NCT05151315

NitrX Total Knee Arthroplasty RSA

Component Migration, Polyethylene Wear, and Joint Inflammation of the Evolution Versus Evolution NitrX Total Knee Arthroplasty System

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Total Knee Arthroplasty
• Knee Osteoarthritis
• Radiostereometric Analysis

Interventions

Type	Name	Description
DEVICE	Total Knee Arthroplasty with Evolution® NitrX™ Knee System	Patients will receive cemented Evolution knee system with NitrX coating for their total knee arthroplasty.
DEVICE	Total Knee Arthroplasty with Evolution Knee System	Patients will receive cemented Evolution knee system without NitrX coating for their total knee arthroplasty.

Timeline

• Start date: 2022-08-01
• Primary completion: 2025-12-31
• Completion: 2026-02-28
• First posted: 2021-12-09
• Last updated: 2025-03-24

Locations

1 site across 1 country: Canada