<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04486365</url>
  </required_header>
  <id_info>
    <org_study_id>Ilizarov ring external fixator</org_study_id>
    <nct_id>NCT04486365</nct_id>
  </id_info>
  <brief_title>Bifocal vs Trifocal External Bone Transport by Ilizarov Ring External Fixator in Lower Limbs</brief_title>
  <official_title>Bifocal Versus Trifocal External Bone Transport by Ilizarov Ring External Fixator as a Treatment Method for Posttraumatic Bone Defects More Than 5cm in Lower Extremities in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare between bifocal and trifocal external bone transport by ilizarov ring external&#xD;
      fixator as a treatment method for posttraumatic bone defects more than 5cm in lower&#xD;
      extremities regarding:&#xD;
&#xD;
        -  External fixation index .&#xD;
&#xD;
        -  The need of any further surgical procedures as debridement at docking site , the need of&#xD;
           cancellous bone graft or the use of internal fixation.&#xD;
&#xD;
        -  Functional outcome, complication rate as well as limb length discrepancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Distraction osteogenesis is formation of new bone(regenerate bone) when bone segments undergo&#xD;
      gradual, controlled separation.&#xD;
&#xD;
      There are three treatment approaches by ilizarov ring external fixator according to number of&#xD;
      bone osteotomies. First one is the monofocal approach with closure of defect without any&#xD;
      osteotomies. Second one is the bifocal approach with a single osteotomy to create one&#xD;
      transported bone segment between the osteotomy and the defect. Third one is the trifocal&#xD;
      approach with two osteotomies creating two separate transported bone segments.&#xD;
&#xD;
      Hypothetically, trifocal approach has shorter treatment time than bifocal one as it is a&#xD;
      double level bone transport so closes the defect faster. However, there are other&#xD;
      considerations as complications that may occur and the need of further surgical procedures&#xD;
      and this is what will be discussed in this research.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>External fixation index</measure>
    <time_frame>12 to 15 months</time_frame>
    <description>the number of days the external fixator is attached to the bone per centimeter of length gained.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Bone Loss</condition>
  <arm_group>
    <arm_group_label>Bifocal bone transport</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The bifocal approach is a single osteotomy to create one transported bone segment between the osteotomy and the defect.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trifocal bone transport</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The trifocal approach is two osteotomies creating two separate transported bone segments between osteotomy and defect.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bifocal bone transport.</intervention_name>
    <description>The bifocal approach is a single osteotomy to create one transported bone segment between the osteotomy and the defect.</description>
    <arm_group_label>Bifocal bone transport</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Trifocal bone transport</intervention_name>
    <description>The trifocal approach is two osteotomies creating two separate transported bone segments.</description>
    <arm_group_label>Trifocal bone transport</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1)Age from 18-60ys . 2)Posttraumatic bone defects more than 5 cm. 3)Lower extremity&#xD;
             bone defects.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1)Young pts &lt;18 or old pts&gt;60. 2)Post infectious or post-resection of a tumor bone&#xD;
             defects. 3)Upper extremity bone defects.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Khaled Mohsen, Bachelor</last_name>
    <phone>01065699144</phone>
    <email>kmm1821995@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ahmed Ekram, MD</last_name>
    <phone>01012756356</phone>
    <email>ahmed.osman@aun.edu.eg</email>
  </overall_contact_backup>
  <reference>
    <citation>Hansen M, Mehler D, Voltmer W, Rommens PM. [The extraarticular proximal tibial fractures]. Unfallchirurg. 2002 Oct;105(10):858-72. doi: 10.1007/s00113-002-0529-x. German.</citation>
    <PMID>12376892</PMID>
  </reference>
  <reference>
    <citation>Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.</citation>
    <PMID>16814787</PMID>
  </reference>
  <reference>
    <citation>Gaebler C, Berger U, Schandelmaier P, Greitbauer M, Schauwecker HH, Applegate B, Zych G, Vecsei V. Rates and odds ratios for complications in closed and open tibial fractures treated with unreamed, small diameter tibial nails: a multicenter analysis of 467 cases. J Orthop Trauma. 2001 Aug;15(6):415-23. doi: 10.1097/00005131-200108000-00006.</citation>
    <PMID>11514768</PMID>
  </reference>
  <reference>
    <citation>Giannoudis PV, Papakostidis C, Roberts C. A review of the management of open fractures of the tibia and femur. J Bone Joint Surg Br. 2006 Mar;88(3):281-9. doi: 10.1302/0301-620X.88B3.16465. No abstract available.</citation>
    <PMID>16497997</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Khaled Mohsen Mohammed Ahmed</investigator_full_name>
    <investigator_title>Resident physician in orthopedic surgery department.</investigator_title>
  </responsible_party>
  <keyword>bone transport / ilizarov ring external fixator</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04486365
org study id: Ilizarov ring external fixator
nct id: NCT04486365
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To compare between bifocal and trifocal external bone transport by ilizarov ring external
      fixator as a treatment method for posttraumatic bone defects more than 5cm in lower
      extremities regarding:

        -  External fixation index .

        -  The need of any further surgical procedures as debridement at docking site , the need of
           cancellous bone graft or the use of internal fixation.

        -  Functional outcome, complication rate as well as limb length discrepancy.
Distraction osteogenesis is formation of new bone(regenerate bone) when bone segments undergo
      gradual, controlled separation.

      There are three treatment approaches by ilizarov ring external fixator according to number of
      bone osteotomies. First one is the monofocal approach with closure of defect without any
      osteotomies. Second one is the bifocal approach with a single osteotomy to create one
      transported bone segment between the osteotomy and the defect. Third one is the trifocal
      approach with two osteotomies creating two separate transported bone segments.

      Hypothetically, trifocal approach has shorter treatment time than bifocal one as it is a
      double level bone transport so closes the defect faster. However, there are other
      considerations as complications that may occur and the need of further surgical procedures
      and this is what will be discussed in this research.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: External fixation index
time frame: 12 to 15 months
description: the number of days the external fixator is attached to the bone per centimeter of length gained.
arm group label: Bifocal bone transport
arm group type: Active Comparator
description: The bifocal approach is a single osteotomy to create one transported bone segment between the osteotomy and the defect.
arm group label: Trifocal bone transport
arm group type: Active Comparator
description: The trifocal approach is two osteotomies creating two separate transported bone segments between osteotomy and defect.
intervention type: Procedure
intervention name: Bifocal bone transport.
description: The bifocal approach is a single osteotomy to create one transported bone segment between the osteotomy and the defect.
arm group label: Bifocal bone transport
intervention type: Procedure
intervention name: Trifocal bone transport
description: The trifocal approach is two osteotomies creating two separate transported bone segments.
arm group label: Trifocal bone transport
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Khaled Mohsen, Bachelor
phone: 01065699144
email: kmm1821995@gmail.com
last name: Ahmed Ekram, MD
phone: 01012756356
email: ahmed.osman@aun.edu.eg
citation: Hansen M, Mehler D, Voltmer W, Rommens PM. [The extraarticular proximal tibial fractures]. Unfallchirurg. 2002 Oct;105(10):858-72. doi: 10.1007/s00113-002-0529-x. German.
PMID: 12376892
citation: Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.
PMID: 16814787
citation: Gaebler C, Berger U, Schandelmaier P, Greitbauer M, Schauwecker HH, Applegate B, Zych G, Vecsei V. Rates and odds ratios for complications in closed and open tibial fractures treated with unreamed, small diameter tibial nails: a multicenter analysis of 467 cases. J Orthop Trauma. 2001 Aug;15(6):415-23. doi: 10.1097/00005131-200108000-00006.
PMID: 11514768
citation: Giannoudis PV, Papakostidis C, Roberts C. A review of the management of open fractures of the tibia and femur. J Bone Joint Surg Br. 2006 Mar;88(3):281-9. doi: 10.1302/0301-620X.88B3.16465. No abstract available.
PMID: 16497997
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Khaled Mohsen Mohammed Ahmed
investigator title: Resident physician in orthopedic surgery department.