Orthopedic Implant

Evolution with NitrX Total Knee Arthroplasty system for Radiostereometric Analysis

Led By Edward M Vasarhelyi, MD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Varus knee deformity of 0 to 10 degrees
Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Uppre-operative, 1 and 2 years post-operatively.
Awards & highlights
No Placebo-Only Group

Study Summary

This trial compares knee implants used in total knee arthroplasty surgery to see if one type (with added coating) is more stable and reduces metal hypersensitivity reactions. 50 patients are involved, with x-rays, MR imaging & blood draws to measure metal levels.

Eligible Conditions
  • Radiostereometric Analysis
  • Total Knee Replacement
  • Osteoarthritis

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-operative, 1 and 2 years post-operatively.
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-operative, 1 and 2 years post-operatively. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Implant Migration (Tibial Component)
Secondary outcome measures
Implant Migration (Femoral Component)
Other outcome measures
Circulating metal levels
European Quality of Life - 5 Dimension (EQ-5D)
Forgotten Joint Score (FJS)
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Evolution with NitrX Total Knee Arthroplasty systemExperimental Treatment1 Intervention
Patients will undergo total knee arthroplasty with the NitrX Evolution Total Knee System which has the specialized protective coating
Group II: Evolution Total Knee Arthroplasty systemActive Control1 Intervention
Patients will undergo total knee arthroplasty with the Evolution Total Knee System

Find a site

Who is running the clinical trial?

MicroPort Orthopedics Inc.Industry Sponsor
30 Previous Clinical Trials
3,391 Total Patients Enrolled
Lawson Health Research InstituteLead Sponsor
644 Previous Clinical Trials
408,909 Total Patients Enrolled
1 Trials studying Radiostereometric Analysis
33 Patients Enrolled for Radiostereometric Analysis
Edward M Vasarhelyi, MDPrincipal Investigator
London Health Sciences Centre
1 Previous Clinical Trials
194 Total Patients Enrolled
Matthew Teeter, PhDPrincipal Investigator
London Health Science Centre

Media Library

Evolution Knee System (Orthopedic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT05151315 — N/A
Radiostereometric Analysis Research Study Groups: Evolution with NitrX Total Knee Arthroplasty system, Evolution Total Knee Arthroplasty system
Radiostereometric Analysis Clinical Trial 2023: Evolution Knee System Highlights & Side Effects. Trial Name: NCT05151315 — N/A
Evolution Knee System (Orthopedic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05151315 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what demographic is enrollment for this trial open?

"To meet the criteria for this trial, individuals must have been diagnosed with osteoarthritis and between 21-80 years of age. Fifty people will be accepted into the study in total."

Answered by AI

Does the enrollment criteria for this clinical study extend beyond 30 years of age?

"The age bracket for applicants of this clinical trial is set between 21 and 80. For those outside that range, there are 36 studies available to under-18s and 694 trials open to individuals above 65."

Answered by AI

Are there any vacancies for research participants in this experiment?

"As per the details on clinicaltrials.gov, this research venture is still recruiting applicants. It was first made public on August 1st 2022 and recently revised on May 29th 2023."

Answered by AI

How many participants can the trial accommodate?

"Affirmative. Clinicaltrials.gov supports this, affirming that the clinical trial was first advertised on August 1st 2022 and has recently been updated as of May 29th 2023. The study is currently accepting 50 patients for enrollment at one medical facility."

Answered by AI
~15 spots leftby Apr 2024