<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/NCT04473638</url>
  </required_header>
  <id_info>
    <org_study_id>Arthroscopic_Deltoid_Fx_EPM</org_study_id>
    <nct_id>NCT04473638</nct_id>
  </id_info>
  <brief_title>Deltoid Ligament Arthroscopic Repair in Ankle Fractures: Case Series</brief_title>
  <official_title>Deltoid Ligament Arthroscopic Repair in Ankle Fractures: Case Series</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of São Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To demonstrate the functional results of patients with ankle fractures operated with&#xD;
      arthroscopic deltoid repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: The diagnosis and treatment of ankle medial ligament lesions in malleolar&#xD;
      fractures have always been surrounded by controversies. Even in the certainty of deltoid&#xD;
      involvement and its consequent instability, the direct repair of this structure is not a&#xD;
      consensus. In recent years, the arthroscopic technique to approach this ligament has been&#xD;
      described with the objective of potentiating clinical results and minimizing possible&#xD;
      complications.&#xD;
&#xD;
      Objective: To demonstrate the functional results of patients with ankle fractures operated&#xD;
      with arthroscopic deltoid repair.&#xD;
&#xD;
      Methods: This is a retrospective study in patients diagnosed with ankle fractures associated&#xD;
      with acute deltoid injuries and submitted to a malleolar fixation and deltoid arthroscopic&#xD;
      repair between January 2018 and January 2020. All patients will fill an epidemiological&#xD;
      questionnaire and will be evaluated for pain and function according to the Visual Analogue&#xD;
      Scale (VAS) and the American Orthopaedic Foot and Ankle Society Score (AOFAS) at 12 months&#xD;
      (6-24 months) average of follow-up.&#xD;
&#xD;
      Discussion: The inclusion of the deltoid complex and the low invasiveness of this technique&#xD;
      can improve the clinical outcomes of these patients. Additional studies, with a prospective&#xD;
      and comparative methodology are required to sustain this proposal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Actual">July 10, 2021</completion_date>
  <primary_completion_date type="Actual">November 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>American Orthopedic Foot and Ankle Society - Hindfoot Score (AOFAS)</measure>
    <time_frame>Time Frame: 6th post-operative month</time_frame>
    <description>Functional Score (0 to 100 | 100 best score possible | 0 worst score possible)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale (VAS)</measure>
    <time_frame>Time Frame: 6th post-operative month</time_frame>
    <description>Pain Score (0 to 10 | 10 worst score possible | 0 best score possible)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Complications related to Treatment</measure>
    <time_frame>6th post-operative month</time_frame>
    <description>Complications were established as dehiscence, neural damage, infection, and re-rupture. Dehiscence was set inability to heal the soft tissue coverage until the end of the 4th post-operative week. Peripherical nerve damage defined as hypoesthesia or paresthesia not solved until the end of the 6th month after the surgery. Infection termed as clinical signs infection or pus drainage at the wound that required the use of antibiotics. Re-rupture classified as an ankle sprain event during the follow-up.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Ankle Injuries</condition>
  <condition>Ankle Fractures</condition>
  <condition>Deltoid Ligament; Sprain (Strain) (Ankle)</condition>
  <condition>Ligament Rupture</condition>
  <arm_group>
    <arm_group_label>Arthroscopic</arm_group_label>
    <description>Deltoid Arthroscopic Repair in Ankle Fractures</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arthroscopic Deltoid Repair</intervention_name>
    <description>. A 4.5 mm arthroscopic set was used to clean the joint and assess medial and associated injuries. After deltoid injury confirmation through the method already mentioned, the medial gutter was prepared. The ideal positioning for the bone anchor in the medial malleolus followed Vega's recommendations and was located in the inferolateral quadrant created by the intersection of two lines: (1) tibia-talar joint line and (2) tangent line to the medial malleolus joint surface.(14). Sutures were passed respecting the safe zone illustrated by Acevedo at al, at the area between the posterior tibial tendon and the saphenous vein (16-25mm) (15). Sutures were passed but not tightened.</description>
    <arm_group_label>Arthroscopic</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Tertiary/Quaternary hospital patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - acute (less than two weeks) ankle fracture containing a medial ligament injury suspicion&#xD;
        will be included. Syndesmotic lesion with a deltoid association will also be addressed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous surgery&#xD;
&#xD;
          -  autoimmune diseases&#xD;
&#xD;
          -  neuropathy&#xD;
&#xD;
          -  inflammatory diseases&#xD;
&#xD;
          -  radiographic preoperative findings of ankle arthritis&#xD;
&#xD;
          -  open medial wound&#xD;
&#xD;
          -  coagulopathies&#xD;
&#xD;
          -  any other condition that would contraindicate surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nacime Salomão Barbachan Mansur, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal University of Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>04022-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 15, 2021</last_update_submitted>
  <last_update_submitted_qc>July 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>Nacime Salomão Barbachan Mansur</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Rupture</mesh_term>
    <mesh_term>Ankle Fractures</mesh_term>
    <mesh_term>Ankle Injuries</mesh_term>
    <mesh_term>Sprains and Strains</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>According to the ICMJE data sharing police, core records will be shared at an online depository and available upon request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>After article publication.</ipd_time_frame>
    <ipd_access_criteria>A formal requisition will be needed, directly addressed to the main researcher. A good scientific reason must be included.</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04473638
org study id: Arthroscopic_Deltoid_Fx_EPM
nct id: NCT04473638
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To demonstrate the functional results of patients with ankle fractures operated with
      arthroscopic deltoid repair.
Introduction: The diagnosis and treatment of ankle medial ligament lesions in malleolar
      fractures have always been surrounded by controversies. Even in the certainty of deltoid
      involvement and its consequent instability, the direct repair of this structure is not a
      consensus. In recent years, the arthroscopic technique to approach this ligament has been
      described with the objective of potentiating clinical results and minimizing possible
      complications.

      Objective: To demonstrate the functional results of patients with ankle fractures operated
      with arthroscopic deltoid repair.

      Methods: This is a retrospective study in patients diagnosed with ankle fractures associated
      with acute deltoid injuries and submitted to a malleolar fixation and deltoid arthroscopic
      repair between January 2018 and January 2020. All patients will fill an epidemiological
      questionnaire and will be evaluated for pain and function according to the Visual Analogue
      Scale (VAS) and the American Orthopaedic Foot and Ankle Society Score (AOFAS) at 12 months
      (6-24 months) average of follow-up.

      Discussion: The inclusion of the deltoid complex and the low invasiveness of this technique
      can improve the clinical outcomes of these patients. Additional studies, with a prospective
      and comparative methodology are required to sustain this proposal.
observational model: Case-Only
time perspective: Retrospective
measure: American Orthopedic Foot and Ankle Society - Hindfoot Score (AOFAS)
time frame: Time Frame: 6th post-operative month
description: Functional Score (0 to 100 | 100 best score possible | 0 worst score possible)
measure: Visual Analogue Scale (VAS)
time frame: Time Frame: 6th post-operative month
description: Pain Score (0 to 10 | 10 worst score possible | 0 best score possible)
measure: Number of Complications related to Treatment
time frame: 6th post-operative month
description: Complications were established as dehiscence, neural damage, infection, and re-rupture. Dehiscence was set inability to heal the soft tissue coverage until the end of the 4th post-operative week. Peripherical nerve damage defined as hypoesthesia or paresthesia not solved until the end of the 6th month after the surgery. Infection termed as clinical signs infection or pus drainage at the wound that required the use of antibiotics. Re-rupture classified as an ankle sprain event during the follow-up.
arm group label: Arthroscopic
description: Deltoid Arthroscopic Repair in Ankle Fractures
intervention type: Procedure
intervention name: Arthroscopic Deltoid Repair
description: . A 4.5 mm arthroscopic set was used to clean the joint and assess medial and associated injuries. After deltoid injury confirmation through the method already mentioned, the medial gutter was prepared. The ideal positioning for the bone anchor in the medial malleolus followed Vega's recommendations and was located in the inferolateral quadrant created by the intersection of two lines: (1) tibia-talar joint line and (2) tangent line to the medial malleolus joint surface.(14). Sutures were passed respecting the safe zone illustrated by Acevedo at al, at the area between the posterior tibial tendon and the saphenous vein (16-25mm) (15). Sutures were passed but not tightened.
arm group label: Arthroscopic
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 75 Years
healthy volunteers: No
last name: Nacime Salomão Barbachan Mansur, MD, PhD
role: Principal Investigator
affiliation: Federal University of Sao Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: Nacime Salomão Barbachan Mansur
investigator title: Principal Investigator
mesh term: Fractures, Bone
mesh term: Rupture
mesh term: Ankle Fractures
mesh term: Ankle Injuries
mesh term: Sprains and Strains
sharing ipd: Yes
ipd description: According to the ICMJE data sharing police, core records will be shared at an online depository and available upon request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: After article publication.
ipd access criteria: A formal requisition will be needed, directly addressed to the main researcher. A good scientific reason must be included.