Bone Transport Through Induced Membrane Technique Versus Conventional Bone Transport Technique in Management of Bone Defects of Lower Limbs
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- complications rate
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
complications rate
Time Frame: through study completion, an average of 1 year
number of complications in each group
additional operations
Time Frame: through study completion, an average of 1 year
number of additional operations in each group
External fixation time
Time Frame: 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
Time Frame: through study completion, an average of 1 year
scoring system for bone and functional results
External fixation index
Time Frame: through study completion, an average of 1 year
calculated by dividing the EFT (months) by the bone defect size (centimeters)
Docking time
Time Frame: 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)
Secondary Outcomes
No secondary outcomes reported