NCT03060057

Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study"

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: United Orthopedic Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, single arm, multi-center, post-approval study designed to evaluate the short and long term clinical performance and safety in subjects receiving primary total knee arthroplasty (TKA) with the U2 Knee™ System. The study will enroll up to 200 subjects with scheduled pre-discharge, 6-week, 3- and 6-month and up to 5-year annual follow-up visits. Study outcomes will be analyzed and published when 1.) all enrolled and implanted subjects complete their 6-week follow up, 2.) all implanted subjects complete their 2-year follow up, 3.) at the conclusion of the study. The study will follow GCP guidelines and will be registered on clinicaltrials.gov.

Conditions

• Osteo Arthritis Knee

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-03-30
• Primary completion: 2024-03-30
• Completion: 2026-03-30
• First posted: 2017-02-23
• Last updated: 2023-06-05

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study