<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/NCT04478383</url>
  </required_header>
  <id_info>
    <org_study_id>M2018008</org_study_id>
    <nct_id>NCT04478383</nct_id>
  </id_info>
  <brief_title>Repair of Achilles Sleeve Avulsion: a New Transosseous Suture Technique</brief_title>
  <official_title>Repair of Achilles Sleeve Avulsion: a New Transosseous Suture Technique</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This retrospective study identified 12 patients with Achilles sleeve avulsion from November&#xD;
      2013 to March 2016, aiming to explore a new transosseous suture technique for the repair of&#xD;
      Achilles sleeve avulsion and observe the short-term curative effect.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose: To explore a new transosseous suture technique for the repair of Achilles sleeve&#xD;
      avulsion and observe the short-term curative effect.&#xD;
&#xD;
      Methods:In total, 11 patients diagnosed with Achilles sleeve avulsion underwent this new&#xD;
      surgical technique and were followed for a mean time of 40 months. Clinical outcomes were&#xD;
      measured using the visual analog scale (VAS), American Orthopaedic Foot &amp; Ankle Society&#xD;
      (AOFAS) score, Victorian Institute of Sports Assessment-Achilles (VISA-A) score, Tegner&#xD;
      score, and time taken to return to activities. Preoperative and postoperative MRI, the&#xD;
      ability to perform heel rise, and complications were also evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">May 1, 2018</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>change of Victorian Institute of Sports Assessment-Achilles 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 visual analog 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 &amp; Ankle Society 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 Tegner 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>
  <enrollment type="Actual">11</enrollment>
  <condition>Achilles Tendon Rupture</condition>
  <condition>Fracture, Avulsion</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>a new transosseous suture technique</intervention_name>
    <description>a new technique using the spur base on the insertional site to drill the suture tunnel to repair Achilles sleeve avulsion.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        One patient was lost to follow-up because she could not be contacted, having moved out of&#xD;
        the country. The remaining 11 patients (10 men and one woman, average age: 46 years) were&#xD;
        reviewed with an average follow-up time of 40 months (30-57 months).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical presentations and physical examination, routine ankle X ray and MRI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  calcaneal tuberosity avulsion fractures&#xD;
&#xD;
          -  Achilles tendon rerupture&#xD;
&#xD;
          -  previous surgical procedure on the affected Achilles tendon&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Haidian District</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sleeve Avulsion</keyword>
  <keyword>Achilles Tendinopathy</keyword>
  <keyword>Suture, transosseous</keyword>
  <keyword>Achilles Tendon</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rupture</mesh_term>
    <mesh_term>Fractures, Avulsion</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/NCT04478383
org study id: M2018008
nct id: NCT04478383
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This retrospective study identified 12 patients with Achilles sleeve avulsion from November
      2013 to March 2016, aiming to explore a new transosseous suture technique for the repair of
      Achilles sleeve avulsion and observe the short-term curative effect.
Purpose: To explore a new transosseous suture technique for the repair of Achilles sleeve
      avulsion and observe the short-term curative effect.

      Methods:In total, 11 patients diagnosed with Achilles sleeve avulsion underwent this new
      surgical technique and were followed for a mean time of 40 months. Clinical outcomes were
      measured using the visual analog scale (VAS), American Orthopaedic Foot & Ankle Society
      (AOFAS) score, Victorian Institute of Sports Assessment-Achilles (VISA-A) score, Tegner
      score, and time taken to return to activities. Preoperative and postoperative MRI, the
      ability to perform heel rise, and complications were also evaluated.
observational model: Case-Only
time perspective: Retrospective
measure: change of Victorian Institute of Sports Assessment-Achilles 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 visual analog 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 & Ankle Society 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 Tegner 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.
intervention type: Procedure
intervention name: a new transosseous suture technique
description: a new technique using the spur base on the insertional site to drill the suture tunnel to repair Achilles sleeve avulsion.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Rupture
mesh term: Fractures, Avulsion
sharing ipd: No