Your session is about to expire
← 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 belowSelect...
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.
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 moreTrial 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
664 Previous Clinical Trials
414,026 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had an infection before or have one now.My knee bends slightly inward.I am between 21 and 80 years old.I need a knee replacement due to severe arthritis pain.My knee's main supporting ligament is healthy enough to keep.I need surgery involving bone implants or special supports.I have PCL deficiency.I have a type of joint inflammation.I cannot undergo major surgery due to my health condition.I have had my kneecap surgically removed.My knee bends outward.
Research Study Groups:
This trial has the following groups:- Group 1: Evolution with NitrX Total Knee Arthroplasty system
- Group 2: Evolution Total Knee Arthroplasty system
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger