NitrX Total Knee Arthroplasty RSA

March 20, 2025 updated by: Edward Vasarhelyi, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Component Migration, Polyethylene Wear, and Joint Inflammation of the Evolution Versus Evolution NitrX Total Knee Arthroplasty System

Metal hypersensitivity is a recognized complication in some patients following total joint arthroplasty. This can result in a reaction to metal particles from the implants placed in the joint and cause tissue injury. The Evolution® NitrX™ (MicroPort Orthopaedics, Memphis, TN) knee implant was designed with the addition of a coating meant to create a barrier against the release of metal ions. The primary purpose of this study is to compare the Evolution and Evolution NitrX implant (implants your surgeon uses in total knee arthroplasty surgery). This study will compare the stability of these knee implants (any movement the implant makes after surgery) through the use of specialized xrays, called "radiostereometric analysis" (RSA for short). The investigators will also compare levels of circulating metal particles with blood draws and the effects of any circulating metal with MR imaging. The investigators will also be looking at the participants clinical outcomes using joint function and patient satisfaction questionnaires. A total of 50 patients will be enrolled into the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A5A5
        • London Health Sciences Centre

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
  • Varus knee deformity of 0 to 10 degrees
  • Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
  • Between ages of 21 and 80 inclusive
  • Patients willing and able to comply with follow-up requirements and self-evaluations
  • Ability to give informed consent
  • No contraindications to Magnetic Resonance Imaging (MRI)

Exclusion Criteria:

  • Active or previous infection
  • Medical condition precluding major surgery
  • Inflammatory arthropathy
  • Prior Patellectomy
  • PCL deficiency
  • Major Coronal plane deformity
  • Valgus deformity
  • Bone defects requiring augments, cones and/or stemmed implants

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Evolution Total Knee Arthroplasty system
Patients will undergo total knee arthroplasty with the Evolution Total Knee System
Device: Total Knee Arthroplasty with Evolution Knee System
Patients will receive cemented Evolution knee system without NitrX coating for their total knee arthroplasty.
Experimental: Evolution with NitrX Total Knee Arthroplasty system
Patients will undergo total knee arthroplasty with the NitrX Evolution Total Knee System which has the specialized protective coating
Device: Total Knee Arthroplasty with Evolution® NitrX™ Knee System
Patients will receive cemented Evolution knee system with NitrX coating for their total knee arthroplasty.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Implant Migration (Tibial Component)
Time Frame: 2 years
Model based Radiostereometric Analysis (RSA, specialized Xrays) will be used to register the location of the tibial implant components during supine and standing exams and measure implant movement. Changes throughout the different time points of potential tibial migration, with the use of the tibial bone beads, will be measured in millimeters.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Implant Migration (Femoral Component)
Time Frame: 2 years
Model based Radiostereometric Analysis (specialized Xrays) will be used to register the location of the femoral components during supine and standing exams and measure implant movement. Changes throughout the different time points of potential femoral migration, with the use of the femoral bone beads, will be measured in millimeters.
2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Wear Rates
Time Frame: 2 weeks (baseline), 6 weeks, 3 months, 6 months, 1 year, and 2 years.
Model based Radiostereometric Analysis (specialized Xrays) will be used to register the location of the femoral and tibial components in both standing and supine exams where the minimum joint space width between components on the medial and lateral condyles can be calculated as a measurement (in millimeters) of polyethylene wear.
2 weeks (baseline), 6 weeks, 3 months, 6 months, 1 year, and 2 years.
Circulating metal levels
Time Frame: Pre-operative, 1 and 2 years post-operatively.
Patients will have blood drawn and the levels of circulating cobalt, chromium, and nickel will be measured in whole blood. One vial of blood will be drawn from the patient (in milliliters).
Pre-operative, 1 and 2 years post-operatively.
Synovial Joint Inflammation observation
Time Frame: 2 Years
Patients will complete an MRI exam using metal artefact reduction sequences. Scans will be evaluated and scored for synovial inflammation and fibrosis, indicative of reactions to metal debris, and the presence of fibrous tissue at the bone-cement-implant interface, indicative of component loosening.
2 Years
Knee Injury and Osteoarthritis Outcome score (KOOS)
Time Frame: Pre-operative, 3 months, 1 year, and 2 year post-operative
Patient reported outcome measure. Holds 42 items that asks patient about pain, functional daily living, and sport and recreation. Questionnaire measures levels in frequency (never to always) and severity (none to extreme). Scores are from 0-100, with higher scores indicating no knee problems.
Pre-operative, 3 months, 1 year, and 2 year post-operative
Forgotten Joint Score (FJS)
Time Frame: Pre-operative, 3 months, 1 year, and 2 year post-operative
Patient reported outcome measure observing the ability of a patient to forget about a joint due to successful treatment. Contains 12 items with frequency level measurement (never to mostly). The higher the score (0-100), the less aware the patient is of their affected joint when performing daily activity.
Pre-operative, 3 months, 1 year, and 2 year post-operative
Veterans-Rand 12 Item Health Survey (VR-12)
Time Frame: Pre-operative, 3 months, 1 year, and 2 year post-operative
Patient reported outcome measure observing physical and mental health status of patient. Contains 14 items measuring levels of severity (excellent to poor) and frequency (None of the time to Yes, all of the time). Higher scores indicate higher quality of life and vice versa.
Pre-operative, 3 months, 1 year, and 2 year post-operative
European Quality of Life - 5 Dimension (EQ-5D)
Time Frame: Pre-operative, 3 months, 1 year, and 2 year
Patient reported outcome measure. Standardized 5 item instrument measuring generic health status of patient. The EQ5D uses a Likert scale which assesses five states (mobility, self care, usual care, pain and discomfort and anxiety and depression) at five different levels - none(0), slight(1), moderate(2), severe(3) or unable to perform(5). Levels are coded 1-5 and an index score is then generated. Higher scores indicate higher health status of patient.
Pre-operative, 3 months, 1 year, and 2 year
Metal Exposure/Sensitivity
Time Frame: Pre-operative
Patient reported outcome measure. Screening tool for noting pre-operative environmental metal exposures. Questionnaire contains Yes or No questions. Higher scores would indicate greater exposure and/or metal sensitivity.
Pre-operative

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
MicroPort Orthopedics Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Edward M Vasarhelyi, MD, London Health Sciences Centre
  • Principal Investigator: Matthew Teeter, PhD, London Health Science Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 119937

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

No

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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