Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05435261
Study type Observational
Source Assiut University
Contact Mohamed Mahmoud Abdelkarem, M.B.B.CH
Phone 01017781468
Email Mohamed.20134306@med.au.edu.eg
Status Not yet recruiting
Phase
Start date December 1, 2022
Completion date May 2024

See also
  Status Clinical Trial Phase
Completed NCT00512434 - Percutaneous Autologous Bone-marrow Grafting for Open Tibial Shaft Fracture N/A
Enrolling by invitation NCT06055712 - Antibiotic Prophylaxis in Pediatric Open Fractures Phase 4
Terminated NCT03196258 - Cognitive Behavioural Therapy to Reduce Persistent Post-Surgical Pain After Fracture N/A
Not yet recruiting NCT06400732 - Post Market Evaluation of Clinical Safety and Performance of the Fitbone Transport and Lengthening System
Not yet recruiting NCT03141502 - The New Skin Stretching Device for Treatment of Limb Tension Wounds Phase 4
Terminated NCT02400112 - Local Application of Vancomycin Powder in Grade I-IIIA Open Fractures Phase 4
Recruiting NCT00870064 - The Treatment of Type I Open Fractures in Pediatrics N/A
Recruiting NCT04730739 - FastFrame Knee Spanning and Damage Control Kit PMCF N/A
Completed NCT04872400 - Acute Application of Antibiotic Powder in Open Fracture Wounds Phase 4
Recruiting NCT04299022 - Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
Terminated NCT03705962 - Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures Phase 3
Terminated NCT03673358 - Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Pilot N/A
Recruiting NCT04274530 - Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Trial N/A
Recruiting NCT04964947 - Tobramycin Injection to Prevent Infection in Open Fractures Phase 3
Recruiting NCT06130397 - AI Assisted Detection of Fractures on X-Rays (FRACT-AI)
Recruiting NCT05260463 - LOQTEQ® Antibacterial Pre-Market Study N/A