NitrX Total Knee Arthroplasty RSA

Not Applicable

Active, not recruiting

• Conditions: Total Knee Arthroplasty; Knee Osteoarthritis; Radiostereometric Analysis
• Interventions: Device: Total Knee Arthroplasty with Evolution Knee System; Device: Total Knee Arthroplasty with Evolution® NitrX™ Knee System

• Registration Number: NCT05151315
• Lead Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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

Not available

Study Timeline

• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-25
• Study First Posted: 2021-12-09
• Study Start: 2022-08-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-24
• Primary Completion: 2025-12-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
• Varus knee deformity of 0 to 10 degrees
• Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
• Between ages of 21 and 80 inclusive
• Patients willing and able to comply with follow-up requirements and self-evaluations
• Ability to give informed consent
• No contraindications to Magnetic Resonance Imaging (MRI)

Exclusion Criteria

• Active or previous infection
• Medical condition precluding major surgery
• Inflammatory arthropathy
• Prior Patellectomy
• PCL deficiency
• Major Coronal plane deformity
• Valgus deformity
• Bone defects requiring augments, cones and/or stemmed implants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Evolution Total Knee Arthroplasty system	Total Knee Arthroplasty with Evolution Knee System	Patients will undergo total knee arthroplasty with the Evolution Total Knee System
Evolution with NitrX Total Knee Arthroplasty system	Total Knee Arthroplasty with Evolution® NitrX™ Knee System	Patients will undergo total knee arthroplasty with the NitrX Evolution Total Knee System which has the specialized protective coating

Primary Outcome Measures

Name	Time	Method
Implant Migration (Tibial Component)	2 years	Model based Radiostereometric Analysis (RSA, specialized Xrays) will be used to register the location of the tibial implant components during supine and standing exams and measure implant movement. Changes throughout the different time points of potential tibial migration, with the use of the tibial bone beads, will be measured in millimeters.

Secondary Outcome Measures

Name	Time	Method
Implant Migration (Femoral Component)	2 years	Model based Radiostereometric Analysis (specialized Xrays) will be used to register the location of the femoral components during supine and standing exams and measure implant movement. Changes throughout the different time points of potential femoral migration, with the use of the femoral bone beads, will be measured in millimeters.

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada