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
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.
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.
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.
Exclusion Criteria:
Subjects previously received knee replacement
Device: Journey UNI Unicompartmental Knee System
Lateral or medial knee compartment replacement
Implant survival rate
Did knee survive with no revision through 5 years
Time frame: 5 years
Quality of Life - KSS
2011 Knee Society Score
Time frame: 5 Years
Quality of Life - EQ-5D - 3L
EuroQol Five Dimensions Questionnaire
Time frame: 5 Years
Quality of Life - SAPSS
Self-Administered Patient Satisfaction Survey
Time frame: 5 Years
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
Adverse Events (AEs)
All AEs will be collected and reported
Time frame: 5 Years
Radiographic Outcomes
Perform weight-bearing AP and lateral standard x-rays
Time frame: 5 Years
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Smith & Nephew, Inc.