<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/NCT02978365</url>
  </required_header>
  <id_info>
    <org_study_id>IDF-1702-2016</org_study_id>
    <secondary_id>0177-16-WOMC</secondary_id>
    <nct_id>NCT02978365</nct_id>
  </id_info>
  <brief_title>Factors Associated With Full Recovery After Surgical Repair of Shoulder Instability</brief_title>
  <official_title>Factors Associated With Full Recovery After Surgical Repair of Shoulder Instability - Cross Sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uri Gottlieb</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wolfson Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical Corps, Israel Defense Force</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Case control study to evaluate different factors (e.g muscle strength, psychological factors)&#xD;
      that are associated with full recovery and functional status 6 months after surgical repair&#xD;
      of shoulder instability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study the investigators will try to find correlations between different factors and&#xD;
      functional abilities of patients 6 months post shoulder surgery.&#xD;
&#xD;
      Patients will be examined in a single encounter for muscle strength, fear avoidance beliefs&#xD;
      and functional abilities.&#xD;
&#xD;
      Functional abilities will be examined using two validated questionnaires:&#xD;
&#xD;
        1. The Western Ontario Shoulder Instability index (WOSI)&#xD;
&#xD;
        2. Disabilities of the Arm, Shoulder and Hand (DASH)&#xD;
&#xD;
      Fear avoidance will be evaluated using the Fear Avoidance Belief Questionnaire (FABQ)&#xD;
&#xD;
      Muscle strength of the rotator cuff muscles will be measured using Biodex Isokinetic system,&#xD;
      model 4.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 16, 2017</start_date>
  <completion_date type="Actual">March 22, 2018</completion_date>
  <primary_completion_date type="Actual">March 22, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Western Ontario Shoulder Instability index (WOSI)</measure>
    <time_frame>26-28 weeks post surgery</time_frame>
    <description>Functional scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fear avoidance belief questionnaire (FABQ)</measure>
    <time_frame>26-28 weeks post surgery</time_frame>
    <description>Fear avoidance questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Isokinetic strength</measure>
    <time_frame>26-28 weeks post surgery</time_frame>
    <description>Ratios between Internal and External rotation strength in both shoulders</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disabilities of Arm, Shoulder and Hand Questionnaire (DASH)</measure>
    <time_frame>26-28 weeks post surgery</time_frame>
    <description>Functional scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Chronic Instability of Joint</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Male patients who undergone shoulder surgery to repair chronic instability (at least 1 shoulder dislocation prior to surgery). Time since surgery will be between 26 and 28 weeks. Patients will go through filling questionnaires and isokinetic strength measurements.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Patients will fill self-reported functional shoulder scales (1. Western Ontario Shoulder Instability index - WOSI, and 2. Disabilities of Arm, Shoulder and Hand questionnaire - DASH), as well as a Fear Avoidance Belief Questionnaire (FABQ).</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Isokinetic Strength Measurement</intervention_name>
    <description>Isokinetic strength will be measured using a Biodex Isokinetic System 4.0 (Shirley, NY)</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  26-28 weeks s/p surgical repair of shoulder instability&#xD;
&#xD;
          -  At least 1 shoulder dislocation prior to surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous surgery in either shoulders&#xD;
&#xD;
          -  Any injury in the non-operated shoulder in the last 6 months&#xD;
&#xD;
          -  Any history of shoulder dislocation or subluxation in the non-operated shoulder&#xD;
&#xD;
          -  Any tendon repair during the surgery.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arnon Gam, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Corp, Israel Defense Forces</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IDF Medical Corp</name>
      <address>
        <city>Zrifin</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>June 6, 2018</last_update_submitted>
  <last_update_submitted_qc>June 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Medical Corps, Israel Defense Force</investigator_affiliation>
    <investigator_full_name>Uri Gottlieb</investigator_full_name>
    <investigator_title>Head of Physical Therapy Clinic</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Instability</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be published after statistical analysis only.</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/NCT02978365
org study id: IDF-1702-2016
secondary id: 0177-16-WOMC
nct id: NCT02978365
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Case control study to evaluate different factors (e.g muscle strength, psychological factors)
      that are associated with full recovery and functional status 6 months after surgical repair
      of shoulder instability.
In this study the investigators will try to find correlations between different factors and
      functional abilities of patients 6 months post shoulder surgery.

      Patients will be examined in a single encounter for muscle strength, fear avoidance beliefs
      and functional abilities.

      Functional abilities will be examined using two validated questionnaires:

        1. The Western Ontario Shoulder Instability index (WOSI)

        2. Disabilities of the Arm, Shoulder and Hand (DASH)

      Fear avoidance will be evaluated using the Fear Avoidance Belief Questionnaire (FABQ)

      Muscle strength of the rotator cuff muscles will be measured using Biodex Isokinetic system,
      model 4.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Western Ontario Shoulder Instability index (WOSI)
time frame: 26-28 weeks post surgery
description: Functional scale
measure: Fear avoidance belief questionnaire (FABQ)
time frame: 26-28 weeks post surgery
description: Fear avoidance questionnaire
measure: Isokinetic strength
time frame: 26-28 weeks post surgery
description: Ratios between Internal and External rotation strength in both shoulders
measure: Disabilities of Arm, Shoulder and Hand Questionnaire (DASH)
time frame: 26-28 weeks post surgery
description: Functional scale
arm group label: Patients
arm group type: Experimental
description: Male patients who undergone shoulder surgery to repair chronic instability (at least 1 shoulder dislocation prior to surgery). Time since surgery will be between 26 and 28 weeks. Patients will go through filling questionnaires and isokinetic strength measurements.
intervention type: Other
intervention name: Questionnaires
description: Patients will fill self-reported functional shoulder scales (1. Western Ontario Shoulder Instability index - WOSI, and 2. Disabilities of Arm, Shoulder and Hand questionnaire - DASH), as well as a Fear Avoidance Belief Questionnaire (FABQ).
arm group label: Patients
intervention type: Device
intervention name: Isokinetic Strength Measurement
description: Isokinetic strength will be measured using a Biodex Isokinetic System 4.0 (Shirley, NY)
arm group label: Patients
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: No
last name: Arnon Gam, M.D
role: Principal Investigator
affiliation: Medical Corp, Israel Defense Forces
facility: 
country: Israel
responsible party type: Sponsor-Investigator
investigator affiliation: Medical Corps, Israel Defense Force
investigator full name: Uri Gottlieb
investigator title: Head of Physical Therapy Clinic
mesh term: Joint Instability
sharing ipd: No
ipd description: Data will be published after statistical analysis only.