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NitrX Total Knee Arthroplasty RSA

StatusActive, Not Recruiting
PhaseNot applicable
Started2022-08-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 13 months later Dec 31, 2025 → Feb 2027
See other at-risk trials from London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Amendment history

2026-09-23
Primary completion pushed: 2025-12-31 → 2027-02
Completion pushed: 2026-02-28 → 2027-02
2025-03-20
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v4
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-04-30→2025-12-31
Completion date2024-11-30→2026-02-28
Study sitesdetails revised at 1 of 1 site
2023-05-29
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2022-06-17
Study Status v2
Start date2022-02-01→2022-08-01
2021-12-23
Study Status, Sponsor/Collaborators, Arms and Interventions v1
Start date2021-11-30→2022-02-01
2021-11-25
Original filing
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.
Trial Details
NCT Number NCT05151315
Lead Sponsor London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborators: MicroPort Orthopedics Inc.
Conditions Total Knee Arthroplasty, Knee Osteoarthritis, Radiostereometric Analysis
Enrollment 50 participants
Start Date 2022-08-01
Primary Completion 2027-02 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-09-22