Clinical trial NCT05631951: Bone Transport Through Induced Membrane vs Conventional Bone Transport in Management of Bone Defects of Lower Limbs
Official title: Bone Transport Through Induced Membrane Technique Versus Conventional Bone Transport Technique in Management of Bone Defects of Lower Limbs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Loss
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: External fixation time
timeFrame: through study completion, an average of 1 year
measure: External fixation index
timeFrame: through study completion, an average of 1 year
measure: Docking time
timeFrame: through study completion, an average of 1 year
measure: Association for the Study and Application of the Method of Ilizarov (ASAMI) Scoring System
timeFrame: through study completion, an average of 1 year
measure: complications rate
timeFrame: through study completion, an average of 1 year
measure: additional operations
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Professor Ain Shams University
name: Mootaz F Thakeb, MD
role: STUDY_CHAIR
References:
citation: Marais LC, Ferreira N. Bone transport through an induced membrane in the management of tibial bone defects resulting from chronic osteomyelitis. Strategies Trauma Limb Reconstr. 2015 Apr;10(1):27-33. doi: 10.1007/s11751-015-0221-7. Epub 2015 Apr 4.
citation: Uzel AP, Lemonne F, Casoli V. Tibial segmental bone defect reconstruction by Ilizarov type bone transport in an induced membrane. Orthop Traumatol Surg Res. 2010 Apr;96(2):194-8. doi: 10.1016/j.rcot.2010.02.001.