Ignite Creation Date:
2025-12-18 @ 8:27 AM
Ignite Modification Date:
2025-12-23 @ 10:02 PM
Study NCT ID:
NCT05151315
Status:
None
Last Update Posted:
2025-03-24 00:00:00
First Post:
2021-11-05 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NitrX Total Knee Arthroplasty RSA
Sponsor:
None
Organization:
Study Overview
Official Title:
Component Migration, Polyethylene Wear, and Joint Inflammation of the Evolution Versus Evolution NitrX Total Knee Arthroplasty System
Status:
None
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: