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

February 2, 2026 updated by: MicroPort Orthopedics Inc.
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fremont, California, United States, 94538
        • Sah Orthopaedic Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Single study group with either newly or previously implanted patients with all Evolution® NitrX components: Non-Porous Keeled Tibia, CS/CR Non-Porous Femur component, and Evolution® MP CS Tibial insert.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Newly or previously implanted patients
Single center, non-interventional prospective follow-up of newly or previously implanted subjects. Previously implanted subjects must be enrolled within 14 months of the study index surgery. Single study group with either newly or previously implanted patients with all EVOLUTION® NitrX™ components: Non-Porous Keeled Tibia, CS/CR Non-Porous Femur component, and EVOLUTION® MP CS tibial insert
Device: EVOLUTION® NitrX™
EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MicroPort Orthopedics Inc.

Investigators

  • Principal Investigator: Alexander Sah, MD, Sah Orthopaedic Associates, Fremont, California, United States 94538

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2025

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

February 2, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25DM0004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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