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NCT05151315
NitrX Total Knee Arthroplasty RSA
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.
31 December 2025
Quick facts
| Lead sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 1 August 2022 |
| Primary completion | 31 December 2025 |
| Estimated completion | 28 February 2026 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Total Knee Arthroplasty with Evolution® NitrX™ Knee System
- Total Knee Arthroplasty with Evolution Knee System
Conditions studied
- Total Knee Arthroplasty — all drugs for Total Knee Arthroplasty →
- Knee Osteoarthritis — all drugs for Knee Osteoarthritis →
- Radiostereometric Analysis — all drugs for Radiostereometric Analysis →
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.
Verify or expand the search:
- PubMed search for NCT05151315
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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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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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05151315 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Last refreshed: 24 March 2025
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