<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/NCT04465994</url>
  </required_header>
  <id_info>
    <org_study_id>M2019465</org_study_id>
    <nct_id>NCT04465994</nct_id>
  </id_info>
  <brief_title>Comparison of Primary Repair Versus Gastrocnemius Turn-down Flaps of Acute Achilles Tendon Rupture</brief_title>
  <official_title>Comparison of Mid-term Curative Effect After Primary Repair Versus Gastrocnemius Turn-down Flaps of Acute Achilles Tendon Rupture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This retrospective study includes 74 patients with acute Achilles tendon rupture from March&#xD;
      2012 to September 2018, aiming to compare the mid-term curative effect of primary repair and&#xD;
      gastrocnemius turn-down flaps and guide clinical decision.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To explore the surgical methods and observe the med-term curative effect of&#xD;
      primary repair and gastrocnemius turn-down flaps for acute Achilles tendon rupture, so as to&#xD;
      guide clinical decision. Methods: This retrospective study includes 74 patients with acute&#xD;
      Achilles tendon rupture from March 2012 to September 2018, whose surgeries was completed by&#xD;
      the sponsor with either primary repair or gastrocnemius turn-down flaps. The recovery and&#xD;
      motor function of the patients were followed up by outpatient clinic and telephone at 3&#xD;
      months, 6 months, 12 months and 24 months after operation, respectively, so as to&#xD;
      statistically analyze the med-term curative effects of two surgeries. Specific indicators&#xD;
      include: Visual Analogue Scale, American Orthopaedic Foot and Ankle Society Ankle-Hindfoot&#xD;
      Score, The Victorian Institute of Sport Assessment-Achilles, The Achilles tendon Total&#xD;
      Rupture Score, the Tegner Activity Score, Biodex isokinetic dynamometer system, Postoperative&#xD;
      rehabilitation index and complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2020</start_date>
  <completion_date type="Actual">May 5, 2020</completion_date>
  <primary_completion_date type="Actual">February 5, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>change of Visual Analogue Scale</measure>
    <time_frame>from pre-surgery to two years after surgery</time_frame>
    <description>The Visual Analogue Scale (VAS) is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to the amount of pain they experienced. This gives them the greatest freedom to choose their pain's exact intensity. It also gives the maximum opportunity for each respondent to express a personal response style. The minimum and maximum values of VAS are 10 and 0, respectively. And higher scores mean a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change of American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score</measure>
    <time_frame>from pre-surgery to two years after surgery</time_frame>
    <description>The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score combines subjective scores of pain and function provided by the patient with objective scores based on the surgeon's physical examination of the patient (to assess sagittal motion, hindfoot motion, ankle-hindfoot stability and alignment of the ankle-hindfoot). The scale includes nine items that can be divided into three subscales (pain, function and alignment). The minimum and maximum values of AOFAS are 100 and 0, respectively. And higher scores mean a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change of The Victorian Institute of Sport Assessment-Achilles</measure>
    <time_frame>from pre-surgery to two years after surgery</time_frame>
    <description>The VISA-A questionnaire displayed construct validity when used in two populations of patients with Achilles tendinopathy and control subjects. The questionnaire avoids the redundant components of non-specific scoring systems such as that developed for hind foot problems by the American Orthopaedic Society, and those devised for Achilles tendon rupture. Results range from 0 to 100, where 100 represents the perfect score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change of The Achilles tendon Total Rupture Score</measure>
    <time_frame>from pre-surgery to two years after surgery</time_frame>
    <description>The VISA-A questionnaire displayed construct validity when used in two populations of patients with Achilles tendinopathy and control subjects. The questionnaire avoids the redundant components of non-specific scoring systems such as that developed for hind foot problems by the American Orthopaedic Society, and those devised for Achilles tendon rupture. Results range from 0 to 100, where 100 represents the perfect score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change of the Tegner Activity Score</measure>
    <time_frame>from pre-surgery to two years after surgery</time_frame>
    <description>The Tegner activity scale was first described in 1985 and initially designed for physician administration after ACL and meniscal injuries. To date, the Tegner activity score has been a frequently used patient-administered activity rating system for patients with various knee disorders. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biodex</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>Biodex isokinetic dynamometer system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>complications</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>rerupture, infection, wound scar</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">74</enrollment>
  <condition>Acute Rupture of Achilles Tendon (Disorder)</condition>
  <arm_group>
    <arm_group_label>primary repair</arm_group_label>
    <description>Patients with acute achilles tendon ruptures who received the treatment of primary repair.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>gastrocnemius turn-down flaps</arm_group_label>
    <description>Patients with acute achilles tendon ruptures who received the treatment of gastrocnemius turn-down flaps.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>gastrocnemius turn-down flaps</intervention_name>
    <description>We classified the patients with acute achilles tendon rupture by type of surgery. The group who received the gastrocnemius turn-down flaps is the intervention group.</description>
    <arm_group_label>gastrocnemius turn-down flaps</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This retrospective study includes 74 patients with acute Achilles tendon rupture from March&#xD;
        2012 to September 2018, including 68 male patients and 6 female patients. The average age&#xD;
        is 36 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  history of Achilles tendon injury&#xD;
&#xD;
          -  within two weeks of injury&#xD;
&#xD;
          -  inability to single heel rise&#xD;
&#xD;
          -  more than one year of follow-up&#xD;
&#xD;
          -  age under 65&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  open Achilles tendon rupture&#xD;
&#xD;
          -  Achilles tendon terminal disease&#xD;
&#xD;
          -  rerupture of Achilles tendon&#xD;
&#xD;
          -  history of local corticosteroid injection around the Achilles tendon&#xD;
&#xD;
          -  accompanied by fracture, vascular or nerve damage&#xD;
&#xD;
          -  not available for regular follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yingfang Ao, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking Univerisity Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Achilles Tendon</keyword>
  <keyword>Acute injury</keyword>
  <keyword>Primary repair</keyword>
  <keyword>gastrocnemius turn-down flaps</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>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/NCT04465994
org study id: M2019465
nct id: NCT04465994
lead sponsor: 
has dmc: No
This retrospective study includes 74 patients with acute Achilles tendon rupture from March
      2012 to September 2018, aiming to compare the mid-term curative effect of primary repair and
      gastrocnemius turn-down flaps and guide clinical decision.
Objective: To explore the surgical methods and observe the med-term curative effect of
      primary repair and gastrocnemius turn-down flaps for acute Achilles tendon rupture, so as to
      guide clinical decision. Methods: This retrospective study includes 74 patients with acute
      Achilles tendon rupture from March 2012 to September 2018, whose surgeries was completed by
      the sponsor with either primary repair or gastrocnemius turn-down flaps. The recovery and
      motor function of the patients were followed up by outpatient clinic and telephone at 3
      months, 6 months, 12 months and 24 months after operation, respectively, so as to
      statistically analyze the med-term curative effects of two surgeries. Specific indicators
      include: Visual Analogue Scale, American Orthopaedic Foot and Ankle Society Ankle-Hindfoot
      Score, The Victorian Institute of Sport Assessment-Achilles, The Achilles tendon Total
      Rupture Score, the Tegner Activity Score, Biodex isokinetic dynamometer system, Postoperative
      rehabilitation index and complications.
observational model: Case-Control
time perspective: Retrospective
measure: change of Visual Analogue Scale
time frame: from pre-surgery to two years after surgery
description: The Visual Analogue Scale (VAS) is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to the amount of pain they experienced. This gives them the greatest freedom to choose their pain's exact intensity. It also gives the maximum opportunity for each respondent to express a personal response style. The minimum and maximum values of VAS are 10 and 0, respectively. And higher scores mean a worse outcome.
measure: change of American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score
time frame: from pre-surgery to two years after surgery
description: The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score combines subjective scores of pain and function provided by the patient with objective scores based on the surgeon's physical examination of the patient (to assess sagittal motion, hindfoot motion, ankle-hindfoot stability and alignment of the ankle-hindfoot). The scale includes nine items that can be divided into three subscales (pain, function and alignment). The minimum and maximum values of AOFAS are 100 and 0, respectively. And higher scores mean a better outcome.
measure: change of The Victorian Institute of Sport Assessment-Achilles
time frame: from pre-surgery to two years after surgery
description: The VISA-A questionnaire displayed construct validity when used in two populations of patients with Achilles tendinopathy and control subjects. The questionnaire avoids the redundant components of non-specific scoring systems such as that developed for hind foot problems by the American Orthopaedic Society, and those devised for Achilles tendon rupture. Results range from 0 to 100, where 100 represents the perfect score.
measure: change of The Achilles tendon Total Rupture Score
time frame: from pre-surgery to two years after surgery
description: The VISA-A questionnaire displayed construct validity when used in two populations of patients with Achilles tendinopathy and control subjects. The questionnaire avoids the redundant components of non-specific scoring systems such as that developed for hind foot problems by the American Orthopaedic Society, and those devised for Achilles tendon rupture. Results range from 0 to 100, where 100 represents the perfect score.
measure: change of the Tegner Activity Score
time frame: from pre-surgery to two years after surgery
description: The Tegner activity scale was first described in 1985 and initially designed for physician administration after ACL and meniscal injuries. To date, the Tegner activity score has been a frequently used patient-administered activity rating system for patients with various knee disorders. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
measure: Biodex
time frame: through study completion, an average of 2 years
description: Biodex isokinetic dynamometer system
measure: complications
time frame: through study completion, an average of 2 years
description: rerupture, infection, wound scar
arm group label: primary repair
description: Patients with acute achilles tendon ruptures who received the treatment of primary repair.
arm group label: gastrocnemius turn-down flaps
description: Patients with acute achilles tendon ruptures who received the treatment of gastrocnemius turn-down flaps.
intervention type: Procedure
intervention name: gastrocnemius turn-down flaps
description: We classified the patients with acute achilles tendon rupture by type of surgery. The group who received the gastrocnemius turn-down flaps is the intervention group.
arm group label: gastrocnemius turn-down flaps
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 65 Years
healthy volunteers: No
last name: Yingfang Ao, MD
role: Study Chair
affiliation: Peking University Third Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Rupture
sharing ipd: No