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

Not Applicable

• Conditions: Bone Loss
• Interventions: Procedure: Trifocal bone transport; Procedure: Bifocal bone transport.

• Registration Number: NCT04486365
• Lead Sponsor: Assiut University

Brief Summary

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.

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 Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-23
• Last Update Submitted: 2020-07-23
• Study First Posted: 2020-07-24
• Last Update Posted: 2020-07-24
• Study Start: 2020-08-01
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trifocal bone transport	Trifocal bone transport	The trifocal approach is two osteotomies creating two separate transported bone segments between osteotomy and defect.
Bifocal bone transport	Bifocal bone transport.	The bifocal approach is a single osteotomy to create one transported bone segment between the osteotomy and the defect.

Primary Outcome Measures

Name	Time	Method
External fixation index	12 to 15 months	the number of days the external fixator is attached to the bone per centimeter of length gained.