Active — Not RecruitingNot Applicable

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

United States100 participantsStarted 2025-08-18

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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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.

What they're measuring

Knee Injury and Osteoarthritis Outcome Score- Joint Replacement (KOOS JR)

Timeframe: 10 years

Trial details

NCT IDNCT07391592

SponsorMicroPort Orthopedics Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2032-12-31