<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/NCT02996253</url>
  </required_header>
  <id_info>
    <org_study_id>2015/16389</org_study_id>
    <nct_id>NCT02996253</nct_id>
  </id_info>
  <brief_title>Endoscopic Transfer of Flexor Hallucis Longus Tendon for Chronic Achilles Tendon Rupture</brief_title>
  <official_title>Endoscopic Assisted Transfer of Flexor Hallucis Longus Tendon for Chronic Achilles Tendon Rupture. A Prospective Multi Center Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Central Hospital, Fredrikstad</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The transfer of Flexor Hallucis Longus (FHL) in the management of chronic Achilles tendon&#xD;
      ruptures has demonstrated good functional outcome, but an extensive surgical field at a&#xD;
      vulnerable location may lead to increased risk for soft tissue problems. The arthroscopic FHL&#xD;
      transfer may reduce the risk for soft tissue problems. Functional outcome parameters are&#xD;
      investigated, wound/soft tissue complications registered.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The transfer of FHL in the management of chronic Achilles tendon ruptures has demonstrated&#xD;
      good functional outcome with American Orthopaedic Foot ane Ankle Society (AOFAS) hindfoot&#xD;
      scores at 80-89. The extensive surgical field by either a two-incision approach or a single&#xD;
      longitudinal posterior approach to the Achilles tendon may lead to an increased risk for soft&#xD;
      tissue problems, both infections and wound healing problems. The endoscopic FHL transfer may&#xD;
      reduce the risk for soft tissue problems while retaining a good functional outcome. Several&#xD;
      functional outcome measures and scores are evaluated a year after surgery.&#xD;
&#xD;
      Prospective study for evaluation of the surgical procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>December 2015</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Actual">February 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The Victorian Institute of Sports Assessment- Achilles Questionnaire (VISA-A) outcome score</measure>
    <time_frame>one year after FHL transfer</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale for Pain (VAS pain) score</measure>
    <time_frame>3, 6 and 12 months after FHL transfer</time_frame>
    <description>patient reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient reported function score (PRFS)</measure>
    <time_frame>6, 12 months</time_frame>
    <description>patient reported Activity related disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magnetic resonance imagine (MRI)</measure>
    <time_frame>one year post surgery</time_frame>
    <description>FHL hypertrophy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>functional test battery</measure>
    <time_frame>12 months</time_frame>
    <description>jump- and strength tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>local wound conditions</measure>
    <time_frame>within 12 weeks</time_frame>
    <description>wound infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AOFAS hindfoot</measure>
    <time_frame>3,6,12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VISA-A</measure>
    <time_frame>6 months after surgery</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">38</enrollment>
  <condition>Achilles Tendon Rupture</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>FHL transfer</intervention_name>
    <description>endoscopic transfer og flexor hallucis longus</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients With chronic Achilles Tendon Rupture&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic Achilles Tendon Rupture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  BMI&lt;18.5 or &gt;39.9&#xD;
&#xD;
          -  Insufficient Norwegian Language proficiency lack of communication skills local skin&#xD;
             conditions at site for planned surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elisabeth E Husebye, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0450</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>March 21, 2023</last_update_submitted>
  <last_update_submitted_qc>March 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Elisabeth Ellingsen Husebye</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>Rupture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02996253
org study id: 2015/16389
nct id: NCT02996253
lead sponsor: 
collaborator: 
has dmc: No
The transfer of Flexor Hallucis Longus (FHL) in the management of chronic Achilles tendon
      ruptures has demonstrated good functional outcome, but an extensive surgical field at a
      vulnerable location may lead to increased risk for soft tissue problems. The arthroscopic FHL
      transfer may reduce the risk for soft tissue problems. Functional outcome parameters are
      investigated, wound/soft tissue complications registered.
The transfer of FHL in the management of chronic Achilles tendon ruptures has demonstrated
      good functional outcome with American Orthopaedic Foot ane Ankle Society (AOFAS) hindfoot
      scores at 80-89. The extensive surgical field by either a two-incision approach or a single
      longitudinal posterior approach to the Achilles tendon may lead to an increased risk for soft
      tissue problems, both infections and wound healing problems. The endoscopic FHL transfer may
      reduce the risk for soft tissue problems while retaining a good functional outcome. Several
      functional outcome measures and scores are evaluated a year after surgery.

      Prospective study for evaluation of the surgical procedure.
observational model: Cohort
time perspective: Prospective
measure: The Victorian Institute of Sports Assessment- Achilles Questionnaire (VISA-A) outcome score
time frame: one year after FHL transfer
measure: Visual Analogue Scale for Pain (VAS pain) score
time frame: 3, 6 and 12 months after FHL transfer
description: patient reported outcome
measure: patient reported function score (PRFS)
time frame: 6, 12 months
description: patient reported Activity related disability
measure: Magnetic resonance imagine (MRI)
time frame: one year post surgery
description: FHL hypertrophy
measure: functional test battery
time frame: 12 months
description: jump- and strength tests
measure: local wound conditions
time frame: within 12 weeks
description: wound infection
measure: AOFAS hindfoot
time frame: 3,6,12 months
measure: VISA-A
time frame: 6 months after surgery
intervention type: Procedure
intervention name: FHL transfer
description: endoscopic transfer og flexor hallucis longus
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: No
last name: Elisabeth E Husebye, MD, PhD
role: Study Chair
affiliation: Oslo University Hospital
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Elisabeth Ellingsen Husebye
investigator title: MD, PhD
mesh term: Rupture
sharing ipd: No