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

Osteo Arthritis Knee Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03060057
Study type Observational
Source United Orthopedic Corporation
Contact
Status Active, not recruiting
Phase
Start date March 30, 2017
Completion date March 30, 2026
View Details
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