The purpose of this study is to evaluate the safety and effectiveness of the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement.
This is a prospective, non-randomized, single cohort, multicenter study to evaluate the clinical outcomes of TKA using the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement. One hundred and seventy (170) subjects will be enrolled at up to 18 clinical sites globally. Follow-up clinical assessments will be performed at 3 months, 1 year, 2 years, 5 years, and 10 years post-operatively.
Study Type
OBSERVATIONAL
Enrollment
170
TKA with Journey II CR Total Knee System
Orthopedic Institute of the West
Phoenix, Arizona, United States
Rush University Medical Center
Chicago, Illinois, United States
Anne Arundel Health System Research Institute, Inc
Annapolis, Maryland, United States
Equivalence in 1 year post-operative mean Range of Motion (ROM) in subjects receiving the J II CR TKS as compared to the literature reference mean ROM
Time frame: 1 year post-op analysis
Non-inferiority of the survival rate of the J II CR TKS with the reference survival rate of a literature reference at 5 and 10-years post-operatively
Time frame: Up to 10 year post-operative analysis
Clinical Outcomes: EuroQol 5D (EQ-5D) scale
Time frame: Pre-Op to 10 yrs
Clinical Outcomes: 2011 Knee Society Score (2011 KSS) clinical evaluation
Time frame: Pre-Op to 10 yrs
Clinical Outcomes: Self-Administered Patient Satisfaction Scale for Primary Hip and Knee Arthroplasty (SAPSS
Time frame: Pre-Op to 10 yrs
Health Economic Endpoints : Physical therapy visit quantification/duration
Time frame: 30, 60, and 90-day hospital re-admission rate
Health Economic Endpoints: Discharge destination(s)/length of stay
Time frame: 30, 60, and 90 days
Health Economic Endpoints: Unscheduled professional visits (e.g. hospital, emergency room, orthopedic clinic, primary care physician)
Time frame: 30, 60, and 90 days
Health Economic Endpoints: Concomitant medications/procedures associated with the knee
Time frame: 30, 60, and 90 days
Safety Endpoints:Adverse events, to be evaluated by type, frequency, severity, and relatedness to the study treatment.
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Center for Hip and Knee Replacement at Columbia University Medical Center
New York, New York, United States
Wake Forest University
Winston-Salem, North Carolina, United States
The Lindner Research Center, Musculo-Skeletal Division - The Christ Hospital Health Network
Cincinnati, Ohio, United States
Hospital Parc Taulí Servei de Cirurgia Ortopèdica I Traumatologia
Barcelona, Spain
Royal National Orthopaedic Hospital NHS Trust
Stanmore, United Kingdom
Barts Health NHS Trust
Whitechapel, United Kingdom
Time frame: Pre-Op to 10 yrs
Safety Endpoints: Manipulations under anesthesia
Time frame: Pre-Op to 10 yrs
Safety Endpoints: Radiographic analysis
Time frame: Pre-Op to 10 yrs