NitrX Total Knee Arthroplasty RSA

May 29, 2023 updated by: Edward Vasarhelyi, Lawson Health Research Institute

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • 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 Backup

Study Locations

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

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
Intervention / Treatment
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

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

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

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

Lawson Health Research Institute

Collaborators

MicroPort Orthopedics Inc.

Investigators

  • 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)

August 1, 2022

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

November 5, 2021

First Submitted That Met QC Criteria

November 25, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 29, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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