NCT05435261

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

June 23, 2022

Last Update Submit

August 17, 2022

Conditions

Fractures, Open

Outcome Measures

Primary Outcomes (1)

  • sensitivity and specificity GHS in type- IIIA/B open tibial fractures

    salvage with score below 14 and Amputation with score above 14

    one year

Study Arms (2)

Group I

with a score below 14

Procedure: Debridement with Ex_Fix (salvage)

Group II

with a score above 14

Procedure: BKA

Interventions

BKAPROCEDURE

Below Knee Amputation: * Under spinal anesthesia * BKA * closure in layers (terminal closure) with suction drain.

Group II
Debridement with Ex_Fix (salvage)PROCEDURE

Debridement and External Fixation (salvage): * Under spinal anesthesia * wound debridement and wash. * external fixation.

Group I

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

trauma patient with open tibial fractures type-IIIA/B

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 23248730BACKGROUND

  • Gustilo 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.

    PMID: 773941BACKGROUND

  • Kumar 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.

    PMID: 33897152BACKGROUND

  • Rajasekaran 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.

    PMID: 17012427BACKGROUND

  • Rajasekaran 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.

    PMID: 16950263BACKGROUND

  • Al-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.

    PMID: 31362546BACKGROUND

  • Messner 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.

    PMID: 29589503BACKGROUND

  • Venkatadass 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.

    PMID: 28918873BACKGROUND

  • Shanmuganathan 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.

    PMID: 19753223BACKGROUND

  • Rajasekaran 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.

    PMID: 26038161BACKGROUND

  • Durham 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.

    PMID: 8942565BACKGROUND

  • Caudle RJ, Stern PJ. Severe open fractures of the tibia. J Bone Joint Surg Am. 1987 Jul;69(6):801-7.

    PMID: 3597491BACKGROUND

  • Madhuchandra 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.

    PMID: 25482348BACKGROUND

MeSH Terms

Conditions

Fractures, Open

Interventions

DebridementSalvage Therapy

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeTherapeutics

Study Officials

  • Ali Mohamadean Mohamed, Professor

    Prof. Dr

    STUDY CHAIR

  • Hossam Mohamed Abubeih, Assistant Professor

    Ass. Prof. Dr

    STUDY DIRECTOR

Central Study Contacts

Mohamed Mahmoud Abdelkarem, M.B.B.CH

CONTACT

01017781468Mohamed.20134306@med.au.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

June 23, 2022

First Posted

June 28, 2022

Study Start

December 1, 2022

Primary Completion

May 1, 2023

Study Completion

May 1, 2024

Last Updated

August 18, 2022

Record last verified: 2022-08