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Orthopedic Implant

Coated vs. Standard Knee Implants for Osteoarthritis

N/A
Recruiting
Led By Matthew Teeter, PhD
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
Must not have
Active or previous infection
Bone defects requiring augments, cones and/or stemmed implants
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-operative, 1 and 2 years post-operatively.
Awards & highlights
No Placebo-Only Group

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.
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.
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
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My knee bends slightly inward.
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I am between 21 and 80 years old.
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I need a knee replacement due to severe arthritis pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had an infection before or have one now.
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I need surgery involving bone implants or special supports.
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I have PCL deficiency.
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I have a type of joint inflammation.
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I cannot undergo major surgery due to my health condition.
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I have had my kneecap surgically removed.
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My knee bends outward.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Implant Migration (Tibial Component)
Secondary study objectives
Implant Migration (Femoral Component)
Other study objectives
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 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
680 Previous Clinical Trials
421,883 Total Patients Enrolled
Matthew Teeter, PhDPrincipal InvestigatorLondon Health Science Centre
1 Previous Clinical Trials
21 Total Patients Enrolled

Media Library

Evolution Knee System (Orthopedic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT05151315 — N/A
Total Knee Replacement Research Study Groups: Evolution with NitrX Total Knee Arthroplasty system, Evolution Total Knee Arthroplasty system
Total Knee Replacement 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
~15 spots leftby Nov 2025
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