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

The purpose of this study is to evaluate both short and long term clinical performance and safety of the commercially available U2 Knee™ System.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Device: 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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Florida
    • Bradenton, Florida, United States, 34209
      • Coastal Orthopedics
    • Jacksonville, Florida, United States, 32204
      • Jacksonville Orthopaedic Institute
    • Vero Beach, Florida, United States, 32960
      • Orthopedic Center of Vero Beach
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Rubin Institute for Advanced Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: United Orthopedic Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2017
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: February 10, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 03-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No