Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study"
- Conditions
- Osteo Arthritis Knee
- Registration Number
- NCT03060057
- Lead Sponsor
- United Orthopedic Corporation
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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;
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Implant Survivorship 2 Years Device Survivorship defined as no revision of removal of any parts of the system
- Secondary Outcome Measures
Name Time Method Change in EQ-5D Over Time Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years 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.
Change in EQ-5D VAS Over Time Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years 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.
Radiographic Analysis 24 months, 5 years This endpoint is defined as incidence rate of new radiographic failures at each follow-up visit.
Subject Satisfaction Survey 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years. Subject satisfaction with their knee surgery.
Change in KOOS, JR. Over Time Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years This endpoint is defined as difference in the KOOS, Jr interval score measured at current and pre-discharge visits.
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 This endpoint is defined as differences in both pain and functional parameters measured at current and pre-discharge visits
Operative characteristics Operative Descriptive statistics in operative characteristics will be reported as secondary endpoints to evaluate operative success
Trial Locations
- Locations (4)
Coastal Orthopedics
🇺🇸Bradenton, Florida, United States
Jacksonville Orthopaedic Institute
🇺🇸Jacksonville, Florida, United States
Orthopedic Center of Vero Beach
🇺🇸Vero Beach, Florida, United States
Rubin Institute for Advanced Orthopedics
🇺🇸Baltimore, Maryland, United States