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/NCT06030908</url>
    </required_header>
    <id_info>
      <org_study_id>AST_2023</org_study_id>
      <nct_id>NCT06030908</nct_id>
    </id_info>
    <brief_title>Outcome After Surgical Reconstruction of the Achilles Tendon Insertion.</brief_title>
    <official_title>Functional Outcomes and Return to Sports After Surgical Treatment of Insertional Achilles Tendinopathy With Tendon Debridement and Anchor Refixation.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Krankenhaus Barmherzige Schwestern Linz</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Krankenhaus Barmherzige Schwestern Linz</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the functional outcomes and sports ability after&#xD;
        surgical treatment of insertional Achilles tendon tendinopathy using tendon detachment,&#xD;
        debridement, and double-row anchor refixation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The lifetime risk of Achilles tendon pain is approximately 6%, one-third of whom complain of&#xD;
        pain at the bony attachment of the Achilles tendon to the calcaneus.&#xD;
  &#xD;
        Primary treatment of these insertional tendinopathies is always nonsurgical with physical&#xD;
        therapy, orthotics, shock wave therapy, or various forms of injections. If there is no&#xD;
        response to therapy, surgery is warranted after three to six months. In this procedure, the&#xD;
        tendon is detached from the bone, the damaged portions of the tendon are removed, bony&#xD;
        prominences are rounded, and finally the tendon attachment is reconstructed and fixed with&#xD;
        anchors. Various anchor systems are available for this purpose.&#xD;
  &#xD;
        The double-row anchor system used by the investigators in recent years allows stable,&#xD;
        knotless, two-dimensional refixation of the Achilles tendon to the calcaneus and thus permits&#xD;
        rapid rehabilitation. Recent studies show good functional results 33 months after&#xD;
        reconstruction of the Achilles tendon attachment with the &quot;Speed Bridge&quot; System. To the best&#xD;
        of our knowledge, however, there are no studies to date on sports ability after this&#xD;
        operation.&#xD;
  &#xD;
        The investigators are therefore conducting a retrospective collection of clinical patient&#xD;
        data combined with a planned (prospective) questionnaire survey of patients with insertional&#xD;
        Achilles tendon tendinopathy who received surgical treatment with tendon refixation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">September 13, 2022</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</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>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Return to sports Rate</measure>
      <time_frame>minimum 12 months from surgery to follow-up</time_frame>
      <description>in percentage compared to preoperatively</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of sport units per week, sport disciplines practiced</measure>
      <time_frame>minimum 12 months from surgery to follow-up</time_frame>
      <description>in absolute numbers</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of sport units</measure>
      <time_frame>minimum 12 months from surgery to follow-up</time_frame>
      <description>in minutes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Range of motion after surgery</measure>
      <time_frame>minimum 12 months from surgery to follow-up</time_frame>
      <description>in degrees</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective change of instability after surgery</measure>
      <time_frame>minimum 12 months from surgery to follow-up</time_frame>
      <description>Visual analog scale; 0-10; 0 means no instability, 10 means worst instability</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of pain after surgery</measure>
      <time_frame>minimum 12 months from surgery to follow-up</time_frame>
      <description>Visual analog scale; 0-10; 0 means no pain, 10 means worst pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction with result</measure>
      <time_frame>minimum 12 months from surgery to follow-up</time_frame>
      <description>Visual analog scale; 0-10; 0 means not satisfied, 10 means maximum satisfaction</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">23</enrollment>
    <condition>Achilles Tendinopathy</condition>
    <condition>Insertional Achilles Tendinopathy</condition>
    <arm_group>
      <arm_group_label>Study Population</arm_group_label>
      <description>Patients who underwent surgical reconstruction of the Achilles tendon insertion using a knotless, double-row anchor system.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Reconstruction of Achilles tendon insertion</intervention_name>
      <description>knotless double-row anchor fixation of the achilles tendon insertion</description>
      <arm_group_label>Study Population</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All patients who underwent reconstruction and double-row anchor refixation of the Achilles&#xD;
          tendon insertion between 01/2018 and 10/2021.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients who underwent reconstruction and double-row anchor refixation of the&#xD;
               Achilles tendon insertion due to an insertional tendinopathy of the Achilles tendon.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Lack of informed consent&#xD;
  &#xD;
            -  Revision surgery&#xD;
  &#xD;
            -  Patients who had another operation on the same leg during the same procedure or 6&#xD;
               months later&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Ordensklinikum Linz, Barmherzige Schwestern Abteilung Orthopädie</name>
        <address>
          <city>Linz</city>
          <zip>4010</zip>
          <country>Austria</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Austria</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>insertional</keyword>
    <keyword>Achilles Tendinopathy</keyword>
    <keyword>surgery</keyword>
    <keyword>sport</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tendinopathy</mesh_term>
    </condition_browse>
    <!-- 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/NCT06030908
  org study id: AST_2023
  nct id: NCT06030908
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The purpose of this study is to evaluate the functional outcomes and sports ability after
        surgical treatment of insertional Achilles tendon tendinopathy using tendon detachment,
        debridement, and double-row anchor refixation.
  The lifetime risk of Achilles tendon pain is approximately 6%, one-third of whom complain of
        pain at the bony attachment of the Achilles tendon to the calcaneus.
  
        Primary treatment of these insertional tendinopathies is always nonsurgical with physical
        therapy, orthotics, shock wave therapy, or various forms of injections. If there is no
        response to therapy, surgery is warranted after three to six months. In this procedure, the
        tendon is detached from the bone, the damaged portions of the tendon are removed, bony
        prominences are rounded, and finally the tendon attachment is reconstructed and fixed with
        anchors. Various anchor systems are available for this purpose.
  
        The double-row anchor system used by the investigators in recent years allows stable,
        knotless, two-dimensional refixation of the Achilles tendon to the calcaneus and thus permits
        rapid rehabilitation. Recent studies show good functional results 33 months after
        reconstruction of the Achilles tendon attachment with the "Speed Bridge" System. To the best
        of our knowledge, however, there are no studies to date on sports ability after this
        operation.
  
        The investigators are therefore conducting a retrospective collection of clinical patient
        data combined with a planned (prospective) questionnaire survey of patients with insertional
        Achilles tendon tendinopathy who received surgical treatment with tendon refixation.
  observational model: Case-Only
  time perspective: Other
  measure: Return to sports Rate
  time frame: minimum 12 months from surgery to follow-up
  description: in percentage compared to preoperatively
  measure: Number of sport units per week, sport disciplines practiced
  time frame: minimum 12 months from surgery to follow-up
  description: in absolute numbers
  measure: Length of sport units
  time frame: minimum 12 months from surgery to follow-up
  description: in minutes
  measure: Range of motion after surgery
  time frame: minimum 12 months from surgery to follow-up
  description: in degrees
  measure: Subjective change of instability after surgery
  time frame: minimum 12 months from surgery to follow-up
  description: Visual analog scale; 0-10; 0 means no instability, 10 means worst instability
  measure: Change of pain after surgery
  time frame: minimum 12 months from surgery to follow-up
  description: Visual analog scale; 0-10; 0 means no pain, 10 means worst pain
  measure: Satisfaction with result
  time frame: minimum 12 months from surgery to follow-up
  description: Visual analog scale; 0-10; 0 means not satisfied, 10 means maximum satisfaction
  arm group label: Study Population
  description: Patients who underwent surgical reconstruction of the Achilles tendon insertion using a knotless, double-row anchor system.
  intervention type: Procedure
  intervention name: Reconstruction of Achilles tendon insertion
  description: knotless double-row anchor fixation of the achilles tendon insertion
  arm group label: Study Population
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  facility: 
  country: Austria
  responsible party type: Sponsor
  mesh term: Tendinopathy