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

NCT07391592

Active Not RecruitingN/A

Sponsor: MicroPort Orthopedics Inc.

Conditions: Osteoarthitis, Arthritis Knee, Joint Diseases, Avascular Necrosis, Rheumatoid Arthritis of Knee

Interventions: EVOLUTION® NitrX™

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 21 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Subjects \> 18 years of age at the time of surgery
* Subjects who were implanted with the Evolution® NitrX (SKU # listed below) in MicroPort Orthopedics' intended patient population listed within the Instructions for Use (IFU).
* Willing and able to participate in clinical study

Exclusion Criteria:

* Subjects without follow-up history
* Subjects not meeting the inclusion criteria
* Contraindications as listed in the IFU
* Currently enrolled in another study that could affect the endpoints of this protocol.

Locations (1)

Fremont, California, United States