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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Bone Loss

Intervention / Treatment
-----------------
* Procedure: Bifocal bone transport.
* Procedure: Trifocal bone transport


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bifocal bone transport<br>The bifocal approach is a single osteotomy to create one transported bone segment between the osteotomy and the defect. | Procedure: Bifocal bone transport.<br>* The bifocal approach is a single osteotomy to create one transported bone segment between the osteotomy and the defect.<br>|
| Active Comparator: Trifocal bone transport<br>The trifocal approach is two osteotomies creating two separate transported bone segments between osteotomy and defect. | Procedure: Trifocal bone transport<br>* The trifocal approach is two osteotomies creating two separate transported bone segments.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone transport / ilizarov ring external fixator