<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/NCT02995382</url>
  </required_header>
  <id_info>
    <org_study_id>2016-2361</org_study_id>
    <nct_id>NCT02995382</nct_id>
  </id_info>
  <brief_title>Health-Related Quality of Life in Cases of Cubital Tunnel Syndrome</brief_title>
  <official_title>Health-Related Quality of Life in Cases of Anterior Intramuscular Transposition for Cubital Tunnel Syndrome: A Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to determine the Health Related Quality of life (HRQOL) (the physical,&#xD;
      mental, emotional and social functioning) of patients with cubital tunnel syndrome following&#xD;
      anterior intramuscular transposition, after one year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As there are many different surgical procedures to address cubital tunnel syndrome, HRQOL&#xD;
      will be used to determine if anterior intramuscular transposition provides patients with&#xD;
      positive outcomes. To measure HRQOL 3 specific scales will be administered:&#xD;
&#xD;
        1. A generic scale, the Short Form-36&#xD;
&#xD;
        2. A condition specific scale, the Patient-Rated Ulnar Nerve Evaluation (PRUNE)&#xD;
&#xD;
        3. A utility scale, the EuroQOL, five dimension questionnaire&#xD;
&#xD;
      These scales are widely reported in the literature, are valid, reliable and easy to fill out.&#xD;
      Using these scales we can determine HRQOL as well as Quality Adjusted Life Years, which,&#xD;
      allows us to do a cost-utility analysis (economic evaluation) on this specific procedure.&#xD;
&#xD;
      Patients will be asked to fill out the above mentioned questionnaires, as well as perform 2&#xD;
      performance tests (grip strength, and a moving 2-point discrimination test) at the following&#xD;
      time points:&#xD;
&#xD;
        1. 1 week prior to surgery&#xD;
&#xD;
        2. 1 day prior to surgery&#xD;
&#xD;
        3. 3 months post surgery&#xD;
&#xD;
        4. 6 months post surgery&#xD;
&#xD;
        5. 12 months post surgery&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Funding was not received and the study could not proceed without this support.&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 2023</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">April 2023</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Is there improvement in Health Related Quality of Life?</measure>
    <time_frame>1 week and 1 day pre-op &amp; 3, 6, 12 months post op</time_frame>
    <description>HRQOL will be determined using 3 questionnaires: a generic widely reported scale (SF-36), a condition specific valid and reliable scale (The PRUNE), and a utility scale EuroQol-5D)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Which Domains of Health Related Quality of Life Improve?</measure>
    <time_frame>1 week and 1 day pre-op &amp; 3, 6, 12 months post op</time_frame>
    <description>There are different domains listed in the questionnaires, depending on the response from the patients we will determine where the improvement was seen (physical, mental, emotional, etc)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Is there improvement in physical performance?</measure>
    <time_frame>1 week and 1 day pre-op &amp; 3, 6, 12 months post op</time_frame>
    <description>This will be measured by using grip strength and moving 2-point discrimination</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Cubital Tunnel Syndrome</condition>
  <arm_group>
    <arm_group_label>Anterior Intramuscular Transposition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is the only arm in our study, patients with cubital tunnel syndrome will undergo anterior intramuscular transposition, one of many surgical techniques utilized on patients with Cubital Tunnel Syndrome to alleviate symptoms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Anterior Intramuscular Transposition</intervention_name>
    <description>Anterior intramuscular transposition technique to decompress the ulnar nerve at the level of the elbow</description>
    <arm_group_label>Anterior Intramuscular Transposition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of cubital tunnel syndrome confirmed with Electromyography (EMG) testing or&#xD;
             Ultrasound imaging&#xD;
&#xD;
          -  Ability to comprehend English and complete health related quality of life&#xD;
             questionnaires&#xD;
&#xD;
          -  Willing to provide informed consent&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Not pregnant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior ipsilateral cubital tunnel release&#xD;
&#xD;
          -  Evidence of symptomatic clinical double crush syndrome confirmed by EMG/Nerve&#xD;
             Conduction Study (NCS)&#xD;
&#xD;
          -  Patients with rheumatoid arthritis, connective tissue disorder, tenosynovitis, or&#xD;
             diagnosed neurological condition that could confound the assessment of health-related&#xD;
             quality of life with regard to the affected arm and hand&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew McRae, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</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>Cubital Tunnel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will not be shared to other researchers</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/NCT02995382
org study id: 2016-2361
nct id: NCT02995382
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
This study aims to determine the Health Related Quality of life (HRQOL) (the physical,
      mental, emotional and social functioning) of patients with cubital tunnel syndrome following
      anterior intramuscular transposition, after one year.
As there are many different surgical procedures to address cubital tunnel syndrome, HRQOL
      will be used to determine if anterior intramuscular transposition provides patients with
      positive outcomes. To measure HRQOL 3 specific scales will be administered:

        1. A generic scale, the Short Form-36

        2. A condition specific scale, the Patient-Rated Ulnar Nerve Evaluation (PRUNE)

        3. A utility scale, the EuroQOL, five dimension questionnaire

      These scales are widely reported in the literature, are valid, reliable and easy to fill out.
      Using these scales we can determine HRQOL as well as Quality Adjusted Life Years, which,
      allows us to do a cost-utility analysis (economic evaluation) on this specific procedure.

      Patients will be asked to fill out the above mentioned questionnaires, as well as perform 2
      performance tests (grip strength, and a moving 2-point discrimination test) at the following
      time points:

        1. 1 week prior to surgery

        2. 1 day prior to surgery

        3. 3 months post surgery

        4. 6 months post surgery

        5. 12 months post surgery
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Is there improvement in Health Related Quality of Life?
time frame: 1 week and 1 day pre-op & 3, 6, 12 months post op
description: HRQOL will be determined using 3 questionnaires: a generic widely reported scale (SF-36), a condition specific valid and reliable scale (The PRUNE), and a utility scale EuroQol-5D)
measure: Which Domains of Health Related Quality of Life Improve?
time frame: 1 week and 1 day pre-op & 3, 6, 12 months post op
description: There are different domains listed in the questionnaires, depending on the response from the patients we will determine where the improvement was seen (physical, mental, emotional, etc)
measure: Is there improvement in physical performance?
time frame: 1 week and 1 day pre-op & 3, 6, 12 months post op
description: This will be measured by using grip strength and moving 2-point discrimination
arm group label: Anterior Intramuscular Transposition
arm group type: Experimental
description: This is the only arm in our study, patients with cubital tunnel syndrome will undergo anterior intramuscular transposition, one of many surgical techniques utilized on patients with Cubital Tunnel Syndrome to alleviate symptoms.
intervention type: Procedure
intervention name: Anterior Intramuscular Transposition
description: Anterior intramuscular transposition technique to decompress the ulnar nerve at the level of the elbow
arm group label: Anterior Intramuscular Transposition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthew McRae, MD
role: Principal Investigator
affiliation: McMaster University
responsible party type: Sponsor
mesh term: Cubital Tunnel Syndrome
mesh term: Syndrome
sharing ipd: No
ipd description: Data will not be shared to other researchers