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

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ClinicalTrials.gov Identifier: NCT03060057
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Osteo Arthritis Knee 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
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study"
Actual Study Start Date : March 30, 2017
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : March 30, 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: U2 Knee™ System
    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.


Primary Outcome Measures :
  1. Implant Survivorship [ Time Frame: 2 Years ]
    Device Survivorship defined as no revision of removal of any parts of the system


Secondary Outcome Measures :
  1. Change in Knee Society Score (KSS) Over Time [ Time Frame: 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

  2. Change in EQ-5D Over Time [ Time Frame: 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.

  3. Change in EQ-5D VAS Over Time [ Time Frame: 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.

  4. Change in KOOS, JR. Over Time [ Time Frame: 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.

  5. Radiographic Analysis [ Time Frame: 24 months, 5 years ]
    This endpoint is defined as incidence rate of new radiographic failures at each follow-up visit.

  6. Operative characteristics [ Time Frame: Operative ]
    Descriptive statistics in operative characteristics will be reported as secondary endpoints to evaluate operative success

  7. Subject Satisfaction Survey [ Time Frame: 6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years. ]
    Subject satisfaction with their knee surgery.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060057


Contacts
Contact: Mindy Carlson 612-562-0060 mindy.carlson@uocusa.com

Locations
United States, Florida
Coastal Orthopedics Recruiting
Bradenton, Florida, United States, 34209
Contact: Christine Scheuerman, RN, BSN    941-782-1353 ext 3450    cscheuerman@coastalorthopedics.com   
Principal Investigator: David Cashen, MD         
Sub-Investigator: Alan Valadie, MD         
Sub-Investigator: Arthur Valadie, MD         
Sub-Investigator: Daniel Lamar, MD         
Jacksonville Orthopaedic Institute Recruiting
Jacksonville, Florida, United States, 32204
Contact: Carol Collins    904-388-1400      
Principal Investigator: Stanton Longenecker, MD         
Orthopedic Center of Vero Beach Recruiting
Vero Beach, Florida, United States, 32960
Contact: Nicki Allen    772-778-2009      
Principal Investigator: Richard Steinfeld, MD         
United States, Maryland
Rubin Institute for Advanced Orthopedics Not yet recruiting
Baltimore, Maryland, United States, 21215
Contact: Ashwin Mahajan    410-601-8500      
Sub-Investigator: Ronald Delanois, MD         
Principal Investigator: James Nace, MD         
Sponsors and Collaborators
United Orthopedic Corporation

Responsible Party: United Orthopedic Corporation
ClinicalTrials.gov Identifier: NCT03060057     History of Changes
Other Study ID Numbers: 03-2017
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases