This study was designed to demonstrate the safety and performance of the JOURNEY II XR total knee system by evaluating implant survival rates at 10 years using Kaplan-Meier analysis. All participants will be implanted with the JOURNEY II XR total knee system.
Total knee arthroplasty (TKA) is considered the most beneficial and cost-effective treatment for end-stage knee arthritis and is the most frequently performed joint replacement surgery. TKA is also indicated for earlier osteoarthritis (OA) interventions, such as osteotomy or unicompartmental replacement, when additional treatment is warranted. One device option available once the decision is made to perform TKA is the JOURNEY II XR Total Knee System. The JOURNEY II XR Total Knee System is designed to be a more "natural feeling" total knee replacement. The goal of the JOURNEY II XR is to enable a higher level of function after total knee replacement by relieving pain and restoring the ability to participate in active lifestyles. The main aim of this study is to generate long-term safety and performance data for the JOURNEY™ II XR Total Knee System. Effectiveness information such as short- and long-term function, subject satisfaction, and quality of life will also be measured.
Study Type
OBSERVATIONAL
Enrollment
176
JOURNEY II XR Total Knee System
Loma Linda University Dept. of Orthopaedic Surgery
Loma Linda, California, United States
Holy Cross Orthopedic Institute
Fort Lauderdale, Florida, United States
Implant survival rate
Did knee survive with no revision through 10 years
Time frame: 10 years
Knee function
Lateral Step-Up Test
Time frame: 10 years
Quality of Life - EQ-5D - 3L
Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D - 3L) questionnaire
Time frame: 10 years
Quality of Life - FJS
Patient Reported Outcomes using Forgotten Joint Score (FJS) questionnaire
Time frame: 10 years
Quality of Life - KOOS
Patient Reported Outcomes using Knee Injury and Osteoarthritic Outcome Scores (KOOS) questionnaire
Time frame: 10 years
Quality of Life - ABC scale
Patient Reported Outcomes using Activities-specific Balance Confidence (ABC) questionnaire
Time frame: 10 years
Quality of Life - SAPSS
Patient Reported Outcomes using Self-Administered Patient Satisfaction Score (SAPSS) questionnaire
Time frame: 10 years
Physiotherapy (PT) utilization - No. of visits
Number of PT visits required up to 6 months after surgery
Time frame: 6 Months Post-operatively
Physiotherapy (PT) utilization - Period of visits
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Castle Orthopaedics & Sports Medicine, S.C.
Aurora, Illinois, United States
Midwest Orthopaedics at Rush
Chicago, Illinois, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
DeClaire LaMacchia Orthopaedic Institute
Rochester, Michigan, United States
Reno Orthopaedic Center
Reno, Nevada, United States
Mercer Bucks Orthopaedics
Hamilton, New Jersey, United States
NYU Hospital for Joint Diseases / NYU Langone Medical Center
New York, New York, United States
Hospital for Special Surgery
New York, New York, United States
...and 4 more locations
Time period during which PT appointments are required up to 6 months after surgery
Time frame: 6 Months Post-operatively
Radiographic outcomes
X-rays of index joint
Time frame: 10 years
Adverse Events (AEs)
All AEs will be collected and reported
Time frame: 10 years