NitrX Total Knee Arthroplasty RSA
NCT: NCT05151315 · ACTIVE_NOT_RECRUITING
Brief 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.
Frequently Asked Questions
What is NitrX Total Knee Arthroplasty RSA?
NitrX Total Knee Arthroplasty RSA is a clinical trial registered under NCT05151315. Current status: ACTIVE_NOT_RECRUITING.
What is the status of NCT05151315?
The current status of NCT05151315 (NitrX Total Knee Arthroplasty RSA) is: ACTIVE_NOT_RECRUITING.
When did NitrX Total Knee Arthroplasty RSA start?
NitrX Total Knee Arthroplasty RSA started on 2022-08-01.
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Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.