<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/NCT04440384</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL20_0399</org_study_id>
    <nct_id>NCT04440384</nct_id>
  </id_info>
  <brief_title>Long Term Evaluation of Function and Quality of Life After Pollicisation</brief_title>
  <acronym>Polliglobal</acronym>
  <official_title>Long Term Evaluation of Function and Quality of Life After Pollicisation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      The study aims at describing long term functional outcome of patients that underwent&#xD;
      pollicisation surgery.&#xD;
&#xD;
      The hypothesis of the study is that there are prognostic factors of good function results of&#xD;
      pollicisation (based on T-GAP classification for function) that will be searched on&#xD;
      univariate and multivariate analysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    0 INCLUSION&#xD;
  </why_stopped>
  <start_date type="Actual">September 2, 2020</start_date>
  <completion_date type="Actual">September 2, 2022</completion_date>
  <primary_completion_date type="Actual">September 2, 2022</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>T-GAP score</measure>
    <time_frame>At baseline, Day 0 (&gt;5 years post-surgery)</time_frame>
    <description>The Thumb Grasp and Pinch assessment (T-GAP) is a new outcome measure that classifies grasp and pinch styles to quantify use of the new thumb.&#xD;
Scoring is based on principles of hand development and skill using a 7-point hierarchical scale including abnormal (scores of 1e3) and normal (scores of 4e7) grasp patterns, with more mature patterns receiving higher points.</description>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Patients That Had Pollicization Surgery</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Functional evaluation</intervention_name>
    <description>Patients will complete these forms and tests :&#xD;
Box and block test, Purdue peg board, Percival, Nine hole peg, T-GAP, EGF, MAHVIE, DASH, RAND36, CHQ-PF28, CHQ-CF45, CGI-S</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient that underwent pollicisation surgery more than 5 years before&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  More than 7 years and less than 50 years&#xD;
&#xD;
          -  Underwent unilateral or bilateral pollicisation surgery&#xD;
&#xD;
          -  For children : non opposition of the parents&#xD;
&#xD;
          -  For adults : non opposition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patients able to understand the research and to answer to forms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital femme mère enfant</name>
      <address>
        <city>Bron</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>November 25, 2022</last_update_submitted>
  <last_update_submitted_qc>November 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04440384
org study id: 69HCL20_0399
nct id: NCT04440384
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aims at describing long term functional outcome of patients that underwent
      pollicisation surgery.

      The hypothesis of the study is that there are prognostic factors of good function results of
      pollicisation (based on T-GAP classification for function) that will be searched on
      univariate and multivariate analysis.
observational model: Cohort
time perspective: Cross-Sectional
measure: T-GAP score
time frame: At baseline, Day 0 (>5 years post-surgery)
description: The Thumb Grasp and Pinch assessment (T-GAP) is a new outcome measure that classifies grasp and pinch styles to quantify use of the new thumb.
Scoring is based on principles of hand development and skill using a 7-point hierarchical scale including abnormal (scores of 1e3) and normal (scores of 4e7) grasp patterns, with more mature patterns receiving higher points.
intervention type: Other
intervention name: Functional evaluation
description: Patients will complete these forms and tests :
Box and block test, Purdue peg board, Percival, Nine hole peg, T-GAP, EGF, MAHVIE, DASH, RAND36, CHQ-PF28, CHQ-CF45, CGI-S
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor