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

 1. Subject is between 18 and 75 years of age

 2. Subject is indicated for a unilateral total knee arthroplasty (TKA) based on the
 approved labeling of the device

 3. Subject has no history of previous prosthetic replacement device or orthopedic
 surgeries on the operative knee

 4. Subject is willing and able to provide informed consent to participate in the study;

 5. Subject is willing and able to understand the purpose of the study, his/her role, and
 is available to return to the clinic/hospital for all required follow-up visits;

 Exclusion Criteria:

 -  Subjects will be excluded if, in the opinion of the Investigator, the subject does not
 qualify based on approved labeling requirements or Subject Inclusion criteria.