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临床试验/NCT05435092
NCT05435092进行中(未招募)不适用

Influence of Native Knee Anatomy on Alignment and Outcome After Total Knee Arthroplasty CAT - Clinical Correlation of TKA Alignment and Native Knee Alignment

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
75
试验地点
1
主要终点
Deviation of TKA alignment from preoperative native knee alignment in the coronal plane

研究概览

简要总结

Total knee arthroplasty (TKA) is still considered the treatment of choice for painful osteoarthritis. In the last decades neutral mechanical knee alignment in the coronal plane has been considered the gold standard. However, the optimal TKA alignment is still debated. Today, component rotation measurements on three-dimensional (3D) reconstructed computed tomography (CT) images are considered the gold standard for assessing native preoperative alignment and TKA component position. In this study pre-and postoperative radiographic measurements, functional scores, and biomechanical parameters of patients with knee osteoarthritis will be assessed with the aim to investigate the relationship between deviations of TKA alignment from native preoperative alignment and clinical, functional and biomechanical alignment.

详细描述

Total knee arthroplasty (TKA) is still considered the treatment of choice for painful osteoarthritis resulting in pain and functional improvement. Despite the development of novel prosthetic design and improved outcome, about 20% of patients report persisting pain interfering with their daily activities.Total knee prostheses are aligned in the coronal, sagittal and axial planes during implantation. In the last decades, neutral mechanical knee alignment in the coronal plane has been considered the gold standard. The aim of mechanical alignment in TKA is to achieve a femorotibial joint line that is perpendicular to the mechanical axis of the long leg axis hence correcting any varus-valgus deformity via prosthesis placement with the goal of equally distributing the load between the medial and lateral prosthesis component. However, the optimal TKA alignment is still debated. Traditionally, knee alignment and total knee arthroplasty component position have been assessed using radiographs. However, this method has a low accuracy and reliability because of variation in limb rotation, knee extension deficit, patient positioning, or magnification factors. Component rotation measurements on three-dimensional (3D) reconstructed computed tomography (CT) images have replaced former methods and are now considered the gold standard for assessing native preoperative alignment and TKA component position. In this study pre-and postoperative radiographic measurements, functional scores, and biomechanical parameters of patients with knee osteoarthritis will be assessed with the aim to investigate the relationship between deviations of TKA alignment from native preoperative alignment and clinical, functional and biomechanical alignment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Age > 18 years
  • Diagnosed osteoarthritis of the knee
  • Planned primary total knee arthroplasty (cruciate retaining (CR) or posterior stabilizing (PS) designs)

排除标准

  • Inability to provide informed consent
  • Inability to communicate in German, French, Italian or English
  • Any previous ipsilateral bony knee procedure prior to TKA
  • Planned partial knee arthroplasty, semi- or full-constrained knee prosthesis
  • Patients unlikely to attend clinical follow-up (e.g., when living abroad)
  • Pregnancy
  • Female participants of childbearing potential, not using a medically reliable method of contraception, who do not wish to undergo a pregnancy test prior to exposure to i ionizing radiation

结局指标

主要结局

Deviation of TKA alignment from preoperative native knee alignment in the coronal plane

时间窗: 3 months

Primary radiographic endpoints to assess alignment deviations in the coronal plane: 1. Whole limb mechanical axis (hip-knee-ankle (HKA) angle, preoperative) 2. Native femoral varus/valgus alignment (preoperative) 3. Native tibial varus/valgus alignment (preoperative) 4. Femoral component varus/valgus alignment 5. Tibial component varus/valgus alignment

次要结局

  • Evaluation of the Sagittal alignment(3 months)
  • Evaluation of the Axial alignment(3 months)
  • Assessment of Clinical, functional and biomechanical parameters(2 years)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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