Journey™ UNI Post Market Clinical Follow-Up

Active, not recruiting

• Conditions: Non-inflammatory Degenerative Joint Disease
• Interventions: Device: Journey UNI Unicompartmental Knee System

• Registration Number: NCT03442231
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-02-16
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-22
• Study Start: 2018-04-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20
• Primary Completion: 2025-04-11
• Study Completion: 2025-04-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 147

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Journey™ UNI Unicompartmental Knee System	Journey UNI Unicompartmental Knee System	Subjects previously received knee replacement

Primary Outcome Measures

Name	Time	Method
Implant survival rate	5 years	Did knee survive with no revision through 5 years

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Tennesee Orthopaedic Alliance, P.A.; 🇺🇸 Nashville, Tennessee, United States

Orthopaedic Specialists of Central Arizona-Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

Orthopaedic Surgery Specialists, Ltd.; 🇺🇸 Park Ridge, Illinois, United States

London Health Sciences Centre-University Hospital; 🇨🇦 London, Ontario, Canada