<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/NCT04459910</url>
  </required_header>
  <id_info>
    <org_study_id>Multi_EPM</org_study_id>
    <nct_id>NCT04459910</nct_id>
  </id_info>
  <brief_title>Medial and Lateral Combined Ligament Arthroscopic Repair for Multidirectional Ankle Instability: Case Series</brief_title>
  <official_title>Medial and Lateral Combined Ligament Arthroscopic Repair for Multidirectional Ankle Instability: 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>
      Abstract Introduction: The high prevalence of sprains in the population has provided a&#xD;
      substantial number of patients with lateral instability of the ankle. The continuity of this&#xD;
      condition can lead to the progressive loosening of the medial containment structures,&#xD;
      generating a multidirectional rotational instability. The deltoid approach through the&#xD;
      imbrication of its components has been proposed as a solution for these patients. The&#xD;
      arthroscopic technique has been described as an alternative.&#xD;
&#xD;
      Methods: This is a retrospective study with patients diagnosed with multidirectional&#xD;
      instability and submitted to an ankle arthroscopy with medial repair (arthroscopic&#xD;
      tensioning) and lateral (arthroscopic Brostrom) between January 2018 and January 2020. All&#xD;
      patients will fill an epidemiological questionnaire and will be evaluated for pain and&#xD;
      function according to the Visual Analogue Scale (VAS) and the American Orthopaedic Foot and&#xD;
      Ankle Society Score (AOFAS) at 12 months (6-24 months) average of follow-up.&#xD;
&#xD;
      Discussion: The combined medial and lateral arthroscopic repair may be an effective and safe&#xD;
      alternative in the treatment of multidirectional instability. The inclusion of the deltoid&#xD;
      complex and the low invasiveness of this technique can improve the clinical outcomes of these&#xD;
      patients. Additional studies, with a prospective and comparative methodology are required to&#xD;
      sustain this proposal.&#xD;
&#xD;
      Design: Level IV. Retrospective case series.&#xD;
&#xD;
      Keywords: ankle injuries; lateral ligament; collateral ligaments; joint instability&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">January 1, 2021</completion_date>
  <primary_completion_date type="Actual">September 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>6th post-operataive 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>6th post-operataive month</time_frame>
    <description>Pain Score (0 to 10 | 10 worst score possible | 0 best score possible)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>6th post-operataive month</time_frame>
    <description>Surgical complications</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">29</enrollment>
  <condition>Ankle Injuries</condition>
  <condition>Ligament Injury</condition>
  <condition>Joint Instability</condition>
  <condition>Deltoid Ligament; Sprain (Strain) (Ankle)</condition>
  <condition>Talofibular Ligament Tear</condition>
  <arm_group>
    <arm_group_label>Multidirectional</arm_group_label>
    <description>Arthroscopic lateral ligament repair combined with deltoid arthroscopic ligament repair.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arthroscopic Brostrom combined with Arthroscopic Deltoid Repair</intervention_name>
    <description>After anesthesia and surgical site preparation, traditional arthroscopic portals were performed. A 4.5mm set was used to clean the joint and assess possible associated injuries. Anterolateral and anteromedial impacts were resected when needed. Lateral and medial instability were confirmed arthroscopically, and ligament repairs prepared, starting by the lateral compartment. A traditional Arthroscopic Brostrom was performed, using one anchor and suture passers. Sutures are passed but not tightened. Medial anchor insertion is executed at the medial malleolus, in the quadrant described by Vega et al. Sutures were passed respecting the safe zone illustrated by Acevedo at al. The ankle was positioned in neutral (no posterior drawer) and the lateral sutures tightened with arthroscopic knots. Finally, the medial repair is finalized by tightening the deltoid sutures with the ankle at the same position. Portals were closed and a dressing applied.</description>
    <arm_group_label>Multidirectional</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Tertiary teaching hospital patients, athletes and non-athletes.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  complaints about ankle loosening for the last six months&#xD;
&#xD;
          -  clinical findings of lateral and medial instability&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  existence of previous surgery&#xD;
&#xD;
          -  autoimmune diseases&#xD;
&#xD;
          -  neuropathy&#xD;
&#xD;
          -  inflammatory disease&#xD;
&#xD;
          -  isolated medial instability&#xD;
&#xD;
          -  flatfoot&#xD;
&#xD;
          -  previous ankle infiltration&#xD;
&#xD;
          -  radiographic findings of ankle arthritis&#xD;
&#xD;
          -  cavovarus deformity&#xD;
&#xD;
          -  coagulopathies&#xD;
&#xD;
          -  body mass index over 35&#xD;
&#xD;
          -  associated injuries, such as osteochondral lesions&#xD;
&#xD;
          -  syndesmosis instability&#xD;
&#xD;
          -  tendon ruptures&#xD;
&#xD;
          -  fractures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>65 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>February 2021</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 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>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Instability</mesh_term>
    <mesh_term>Wounds and Injuries</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 the article is published.</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/NCT04459910
org study id: Multi_EPM
nct id: NCT04459910
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Abstract Introduction: The high prevalence of sprains in the population has provided a
      substantial number of patients with lateral instability of the ankle. The continuity of this
      condition can lead to the progressive loosening of the medial containment structures,
      generating a multidirectional rotational instability. The deltoid approach through the
      imbrication of its components has been proposed as a solution for these patients. The
      arthroscopic technique has been described as an alternative.

      Methods: This is a retrospective study with patients diagnosed with multidirectional
      instability and submitted to an ankle arthroscopy with medial repair (arthroscopic
      tensioning) and lateral (arthroscopic Brostrom) 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 combined medial and lateral arthroscopic repair may be an effective and safe
      alternative in the treatment of multidirectional instability. 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.

      Design: Level IV. Retrospective case series.

      Keywords: ankle injuries; lateral ligament; collateral ligaments; joint instability
observational model: Case-Only
time perspective: Retrospective
measure: American Orthopedic Foot and Ankle Society - Hindfoot Score (AOFAS)
time frame: 6th post-operataive month
description: Functional Score (0 to 100 | 100 best score possible | 0 worst score possible)
measure: Visual Analogue Scale (VAS)
time frame: 6th post-operataive month
description: Pain Score (0 to 10 | 10 worst score possible | 0 best score possible)
measure: Complications
time frame: 6th post-operataive month
description: Surgical complications
arm group label: Multidirectional
description: Arthroscopic lateral ligament repair combined with deltoid arthroscopic ligament repair.
intervention type: Procedure
intervention name: Arthroscopic Brostrom combined with Arthroscopic Deltoid Repair
description: After anesthesia and surgical site preparation, traditional arthroscopic portals were performed. A 4.5mm set was used to clean the joint and assess possible associated injuries. Anterolateral and anteromedial impacts were resected when needed. Lateral and medial instability were confirmed arthroscopically, and ligament repairs prepared, starting by the lateral compartment. A traditional Arthroscopic Brostrom was performed, using one anchor and suture passers. Sutures are passed but not tightened. Medial anchor insertion is executed at the medial malleolus, in the quadrant described by Vega et al. Sutures were passed respecting the safe zone illustrated by Acevedo at al. The ankle was positioned in neutral (no posterior drawer) and the lateral sutures tightened with arthroscopic knots. Finally, the medial repair is finalized by tightening the deltoid sutures with the ankle at the same position. Portals were closed and a dressing applied.
arm group label: Multidirectional
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 65 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: MD, PhD
mesh term: Joint Instability
mesh term: Wounds and Injuries
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 the article is published.
ipd access criteria: A formal requisition will be needed, directly addressed to the main researcher. A good scientific reason must be included.