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

United Orthopedic Corporation200 enrolled

Overview

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

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

200

Conditions

Osteo Arthritis Knee

Interventions

U2 Knee™ SystemDEVICE

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

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

Implant Survivorship

Device Survivorship defined as no revision of removal of any parts of the system

Time frame: 2 Years

Secondary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 24 months, 5 years

Operative characteristics

Data from ClinicalTrials.gov

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