Journey™ UNI Post Market Clinical Follow-Up

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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:

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03442231
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Smith & Nephew, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Salima Reddy
Principal Investigator Affiliation Smith & Nephew, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Enrolling by invitation
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Non-inflammatory Degenerative Joint Disease
Additional Details

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.

Arms & Interventions

Arms

: Journey™ UNI Unicompartmental Knee System

Subjects previously received knee replacement

Interventions

Device: - Journey UNI Unicompartmental Knee System

Lateral or medial knee compartment replacement

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Scottsdale, Arizona

Status

Address

Orthopaedic Specialists of Central Arizona-Scottsdale

Scottsdale, Arizona, 85255

Orthopaedic Surgery Specialists, Ltd., Park Ridge, Illinois

Status

Address

Orthopaedic Surgery Specialists, Ltd.

Park Ridge, Illinois, 60068

Tennesee Orthopaedic Alliance, P.A., Nashville, Tennessee

Status

Address

Tennesee Orthopaedic Alliance, P.A.

Nashville, Tennessee, 37209

International Sites

London, Ontario, Canada

Status

Address

London Health Sciences Centre-University Hospital

London, Ontario, N6A5A5