<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/NCT01673776</url>
  </required_header>
  <id_info>
    <org_study_id>FEMO</org_study_id>
    <nct_id>NCT01673776</nct_id>
  </id_info>
  <brief_title>Multimodal Approach to Improve the Outcome of Patients With a Proximal Femoral Fracture</brief_title>
  <acronym>FEMO</acronym>
  <official_title>Can a Multimodal Approach Improve the Outcome of Patients With a Proximal Femoral Fracture?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technical University of Munich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to compare the outcome of patients with proximal femoral fractures&#xD;
      with different perioperative regimes: a group with a multimodal intervention and a control&#xD;
      group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Femoral neck fractures constitute both a social and economic challenge. The one year&#xD;
      mortality of affected patients amounts to 33%, wherein cardio-vascular complications are the&#xD;
      major contributor. It is an objective of the present study to investigate whether a&#xD;
      multi-modal perioperative intervention can improve the outcome of these patients.&#xD;
&#xD;
      We plan to carry out a prospective randomized controlled clinical study. Patients with an age&#xD;
      above 60 years and proximal femoral fractures (femoral neck fractures or pertrochanteric&#xD;
      femoral fractures) are to be included. These are divided into two groups, K and M. General&#xD;
      anaesthesia is applied to both groups. In group K a commonly used therapy will be applied&#xD;
      whereas in group M an intesified perioperative care will be carried out. The objectives are&#xD;
      to provide sufficient analgesia, normotonia and normothermia. Hence, a femoral catheter is&#xD;
      applied for pain therapy already preoperatively. Moreover, the pulmonal situation is improved&#xD;
      by means of oxygen as needed. The cardiovascular situation is evaluated and optimized by&#xD;
      means of extended hemodynamic monitoring both pre- and postoperatively. If needed, the&#xD;
      nutrition of the patients is supplemented with highly caloric drinks.&#xD;
&#xD;
      A primary common endpoint is the appearance of postoperative complications. These include&#xD;
      cardiovascular, cerebrovascular, pulmonal, renal and surgical complications. Secondary&#xD;
      endpoints are mortality, duration of the stay at the hospital and intensive care duration. It&#xD;
      is the objective of the study to reduce the probability for at least one postoperative&#xD;
      complication from 50% to 25% (α=0,05 and 1-β=0,80). To this end 132 patients would have to be&#xD;
      included in the study.&#xD;
&#xD;
      All participants are to be contacted by phone one year after the surgery and their health&#xD;
      situation is to be determined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">October 15, 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>postoperative complications</measure>
    <time_frame>The participants will be followed for the duration of hospital stay, an expected average of 14 days</time_frame>
    <description>postoperative complications: cardiovascular, cerebrovascular, pulmonal, renal and surgical complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of the stay at the hospital</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intensive care duration</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Proximal Femoral Fracture</condition>
  <arm_group>
    <arm_group_label>K group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>commonly used therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>M group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>multimodal intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PulsioFlex® Monitoring</intervention_name>
    <description>goal directed therapy according to PulsioFlex® Monitoring- measurements&#xD;
femoral catheter&#xD;
extended perioperative monitoring&#xD;
nutritional supplementation, (if necessary)</description>
    <arm_group_label>M group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  proximal femoral fracture (femoral neck fracture/ pertrochanteric femoral fracture)&#xD;
&#xD;
          -  Age ≥ 60 years&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pathological fracture&#xD;
&#xD;
          -  multiple trauma&#xD;
&#xD;
          -  fracture during a hospital stay due to a different disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bettina Jungwirth, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München</name>
      <address>
        <city>Munic</city>
        <state>Bavaria</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Pedersen SJ, Borgbjerg FM, Schousboe B, Pedersen BD, Jorgensen HL, Duus BR, Lauritzen JB; Hip Fracture Group of Bispebjerg Hospital. A comprehensive hip fracture program reduces complication rates and mortality. J Am Geriatr Soc. 2008 Oct;56(10):1831-8. doi: 10.1111/j.1532-5415.2008.01945.x.</citation>
    <PMID>19054201</PMID>
  </reference>
  <reference>
    <citation>Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesth Analg. 2011 Jun;112(6):1392-402. doi: 10.1213/ANE.0b013e3181eeaae5. Epub 2010 Oct 21.</citation>
    <PMID>20966436</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>August 6, 2018</last_update_submitted>
  <last_update_submitted_qc>August 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Proximal femoral fracture</keyword>
  <keyword>multimodal intervention</keyword>
  <keyword>goal directed therapy (GDT)</keyword>
  <keyword>hemodynamic intervention</keyword>
  <keyword>outcome</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/NCT01673776
org study id: FEMO
nct id: NCT01673776
lead sponsor: 
has dmc: Yes
This study is designed to compare the outcome of patients with proximal femoral fractures
      with different perioperative regimes: a group with a multimodal intervention and a control
      group.
Femoral neck fractures constitute both a social and economic challenge. The one year
      mortality of affected patients amounts to 33%, wherein cardio-vascular complications are the
      major contributor. It is an objective of the present study to investigate whether a
      multi-modal perioperative intervention can improve the outcome of these patients.

      We plan to carry out a prospective randomized controlled clinical study. Patients with an age
      above 60 years and proximal femoral fractures (femoral neck fractures or pertrochanteric
      femoral fractures) are to be included. These are divided into two groups, K and M. General
      anaesthesia is applied to both groups. In group K a commonly used therapy will be applied
      whereas in group M an intesified perioperative care will be carried out. The objectives are
      to provide sufficient analgesia, normotonia and normothermia. Hence, a femoral catheter is
      applied for pain therapy already preoperatively. Moreover, the pulmonal situation is improved
      by means of oxygen as needed. The cardiovascular situation is evaluated and optimized by
      means of extended hemodynamic monitoring both pre- and postoperatively. If needed, the
      nutrition of the patients is supplemented with highly caloric drinks.

      A primary common endpoint is the appearance of postoperative complications. These include
      cardiovascular, cerebrovascular, pulmonal, renal and surgical complications. Secondary
      endpoints are mortality, duration of the stay at the hospital and intensive care duration. It
      is the objective of the study to reduce the probability for at least one postoperative
      complication from 50% to 25% (α=0,05 and 1-β=0,80). To this end 132 patients would have to be
      included in the study.

      All participants are to be contacted by phone one year after the surgery and their health
      situation is to be determined.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: postoperative complications
time frame: The participants will be followed for the duration of hospital stay, an expected average of 14 days
description: postoperative complications: cardiovascular, cerebrovascular, pulmonal, renal and surgical complications
measure: mortality
time frame: 1 year
measure: duration of the stay at the hospital
time frame: 1 year
measure: intensive care duration
time frame: 1 year
arm group label: K group
arm group type: No Intervention
description: commonly used therapy
arm group label: M group
arm group type: Experimental
description: multimodal intervention
intervention type: Device
intervention name: PulsioFlex® Monitoring
description: goal directed therapy according to PulsioFlex® Monitoring- measurements
femoral catheter
extended perioperative monitoring
nutritional supplementation, (if necessary)
arm group label: M group
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Bettina Jungwirth, MD
role: Principal Investigator
affiliation: Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München
facility: 
country: Germany
citation: Pedersen SJ, Borgbjerg FM, Schousboe B, Pedersen BD, Jorgensen HL, Duus BR, Lauritzen JB; Hip Fracture Group of Bispebjerg Hospital. A comprehensive hip fracture program reduces complication rates and mortality. J Am Geriatr Soc. 2008 Oct;56(10):1831-8. doi: 10.1111/j.1532-5415.2008.01945.x.
PMID: 19054201
citation: Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesth Analg. 2011 Jun;112(6):1392-402. doi: 10.1213/ANE.0b013e3181eeaae5. Epub 2010 Oct 21.
PMID: 20966436
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Femoral Fractures