The purpose of this study is to evaluate both short and long term clinical performance and safety of the commercially available U2 Knee System.
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.
|Treatment||U2 Knee™ System|
|Clinical Study Identifier||NCT03060057|
|Sponsor||United Orthopedic Corporation|
|Last Modified on||25 November 2020|
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