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Journey™ UNI Post Market Clinical Follow-Up (Journey UNI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03442231
Recruitment Status : Enrolling by invitation
First Posted : February 22, 2018
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Brief Summary:
This is a retrospective/prospective, open-label single cohort, multicenter study to collect relevant clinical data from 147 subjects with unicompartmental degeneration of the knee in whom the Journey UNI UKS was previously implanted.

Condition or disease Intervention/treatment
Non-inflammatory Degenerative Joint Disease Device: Journey UNI Unicompartmental Knee System

Detailed Description:
The purpose of the current investigation is to assess the safety and effectiveness of the JOURNEY UNI Unicompartmental Knee System (UKS) in patients with non-inflammatory degenerative joint disease (NIDJD) of the knee who previously had the Journey UNI UKS implanted. This clinical study will prospectively evaluate the 36 and 60-month safety and performance of the JOURNEY UNI UKS in patients with NIDJD of the knee who required lateral or medial knee compartment replacement.

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Study Type : Observational
Estimated Enrollment : 147 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Follow-Up of Subjects With a Journey™ UNI Unicompartmental Knee System Implant
Actual Study Start Date : April 11, 2018
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Journey™ UNI Unicompartmental Knee System
Subjects previously received knee replacement
Device: Journey UNI Unicompartmental Knee System
Lateral or medial knee compartment replacement




Primary Outcome Measures :
  1. Implant survival rate [ Time Frame: 5 years ]
    Did knee survive with no revision through 5 years


Secondary Outcome Measures :
  1. Quality of Life - KSS [ Time Frame: 5 Years ]
    2011 Knee Society Score

  2. Quality of Life - EQ-5D - 3L [ Time Frame: 5 Years ]
    EuroQol Five Dimensions Questionnaire

  3. Quality of Life - SAPSS [ Time Frame: 5 Years ]
    Self-Administered Patient Satisfaction Survey

  4. Quality of Life - Forgotten Joint Score [ Time Frame: 5 Years ]
    Forgotten Joint Score (FJS) questionnaire measures how often subject is aware of affected knee in everyday life. Score consists of 12 questions where subjects are asked to rate their awareness of their joint replacement during various activities. rating is never, almost never, seldom, sometimes or mostly.

  5. Adverse Events (AEs) [ Time Frame: 5 Years ]
    All AEs will be collected and reported

  6. Radiographic Outcomes [ Time Frame: 5 Years ]
    Perform weight-bearing AP and lateral standard x-rays



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Investigators will pre-screen all subjects that have previously undergone UKA using the Journey UNI UKS system between 12 and 48 months previously using only the existing information in the medical records.
Criteria

Inclusion Criteria:

  1. Between 12 and 48 months previously, subject had unicompartmental knee replacement implanted for unicompartmental, NIDJD including OA, traumatic arthritis, avascular necrosis, for correction of functional deformity, or to repair a fracture that was unmanageable using other techniques.
  2. Subject received a Journey UKS implant (consisting of a femoral component, tibial baseplate, and a tibial insert).
  3. Subject was considered skeletally mature at the time of surgery and was at least 18 years of age.
  4. Subject is willing to have retrospective data collected and to participate in required prospective follow-up visit(s) at the investigational site and to complete study procedures and questionnaires.
  5. Subject has consented to participate in the study by signing the Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent form (ICF).

Exclusion Criteria:

  • Subject has Body Mass Index (BMI) > 40 within 1 month of surgery. 2. Subjects who have received the Journey UNI UKS as part of a revision surgery.

    3. Subject has a condition that may interfere with the unicompartmental knee arthroplasty (UKA) survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).

    4. Subject has a known allergy to study device or one or more of its components.

    5. Subject, in the opinion of the Principal Investigator (PI), has an emotional or neurological condition that would preempt his/her ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.

    6. Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product in the past 30 days.

    7. Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.


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): NCT03442231


Locations
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United States, Arizona
Orthopaedic Specialists of Central Arizona-Scottsdale
Prescott, Arizona, United States, 86305
United States, Illinois
Orthopaedic Surgery Specialists, Ltd.
Park Ridge, Illinois, United States, 60068
United States, Tennessee
Tennesee Orthopaedic Alliance, P.A.
Nashville, Tennessee, United States, 37209
Canada, Ontario
London Health Sciences Centre-University Hospital
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
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Study Chair: Beate Hanson, VP, PhD Vice President, Global Clinical Strategy

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Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT03442231     History of Changes
Other Study ID Numbers: 17-4049-03
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Smith & Nephew, Inc.:
osteoarthritis
traumatic arthritis
avascular necrosis

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