NitrX Total Knee Arthroplasty RSA

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

Status: Active, not recruiting

Conditions: Radiostereometric Analysis; Knee Osteoarthritis; Total Knee Arthroplasty

Treatments: Device: Total Knee Arthroplasty with Evolution Knee System; Device: Total Knee Arthroplasty with Evolution® NitrX™ Knee System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05151315

119937

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Evolution Total Knee Arthroplasty system

Active Comparator group

Description:

Patients will undergo total knee arthroplasty with the Evolution Total Knee System

Treatment:

Device: Total Knee Arthroplasty with Evolution Knee System

Evolution with NitrX Total Knee Arthroplasty system

Experimental group

Description:

Patients will undergo total knee arthroplasty with the NitrX Evolution Total Knee System which has the specialized protective coating

Treatment:

Device: Total Knee Arthroplasty with Evolution® NitrX™ Knee System