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NCT05151315

NitrX Total Knee Arthroplasty RSA

Active, enrolled NA Last updated 24 March 2025
What this trial tests

NA trial testing Total Knee Arthroplasty with Evolution® NitrX™ Knee System in Total Knee Arthroplasty in 50 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 August 2022
Primary endpoint
31 December 2025
28 February 2026

Quick facts

Lead sponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment50
Start date1 August 2022
Primary completion31 December 2025
Estimated completion28 February 2026
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Who can join

Adults 21 to 80, any sex, with Total Knee Arthroplasty or Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Total Knee Arthroplasty

Currently open trials in the same condition.

Other London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05151315.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing