Journey™ UNI Post Market Clinical Follow-Up

Non-inflammatory Degenerative Joint Disease Clinical Trial

— Journey UNI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03442231
• Other study ID #: 17-4049-03
• Status: Active, not recruiting
• Start date: April 11, 2018
• Est. completion date: April 11, 2025

Study information

• Verified date: February 2024
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 147
• Est. completion date: April 11, 2025
• Est. primary completion date: April 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Non-inflammatory Degenerative Joint Disease
• Osteoarthritis

Intervention

Device:
• Journey UNI Unicompartmental Knee System
Lateral or medial knee compartment replacement

Locations

Country	Name	City	State
Canada	London Health Sciences Centre-University Hospital	London	Ontario
United States	Tennesee Orthopaedic Alliance, P.A.	Nashville	Tennessee
United States	Orthopaedic Surgery Specialists, Ltd.	Park Ridge	Illinois
United States	Orthopaedic Specialists of Central Arizona-Scottsdale	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival rate	Did knee survive with no revision through 5 years	5 years
Secondary	Quality of Life - KSS	2011 Knee Society Score	5 Years
Secondary	Quality of Life - EQ-5D - 3L	EuroQol Five Dimensions Questionnaire	5 Years
Secondary	Quality of Life - SAPSS	Self-Administered Patient Satisfaction Survey	5 Years
Secondary	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.	5 Years
Secondary	Adverse Events (AEs)	All AEs will be collected and reported	5 Years
Secondary	Radiographic Outcomes	Perform weight-bearing AP and lateral standard x-rays	5 Years