<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/NCT01711307</url>
  </required_header>
  <id_info>
    <org_study_id>Version1</org_study_id>
    <nct_id>NCT01711307</nct_id>
  </id_info>
  <brief_title>Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon</brief_title>
  <acronym>AchillesRCT</acronym>
  <official_title>Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon: A Multi-centered Randomized Control Trial Using Standardized Objective and Subjective Outcome Measurement to Determine Rerupture Rate.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mark Glazebrook</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nova Scotia Health Authority</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nova Scotia Health Authority</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed trial is a multi-centre prospective randomized controlled trial comparing&#xD;
      outcomes of patients with acute Achilles tendon ruptures treated either non-operatively or&#xD;
      with open operative tendon repair. All patients will undergo accelerated functional&#xD;
      rehabilitation. The primary outcome measure is Achilles tendon re-rupture rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Equivalent clinical outcomes to surgical repair; reduced morbidity and disability to subjects&#xD;
      through elimination of a surgical repair; reduction of cost to patients by eliminating need&#xD;
      for surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">October 1, 2012</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Operative vs non operative Treatment of acute ruptures of Achilles tendon.</measure>
    <time_frame>1 year</time_frame>
    <description>The primary outcome measure is Achilles tendon re-rupture rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon</measure>
    <time_frame>2 year</time_frame>
    <description>1. The Achilles tendon Total Rupture Score (ATRS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Ruptured Achilles Tendon</condition>
  <arm_group>
    <arm_group_label>non-operative</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cast applied within 48 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>operative</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>cast applied within 48 hours and surgery within 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>operative</intervention_name>
    <arm_group_label>operative</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>non-operative</intervention_name>
    <description>casting within 48 hrs</description>
    <arm_group_label>non-operative</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Complete mid-substance rupture of the Achilles tendon as diagnosed on clinical exam&#xD;
&#xD;
          -  Present for initial assessment and treatment with application of a plantar-flexed cast&#xD;
             within 48 hours of their injury.&#xD;
&#xD;
          -  Referred to one of the participating orthopaedics surgeons in a timely fashion so as&#xD;
             to allow for further treatment (operative repair or initiation of the rehabilitation&#xD;
             protocol) within 14 days of their injury.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Open Achilles injury&#xD;
&#xD;
          -  Achilles injury that is not a mid-substance tendon injury&#xD;
&#xD;
          -  Any additional injury to the ipsilateral lower extremity&#xD;
&#xD;
          -  Contraindication to surgery or anesthetic&#xD;
&#xD;
          -  (Physical or mental) that may interfere with compliance with the rehabilitation&#xD;
             protocol&#xD;
&#xD;
          -  Any known factor for increased risk of Achilles tendon rupture (i.e. diabetes&#xD;
             mellitus, immunosuppressive therapy including local or systemic steroids, and&#xD;
             fluoroquinolone use).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Mark Glazebrook, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Capital Health District Authority</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Halifax Infirmary</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 3A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nova Scotia Health Authority</investigator_affiliation>
    <investigator_full_name>Mark Glazebrook</investigator_full_name>
    <investigator_title>Dr Mark Glazebrook, MSc,PHD, Dip Sports Med, MD FRCS(c)</investigator_title>
  </responsible_party>
  <keyword>Achilles</keyword>
  <keyword>Rupture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>COA AAOS AOFAS</ipd_description>
  </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/NCT01711307
org study id: Version1
nct id: NCT01711307
lead sponsor: 
collaborator: 
has dmc: No
The proposed trial is a multi-centre prospective randomized controlled trial comparing
      outcomes of patients with acute Achilles tendon ruptures treated either non-operatively or
      with open operative tendon repair. All patients will undergo accelerated functional
      rehabilitation. The primary outcome measure is Achilles tendon re-rupture rate.
Equivalent clinical outcomes to surgical repair; reduced morbidity and disability to subjects
      through elimination of a surgical repair; reduction of cost to patients by eliminating need
      for surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Operative vs non operative Treatment of acute ruptures of Achilles tendon.
time frame: 1 year
description: The primary outcome measure is Achilles tendon re-rupture rate
measure: Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon
time frame: 2 year
description: 1. The Achilles tendon Total Rupture Score (ATRS)
arm group label: non-operative
arm group type: Experimental
description: cast applied within 48 hours
arm group label: operative
arm group type: Active Comparator
description: cast applied within 48 hours and surgery within 14 days
intervention type: Procedure
intervention name: operative
arm group label: operative
intervention type: Procedure
intervention name: non-operative
description: casting within 48 hrs
arm group label: non-operative
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dr. Mark Glazebrook, MD
role: Principal Investigator
affiliation: Capital Health District Authority
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: Nova Scotia Health Authority
investigator full name: Mark Glazebrook
investigator title: Dr Mark Glazebrook, MSc,PHD, Dip Sports Med, MD FRCS(c)
mesh term: Rupture
sharing ipd: Yes
ipd description: COA AAOS AOFAS