Bone Loss
Conditions
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)
Interventions
PROCEDUREbone transport through induced membrane
Debridement done followed by external fixator and cement application to be followed by removal of cement (after 6 weeks) and start bone transport
PROCEDUREbone transport
Debridement done then external fixator was applied then bone transport started.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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 |
| 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 |
Countries
Egypt
Outcome results
None listed