Coated vs. Standard Knee Implants for Osteoarthritis
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the Evolution Knee System, Evolution® NitrX™ Knee System treatment for osteoarthritis?
Research on similar knee implant systems suggests that newer designs can improve patient satisfaction and functional outcomes. For example, studies have shown that high-flexion and kinematic designs in knee implants can enhance range of motion and reduce bone resorption, which may indicate potential benefits for the Evolution Knee System.12345
Is the Evolution® NitrX™ Knee System safe for humans?
A study comparing standard and coated knee implants found that both had similar safety outcomes, with a 98% survival rate for coated implants and 97% for uncoated ones after 5 years. Most blood markers for inflammation were similar, although some were slightly higher in the uncoated group, suggesting the coated implants are generally safe.15678
What makes the Evolution® NitrX™ Knee System treatment unique for osteoarthritis?
The Evolution® NitrX™ Knee System is unique because it uses a special coating that may enhance bone ingrowth, potentially leading to better stability and longevity of the knee implant compared to standard options. This coating approach is similar to other successful knee systems that use coatings like hydroxyapatite to improve fixation without the need for cement.910111213
What is the purpose of this trial?
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.
Research Team
Edward M Vasarhelyi, MD
Principal Investigator
London Health Sciences Centre
Matthew Teeter, PhD
Principal Investigator
London Health Science Centre
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Assessment
Participants undergo pre-operative assessments including blood draws and questionnaires to evaluate baseline health status and metal exposure/sensitivity
Surgery and Initial Recovery
Participants undergo total knee arthroplasty surgery with either the Evolution or Evolution NitrX Total Knee System
Post-operative Monitoring
Participants are monitored for implant stability and metal levels through radiostereometric analysis, blood draws, and MR imaging
Follow-up
Participants are monitored for safety and effectiveness after treatment, including joint function and patient satisfaction assessments
Treatment Details
Interventions
- Evolution Knee System
- Evolution® NitrX™ Knee System
Find a Clinic Near You
Who Is Running the Clinical Trial?
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Lead Sponsor
Lawson Health Research Institute
Lead Sponsor
MicroPort Orthopedics Inc.
Industry Sponsor