Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study"
U-Propel
1 other identifier
observational
200
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedStudy Start
First participant enrolled
March 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2026
CompletedJune 5, 2023
June 1, 2023
7 years
February 10, 2017
June 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Implant Survivorship
Device Survivorship defined as no revision of removal of any parts of the system
2 Years
Secondary Outcomes (7)
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
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
Change in KOOS, JR. 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
- +2 more secondary outcomes
Interventions
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.
Eligibility Criteria
The U2 Knee™ System is intended for use in subjects who require primary total knee arthroplasty for reduction or relief of pain and/or improved knee function.
You may qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Coastal Orthopedics
Bradenton, Florida, 34209, United States
Jacksonville Orthopaedic Institute
Jacksonville, Florida, 32204, United States
Orthopedic Center of Vero Beach
Vero Beach, Florida, 32960, United States
Rubin Institute for Advanced Orthopedics
Baltimore, Maryland, 21215, United States
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2017
First Posted
February 23, 2017
Study Start
March 30, 2017
Primary Completion
March 30, 2024
Study Completion
March 30, 2026
Last Updated
June 5, 2023
Record last verified: 2023-06