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NCT Number: NCT07391592

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteoarthitis Arthritis Knee Avascular Necrosis Bone Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatoid Arthritis of Knee

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sah Orthopaedic Associates

Fremont, California, 94538, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EVOLUTION® NitrX™

Device

EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert

Primary outcomes

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

    Time frame: 10 years

    KOOS is a validated patient-reported outcome measure designed to assess short- and long- term symptoms and functions in individuals with knee injuries and osteoarthritis. It is a 42-item questionnaire. KOOS JR is its short form, developed using Rasch analysis to provide a more efficient tool for clinical and research use. It has 7 items which measure pain, stiffness and function in daily life. Each item is scored from 0 (none) to 4 (extreme). The raw score (0-28) is converted to an interval score ranging from 0 to 100, where 100 indicates the best health and 0 means the worst health.

Sponsors and collaborators

Lead sponsor

MicroPort Orthopedics Inc.

Industry

Registry information

Acronym: NitrX

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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