<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/NCT04441723</url>
  </required_header>
  <id_info>
    <org_study_id>STVSDY</org_study_id>
    <nct_id>NCT04441723</nct_id>
  </id_info>
  <brief_title>Comparison of Dynamic Versus Static Lag Screw Modes for Cephalomedullary Nails Used to Fix Intertrochanteric Fragility Fractures</brief_title>
  <official_title>Comparison of Dynamic Versus Static Lag Screw Modes for Cephalomedullary Nails Used to Fix Peritrochanteric Fragility Fractures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Traumatologico Dr. Teodoro Gebauer Weisser</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Traumatologico Dr. Teodoro Gebauer Weisser</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to compare the failure rate between two modes of fixing the&#xD;
      lag screw of the cephalomedullary nail.&#xD;
&#xD;
      The sample studied will be patients who have been diagnosed with a fragility&#xD;
      intertrochanteric fracture.&#xD;
&#xD;
      Investigators hypothesis is that the dynamic mode will have a lower failure rate compared to&#xD;
      the static mode.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intertrochanteric fragility fractures are one of the most frequent fractures in the elderly .&#xD;
      They produce great disability and complications in our patients and they are recognized&#xD;
      worldwide as a major public health problem.&#xD;
&#xD;
      The treatment that presents the best results is surgical treatment, since it reduces the&#xD;
      mortality of the patients and allows early loading . Thus, avoids secondary complications to&#xD;
      the prostration state such as pneumonia, bedsores, pulmonary embolisms, among others.&#xD;
&#xD;
      Currently, the treatment that has shown the best clinical and biomechanical results is&#xD;
      osteosynthesis with a cephalomedullary nail, which despite having good results is not free&#xD;
      from complications such as implant failure, loss of femoral offset.&#xD;
&#xD;
      Changes are constantly made in the design and surgical techniques of these implants in order&#xD;
      to decrease the rate of complications.&#xD;
&#xD;
      This study will particularly assess whether there is any difference in the complication rate&#xD;
      between dynamic versus static lag screw modes.&#xD;
&#xD;
      Biomechanical studies that compare these two lag screw modes show that axial and lateral&#xD;
      stiffness of the femur-nail construction is greater in static mode than in dynamic modes and&#xD;
      the torsional stiffness is greater in dynamic mode than in static modes.&#xD;
&#xD;
      There are no studies comparing the clinical results of these two variants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 11, 2020</start_date>
  <completion_date type="Anticipated">July 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Implant failure</measure>
    <time_frame>6 months</time_frame>
    <description>Rate of cut out , cut through.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>3 weeks, 3 months , 6 months</time_frame>
    <description>Rate of Infection and Non Union.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Offset</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in femoral offset</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Hip Fractures</condition>
  <arm_group>
    <arm_group_label>lag screw with dynamic mode</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Device: Gamma 3 nail whit lag screw on dynamic mode Surgical stabilization of intertrochanteric hip fractures using two different lag screw modes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lag screw with static mode</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Device: Gamma 3 nail whit lag screw on dynamic mode Surgical stabilization of intertrochanteric hip fractures using two different lag screw modes</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Osteosynthesis with Gamma 3 nail , using a dynamic lag screw as a proximal fixation.</intervention_name>
    <description>Closed reduction and surgical stabilization of intertrochanteric hip fractures using Gamma 3 nail , with dynamic lag screw as proximal fixation</description>
    <arm_group_label>lag screw with dynamic mode</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Osteosynthesis with Gamma 3 nail , using a static lag screw as a proximal fixation.</intervention_name>
    <description>Closed reduction and surgical stabilization of intertrochanteric hip fractures using Gamma 3 nail , with static lag screw as proximal fixation</description>
    <arm_group_label>lag screw with static mode</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Low Energy Mechanism&#xD;
&#xD;
          -  Hip fracture classified as 31.A1.2 - 31 A1.3 and 31.A2 in the AO classification (year&#xD;
             2018)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A fracture due to malignancy&#xD;
&#xD;
          -  Previous contralateral fracture&#xD;
&#xD;
          -  Inability to walk before the fracture&#xD;
&#xD;
          -  An inability to comply with rehabilitation&#xD;
&#xD;
          -  Follow-up of less than 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Pablo Suarez, MD</last_name>
    <phone>+56961572181</phone>
    <email>pablosuarez088@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Instituto Traumatologico</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pablo Suarez, MD</last_name>
      <phone>+56961572181</phone>
      <email>pablosuarez088@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Enrique Cifuentes, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <reference>
    <citation>Kuzyk PR, Shah S, Zdero R, Olsen M, Waddell JP, Schemitsch EH. A biomechanical comparison of static versus dynamic lag screw modes for cephalomedullary nails used to fix unstable peritrochanteric fractures. J Trauma Acute Care Surg. 2012 Feb;72(2):E65-70. doi: 10.1097/ta.0b013e3182170823.</citation>
    <PMID>22439235</PMID>
  </reference>
  <reference>
    <citation>Mahomed N, Harrington I, Kellam J, Maistrelli G, Hearn T, Vroemen J. Biomechanical analysis of the Gamma nail and sliding hip screw. Clin Orthop Relat Res. 1994 Jul;(304):280-8.</citation>
    <PMID>8020229</PMID>
  </reference>
  <reference>
    <citation>Bhandari M, Swiontkowski M. Management of Acute Hip Fracture. N Engl J Med. 2017 Nov 23;377(21):2053-2062. doi: 10.1056/NEJMcp1611090. No abstract available.</citation>
    <PMID>29166235</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hip fractures</keyword>
  <keyword>Intertrochanteric fractures</keyword>
  <keyword>Cephalomedullary Nails</keyword>
  <keyword>Cut-out</keyword>
  <keyword>Cut through</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Hip 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/NCT04441723
org study id: STVSDY
nct id: NCT04441723
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The objective of this study is to compare the failure rate between two modes of fixing the
      lag screw of the cephalomedullary nail.

      The sample studied will be patients who have been diagnosed with a fragility
      intertrochanteric fracture.

      Investigators hypothesis is that the dynamic mode will have a lower failure rate compared to
      the static mode.
Intertrochanteric fragility fractures are one of the most frequent fractures in the elderly .
      They produce great disability and complications in our patients and they are recognized
      worldwide as a major public health problem.

      The treatment that presents the best results is surgical treatment, since it reduces the
      mortality of the patients and allows early loading . Thus, avoids secondary complications to
      the prostration state such as pneumonia, bedsores, pulmonary embolisms, among others.

      Currently, the treatment that has shown the best clinical and biomechanical results is
      osteosynthesis with a cephalomedullary nail, which despite having good results is not free
      from complications such as implant failure, loss of femoral offset.

      Changes are constantly made in the design and surgical techniques of these implants in order
      to decrease the rate of complications.

      This study will particularly assess whether there is any difference in the complication rate
      between dynamic versus static lag screw modes.

      Biomechanical studies that compare these two lag screw modes show that axial and lateral
      stiffness of the femur-nail construction is greater in static mode than in dynamic modes and
      the torsional stiffness is greater in dynamic mode than in static modes.

      There are no studies comparing the clinical results of these two variants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Implant failure
time frame: 6 months
description: Rate of cut out , cut through.
measure: Complications
time frame: 3 weeks, 3 months , 6 months
description: Rate of Infection and Non Union.
measure: Offset
time frame: 6 months
description: Changes in femoral offset
arm group label: lag screw with dynamic mode
arm group type: Active Comparator
description: Device: Gamma 3 nail whit lag screw on dynamic mode Surgical stabilization of intertrochanteric hip fractures using two different lag screw modes
arm group label: lag screw with static mode
arm group type: Active Comparator
description: Device: Gamma 3 nail whit lag screw on dynamic mode Surgical stabilization of intertrochanteric hip fractures using two different lag screw modes
intervention type: Device
intervention name: Osteosynthesis with Gamma 3 nail , using a dynamic lag screw as a proximal fixation.
description: Closed reduction and surgical stabilization of intertrochanteric hip fractures using Gamma 3 nail , with dynamic lag screw as proximal fixation
arm group label: lag screw with dynamic mode
intervention type: Device
intervention name: Osteosynthesis with Gamma 3 nail , using a static lag screw as a proximal fixation.
description: Closed reduction and surgical stabilization of intertrochanteric hip fractures using Gamma 3 nail , with static lag screw as proximal fixation
arm group label: lag screw with static mode
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Pablo Suarez, MD
phone: +56961572181
email: pablosuarez088@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Chile
citation: Kuzyk PR, Shah S, Zdero R, Olsen M, Waddell JP, Schemitsch EH. A biomechanical comparison of static versus dynamic lag screw modes for cephalomedullary nails used to fix unstable peritrochanteric fractures. J Trauma Acute Care Surg. 2012 Feb;72(2):E65-70. doi: 10.1097/ta.0b013e3182170823.
PMID: 22439235
citation: Mahomed N, Harrington I, Kellam J, Maistrelli G, Hearn T, Vroemen J. Biomechanical analysis of the Gamma nail and sliding hip screw. Clin Orthop Relat Res. 1994 Jul;(304):280-8.
PMID: 8020229
citation: Bhandari M, Swiontkowski M. Management of Acute Hip Fracture. N Engl J Med. 2017 Nov 23;377(21):2053-2062. doi: 10.1056/NEJMcp1611090. No abstract available.
PMID: 29166235
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Hip Fractures