Clinical Trial

Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert

Enrolling by Invitation
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Summary
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-03-23; most recent amendment 2024-03-19.
Status change: Not Yet Recruiting → Enrolling by Invitation 2022-01-28
Trial Details
NCT Number NCT04816773
Lead Sponsor MicroPort Orthopedics Inc.
Conditions Joint Diseases, Osteoarthritis, Arthritis Knee, Avascular Necrosis
Enrollment 150 participants
Start Date 2022-01-27
Primary Completion 2034-08 (estimated)
Study Completion 2035-01 (estimated)
Updated on ClinicalTrials.gov 2024-03-20