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临床试验/NCT05435261
NCT05435261Unknown不适用

Ganga Hospital Scoring System In Gustilo And Anderson Classification System Type-IIIA/B Open Tibial Fractures

Assiut University0 个研究点目标入组 87 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
87
主要终点
sensitivity and specificity GHS in type- IIIA/B open tibial fractures

研究概览

简要总结

The aim of this study is to assess interobserver reliability, sensitivity for amputation, and specificity for salvage of GHS in type-III injuries with open tibial fractures and predict the potential number of inpatient days, secondary procedures that would be required, and the rate of infection

详细描述

Open fractures are usually high-energy injuries that can lead to life-threatening multiple injuries. It is classified as an orthopaedic emergency, and successful treatment depends on a thorough assessment and prompt treatment of the patient and wound. With the rise in severe open tibia injuries, an ideal scoring system with high specificity and sensitivity for predicting limb salvage is required. A misdiagnosis can lead to unnecessary amputations or salvage operations. A variety of scoring methods have been described for limb salvaging. The Gustilo and Anderson classification system is still the most used. Following the original classification, typeIII injuries were subdivided into type-IIIA, which denoted adequate soft-tissue coverage of the fracture despite extensive skin loss, type-IIIB, which denoted extensive soft-tissue loss, periosteal stripping, and bone exposure; and type-IIIC, which denoted an open fracture with an associated arterial injury that required repair. It has the limitations of a low intra and inter-observer agreement rate, low specificity and sensitivity to salvage and ambulation, and an inability to predict functional results in the care of Type IIIB injuries. The Ganga Hospital Score (GHS) is an open injury score developed from a high-volume trauma center that treats more than 600 open lower-limb fractures each year, far higher than a typical major trauma center in the United Kingdom. Following three clinical trials, the score was developed and has been shown to accurately predict whether a limb can be saved or must be amputated. The scoring system's nature, which takes into account particular injuries to the bone, skin, and musculotendinous units, as well as comorbid factors, has also been expanded to advise wound treatment. In medicine, scoring systems are used to rate the severity of an illness, predict the outcome, and aid in management decisions. In open injuries, an ideal score would have a sensitivity of 100%, with all limbs requiring amputation scoring at or above the threshold value, and a specificity of 100%, with all limbs that can be preserved scoring below the threshold value. Because these injuries are frequently complex clinical conditions, this is challenging to achieve. Although it is preferable to err on the side of high specificity such that only a small percentage of salvageable limbs score over the amputation threshold, high sensitivity is also necessary to limit the number of secondary amputations.

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

入选标准

  • •All patients aged more than 17 years
  • •open fractures of the tibia irrespective of the fracture site, presenting within 24 h of injury type-IIIA/B

排除标准

  • •Patients with Gustilo and Anderson types I, II, and IIIC injuries.
  • •complete traumatic amputations.
  • •patients who had initial debridement at an outside hospital.
  • •those with an age group less than 17 years

结局指标

主要结局

sensitivity and specificity GHS in type- IIIA/B open tibial fractures

时间窗: one year

salvage with score below 14 and Amputation with score above 14

次要结局

未报告次要终点

研究者

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

Mohamed Mahmoud Abdelkarem

Director

Assiut University

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