Ganga Hospital Scoring System In Type-IIIA/B Open Tibial Fractures

NCT ID: NCT05435261

Last Updated: 2022-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 87 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-05-31

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.

Conditions

Fractures, Open

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group I

with a score below 14

Debridement with Ex_Fix (salvage)

Intervention Type: PROCEDURE

Debridement and External Fixation (salvage):

• Under spinal anesthesia
• wound debridement and wash.
• external fixation.

Group II

with a score above 14

BKA

Intervention Type: PROCEDURE

Below Knee Amputation:

• Under spinal anesthesia
• BKA
• closure in layers (terminal closure) with suction drain.

Interventions

BKA

Below Knee Amputation:

• Under spinal anesthesia
• BKA
• closure in layers (terminal closure) with suction drain.

Intervention Type: PROCEDURE

Debridement with Ex_Fix (salvage)

Debridement and External Fixation (salvage):

• Under spinal anesthesia
• wound debridement and wash.
• external fixation.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Mahmoud Abdelkarem

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Mohamadean Mohamed, Professor

Role: STUDY_CHAIR

Prof. Dr

Hossam Mohamed Abubeih, Assistant Professor

Role: STUDY_DIRECTOR

Ass. Prof. Dr

Central Contacts

Mohamed Mahmoud Abdelkarem, M.B.B.CH

Role: CONTACT

Mohamed.20134306@med.au.edu.eg

01017781468

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Other Identifiers

GHS

Identifier Type: -

Identifier Source: org_study_id