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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteo Arthritis Knee

Intervention / Treatment
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* Device: U2 Knee™ System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is between 18 and 75 years of age Subject is indicated for a unilateral total knee arthroplasty (TKA) based on the approved labeling of the device Subject has no history of previous prosthetic replacement device or orthopedic surgeries on the operative knee Subject is willing and able to provide informed consent to participate in the study; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survivorship | Device Survivorship defined as no revision of removal of any parts of the system | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knee Society Score (KSS) Over Time | This endpoint is defined as differences in both pain and functional parameters measured at current and pre-discharge visits | Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years | 
| Change in EQ-5D Over Time | This endpoint is defined as differences in scores related to the EQ-5D questionnaire and the EQ-VAS measured at current and pre-discharge visits. | Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years | 
| Change in EQ-5D VAS Over Time | This endpoint is defined as differences in scores related to the EQ-5D VAS questionnaire and the EQ-VAS measured at current and pre-discharge visits. | Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years | 
| Change in KOOS, JR. Over Time | This endpoint is defined as difference in the KOOS, Jr interval score measured at current and pre-discharge visits. | Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years | 
| Radiographic Analysis | This endpoint is defined as incidence rate of new radiographic failures at each follow-up visit. | 24 months, 5 years | 
| Operative characteristics | Descriptive statistics in operative characteristics will be reported as secondary endpoints to evaluate operative success | Operative | 
| Subject Satisfaction Survey | Subject satisfaction with their knee surgery. | 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years. |