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

  • STATUS
    Recruiting
  • End date
    Mar 30, 2024
  • participants needed
    200
  • sponsor
    United Orthopedic Corporation
Updated on 26 January 2021

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.

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.

Details
Condition Osteo Arthritis Knee
Treatment U2 Knee™ System
Clinical Study IdentifierNCT03060057
SponsorUnited Orthopedic Corporation
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have Osteo Arthritis Knee?
Do you have any of these conditions: Do you have Osteo Arthritis Knee??
Do you have any of these conditions: Do you have Osteo Arthritis Knee??
Do you have any of these conditions: Do you have Osteo Arthritis Knee??
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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