All-Polyethylene Tibial Components in Total Knee Arthroplasty: A Radiostereometric Analysis Comparing Posterior Stabilizing and Condylar Stabilizing Implants
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Implant Migration
研究概览
简要总结
This is a randomized control trial where patients will be randomized to receive one of two types of total knee arthroplasty (TKA) all-polyethylene (AP) tibial components: cruciate retaining (CR) or posterior stabilized (PS). We will use radiostereometric analysis to assess the stability of the implants at 6 weeks, 3 months, 6 months, 1 year and 2 year post-operatively. The main objective of this project will be to determine which AP tibial component offers the greatest stability. Additionally, we will seek to determine whether patient BMI significantly impacts the stability of AP tibial components.
详细描述
With healthcare expenditures rising as our population ages, there have been significant efforts targeted towards streamlining costs associated with various medical treatments. One area of substantial spending in the orthopaedic surgery field is total joint replacements. The effort to reduce costs has sparked a renewed interest in the use of allpolyethylene (AP) tibial components in total knee arthroplasty (TKA).
In recent years, there has been ample research demonstrating that AP tibial components have performed as good as, or better, than metal-backed (MB) tibial components. Some studies have estimated that cost savings could be as high as 50% with routine use of AP tibial components. While sufficient literature exists demonstrating the equivalence or superiority of AP versus MB designs, there is a paucity of work done comparing different types of AP tibial components.
Tibial components in TKA can be of the posterior stabilizing (PS) or cruciate retaining (CR) variety. To date, we are unaware of any study that directly compares AP tibial PS components to AP tibial CR components.
Radiostereometric analysis (RSA) has evolved as an exceptionally precise and reliable method for assessing the migration of components in total joint arthroplasty. Using RSA data, it is possible to accurately predict, within the first 24 months post-operatively, the survival of a total joint arthroplasty. Furthermore, the use of RSA outcomes in arthroplasty research allows for adequately powered studies with significantly smaller sample sizes than previously required.
The main objective of this project will be to determine which AP tibial component offers the greatest stability. Additionally, we will seek to determine whether patient body mass index (BMI) significantly impacts the stability of AP tibial components.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •osteoarthritis
- •primary total knee arthroplasty
- •able to consent for themself
排除标准
- •inflammatory arthropathy
- •fibromyalgia
- •chronic pain syndrome
- •previous distal femur or proximal tibia open reduction internal fixation
结局指标
主要结局
Implant Migration
时间窗: Change between baseline (taken at 2 weeks post-operatively) and 2 years
Comparison of the two component types using radiostereometric analysis imaging.
次要结局
- VR-12(2 years)
- Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)(2 years)
- EQ-5D(2 years)
- Cost(Intraoperative)
- Oxford Knee Score(2 years)
