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临床试验/NCT06475014
NCT06475014已完成不适用

Application of Knee Measurements on 3D Computed Tomography in Total Knee Replacement

Vinmec Healthcare System1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年4月25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
45
试验地点
1
主要终点
Radiology outcome

研究概览

简要总结

A 3D Computed Tomographic Study of Vietnamese Knee Morphology for Total knee Replacement

详细描述

There were controversies and inconsistent results regarding the effectiveness of PSI.

However, most authors used PSI from commercial manufacturers. From our view, the surgeon's involvement in PSI planning and design can affect the PSI's accuracy. Some other benefits of in-hospital PSI included the use of any type of implant without depending on the manufacturer's software system, faster and cheaper. Therefore, we conducted this study to evaluate the effect of in-hospital PSI in which the surgeons take part in the manufacturing job.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Clinical diagnosis of knee osteoarthritis, grade III, IV
  • •Underwent total knee replacement using patient-specific intrumentation
  • •With pre and post-operative whole limb CT-Scanners

排除标准

  • •Paticipants with valgus knee deformity,
  • •A history of hip arthroplasty,
  • •Large bone defect that required augments.

结局指标

主要结局

Radiology outcome

时间窗: 30/06/2023

Position of implants compare to the plan on CT, measure the discrepancies by degree

Clinical outcome, self-administered questionnaire

时间窗: 30/06/2024

Western Ontario and McMaster Universities Arthritis Index (WOMAC) score, from 0-96, lower is better

Clinical outcome, by surgeon's evaluating

时间窗: 30/06/2024

The 2011 Knee Society Scoring System, from 0 to 100, higher is better

次要结局

未报告次要终点

研究者

发起方
Vinmec Healthcare System
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vo Sy Quyen Nang

MD

Vinmec Healthcare System

研究点 (1)

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