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

Ain Shams University

Status: Active, not recruiting

Conditions: Bone Loss

Treatments: Procedure: bone transport; Procedure: bone transport through induced membrane

Study type: Interventional

Funder types: Other

Identifiers

NCT05631951

FMASU MD57/2020

Details and patient eligibility

About

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.

Full 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)

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

bone transport through induced membrane

Active Comparator group

Description:

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

Treatment:

Procedure: bone transport through induced membrane

bone transport

Active Comparator group

Description:

1. removal of all hardware 2. resection of infected bone segments 3. external fixator was applied 4. metaphyseal osteotomy done

Treatment:

Procedure: bone transport