NitrX Total Knee Arthroplasty RSA

N/AActive Not RecruitingNCT05151315

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Total Knee Arthroplasty Knee Osteoarthritis

Interventions

Total Knee Arthroplasty with Evolution® NitrX™ Knee SystemDEVICE

Patients will receive cemented Evolution knee system with NitrX coating for their total knee arthroplasty.

Total Knee Arthroplasty with Evolution Knee SystemDEVICE

Patients will receive cemented Evolution knee system without NitrX coating for their total knee arthroplasty.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Implant Migration (Tibial Component)

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.

Time frame: 2 years

Secondary Outcomes

Implant Migration (Femoral Component)

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.