<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/NCT04460118</url>
  </required_header>
  <id_info>
    <org_study_id>cui1</org_study_id>
    <nct_id>NCT04460118</nct_id>
  </id_info>
  <brief_title>Clinical and Radiographic Outcomes in Arthroscopic &quot;Inlay&quot;Bristow Surgery With Screw Fixation vs Suture-button Fixation</brief_title>
  <official_title>Clinical and Radiographic Outcomes in Arthroscopic &quot;Inlay&quot;Bristow Surgery With Screw Fixation vs Suture-button Fixation</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Retrospective comparative case-cohort study to investigate the efficacy of the modified&#xD;
      arthroscopic Bristow-Latarjet surgery and to compare the clinical and radiographic outcomes&#xD;
      using screw fixation vs suture-button fixation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background：Some studies have advocated the use of suture-button fixation during&#xD;
      Bristow-latarjet surgery to reduce complications associated with screw fixation. However,&#xD;
      these studies are not comparative studies, and their data are relatively incomplete.&#xD;
&#xD;
      Purpose: To compare the clinical and radiographic outcomes using screw fixation vs&#xD;
      suture-button fixation.&#xD;
&#xD;
      Study Design: Retrospective comparative case-cohort study Methods: Patients who underwent the&#xD;
      modified arthroscopic Bristow-Latarjet surgery between June 2015 and February 2018 were&#xD;
      selected. Shoulders were separated into two groups based on surgical fixation method.&#xD;
      Radiological results on 3D CT scan and clinical results were assessed preoperatively,&#xD;
      immediately after operation, and postoperatively at 3 months, 6 months, 1 year and during the&#xD;
      final follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>VAS for pain score</measure>
    <time_frame>2 years after surgery</time_frame>
    <description>The visual analog scale (VAS) for pain score is the most commonly used to describe pain levels in patients, ranging from 0 to 10, with a higher score indicating more intense pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ASES score</measure>
    <time_frame>2 years after surgery</time_frame>
    <description>The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Active shoulder ranges of motion</measure>
    <time_frame>2 years after surgery</time_frame>
    <description>internal rotation at the side, and external and internal rotation at 90° of abduction,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone block position</measure>
    <time_frame>immediately after surgery.</time_frame>
    <description>Bone block position was evaluated using postoperative CT scans.The ideal position of the bone block was defined as flush to the anterior glenoid rim in the axial view and 4 o'clock in the En face view. The bone block was considered too lateral if it went beyond the glenoid rim by more than 5 mm and it was judged to be too medial if it was medial to the rim by more than 5 mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone union</measure>
    <time_frame>3 months after surgery, 6 months after surgery, 1 year after surgery and 2 years after surgery</time_frame>
    <description>Graft union with the glenoid was assessed using postoperative CT scans. ''Bony union'' of the transplant was defined as no radiolucent zone; ''fibrous union,'' when the transplant had a radiolucent zone of less than 5 mm; and ''migration,'' when the zone was 5 mm or more.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">117</enrollment>
  <condition>Shoulder; Dislocation, Chronic</condition>
  <arm_group>
    <arm_group_label>screw group</arm_group_label>
    <description>coracoid bone block fixed by the screw</description>
  </arm_group>
  <arm_group>
    <arm_group_label>button group</arm_group_label>
    <description>coracoid bone block fixed by the suture-button</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bristow surgery fixed by the screw</intervention_name>
    <description>Bristow surgery fixed by the screw</description>
    <arm_group_label>screw group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bristow surgery fixed by the suture button</intervention_name>
    <description>Bristow surgery fixed by the suture button</description>
    <arm_group_label>button group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all patients undergoing the &quot;Inlay&quot; Bristow surgery in our hospital between June 2015 and&#xD;
        February 2018.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. a glenoid defect ≥10%&#xD;
&#xD;
          2. contact sport athletes with a glenoid defect &lt; 10%&#xD;
&#xD;
          3. failure after Bankart repair.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. epilepsy&#xD;
&#xD;
          2. multidirectional shoulder instability&#xD;
&#xD;
          3. concomitant other lesions including rotator cuff tear, symptomatic acromioclavicular&#xD;
             joint pathology or pathological involvement of the long head of the biceps&#xD;
&#xD;
          4. Follow-up was less than 2 years or incomplete follow-up data.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guoqing Cui, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PekingUTH</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 4, 2020</last_update_submitted>
  <last_update_submitted_qc>July 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Dislocation</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/NCT04460118
org study id: cui1
nct id: NCT04460118
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Retrospective comparative case-cohort study to investigate the efficacy of the modified
      arthroscopic Bristow-Latarjet surgery and to compare the clinical and radiographic outcomes
      using screw fixation vs suture-button fixation.
Background：Some studies have advocated the use of suture-button fixation during
      Bristow-latarjet surgery to reduce complications associated with screw fixation. However,
      these studies are not comparative studies, and their data are relatively incomplete.

      Purpose: To compare the clinical and radiographic outcomes using screw fixation vs
      suture-button fixation.

      Study Design: Retrospective comparative case-cohort study Methods: Patients who underwent the
      modified arthroscopic Bristow-Latarjet surgery between June 2015 and February 2018 were
      selected. Shoulders were separated into two groups based on surgical fixation method.
      Radiological results on 3D CT scan and clinical results were assessed preoperatively,
      immediately after operation, and postoperatively at 3 months, 6 months, 1 year and during the
      final follow-up.
observational model: Cohort
time perspective: Retrospective
measure: VAS for pain score
time frame: 2 years after surgery
description: The visual analog scale (VAS) for pain score is the most commonly used to describe pain levels in patients, ranging from 0 to 10, with a higher score indicating more intense pain.
measure: ASES score
time frame: 2 years after surgery
description: The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints.
measure: Active shoulder ranges of motion
time frame: 2 years after surgery
description: internal rotation at the side, and external and internal rotation at 90° of abduction,
measure: Bone block position
time frame: immediately after surgery.
description: Bone block position was evaluated using postoperative CT scans.The ideal position of the bone block was defined as flush to the anterior glenoid rim in the axial view and 4 o'clock in the En face view. The bone block was considered too lateral if it went beyond the glenoid rim by more than 5 mm and it was judged to be too medial if it was medial to the rim by more than 5 mm.
measure: Bone union
time frame: 3 months after surgery, 6 months after surgery, 1 year after surgery and 2 years after surgery
description: Graft union with the glenoid was assessed using postoperative CT scans. ''Bony union'' of the transplant was defined as no radiolucent zone; ''fibrous union,'' when the transplant had a radiolucent zone of less than 5 mm; and ''migration,'' when the zone was 5 mm or more.
arm group label: screw group
description: coracoid bone block fixed by the screw
arm group label: button group
description: coracoid bone block fixed by the suture-button
intervention type: Procedure
intervention name: Bristow surgery fixed by the screw
description: Bristow surgery fixed by the screw
arm group label: screw group
intervention type: Procedure
intervention name: Bristow surgery fixed by the suture button
description: Bristow surgery fixed by the suture button
arm group label: button group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Guoqing Cui, professor
role: Principal Investigator
affiliation: Peking University Third Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Shoulder Dislocation
sharing ipd: No