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

Not Applicable

Active, not recruiting

• Conditions: Bone Loss
• Interventions: Procedure: bone transport; Procedure: bone transport through induced membrane

• Registration Number: NCT05631951
• Lead Sponsor: Ain Shams University

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)

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2022-11-20
• Study First Posted: 2022-11-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-06
• Last Update Posted: 2023-01-09
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bone transport	bone transport	1. removal of all hardware 2. resection of infected bone segments 3. external fixator was applied 4. metaphyseal osteotomy done
bone transport through induced membrane	bone transport through induced membrane	First stage 1. antibiotic impregnated cement spacer was applied to the bone defect 2. external fixator was applied for 6-8 weeks ϖ Second stage 1.removal of cement spacer done 2.metaphyseal osteotomy done

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt