Component Migration, Polyethylene Wear, and Joint Inflammation of the Evolution Versus Evolution NitrX Total Knee Arthroplasty System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Implant Migration (Tibial Component)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Implant Migration (Tibial Component)
时间窗: 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.
次要结局
- Implant Migration (Femoral Component)(2 years)
研究者
Edward Vasarhelyi
Orthopaedic Surgeon
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's