This clinical study will evaluate the early to midterm safety and performance of the JOURNEY™ II UNI UKS in patients with non-inflammatory degenerative joint disease of the knee requiring lateral or medial knee compartment replacement. Clinical, radiographic, health economic and safety outcomes will be evaluated.
To assess the safety and performance of the JOURNEY™ II UNI UKS in patients with unicompartmental degeneration of the knee by demonstrating non-inferiority of the cumulative percent implant survival in subjects with the JOURNEY™ II UNI UKS implanted, compared to a literature reference rate of 91.7% (AOA annual report 2015)12 at 5 years.
Study Type
OBSERVATIONAL
Enrollment
154
Journey™ II UNI UKS is a CE Marked medical device. The device has been designed to treat both medial and lateral unicompartmental disease. It is a comprehensive system designed to allow surgeons to perform UKA. It is comprised of the following anatomic components: Oxidized zirconium femoral components Titanium tibial components with a grit-blasted surface Polyethylene tibial insert components The device is asymmetric and is available in oxidized zirconium to reduce wear and increase implant longevity.
Rush University Medical Center
Chicago, Illinois, United States
OrthoIllinois, LTD
Rockford, Illinois, United States
Poliambulanza Institute Hospital Foundation
Brescia, Italy
Istituto Clinico Villa Aprica
Como, Italy
Implant survival 5 years postoperatively
Time frame: 5 years
Device-related adverse events
All AEs will be collected and reported
Time frame: 5 year
Radiographic assessments
To assess changes in implant fixation and bone integrity, an evaluation will be performed based upon comparison of Antero posterior and Lateral radiographs over multiple time-points. Radiographs will be also evaluated for radiolucencies, osteolysis, implant positioning, implant migration, implant loosening, periprosthetic fracture, wear of the articulating surfaces of replacement components
Time frame: 5 year
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Zeromski Hospital
Krakow, Poland
Hospital Miejski Zabrze
Zabrze, Poland