 2026-03-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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