xml: <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/NCT06023979</url>
    </required_header>
    <id_info>
      <org_study_id>BASEC Nr. 2023-01242</org_study_id>
      <nct_id>NCT06023979</nct_id>
    </id_info>
    <brief_title>Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles.</brief_title>
    <official_title>Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles. A Single Blinded Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cantonal Hospital of St. Gallen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cantonal Hospital of St. Gallen</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The purpose of this study is to compare the postoperative results after ORIF (Open Reduction&#xD;
        Inner Fixation) with a partial weight-bearing protocol versus an early full weight-bearing&#xD;
        protocol. But in addition, we will measure every patient's actual load by the means of walker&#xD;
        integrated bio-feedback insoles for the first six postoperative weeks to record the adherence&#xD;
        to the protocol.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study aims to compare the postoperative results after PWB (partial weight bearing) and&#xD;
        early FWB (full weight bearing) and to show, that documented early protected weight-bearing&#xD;
        after surgical fixation of unstable ankle fractures leads to an improved early clinical&#xD;
        outcome and a faster return to work compared to PWB. It also aims to show, that an early FWB&#xD;
        is safe in terms of complication rate.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2025</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>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Manchester Oxford Foot and Ankle Questionnaire</measure>
      <time_frame>1 year</time_frame>
      <description>Patient reported Outcome measure</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>other PROMs (patient reported outcome measures)</measure>
      <time_frame>1 year</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Range of Motion</measure>
      <time_frame>1 year</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Secondary dislocation of fracture</measure>
      <time_frame>6 weeks</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">110</enrollment>
    <condition>Post Operative Treatment After Unstable Malleolar Fractures</condition>
    <arm_group>
      <arm_group_label>Full weight bearing</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After 2 weeks after surgery the arm will begin full weight bearing</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Partial weight bearing</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The arm will perform partial weight bearing for 6 weeks after surgery</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Full weight bearing</intervention_name>
      <description>Full weight bearing monitored with a bio-feedback insole</description>
      <arm_group_label>Full weight bearing</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Partial weight bearing</intervention_name>
      <description>Partial weight bearing monitored with a bio-feedback insole</description>
      <arm_group_label>Partial weight bearing</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with surgically stabilized unstable ankle fractures&#xD;
  &#xD;
            -  signed informed consent&#xD;
  &#xD;
            -  closed tibial and fibular epiphysis&#xD;
  &#xD;
            -  age 18 or older&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  dementia and other known cognitive impairment or incapacity of judgement&#xD;
  &#xD;
            -  polytrauma&#xD;
  &#xD;
            -  bilateral injury of the lower extremities&#xD;
  &#xD;
            -  additional injury of the ipsilateral lower extremity which prevents full weight&#xD;
               bearing&#xD;
  &#xD;
            -  associated injury of one or both upper extremities&#xD;
  &#xD;
            -  open fractures grade II° and III°&#xD;
  &#xD;
            -  chronic loss of sensation on plantar aspect of the feet due to known distal neuropathy&#xD;
  &#xD;
            -  open epiphysis&#xD;
  &#xD;
            -  pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Primoz Potocnik, MD</last_name>
      <phone>0041714941111</phone>
      <email>primoz.potocnik@kssg.ch</email>
    </overall_contact>
    <location>
      <facility>
        <name>Canton Hospital St. Gallen</name>
        <address>
          <city>Saint Gallen</city>
          <zip>9007</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <contact>
        <last_name>Primoz Potocnik, MD</last_name>
        <email>primoz.potocnik@kssg.ch</email>
      </contact>
      <contact_backup>
        <last_name>Andreas Toepfer, MD</last_name>
        <email>andreas.toepfer@kssg.ch</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cantonal Hospital of St. Gallen</investigator_affiliation>
      <investigator_full_name>Primoz Potocnik</investigator_full_name>
      <investigator_title>Dr. med. Primoz Potocnik</investigator_title>
    </responsible_party>
    <keyword>malleolar fractures</keyword>
    <keyword>postoperative treatment protocol</keyword>
    <keyword>full weight bearing</keyword>
    <keyword>partial weight bearing</keyword>
    <keyword>bio-feedback insoles</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fractures, Bone</mesh_term>
      <mesh_term>Ankle Fractures</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023979
  org study id: BASEC Nr. 2023-01242
  nct id: NCT06023979
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to compare the postoperative results after ORIF (Open Reduction
        Inner Fixation) with a partial weight-bearing protocol versus an early full weight-bearing
        protocol. But in addition, we will measure every patient's actual load by the means of walker
        integrated bio-feedback insoles for the first six postoperative weeks to record the adherence
        to the protocol.
  This study aims to compare the postoperative results after PWB (partial weight bearing) and
        early FWB (full weight bearing) and to show, that documented early protected weight-bearing
        after surgical fixation of unstable ankle fractures leads to an improved early clinical
        outcome and a faster return to work compared to PWB. It also aims to show, that an early FWB
        is safe in terms of complication rate.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Investigator)
  measure: Manchester Oxford Foot and Ankle Questionnaire
  time frame: 1 year
  description: Patient reported Outcome measure
  measure: other PROMs (patient reported outcome measures)
  time frame: 1 year
  measure: Range of Motion
  time frame: 1 year
  measure: Secondary dislocation of fracture
  time frame: 6 weeks
  arm group label: Full weight bearing
  arm group type: Experimental
  description: After 2 weeks after surgery the arm will begin full weight bearing
  arm group label: Partial weight bearing
  arm group type: Active Comparator
  description: The arm will perform partial weight bearing for 6 weeks after surgery
  intervention type: Other
  intervention name: Full weight bearing
  description: Full weight bearing monitored with a bio-feedback insole
  arm group label: Full weight bearing
  intervention type: Other
  intervention name: Partial weight bearing
  description: Partial weight bearing monitored with a bio-feedback insole
  arm group label: Partial weight bearing
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Primoz Potocnik, MD
  phone: 0041714941111
  email: primoz.potocnik@kssg.ch
  facility: 
  contact: 
  contact backup: 
  country: Switzerland
  responsible party type: Principal Investigator
  investigator affiliation: Cantonal Hospital of St. Gallen
  investigator full name: Primoz Potocnik
  investigator title: Dr. med. Primoz Potocnik
  mesh term: Fractures, Bone
  mesh term: Ankle Fractures
  sharing ipd: No