跳至主要内容
临床试验/NCT03569670
NCT03569670撤回不适用

All-Polyethylene Tibial Components in Total Knee Arthroplasty: A Radiostereometric Analysis Comparing Posterior Stabilizing and Condylar Stabilizing Implants

Lawson Health Research Institute2 个研究点 分布在 1 个国家开始时间: 2020年1月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验