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

January 6, 2023 updated by: Ain Shams University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: bone transport through induced membrane

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
Debridement done followed by external fixator and cement application to be followed by removal of cement (after 6 weeks) and start bone transport
Active Comparator: bone transport
  1. removal of all hardware
  2. resection of infected bone segments
  3. external fixator was applied
  4. metaphyseal osteotomy done
Procedure: bone transport
Debridement done then external fixator was applied then bone transport started.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
through study completion, an average of 1 year
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)
through study completion, an average of 1 year
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)
through study completion, an average of 1 year
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
through study completion, an average of 1 year
complications rate
Time Frame: through study completion, an average of 1 year
number of complications in each group
through study completion, an average of 1 year
additional operations
Time Frame: through study completion, an average of 1 year
number of additional operations in each group
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Mootaz F Thakeb, MD, Professor Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

January 31, 2023

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

November 1, 2022

First Submitted That Met QC Criteria

November 20, 2022

First Posted (Actual)

November 30, 2022

Study Record Updates

Last Update Posted (Estimate)

January 9, 2023

Last Update Submitted That Met QC Criteria

January 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • FMASU MD57/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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