Fractures, OpenNCT05435261
Ganga Hospital Scoring System In Type-IIIA/B Open Tibial Fractures
An observational study of Fractures, Open, run by Assiut University.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractures, Open
- What is being tested?
- BKA and Debridement with Ex_Fix (salvage)
- Type of treatment
- Surgery or procedure
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: trauma patient with open tibial fractures type-IIIA/B
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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
- Being tested
- BKA, Debridement with Ex_Fix (salvage)
- Medical subject headings
- Fractures, Open
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BKAProcedure or surgery
Below Knee Amputation:
- Under spinal anesthesia
- BKA
- closure in layers (terminal closure) with suction drain.
Debridement with Ex_Fix (salvage)Procedure or surgery
Debridement and External Fixation (salvage):
- Under spinal anesthesia
- wound debridement and wash.
- external fixation.
| Study group | Role | What they receive |
|---|---|---|
| Group I | with a score below 14 Receives: Procedure: Debridement with Ex_Fix (salvage) | |
| Group II | with a score above 14 Receives: Procedure: BKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity and specificity GHS in type- IIIA/B open tibial fractures
salvage with score below 14 and Amputation with score above 14
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Dec 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Fractures, OpenStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud Abdelkarem, Assiut University
- Investigators
- Ali Mohamadean Mohamed, Professor, Study chair, Prof. DrHossam Mohamed Abubeih, Assistant Professor, Study director, Ass. Prof. Dr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435261
- Sponsor's protocol ID
- GHS
- Status last verified
- Aug 2022
- First submitted
- 23 Jun 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Griffin M, Malahias M, Khan W, Hindocha S. Update on the management of open lower limb fractures. Open Orthop J. 2012;6:571-7. doi: 10.2174/1874325001206010571. Epub 2012 Nov 30.
PubMed 23248730Gustilo RB, Anderson JT. Prevention of infection in the treatment of one thousand and twenty-five open fractures of long bones: retrospective and prospective analyses. J Bone Joint Surg Am. 1976 Jun;58(4):453-8.
PubMed 773941Kumar KN, Shivanna HYS, Kumar TNS, Pratheeksh. Assessment of Ganga Hospital Open Injury Severity Score of Limbs. J Emerg Trauma Shock. 2020 Oct-Dec;13(4):317-318. doi: 10.4103/JETS.JETS_68_20. Epub 2020 Dec 7. No abstract available.
PubMed 33897152Rajasekaran S, Naresh Babu J, Dheenadhayalan J, Shetty AP, Sundararajan SR, Kumar M, Rajasabapathy S. A score for predicting salvage and outcome in Gustilo type-IIIA and type-IIIB open tibial fractures. J Bone Joint Surg Br. 2006 Oct;88(10):1351-60. doi: 10.1302/0301-620X.88B10.17631.
PubMed 17012427Rajasekaran S, Sabapathy SR. A philosophy of care of open injuries based on the Ganga hospital score. Injury. 2007 Feb;38(2):137-46. doi: 10.1016/j.injury.2006.04.135. Epub 2006 Sep 6.
PubMed 16950263Al-Hourani K, Stoddart M, Khan U, Riddick A, Kelly M. Orthoplastic reconstruction of type IIIB open tibial fractures retaining debrided devitalized cortical segments: the Bristol experience 2014 to 2018. Bone Joint J. 2019 Aug;101-B(8):1002-1008. doi: 10.1302/0301-620X.101B8.BJJ-2018-1526.R2.
PubMed 31362546Messner J, Johnson L, Taylor DM, Harwood P, Britten S, Foster P. Treatment and functional outcomes of complex tibial fractures in children and adolescents using the Ilizarov method. Bone Joint J. 2018 Mar 1;100-B(3):396-403. doi: 10.1302/0301-620X.100B3.BJJ-2017-0863.R1.
PubMed 29589503Venkatadass K, Grandhi TSP, Rajasekaran S. Use of Ganga Hospital Open Injury Severity Scoring for determination of salvage versus amputation in open type IIIB injuries of lower limbs in children-An analysis of 52 type IIIB open fractures. Injury. 2017 Nov;48(11):2509-2514. doi: 10.1016/j.injury.2017.09.010. Epub 2017 Sep 12.
PubMed 28918873Shanmuganathan R. The utility of scores in the decision to salvage or amputation in severely injured limbs. Indian J Orthop. 2008 Oct;42(4):368-76. doi: 10.4103/0019-5413.43371.
PubMed 19753223Rajasekaran S, Sabapathy SR, Dheenadhayalan J, Sundararajan SR, Venkatramani H, Devendra A, Ramesh P, Srikanth KP. Ganga hospital open injury score in management of open injuries. Eur J Trauma Emerg Surg. 2015 Feb;41(1):3-15. doi: 10.1007/s00068-014-0465-9. Epub 2014 Nov 6.
PubMed 26038161Durham RM, Mistry BM, Mazuski JE, Shapiro M, Jacobs D. Outcome and utility of scoring systems in the management of the mangled extremity. Am J Surg. 1996 Nov;172(5):569-73; discussion 573-4. doi: 10.1016/S0002-9610(96)00245-0.
PubMed 8942565Caudle RJ, Stern PJ. Severe open fractures of the tibia. J Bone Joint Surg Am. 1987 Jul;69(6):801-7.
PubMed 3597491Madhuchandra P, Rafi M, Devadoss S, Devadoss A. Predictability of salvage and outcome of Gustilo and Anderson type-IIIA and type-IIIB open tibial fractures using Ganga Hospital Scoring system. Injury. 2015 Feb;46(2):282-7. doi: 10.1016/j.injury.2014.11.003. Epub 2014 Nov 15.
PubMed 25482348
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ganga Hospital Scoring System In Gustilo And Anderson Classification System Type-IIIA/B Open Tibial Fractures
- ClinicalTrials.gov ID
- NCT05435261
- Acronym / sponsor ID
- GHS
- Conditions
- Fractures, Open
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Procedure: Debridement with Ex_Fix (salvage)with a score below 14 |
| Group II | – | Procedure: BKAwith a score above 14 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- trauma patient with open tibial fractures type-IIIA/B
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BKABelow Knee Amputation: * Under spinal anesthesia * BKA * closure in layers (terminal closure) with suction drain. | Procedure or surgery | Group II |
| Debridement with Ex_Fix (salvage)Debridement and External Fixation (salvage): * Under spinal anesthesia * wound debridement and wash. * external fixation. | Procedure or surgery | Group I |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Background: PubMed 23248730Griffin M, Malahias M, Khan W, Hindocha S. Update on the management of open lower limb fractures. Open Orthop J. 2012;6:571-7. doi: 10.2174/1874325001206010571. Epub 2012 Nov 30.
- Background: PubMed 773941Gustilo RB, Anderson JT. Prevention of infection in the treatment of one thousand and twenty-five open fractures of long bones: retrospective and prospective analyses. J Bone Joint Surg Am. 1976 Jun;58(4):453-8.
- Background: PubMed 33897152Kumar KN, Shivanna HYS, Kumar TNS, Pratheeksh. Assessment of Ganga Hospital Open Injury Severity Score of Limbs. J Emerg Trauma Shock. 2020 Oct-Dec;13(4):317-318. doi: 10.4103/JETS.JETS_68_20. Epub 2020 Dec 7. No abstract available.
- Background: PubMed 17012427Rajasekaran S, Naresh Babu J, Dheenadhayalan J, Shetty AP, Sundararajan SR, Kumar M, Rajasabapathy S. A score for predicting salvage and outcome in Gustilo type-IIIA and type-IIIB open tibial fractures. J Bone Joint Surg Br. 2006 Oct;88(10):1351-60. doi: 10.1302/0301-620X.88B10.17631.
- Background: PubMed 16950263Rajasekaran S, Sabapathy SR. A philosophy of care of open injuries based on the Ganga hospital score. Injury. 2007 Feb;38(2):137-46. doi: 10.1016/j.injury.2006.04.135. Epub 2006 Sep 6.
- Background: PubMed 31362546Al-Hourani K, Stoddart M, Khan U, Riddick A, Kelly M. Orthoplastic reconstruction of type IIIB open tibial fractures retaining debrided devitalized cortical segments: the Bristol experience 2014 to 2018. Bone Joint J. 2019 Aug;101-B(8):1002-1008. doi: 10.1302/0301-620X.101B8.BJJ-2018-1526.R2.
- Background: PubMed 29589503Messner J, Johnson L, Taylor DM, Harwood P, Britten S, Foster P. Treatment and functional outcomes of complex tibial fractures in children and adolescents using the Ilizarov method. Bone Joint J. 2018 Mar 1;100-B(3):396-403. doi: 10.1302/0301-620X.100B3.BJJ-2017-0863.R1.
- Background: PubMed 28918873Venkatadass K, Grandhi TSP, Rajasekaran S. Use of Ganga Hospital Open Injury Severity Scoring for determination of salvage versus amputation in open type IIIB injuries of lower limbs in children-An analysis of 52 type IIIB open fractures. Injury. 2017 Nov;48(11):2509-2514. doi: 10.1016/j.injury.2017.09.010. Epub 2017 Sep 12.
- Background: PubMed 19753223Shanmuganathan R. The utility of scores in the decision to salvage or amputation in severely injured limbs. Indian J Orthop. 2008 Oct;42(4):368-76. doi: 10.4103/0019-5413.43371.
- Background: PubMed 26038161Rajasekaran S, Sabapathy SR, Dheenadhayalan J, Sundararajan SR, Venkatramani H, Devendra A, Ramesh P, Srikanth KP. Ganga hospital open injury score in management of open injuries. Eur J Trauma Emerg Surg. 2015 Feb;41(1):3-15. doi: 10.1007/s00068-014-0465-9. Epub 2014 Nov 6.
- Background: PubMed 8942565Durham RM, Mistry BM, Mazuski JE, Shapiro M, Jacobs D. Outcome and utility of scoring systems in the management of the mangled extremity. Am J Surg. 1996 Nov;172(5):569-73; discussion 573-4. doi: 10.1016/S0002-9610(96)00245-0.
- Background: PubMed 3597491Caudle RJ, Stern PJ. Severe open fractures of the tibia. J Bone Joint Surg Am. 1987 Jul;69(6):801-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Mohamadean Mohamed, Professor study chair
Prof. Dr
Hossam Mohamed Abubeih, Assistant Professor study director
Ass. Prof. Dr
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures, Open, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Mahmoud Abdelkarem, M.B.B.CH (01017781468, Mohamed.20134306@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity and specificity GHS in type- IIIA/B open tibial fractures (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05435261, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.