MicroPort Orthopedics Inc. (MPO) plans to market the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert globally, including in the European Union (EU). MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur. These components are used along with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert components that is marketed in the European Union (EU). This type of data collection is required by regulatory authorities for all TKA devices that do not have medium to long-term clinical evidence available.
Study Type
OBSERVATIONAL
Enrollment
150
EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert
Sah Orthopaedic Associates
Fremont, California, United States
MSK Doctors, The Keep Clinic
Grantham, Lincolnshire, United Kingdom
Component Survivorship of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia
The primary endpoint is to evaluate component survivorship of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia out to 10 years follow-up. Percentage of knees survived with no revisions or replacement at 10-year
Time frame: 10 years post-operative
Component Survivorship of the EVOLUTION® NitrX™ CS/CR Non-Porous Femur
The primary endpoint is to evaluate component survivorship of the EVOLUTION® NitrX™ CS/CR Non-Porous Femur out to 10 years follow-up. Percentage of knees survived with no revisions or replacement at 10-year.
Time frame: 10 years post-operative
Component Survivorship of the EVOLUTION® NitrX™ MP CS tibial inserts
The primary endpoint is to evaluate component survivorship of the EVOLUTION® NitrX™ MP CS tibial inserts out to 10 years follow-up. Percentage of knees survived with no revisions or replacement at 10-year.
Time frame: 10 years post-operative
Functional Scores
To assess functional scores utilizing Knee Injury and Osteoarthritis Outcome Score (KOOS).
Time frame: 10 years post-operative
Functional Scores
To assess functional scores utilizing EQ-5D-5L.
Time frame: 10 years post-operative
Functional Scores
To assess functional scores utilizing Forgotten Joint Score (FJS).
Time frame: 10 years post-operative
Subject Satisfaction
To assess subject satisfaction with their TKA procedure via the Satisfaction Survey.
Time frame: 10 years post-operative
Radiolucencies
To assess the presence of radiolucencies surrounding the implanted femoral and tibial components present in each of the 17 zones.
Time frame: 10 years post-operative
To assess subject safety: Adverse Events
To assess safety of the EVOLUTION® NitrX™ system through device-related adverse event findings and/or adverse device effects during follow-up visits.
Time frame: 1, 3, 5, 7, 10 years
To assess device tolerability within subject: Adverse Events
To assess tolerability of the EVOLUTION® NitrX™ system service-related adverse event findings and/or adverse device effects during follow-up visits.
Time frame: 10 years post-operative
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.