Knee Osteoarthritis, Radiostereometric Analysis, Total Knee Arthroplasty
Conditions
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.
Interventions
DEVICETotal Knee Arthroplasty with Evolution® NitrX™ Knee System
Patients will receive cemented Evolution knee system with NitrX coating for their total knee arthroplasty.
DEVICETotal Knee Arthroplasty with Evolution Knee System
Patients will receive cemented Evolution knee system without NitrX coating for their total knee arthroplasty.
Sponsors
MicroPort Orthopedics Inc.
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Synovial Joint Inflammation observation | 2 Years | Patients will complete an MRI exam using metal artefact reduction sequences. Scans will be evaluated and scored for synovial inflammation and fibrosis, indicative of reactions to metal debris, and the presence of fibrous tissue at the bone-cement-implant interface, indicative of component loosening. |
| Knee Injury and Osteoarthritis Outcome score (KOOS) | Pre-operative, 3 months, 1 year, and 2 year post-operative | Patient reported outcome measure. Holds 42 items that asks patient about pain, functional daily living, and sport and recreation. Questionnaire measures levels in frequency (never to always) and severity (none to extreme). Scores are from 0-100, with higher scores indicating no knee problems. |
| Forgotten Joint Score (FJS) | Pre-operative, 3 months, 1 year, and 2 year post-operative | Patient reported outcome measure observing the ability of a patient to forget about a joint due to successful treatment. Contains 12 items with frequency level measurement (never to mostly). The higher the score (0-100), the less aware the patient is of their affected joint when performing daily activity. |
| Wear Rates | 2 weeks (baseline), 6 weeks, 3 months, 6 months, 1 year, and 2 years. | Model based Radiostereometric Analysis (specialized Xrays) will be used to register the location of the femoral and tibial components in both standing and supine exams where the minimum joint space width between components on the medial and lateral condyles can be calculated as a measurement (in millimeters) of polyethylene wear. |
| European Quality of Life - 5 Dimension (EQ-5D) | Pre-operative, 3 months, 1 year, and 2 year | Patient reported outcome measure. Standardized 5 item instrument measuring generic health status of patient. The EQ5D uses a Likert scale which assesses five states (mobility, self care, usual care, pain and discomfort and anxiety and depression) at five different levels - none(0), slight(1), moderate(2), severe(3) or unable to perform(5). Levels are coded 1-5 and an index score is then generated. Higher scores indicate higher health status of patient. |
| Metal Exposure/Sensitivity | Pre-operative | Patient reported outcome measure. Screening tool for noting pre-operative environmental metal exposures. Questionnaire contains Yes or No questions. Higher scores would indicate greater exposure and/or metal sensitivity. |
| Veterans-Rand 12 Item Health Survey (VR-12) | Pre-operative, 3 months, 1 year, and 2 year post-operative | Patient reported outcome measure observing physical and mental health status of patient. Contains 14 items measuring levels of severity (excellent to poor) and frequency (None of the time to Yes, all of the time). Higher scores indicate higher quality of life and vice versa. |
| Circulating metal levels | Pre-operative, 1 and 2 years post-operatively. | Patients will have blood drawn and the levels of circulating cobalt, chromium, and nickel will be measured in whole blood. One vial of blood will be drawn from the patient (in milliliters). |
Countries
Canada
Outcome results
None listed