Clinical trial NCT05435261: Ganga Hospital Scoring System In Type-IIIA/B Open Tibial Fractures
Official title: Ganga Hospital Scoring System In Gustilo And Anderson Classification System Type-IIIA/B Open Tibial Fractures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fractures, Open
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: trauma patient with open tibial fractures type-IIIA/B

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: sensitivity and specificity GHS in type- IIIA/B open tibial fractures
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Prof. Dr
name: Ali Mohamadean Mohamed, Professor
role: STUDY_CHAIR
affiliation: Ass. Prof. Dr
name: Hossam Mohamed Abubeih, Assistant Professor
role: STUDY_DIRECTOR
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