<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/NCT01673048</url>
  </required_header>
  <id_info>
    <org_study_id>3ESINFemur</org_study_id>
    <nct_id>NCT01673048</nct_id>
  </id_info>
  <brief_title>Modification of ESIN-osteosynthesis in a Femoral Fracture Model and Its Transmission to Clinical Practice</brief_title>
  <acronym>ESIN</acronym>
  <official_title>From Bench to Bedside: Modification of Elastic Stable Intramedullary Nailing With a 3rd Nail in a Femoral Spiral Fracture Model and Its Transmission to Clinical Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Luebeck</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Luebeck</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Elastic stable intramedullary nailing (ESIN) is the standard treatment for displaced&#xD;
      diaphyseal femoral fractures in children. However, some literature report high complication&#xD;
      rates (10-50%) in complex fractures. Data of our own patients with special emphasis on&#xD;
      complications showed also mediocre results. Thus, a biomechanical study was conducted to&#xD;
      search for modifications. In this study the stiffness with a 3rd nail implanted was compared&#xD;
      to the classical 2 C-shaped configuration. For each of the 3 configurations of retrograde&#xD;
      ESIN (titanium nails) eight composite femoral grafts (Sawbones®) with an identical spiral&#xD;
      fracture were used: 2C configuration (2 C-shaped nails, 2x3.5 mm), 3CM configuration (3rd&#xD;
      from antero-medial, + 1x2.5 mm) and 3CL configuration (3rd from antero-lateral, + 1x2.5 mm).&#xD;
      Each group underwent biomechanical testing in 4-point bending, IRO/ERO and axial compression&#xD;
      (0°/9°). Due to a significantly higher stiffness of 3CL in the anterior-posterior, internal&#xD;
      rotation and 9° compression directions implantation of 3 nails became standard treatment for&#xD;
      all dislocated femoral fractures at our department.&#xD;
&#xD;
      All patients were followed prospectively. The following data was collected: Type of&#xD;
      osteosynthesis, any kind of complication (additional procedures like cast or external&#xD;
      fixateur, Re-Do operations, misalignment, pseudarthrosis, skin irritation, infection), time&#xD;
      until full weight bearing and time until implant removal. At follow-up the legs were&#xD;
      controlled for a possible length discrepancy and a possible deviation of axis. Patients'&#xD;
      satisfaction was controlled by CSQ (clients satisfaction score, Larsen et al 2002). Further&#xD;
      on the Harris Hip Score was used. X-ray controls were done as standard care protocol after 1&#xD;
      and 3-4 months (dependend on age).&#xD;
&#xD;
      Level of Evidence IV Keywords: Elastic stable intramedullary nailing, biomechanical testing,&#xD;
      fracture, femur, treatment, children, adolescents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      see above&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraoperative and postoperative complications</measure>
    <time_frame>12 months</time_frame>
    <description>All complications will be recorded: Intraoperative and postoperative complications, Re-Do operations</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>misalignment</measure>
    <time_frame>12 m</time_frame>
    <description>Follow up X-rays will be measured for misalignment in degrees (sagittal, frontal and transverse plane) Data will be grouped as&#xD;
a) 1 - 5° b) 6 - 10° c) 11 - 15° d)16 - 20° e) 20 - 30° f) &gt; 30°</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pseudarthrosis</measure>
    <time_frame>12 m</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Limb discrepancy</measure>
    <time_frame>12 m</time_frame>
    <description>both legs will be measured from spina iliaca anterior superior to the lateral malleolus in cm.&#xD;
Results will be grouped as:&#xD;
a) 0 - 0.5 cm b) 0.6 - 1.0 cm c) 1.1 - 1.5 cm d) 1.6 - 2.0 cm e)&gt; 2 cm</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Femoral Fracture</condition>
  <condition>Children</condition>
  <arm_group>
    <arm_group_label>Femoral fracture, ESIN</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Prospectively all patients treated with the 3-nail-configuration for dislocated femoral shaft fractures were enrolled; 25 patients are planned, 18 could be enrolled Comparison will be with own previous data of patients treated with the &quot;classical&quot; 2-C-shaped ESIN-osteosynthesis</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>3-Nail-ESIN in femoral shaft fractures</intervention_name>
    <arm_group_label>Femoral fracture, ESIN</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Dislocated femoral fracture&#xD;
&#xD;
          -  ESIN osteosynthesis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No given informed consent&#xD;
&#xD;
          -  Other osteosynthesis than ESIN&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin M Kaiser, PD Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Luebeck</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Pediatric Surgery</name>
      <address>
        <city>Luebeck</city>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.kinderchirurgie.uni-luebeck.de/</url>
    <description>Department of Pediatric Surgery Luebeck</description>
  </link>
  <reference>
    <citation>Kaiser MM, Zachert G, Wendlandt R, Eggert R, Stratmann C, Gros N, Schulze-Hessing M, Rapp M. Increasing stability by pre-bending the nails in elastic stable intramedullary nailing: a biomechanical analysis of a synthetic femoral spiral fracture model. J Bone Joint Surg Br. 2012 May;94(5):713-8. doi: 10.1302/0301-620X.94B5.28247.</citation>
    <PMID>22529097</PMID>
  </reference>
  <reference>
    <citation>Kaiser MM, Zachert G, Wendlandt R, Rapp M, Eggert R, Stratmann C, Wessel LM, Schulz AP, Kienast BJ. Biomechanical analysis of a synthetic femoral spiral fracture model: Do end caps improve retrograde flexible intramedullary nail fixation? J Orthop Surg Res. 2011 Sep 18;6:46. doi: 10.1186/1749-799X-6-46.</citation>
    <PMID>21923948</PMID>
  </reference>
  <reference>
    <citation>Kaiser MM, Wessel LM, Zachert G, Stratmann C, Eggert R, Gros N, Schulze-Hessing M, Kienast B, Rapp M. Biomechanical analysis of a synthetic femur spiral fracture model: Influence of different materials on the stiffness in flexible intramedullary nailing. Clin Biomech (Bristol, Avon). 2011 Jul;26(6):592-7. doi: 10.1016/j.clinbiomech.2011.01.012. Epub 2011 Feb 22.</citation>
    <PMID>21345557</PMID>
  </reference>
  <results_reference>
    <citation>Kaiser MM, Stratmann C, Zachert G, Schulze-Hessing M, Gros N, Eggert R, Rapp M. Modification of elastic stable intramedullary nailing with a 3rd nail in a femoral spiral fracture model - results of biomechanical testing and a prospective clinical study. BMC Musculoskelet Disord. 2014 Jan 8;15:3. doi: 10.1186/1471-2474-15-3.</citation>
    <PMID>24397612</PMID>
  </results_reference>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>August 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>February 13, 2014</last_update_submitted>
  <last_update_submitted_qc>February 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Luebeck</investigator_affiliation>
    <investigator_full_name>Martin M Kaiser</investigator_full_name>
    <investigator_title>Consultant</investigator_title>
  </responsible_party>
  <keyword>Elastic stable intramedullary nailing</keyword>
  <keyword>biomechanical testing</keyword>
  <keyword>fracture</keyword>
  <keyword>femur</keyword>
  <keyword>treatment</keyword>
  <keyword>children</keyword>
  <keyword>adolescents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Femoral Fractures</mesh_term>
  </condition_browse>
  <!-- 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/NCT01673048
org study id: 3ESINFemur
nct id: NCT01673048
lead sponsor: 
has dmc: No
Elastic stable intramedullary nailing (ESIN) is the standard treatment for displaced
      diaphyseal femoral fractures in children. However, some literature report high complication
      rates (10-50%) in complex fractures. Data of our own patients with special emphasis on
      complications showed also mediocre results. Thus, a biomechanical study was conducted to
      search for modifications. In this study the stiffness with a 3rd nail implanted was compared
      to the classical 2 C-shaped configuration. For each of the 3 configurations of retrograde
      ESIN (titanium nails) eight composite femoral grafts (Sawbones®) with an identical spiral
      fracture were used: 2C configuration (2 C-shaped nails, 2x3.5 mm), 3CM configuration (3rd
      from antero-medial, + 1x2.5 mm) and 3CL configuration (3rd from antero-lateral, + 1x2.5 mm).
      Each group underwent biomechanical testing in 4-point bending, IRO/ERO and axial compression
      (0°/9°). Due to a significantly higher stiffness of 3CL in the anterior-posterior, internal
      rotation and 9° compression directions implantation of 3 nails became standard treatment for
      all dislocated femoral fractures at our department.

      All patients were followed prospectively. The following data was collected: Type of
      osteosynthesis, any kind of complication (additional procedures like cast or external
      fixateur, Re-Do operations, misalignment, pseudarthrosis, skin irritation, infection), time
      until full weight bearing and time until implant removal. At follow-up the legs were
      controlled for a possible length discrepancy and a possible deviation of axis. Patients'
      satisfaction was controlled by CSQ (clients satisfaction score, Larsen et al 2002). Further
      on the Harris Hip Score was used. X-ray controls were done as standard care protocol after 1
      and 3-4 months (dependend on age).

      Level of Evidence IV Keywords: Elastic stable intramedullary nailing, biomechanical testing,
      fracture, femur, treatment, children, adolescents.
see above
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Intraoperative and postoperative complications
time frame: 12 months
description: All complications will be recorded: Intraoperative and postoperative complications, Re-Do operations
measure: misalignment
time frame: 12 m
description: Follow up X-rays will be measured for misalignment in degrees (sagittal, frontal and transverse plane) Data will be grouped as
a) 1 - 5° b) 6 - 10° c) 11 - 15° d)16 - 20° e) 20 - 30° f) > 30°
measure: Pseudarthrosis
time frame: 12 m
measure: Limb discrepancy
time frame: 12 m
description: both legs will be measured from spina iliaca anterior superior to the lateral malleolus in cm.
Results will be grouped as:
a) 0 - 0.5 cm b) 0.6 - 1.0 cm c) 1.1 - 1.5 cm d) 1.6 - 2.0 cm e)> 2 cm
arm group label: Femoral fracture, ESIN
arm group type: Active Comparator
description: Prospectively all patients treated with the 3-nail-configuration for dislocated femoral shaft fractures were enrolled; 25 patients are planned, 18 could be enrolled Comparison will be with own previous data of patients treated with the "classical" 2-C-shaped ESIN-osteosynthesis
intervention type: Procedure
intervention name: 3-Nail-ESIN in femoral shaft fractures
arm group label: Femoral fracture, ESIN
criteria: 
gender: All
minimum age: 3 Years
maximum age: 17 Years
healthy volunteers: No
last name: Martin M Kaiser, PD Dr. med.
role: Principal Investigator
affiliation: University Luebeck
facility: 
country: Germany
url: http://www.kinderchirurgie.uni-luebeck.de/
description: Department of Pediatric Surgery Luebeck
citation: Kaiser MM, Zachert G, Wendlandt R, Eggert R, Stratmann C, Gros N, Schulze-Hessing M, Rapp M. Increasing stability by pre-bending the nails in elastic stable intramedullary nailing: a biomechanical analysis of a synthetic femoral spiral fracture model. J Bone Joint Surg Br. 2012 May;94(5):713-8. doi: 10.1302/0301-620X.94B5.28247.
PMID: 22529097
citation: Kaiser MM, Zachert G, Wendlandt R, Rapp M, Eggert R, Stratmann C, Wessel LM, Schulz AP, Kienast BJ. Biomechanical analysis of a synthetic femoral spiral fracture model: Do end caps improve retrograde flexible intramedullary nail fixation? J Orthop Surg Res. 2011 Sep 18;6:46. doi: 10.1186/1749-799X-6-46.
PMID: 21923948
citation: Kaiser MM, Wessel LM, Zachert G, Stratmann C, Eggert R, Gros N, Schulze-Hessing M, Kienast B, Rapp M. Biomechanical analysis of a synthetic femur spiral fracture model: Influence of different materials on the stiffness in flexible intramedullary nailing. Clin Biomech (Bristol, Avon). 2011 Jul;26(6):592-7. doi: 10.1016/j.clinbiomech.2011.01.012. Epub 2011 Feb 22.
PMID: 21345557
citation: Kaiser MM, Stratmann C, Zachert G, Schulze-Hessing M, Gros N, Eggert R, Rapp M. Modification of elastic stable intramedullary nailing with a 3rd nail in a femoral spiral fracture model - results of biomechanical testing and a prospective clinical study. BMC Musculoskelet Disord. 2014 Jan 8;15:3. doi: 10.1186/1471-2474-15-3.
PMID: 24397612
responsible party type: Principal Investigator
investigator affiliation: University of Luebeck
investigator full name: Martin M Kaiser
investigator title: Consultant
mesh term: Fractures, Bone
mesh term: Femoral Fractures