Bone Transport Through Induced Membrane vs Conventional Bone Transport in Management of Bone Defects of Lower Limbs

Study Overview
=================
Brief Summary
-----------------
This is a prospective randomised controlled comparative study comparing bone transport through induced membrane (BTM) and conventional bone transport (BT) in management of bone defects in infected non united fractures of long bones of lower limbs (femur, tibia) as regard clinical, functional outcomes and possible complications.

Detailed Description
-----------------
A prospective randomised controlled study was conducted at Ain shams university hospitals. A total of 30 patients with infected non united fractures of long bones of lower limbs (femur and tibia) were divided randomly into 15 patients treated by bone transport through induced membrane technique (BTM) (Group A) and 15 patients treated by conventional bone transport technique (BT) (Group B)

Official Title
-----------------
Bone Transport Through Induced Membrane Technique Versus Conventional Bone Transport Technique in Management of Bone Defects of Lower Limbs

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

Intervention / Treatment
-----------------
* Procedure: bone transport through induced membrane
* Procedure: bone transport


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sex: both sexes. Age:18-60 yrs old. Lesion: tibial or femoral bone defects (>4 cm) Defects resulting from infected non-united fractures Exclusion Criteria: Pathological and congenital defects Aseptic traumatic bone defects Defects less than 4 cm Multiple defects Pediatric age group

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 30 patients were included and divided randomly into two equal groups: Group (A) will undergo BTM Group (B) will undergo BT Methods: I. Preoperative evaluation II. Operative interventions: A. Pre-operative: B. Operative interventions first step • resection of infected bone Second step: (A) Group A cement spacer and external fixator were applied then removal of cement spacer and metaphyseal osteotomy done (B)Group B external fixator was applied then metaphyseal osteotomy done C. Post-operative bone transport was started after latency of 7 days (from osteotomy) at rate of 1mm per day in 4 increments per day (rhythm of 0.25 mm every 6 hours) until reaching docking site.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bone transport through induced membrane<br>First stage antibiotic impregnated cement spacer was applied to the bone defect external fixator was applied for 6-8 weeks ϖ Second stage 1.removal of cement spacer done 2.metaphyseal osteotomy done | Procedure: bone transport through induced membrane<br>* Debridement done followed by external fixator and cement application to be followed by removal of cement (after 6 weeks) and start bone transport<br>|
| Active Comparator: bone transport<br>removal of all hardware resection of infected bone segments external fixator was applied metaphyseal osteotomy done | Procedure: bone transport<br>* Debridement done then external fixator was applied then bone transport started.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| External fixation time | time from the initial application of the fixator until removal of fixator (in months) | through study completion, an average of 1 year | 
| External fixation index | calculated by dividing the EFT (months) by the bone defect size (centimeters) | through study completion, an average of 1 year | 
| Docking time | time taken (months) from end of bone transport till union of docking site (both with and without bone graft) | through study completion, an average of 1 year | 
| Association for the Study and Application of the Method of Ilizarov (ASAMI) Scoring System | scoring system for bone and functional results | through study completion, an average of 1 year | 
| complications rate | number of complications in each group | through study completion, an average of 1 year | 
| additional operations | number of additional operations in each group | through study completion, an average of 1 year |