Bifocal vs Trifocal External Bone Transport by Ilizarov Ring External Fixator in Lower Limbs

Bifocal Versus Trifocal External Bone Transport by Ilizarov Ring External Fixator as a Treatment Method for Posttraumatic Bone Defects More Than 5cm in Lower Extremities in Adults

To compare between bifocal and trifocal external bone transport by ilizarov ring external fixator as a treatment method for posttraumatic bone defects more than 5cm in lower extremities regarding:

• External fixation index .
• The need of any further surgical procedures as debridement at docking site , the need of cancellous bone graft or the use of internal fixation.
• Functional outcome, complication rate as well as limb length discrepancy.

Study Overview

• Status: Not yet recruiting
• Conditions: Bone Loss
• Intervention / Treatment: Procedure: Bifocal bone transport.; Procedure: Trifocal bone transport

Detailed Description

Distraction osteogenesis is formation of new bone(regenerate bone) when bone segments undergo gradual, controlled separation.

There are three treatment approaches by ilizarov ring external fixator according to number of bone osteotomies. First one is the monofocal approach with closure of defect without any osteotomies. Second one is the bifocal approach with a single osteotomy to create one transported bone segment between the osteotomy and the defect. Third one is the trifocal approach with two osteotomies creating two separate transported bone segments.

Hypothetically, trifocal approach has shorter treatment time than bifocal one as it is a double level bone transport so closes the defect faster. However, there are other considerations as complications that may occur and the need of further surgical procedures and this is what will be discussed in this research.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khaled Mohsen, Bachelor; Phone Number: 01065699144; Email: kmm1821995@gmail.com
• Study Contact Backup: Name: Ahmed Ekram, MD; Phone Number: 01012756356; Email: ahmed.osman@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1)Age from 18-60ys . 2)Posttraumatic bone defects more than 5 cm. 3)Lower extremity bone defects.

Exclusion Criteria:

• 1)Young pts <18 or old pts>60. 2)Post infectious or post-resection of a tumor bone defects. 3)Upper extremity bone defects.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Bifocal bone transport; The bifocal approach is a single osteotomy to create one transported bone segment between the osteotomy and the defect.	Procedure: Bifocal bone transport.; The bifocal approach is a single osteotomy to create one transported bone segment between the osteotomy and the defect.
ACTIVE_COMPARATOR: Trifocal bone transport; The trifocal approach is two osteotomies creating two separate transported bone segments between osteotomy and defect.	Procedure: Trifocal bone transport; The trifocal approach is two osteotomies creating two separate transported bone segments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
External fixation index	the number of days the external fixator is attached to the bone per centimeter of length gained.	12 to 15 months

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.
• Hansen M, Mehler D, Voltmer W, Rommens PM. [The extraarticular proximal tibial fractures]. Unfallchirurg. 2002 Oct;105(10):858-72. doi: 10.1007/s00113-002-0529-x. German.
• Gaebler C, Berger U, Schandelmaier P, Greitbauer M, Schauwecker HH, Applegate B, Zych G, Vecsei V. Rates and odds ratios for complications in closed and open tibial fractures treated with unreamed, small diameter tibial nails: a multicenter analysis of 467 cases. J Orthop Trauma. 2001 Aug;15(6):415-23. doi: 10.1097/00005131-200108000-00006.
• Giannoudis PV, Papakostidis C, Roberts C. A review of the management of open fractures of the tibia and femur. J Bone Joint Surg Br. 2006 Mar;88(3):281-9. doi: 10.1302/0301-620X.88B3.16465. No abstract available.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2020
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (ACTUAL): July 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: bone transport / ilizarov ring external fixator
• Other Study ID Numbers: Ilizarov ring external fixator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No