← Back to Search

Orthopedic Implant

Coated vs. Standard Knee Implants for Osteoarthritis

N/A

Recruiting

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

Between ages of 21 and 80 inclusive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-operative, 1 and 2 years post-operatively.

Awards & highlights

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.

Who is the study for?

This trial is for adults aged 21-80 with knee osteoarthritis, specifically those who have a varus knee deformity of 0 to 10 degrees and intact ligaments suitable for keeping the posterior cruciate ligament during surgery. Participants must be able to follow up, complete self-evaluations, consent to the study, and have no issues with undergoing MRI scans.Check my eligibility

What is being tested?

The study compares two types of knee implants used in total knee arthroplasty: Evolution NitrX Knee System (with a special coating) versus the standard Evolution Knee System. It aims to assess implant stability using radiostereometric analysis (RSA), measure metal particles in blood, examine effects via MRI, and evaluate joint function and patient satisfaction through questionnaires.See study design

What are the potential side effects?

Potential side effects may include tissue reactions from metal hypersensitivity due to metal particles released by the implants. This can lead to discomfort or other complications around the implanted area.

Eligibility Criteria

Inclusion Criteria

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

Select...

My knee bends slightly inward.

Select...

I am between 21 and 80 years old.

Select...

I need a knee replacement due to severe arthritis pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-operative, 1 and 2 years post-operatively.

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

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

MicroPort Orthopedics Inc.Industry Sponsor

31 Previous Clinical Trials

3,436 Total Patients Enrolled

Lawson Health Research InstituteLead Sponsor

659 Previous Clinical Trials

413,682 Total Patients Enrolled

1 Trials studying Radiostereometric Analysis

33 Patients Enrolled for Radiostereometric Analysis

Edward M Vasarhelyi, MDPrincipal InvestigatorLondon Health Sciences Centre

1 Previous Clinical Trials

194 Total Patients Enrolled

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

Recent research and studies

clinicaltrials.govStudy

NitrX Total Knee Arthroplasty RSA

Edward Vasarhelyi 2022. "NitrX Total Knee Arthroplasty RSA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05151315.

All > Knee Replacement