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

February 15, 2024 updated by: Smith & Nephew, Inc.

Follow-Up of Subjects With a Journey™ UNI Unicompartmental Knee System Implant

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.

Study Overview

Status

Active, not recruiting

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.

Study Type

Observational

Enrollment (Actual)

147

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • London, Ontario, Canada, N6A5A5
        • London Health Sciences Centre-University Hospital
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Orthopaedic Specialists of Central Arizona-Scottsdale
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Orthopaedic Surgery Specialists, Ltd.
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Tennesee Orthopaedic Alliance, P.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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:

  1. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant survival rate
Time Frame: 5 years
Did knee survive with no revision through 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life - KSS
Time Frame: 5 Years
2011 Knee Society Score
5 Years
Quality of Life - EQ-5D - 3L
Time Frame: 5 Years
EuroQol Five Dimensions Questionnaire
5 Years
Quality of Life - SAPSS
Time Frame: 5 Years
Self-Administered Patient Satisfaction Survey
5 Years
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 Years
Adverse Events (AEs)
Time Frame: 5 Years
All AEs will be collected and reported
5 Years
Radiographic Outcomes
Time Frame: 5 Years
Perform weight-bearing AP and lateral standard x-rays
5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Salima Reddy, Smith & Nephew, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2018

Primary Completion (Estimated)

April 11, 2025

Study Completion (Estimated)

April 11, 2025

Study Registration Dates

First Submitted

February 16, 2018

First Submitted That Met QC Criteria

February 16, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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