CClinicalTrials.gg
Active, not recruitingNCT03442231Journey UNIUpdated Feb 20, 2024

Journey™ UNI Post Market Clinical Follow-Up

An observational study in Non-inflammatory Degenerative Joint Disease, sponsored by Smith & Nephew, Inc.. Active, not recruiting at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by Smith & Nephew, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
147
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Non-inflammatory Degenerative Joint Disease

Keywords

  • osteoarthritis
  • traumatic arthritis
  • avascular necrosis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
147 participants (actual)
Patient registry
No

Groups and cohorts

  • Journey™ UNI Unicompartmental Knee System

    Subjects previously received knee replacement

    Device: Journey UNI Unicompartmental Knee System

Interventions

  • DeviceJourney UNI Unicompartmental Knee System

    Lateral or medial knee compartment replacement

05

What researchers measure

Primary outcomes

  1. Implant survival rate

    Did knee survive with no revision through 5 years

    Time frame: 5 years

Secondary outcomes

  1. Quality of Life - KSS

    2011 Knee Society Score

    Time frame: 5 Years

  2. Quality of Life - EQ-5D - 3L

    EuroQol Five Dimensions Questionnaire

    Time frame: 5 Years

  3. Quality of Life - SAPSS

    Self-Administered Patient Satisfaction Survey

    Time frame: 5 Years

  4. Quality of Life - Forgotten Joint Score

    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.

    Time frame: 5 Years

  5. Adverse Events (AEs)

    All AEs will be collected and reported

    Time frame: 5 Years

  6. Radiographic Outcomes

    Perform weight-bearing AP and lateral standard x-rays

    Time frame: 5 Years

06

Study locations

4 sites
  • Orthopaedic Specialists of Central Arizona-Scottsdale
    Scottsdale, Arizona 85255, United States
  • Orthopaedic Surgery Specialists, Ltd.
    Park Ridge, Illinois 60068, United States
  • Tennesee Orthopaedic Alliance, P.A.
    Nashville, Tennessee 37209, United States
  • London Health Sciences Centre-University Hospital
    London, Ontario N6A5A5, Canada
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03442231
Lead sponsor
Smith & Nephew, Inc.
Responsible party
Sponsor
First posted
Feb 22, 2018
Start date
Apr 11, 2018
Primary completion
Apr 11, 2025 (estimated)
Completion
Apr 11, 2025 (estimated)
Last update
Feb 20, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion