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

NCT05631951 | Unknown

• 1 other identifier: FMASU MD57/2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Loss

Outcome Measures

Primary Outcomes (6)

• External fixation time

  time from the initial application of the fixator until removal of fixator (in months)

  through study completion, an average of 1 year

• External fixation index

  calculated by dividing the EFT (months) by the bone defect size (centimeters)

  through study completion, an average of 1 year

• Docking time

  time taken (months) from end of bone transport till union of docking site (both with and without bone graft)

  through study completion, an average of 1 year

• Association for the Study and Application of the Method of Ilizarov (ASAMI) Scoring System

  scoring system for bone and functional results

  through study completion, an average of 1 year

• complications rate

  number of complications in each group

  through study completion, an average of 1 year

• additional operations

  number of additional operations in each group

  through study completion, an average of 1 year

Study Arms (2)

bone transport through induced membrane

ACTIVE COMPARATOR

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

Procedure: bone transport through induced membrane

bone transport

ACTIVE COMPARATOR

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

Procedure: bone transport

Interventions

bone transport through induced membrane PROCEDURE

Debridement done followed by external fixator and cement application to be followed by removal of cement (after 6 weeks) and start bone transport

bone transport through induced membrane

bone transport PROCEDURE

Debridement done then external fixator was applied then bone transport started.

bone transport

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sex: both sexes.
• Age:18-60 yrs old.
• Lesion: tibial or femoral bone defects (\>4 cm)
• Defects resulting from infected non-united fractures

You may not qualify if:

• Pathological and congenital defects
• Aseptic traumatic bone defects
• Defects less than 4 cm
• Multiple defects Pediatric age group

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Publications (2)

• 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.

  PMID: 25840909 BACKGROUND

• 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.

  PMID: 20417920 BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mootaz F Thakeb, MD

  Professor Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 30, 2022
• Study Start: January 1, 2019
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: January 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)