跳至主要内容
临床试验/NCT03628664
NCT03628664Unknown不适用

Preoperative CT Assisted Planning for Primary Total Knee Arthroplasty

Ain Shams University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Western Ontario and McMaster university osteoarthritis index (WOMAC) score

研究概览

简要总结

Total knee arthroplasty is one of the most common management methods of knee osteoarthritis. Patellar complications are one of the important causes of revision total knee arthroplasty. Proper placement of the components in the best rotational and axial alignment would achieve better patellar tracking and the best functional outcomes. Preoperative CT scan can add information regarding the coronal and rotational alignment of the prosthesis components.

详细描述

Total knee arthroplasty is the gold standard treatment for advanced knee osteoarthritis. In spite of the great advance in the prosthesis design, surgical techniques and rehabilitation programs, only 85% (75% to 92%) of patients with total knee arthroplasty are satisfied with their operations and 30% develops patellofemoral complications.

Femoral and tibial components malrotation is a crucial cause of postoperative knee pain, patellar instability, and may lead to revision. In measured resection technique the surgical epicondylar axis (SEA) is the center of rotation of the knee and the femoral component must be parallel to this axis. The surgical epicondylar axis is difficult to be determined intraoperative by palpation.

Commonly, surgeons routinely set the femoral posterior condyle resection at three degrees fixed from the posterior condylar line (PCL) because the PCL was found to be three degrees internally rotated from the (SEA).

The posterior condylar angle on a three-dimensional structure reconstruction of the CT scans in osteoarthritic knees has also been shown as 3.3° ± 1.5°, However, another study documented the posterior condylar angle (PCA) in osteoarthritic knees as 1.6° ± 1.9°. Also there is a two to three degree difference between the surgical epicondylar axis and the anatomical epicondylar axis. Therefore, a routine bone resection of three degrees from the PCL is not universal for all cases and may create malrotation of the femur.

CT scan can provide an adequate template with good but not excellent inter and intra observer reliability for exact determination of the surgical epicondylar axis and femoral component rotation.

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
Triple (Participant, Care Provider, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • Advanced knee osteoarthritis in which total knee arthroplasty is indicated

排除标准

  • Revision total knee arthroplasty

研究组 & 干预措施

CT planned total knee arthroplasty

Active Comparator

Surgeon will follow the CT plan

干预措施: CT scan (Radiation)

Non CT planned total knee arthroplasty

No Intervention

Surgeon will not follow the CT plan

结局指标

主要结局

Western Ontario and McMaster university osteoarthritis index (WOMAC) score

时间窗: One year

Knee Society score (KSS)

时间窗: one year

次要结局

  • Revision rate(one year)
  • Knee range of motion(one year)
  • Patient satisfaction: Knee Society score(KSS) subscale(one year)
  • Patellofemoral functional score(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Saeed Younis

Clinical investigator

Ain Shams University

研究点 (2)

Loading locations...

相似试验