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临床试验/NCT06321952
NCT06321952已完成不适用

A Comparison of Accuracy and Functional Outcome Between Robotic Assisted Surgery and Gyroscopic Based Instrument in Primary Total Knee Arthroplasty

Mahidol University2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年9月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
主要终点
accuracy of Robotic Assisted Surgery and Gyroscopic Based Instrument

研究概览

简要总结

A randomized controlled trial was conducted with 72 participants who had moderate knee osteoarthritis (Kellgren and Lawrence grade 2-3). The patients were randomly assigned to either the robotic-assisted or gyroscopic-assisted group. Baseline characteristics, including age, body mass index, length of stay, and estimated blood loss, were recorded. The primary outcome measure was the accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months. Secondary outcomes included functional outcomes (KOOS, Oxford knee score, EQ-5D-5L, range of motion) assessed preoperatively and postoperatively at 3 months, as well as at 6 months postoperatively.

详细描述

Introduction

Primary total knee arthroplasty is considered the gold standard treatment for end-stage osteoarthritis of the knee. The primary objective of this surgical procedure is to restore mechanical alignment. At Siriraj Hospital, we employ technology to enhance the accuracy of our surgical procedures. The purpose of this study is to compare the accuracy of robotic-assisted surgery (ROSA) and gyroscope-based surgery in primary total knee arthroplasty.

Methods: A randomized controlled trial was conducted with 72 participants who had moderate knee osteoarthritis (Kellgren and Lawrence grade 2-3). The patients were randomly assigned to either the robotic-assisted or gyroscopic-assisted group. Baseline characteristics, including age, body mass index, length of stay, and estimated blood loss, were recorded. The primary outcome measure was the accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months. Secondary outcomes included functional outcomes (KOOS, Oxford knee score, EQ-5D-5L, range of motion) assessed preoperatively and postoperatively at 3 months, as well as at 6 months postoperatively.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • primary osteoarthritis knee with indicated for total knee replacement
  • age equal or more than 55 years old

排除标准

  • revision surgery
  • deformity greater than 15º
  • Intra/Post operative complication

结局指标

主要结局

accuracy of Robotic Assisted Surgery and Gyroscopic Based Instrument

时间窗: preoperative and postoperative 3months

accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months

次要结局

  • Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument(preoperative and postoperative 3months and 6months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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