NCT03442231

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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
147

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
2 countries

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 11, 2018

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2025

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

7 years

First QC Date

February 16, 2018

Last Update Submit

February 15, 2024

Conditions

Non-inflammatory Degenerative Joint Disease

Keywords

osteoarthritistraumatic arthritisavascular necrosis

Outcome Measures

Primary Outcomes (1)

  • Implant survival rate

    Did knee survive with no revision through 5 years

    5 years

Secondary Outcomes (6)

  • Quality of Life - KSS

    5 Years

  • Quality of Life - EQ-5D - 3L

    5 Years

  • Quality of Life - SAPSS

    5 Years

  • Quality of Life - Forgotten Joint Score

    5 Years

  • Adverse Events (AEs)

    5 Years

  • +1 more secondary outcomes

Study Arms (1)

Journey™ UNI Unicompartmental Knee System

Subjects previously received knee replacement

Device: Journey UNI Unicompartmental Knee System

Interventions

Journey UNI Unicompartmental Knee SystemDEVICE

Lateral or medial knee compartment replacement

Journey™ UNI Unicompartmental Knee System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.
  • Subject received a Journey UKS implant (consisting of a femoral component, tibial baseplate, and a tibial insert).
  • Subject was considered skeletally mature at the time of surgery and was at least 18 years of age.
  • 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.
  • Subject has consented to participate in the study by signing the Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent form (ICF).

You may not qualify if:

  • Subject has Body Mass Index (BMI) \> 40 within 1 month of surgery.
  • Subjects who have received the Journey UNI UKS as part of a revision surgery.
  • 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).
  • Subject has a known allergy to study device or one or more of its components.
  • 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.
  • Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product in the past 30 days.
  • Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Orthopaedic Specialists of Central Arizona-Scottsdale

Scottsdale, Arizona, 85255, United States

Location

Orthopaedic Surgery Specialists, Ltd.

Park Ridge, Illinois, 60068, United States

Location

Tennesee Orthopaedic Alliance, P.A.

Nashville, Tennessee, 37209, United States

Location

London Health Sciences Centre-University Hospital

London, Ontario, N6A5A5, Canada

Location

MeSH Terms

Conditions

OsteoarthritisOsteonecrosis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2018

First Posted

February 22, 2018

Study Start

April 11, 2018

Primary Completion

April 11, 2025

Study Completion

April 11, 2025

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(3)CA(1)