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

August 17, 2022 updated by: Mohamed Mahmoud Abdelkarem, Assiut University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

trauma patient with open tibial fractures type-IIIA/B

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group I
with a score below 14
Procedure: Debridement with Ex_Fix (salvage)

Debridement and External Fixation (salvage):

  • Under spinal anesthesia
  • wound debridement and wash.
  • external fixation.
Group II
with a score above 14
Procedure: BKA

Below Knee Amputation:

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity and specificity GHS in type- IIIA/B open tibial fractures
Time Frame: one year
salvage with score below 14 and Amputation with score above 14
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Ali Mohamadean Mohamed, Professor, Prof. Dr
  • Study Director: Hossam Mohamed Abubeih, Assistant Professor, Ass. Prof. Dr

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2022

Primary Completion (ANTICIPATED)

May 1, 2023

Study Completion (ANTICIPATED)

May 1, 2024

Study Registration Dates

First Submitted

June 23, 2022

First Submitted That Met QC Criteria

June 27, 2022

First Posted (ACTUAL)

June 28, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fractures, Open

Clinical Trials on Debridement with Ex_Fix (salvage)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe