Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study"
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteo Arthritis Knee
- Sponsor
- United Orthopedic Corporation
- Enrollment
- 200
- Locations
- 4
- Primary Endpoint
- Implant Survivorship
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Implant Survivorship
Time Frame: 2 Years
Device Survivorship defined as no revision of removal of any parts of the system
Secondary Outcomes
- Change in EQ-5D Over Time(Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years)
- Change in EQ-5D VAS Over Time(Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years)
- Radiographic Analysis(24 months, 5 years)
- Subject Satisfaction Survey(6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years.)
- Change in KOOS, JR. Over Time(Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years)
- Change in Knee Society Score (KSS) Over Time(Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years)
- Operative characteristics(Operative)