Clinical Research Directory
Browse clinical research sites, groups, and studies.
NitrX Total Knee Arthroplasty RSA
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Summary
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.
Official title: Component Migration, Polyethylene Wear, and Joint Inflammation of the Evolution Versus Evolution NitrX Total Knee Arthroplasty System
Key Details
Gender
All
Age Range
21 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2022-08-01
Completion Date
2026-02-28
Last Updated
2025-03-24
Healthy Volunteers
No
Interventions
Total Knee Arthroplasty with Evolution® NitrX™ Knee System
Patients will receive cemented Evolution knee system with NitrX coating for their total knee arthroplasty.
Total Knee Arthroplasty with Evolution Knee System
Patients will receive cemented Evolution knee system without NitrX coating for their total knee arthroplasty.
Locations (1)
London Health Sciences Centre
London, Ontario, Canada