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临床试验/NCT04399304
NCT04399304已完成不适用

Safety of Bilateral HTO: One-Stage vs.Two-Stage: A Randomized Controlled Study

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2014年11月19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
28
试验地点
1
主要终点
Complications

研究概览

简要总结

In this study, bilateral simultaneous high tibial osteotomy (HTO) was compared with staged bilateral HTO in terms of complications. We did not use any grafts to support the osteotomy line and the patients were mobilized immediately with a full load on a postoperative day 1. And our hypothesis is that bilateral simultaneous applications are safe in comparison to the staged ones in terms of complications.

详细描述

Knee osteoarthritis is the most common orthopedic chronic disease, and varus knee abnormalities can often be related. The load from the medial tibiofemoral joint increases significantly in varus alignment disorder and it plays an important role in the structural progression of knee osteoarthritis. Varus malalignment and patients with medial tibiofemoral disease comprise a common patient subset. The probability of progressing to severe disease is 3 to 4 times higher in these patients compared to those with a neutral knee alignment. Although the long-term results of high tibial osteotomy are well documented, but data on bilateral simultaneous HTO are insufficient. In general, staged surgery is preferred in bilateral cases due to the difficult rehabilitation, healing of the osteotomy line, and complications related to surgery. Advances in post-surgical rehabilitation have been made due to increased confidence in stability due to improvements in the technology of plates.The advantages of an bilateral simulatneous HTO is single administration of anesthesia, total shortening of the hospitalization periof and reduced costs.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Bilateral primary genu varus gonarthrosis

排除标准

  • Secondary gonarthrosis

结局指标

主要结局

Complications

时间窗: 2 year

Total complications rate

次要结局

  • Radiologic assesment(2 year)

研究者

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

Orkhan Aliyev

MD, Resident Doctor in Orthopaedic Surgery

Bezmialem Vakif University

研究点 (1)

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