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临床试验/NCT04509895
NCT04509895已完成不适用

Minimally Invasive Calcaneal Fixation Via Sinus Tarsi Approach Vs Standard Lateral Extensile Approach in Calcaneal Fracture ( Randomized Controlled Trial )

Assiut University2 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2021年10月1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
225
试验地点
2
主要终点
AOFAS( American association of foot and ankle score )for hind foot

研究概览

简要总结

a comparison between the standard lateral extensile approach and minimally invasive sinus tarsi approach in this research.

详细描述

Calcaneal fracture occurred in about 2% of patients; they represented almost 60% of all tarsal fractures.

Calcaneal fractures are caused by high velocity Force to the heel, mostly vehicle accident or fall from height. There are many factors affect the fracture pattern: age of the patient, weight , type of fall . Male patients predominated (75%) and younger than 50 years. In most cases, these fractures are bilateral and conjoined with lumbar spine fractures.

According to the result of computed tomography (CT) scanning. The calcaneal fractures can be classified into 4 categories, among which the SANDERS TYPE Ⅱ and Ⅲ fractures are the most common types.2 Thus the development of effective and safe treatment strategies for these two fracture types has always been an issue among orthopedic surgeons.

The treatment of intra-articular calcaneal fractures has always been controversial. Currently open reduction and internal fixation through L-Shape extensile incision has been considered as the gold standard surgical therapy for calcaneal fractures. This approach provide a large view to expose the fracture, allowing accurate reduction of the deformed posterior facet and convenient placement of the plate to achieve stable fixation. Postoperatively, plaster cast is worn for 2 weeks, walking with the crutches for additional 8-12 weeks is prescribed, and return to work is achieved after 6-9 months. However, the high incidence (approximately 30%) of complications associated with this approach, including wound dehiscence and deep infection , remain a non-negligible problem .

To lower the wound complications , a minimally invasive approaches has been introduced such as percutaneously applied distraction systems K-wires or screw fixation of intra-articular fractures , the use of elizarov device , percutaneous arthroscopy assisted osteosynthesis and Sinus Tarsi approaches . The sinus tarsi approach has become one of the most frequently applied minimally invasive approaches because of its ability to provide adequate exposure for the posterior facet, the anterolateral fragment and the lateral wall. Wound complication rate with this approach have been reported to range from 0% to 15.4% . Nevertheless, the poor visualization of the lateral wall of the calcaneus through this small incision makes it difficult to insert the conventional plate for obtaining a stable fixation. Thus, the development of a plate that is adaptable to the anatomic characteristics of the calcaneus and sinus tarsi approach is important.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with calcaneal fractures according to Sanders classification, are Sanders type II or type III.
  • closed calcaneal fractures

排除标准

  • patients with calcaneal fractures classification according to sanders classification , are sanders type I or IV 2)patients who have systemic comorbidity as( cardic ,diabetec ,cirrhotic patients, etc.) or smokers or local lesion as (blisters,vasculopathy , swelling etc.).
  • open calcaneal fractures.

结局指标

主要结局

AOFAS( American association of foot and ankle score )for hind foot

时间窗: baseline

american association foot and ankle score

次要结局

  • Time needed before full weight bearing ( from 3 to 6 month )(baseline)
  • Radiological gissane angle(Baseline)
  • Union rate(baseline)
  • Radiological bohler angle(baseline)
  • Wound complications(baseline)

研究者

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

peter mamdouh shehata

Resident doctor

Assiut University

研究点 (2)

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