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临床试验/NCT05871112
NCT05871112已完成不适用

Establishing Femoral Component Rotation Using a Dynamic Tensioner Does Not Improve Patellar Position After Total Knee Replacement With Use of Anatomic Implants - Matched-cohort Study

Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2021年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
125
试验地点
1
主要终点
Patella positioning in the trochlear groove on computed tomography (CT) after TKR

研究概览

简要总结

Analysis of patellar positioning in the trochlear groove after TKA with and without the use of dynamic tensioner.

详细描述

It appears that by precisely adjusting femoral component rotation and its relation to soft tissues in the area we can achieve better function of the patellofemoral joint and thus reduce the occurrence of anterior knee pain. Achieving proper femoral component rotation is challenging, as the bony landmarks are difficult to identify. This goal may be accomplished by using a dynamic tensioner - a device that intraoperatively measures joint gap stiffness in extension and 90 degrees flexion. This is especially important in knees with high grade arthritis and limb malalignment, where ligaments' and tendons' efficiency is affected.The aim of this study was to analyze patella positioning in the trochlear groove on CT scans of patients undergoing TKR with use of a dynamic tensioner and compare it to the ones undergoing standard measured-resection technique. Secondary outcome was to assess the frequency of anterior knee pain, range of motion and patient-reported outcome 3 and 12 months after the surgery.

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
60 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age over 60
  • BMI < 40
  • ablity to walk for 10meters
  • leg length discrepancy <5mm
  • knee flexion > 90 degrees
  • hip extension < 0 degrees
  • hip flexion > 90 degrees
  • III / IV level of osteoarthritis in Kellgren - Lawrence scale

排除标准

  • varus/valgus/ fixed flexion deformity > 15 degrees
  • revision TKA
  • prior UKA

结局指标

主要结局

Patella positioning in the trochlear groove on computed tomography (CT) after TKR

时间窗: January 2021 - August 2021

Analysis of CT scans of patients undergoing TKR in 30 degrees of knee flexion in the days following the procedure

次要结局

  • Prevalence of anterior knee pain after TKR(January 2021 - January 2022)
  • Patient-reported outcome after TKR(January 2021 - January 2022)
  • Range of motion after TKR(January 2021 - January 2022)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Artur Stolarczyk

Prof.

Medical University of Warsaw

研究点 (1)

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