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临床试验/NCT04434690
NCT04434690
Unknown
不适用

Radiologic Results of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 80 人2020年6月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Gonarthrosis; Primary
发起方
Bezmialem Vakif University
入组人数
80
试验地点
1
主要终点
Radiological examination
最后更新
5年前

概览

简要总结

Many surgeons and patients prefer bilateral total knee arthroplasty (TKA) under one anesthesia as single-stage administration. A single-stage bilateral TKA can be performed in two different ways: single-stage, two-team simultaneous bilateral TKA (two surgeons bilateral TKA), and single-stage, a sequential bilateral TKA (single surgeon bilateral TKA). The purpose of this study is to evaluate the radiological results in the single-stage bilateral TKA in terms of two surgeons bilateral TKA and single surgeon bilateral TKA.

详细描述

Investigators will enroll 136 participants with primary bilateral symptomatic knee osteoarthritis that will refractory to conservative treatment who will undergo bilateral TKA under single anaesthesia after 15.06.2020. Investigators will include patients who were less than 75 years old, with no history of malignancy, without severe extra-articular deformities, and without the systemic inflammatory disease, severe cardiac insufficiency, and morbid obesity (\>40 kg/m2 or 35 or more and experiencing obesity-related health conditions). An informed consent form will be obtained from all patients.

注册库
clinicaltrials.gov
开始日期
2020年6月1日
结束日期
2020年10月31日
最后更新
5年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Orkhan Aliyev

MD, Resident Doctor in Orthopaedic Surgery

Bezmialem Vakif University

入排标准

入选标准

  • Primary bilateral knee osteoarthritis with refractory to conservative treatment Patients who accept participation in the research and the randomization

排除标准

  • no history of malignancy less than 75 years old without severe extra-articular deformities severe cardiac insufficiency and morbid obesity without systemic inflammatory diseases

结局指标

主要结局

Radiological examination

时间窗: 14days

Coronal and Sagittal Alignment

研究点 (1)

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