<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/NCT04420832</url>
  </required_header>
  <id_info>
    <org_study_id>ATR ultrasound study</org_study_id>
    <nct_id>NCT04420832</nct_id>
  </id_info>
  <brief_title>Acute Achilles Tendon Rupture - Choice of Treatment Based on Ultrasound Findings</brief_title>
  <acronym>DUSTAR</acronym>
  <official_title>Diagnostic UltraSonography for the Choice of Treatment of Acute Achilles Tendon Rupture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sahlgrenska University Hospital, Sweden</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>
      Patients with acute achilles tendon rupture will go through an acute ultrasound. Based on the&#xD;
      distance between the ends of the tendon the investigators will decide if the patient is going&#xD;
      to be treated with or without surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">August 2025</completion_date>
  <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in functional outcome between patients treated surgically and non-surgically</measure>
    <time_frame>3 months</time_frame>
    <description>The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated test which combines both the height of each heel-rise and the number of repetitions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in functional outcome between patients treated surgically and non-surgically</measure>
    <time_frame>6 months</time_frame>
    <description>The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated set of tests measuring vertical jump, strength and endurance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in functional outcome between patients treated surgically and non-surgically</measure>
    <time_frame>12 months</time_frame>
    <description>The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated set of tests measuring vertical jump, strength and endurance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in functional outcome between patients treated surgically and non-surgically</measure>
    <time_frame>24 months</time_frame>
    <description>The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated set of tests measuring vertical jump, strength and endurance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ultrasonography (US)</measure>
    <time_frame>6 months</time_frame>
    <description>Achilles tendon length - measured using US extended field of view</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ultrasonography (US)</measure>
    <time_frame>12 months</time_frame>
    <description>Achilles tendon length - measured using US extended field of view</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ultrasonography (US)</measure>
    <time_frame>24 months</time_frame>
    <description>Achilles tendon length - measured using US extended field of view</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Achilles Tendon Rupture Score (ATRS)</measure>
    <time_frame>3 months</time_frame>
    <description>Patient reported outcome measure (PROM) specific for achilles tendon rupture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Achilles Tendon Rupture Score (ATRS)</measure>
    <time_frame>6 months</time_frame>
    <description>Patient reported outcome measure (PROM) specific for achilles tendon rupture. Minimum value 0. Maximum value 100. Higher scores mean better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Achilles Tendon Rupture Score (ATRS)</measure>
    <time_frame>12 months</time_frame>
    <description>Patient reported outcome measure (PROM) specific for achilles tendon rupture. Minimum value 0. Maximum value 100. Higher scores mean better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Achilles Tendon Rupture Score (ATRS)</measure>
    <time_frame>24 months</time_frame>
    <description>Patient reported outcome measure (PROM) specific for achilles tendon rupture. Minimum value 0. Maximum value 100. Higher scores mean better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Scale (PAS)</measure>
    <time_frame>3 months</time_frame>
    <description>PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Scale (PAS)</measure>
    <time_frame>6 months</time_frame>
    <description>PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Scale (PAS)</measure>
    <time_frame>12 months</time_frame>
    <description>PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Scale (PAS)</measure>
    <time_frame>24 months</time_frame>
    <description>PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Achilles Tendon Rupture</condition>
  <condition>Athletic Injuries</condition>
  <condition>Ultrasonography</condition>
  <condition>Rupture</condition>
  <condition>Acute Disease</condition>
  <arm_group>
    <arm_group_label>Surgical treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with a distance of 5 mm or more between tendon ends will be treated surgically and with physiotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-surgical treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients with a distance of less than 5 mm between tendon ends will be treated non-surgically and with physiotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical treatment</intervention_name>
    <description>Se above</description>
    <arm_group_label>Surgical treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-surgical treatment</intervention_name>
    <description>See above</description>
    <arm_group_label>Non-surgical treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  acute achilles tendon rupture diagnosed less than 48 hours from injury&#xD;
&#xD;
          -  mid-substance rupture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous achilles tendon rupture&#xD;
&#xD;
          -  lower leg disability&#xD;
&#xD;
          -  diabetes mellitus&#xD;
&#xD;
          -  neurovascular disease&#xD;
&#xD;
          -  immunosuppression&#xD;
&#xD;
          -  non-Swedish speaker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katarina Nilsson Helander, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sahlgrenska University Hospital, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Orthopedics</name>
      <address>
        <city>Göteborg</city>
        <state>Västra Götalandsregionen</state>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>November 7, 2022</last_update_submitted>
  <last_update_submitted_qc>November 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sahlgrenska University Hospital, Sweden</investigator_affiliation>
    <investigator_full_name>Katarina Nilsson Helander</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>Acute Disease</mesh_term>
    <mesh_term>Rupture</mesh_term>
    <mesh_term>Athletic Injuries</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/NCT04420832
org study id: ATR ultrasound study
nct id: NCT04420832
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with acute achilles tendon rupture will go through an acute ultrasound. Based on the
      distance between the ends of the tendon the investigators will decide if the patient is going
      to be treated with or without surgery.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Difference in functional outcome between patients treated surgically and non-surgically
time frame: 3 months
description: The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated test which combines both the height of each heel-rise and the number of repetitions.
measure: Difference in functional outcome between patients treated surgically and non-surgically
time frame: 6 months
description: The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated set of tests measuring vertical jump, strength and endurance
measure: Difference in functional outcome between patients treated surgically and non-surgically
time frame: 12 months
description: The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated set of tests measuring vertical jump, strength and endurance
measure: Difference in functional outcome between patients treated surgically and non-surgically
time frame: 24 months
description: The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated set of tests measuring vertical jump, strength and endurance
measure: Ultrasonography (US)
time frame: 6 months
description: Achilles tendon length - measured using US extended field of view
measure: Ultrasonography (US)
time frame: 12 months
description: Achilles tendon length - measured using US extended field of view
measure: Ultrasonography (US)
time frame: 24 months
description: Achilles tendon length - measured using US extended field of view
measure: Achilles Tendon Rupture Score (ATRS)
time frame: 3 months
description: Patient reported outcome measure (PROM) specific for achilles tendon rupture
measure: Achilles Tendon Rupture Score (ATRS)
time frame: 6 months
description: Patient reported outcome measure (PROM) specific for achilles tendon rupture. Minimum value 0. Maximum value 100. Higher scores mean better outcome.
measure: Achilles Tendon Rupture Score (ATRS)
time frame: 12 months
description: Patient reported outcome measure (PROM) specific for achilles tendon rupture. Minimum value 0. Maximum value 100. Higher scores mean better outcome.
measure: Achilles Tendon Rupture Score (ATRS)
time frame: 24 months
description: Patient reported outcome measure (PROM) specific for achilles tendon rupture. Minimum value 0. Maximum value 100. Higher scores mean better outcome.
measure: Physical Activity Scale (PAS)
time frame: 3 months
description: PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.
measure: Physical Activity Scale (PAS)
time frame: 6 months
description: PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.
measure: Physical Activity Scale (PAS)
time frame: 12 months
description: PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.
measure: Physical Activity Scale (PAS)
time frame: 24 months
description: PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.
arm group label: Surgical treatment
arm group type: Active Comparator
description: Patients with a distance of 5 mm or more between tendon ends will be treated surgically and with physiotherapy
arm group label: Non-surgical treatment
arm group type: Other
description: Patients with a distance of less than 5 mm between tendon ends will be treated non-surgically and with physiotherapy
intervention type: Procedure
intervention name: Surgical treatment
description: Se above
arm group label: Surgical treatment
intervention type: Other
intervention name: Non-surgical treatment
description: See above
arm group label: Non-surgical treatment
criteria: 
gender: All
minimum age: 16 Years
maximum age: 65 Years
healthy volunteers: No
last name: Katarina Nilsson Helander, MD PhD
role: Principal Investigator
affiliation: Sahlgrenska University Hospital, Sweden
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Sahlgrenska University Hospital, Sweden
investigator full name: Katarina Nilsson Helander
investigator title: Principal investigator
mesh term: Acute Disease
mesh term: Rupture
mesh term: Athletic Injuries