<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/NCT04418050</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0200</org_study_id>
    <nct_id>NCT04418050</nct_id>
  </id_info>
  <brief_title>Prosthetic Arthroplasties in Weight-bearing Shoulders</brief_title>
  <official_title>Prosthetic Arthroplasties in Weight-bearing Shoulders in Individuals With Long-term Wheelchair Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Repeated transfers and wheelchair propulsion in patients with neurological deficit of the&#xD;
      lower limbs leads to a major mechanical overload of the upper limbs, especially on shoulders,&#xD;
      the &quot;weight-bearing&quot; shoulder. Under these conditions, arthroplasty is subject to significant&#xD;
      constraints; such an indication in this condition is always discussed. The objective of this&#xD;
      study was to evaluate the medium-term clinical and functional outcomes of anatomical and&#xD;
      reverse arthroplasty on the weight-bearing shoulder in individuals with long-term wheelchair&#xD;
      use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2010</start_date>
  <completion_date type="Actual">September 1, 2016</completion_date>
  <primary_completion_date type="Actual">February 1, 2010</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>Evolution of joint mobility</measure>
    <time_frame>1 day</time_frame>
    <description>Evolution of joint mobility</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of searches for early implant loosening</measure>
    <time_frame>1 day</time_frame>
    <description>number of searches for early implant loosening</description>
  </secondary_outcome>
  <enrollment type="Actual">11</enrollment>
  <condition>Prosthetic Arthroplasties</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Shoulder arthroplasty</intervention_name>
    <description>Surgery consisting in replacement of gleno-humeral joint by a shoulder prosthesis</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients not walking or rarely walking, long-term users of a wheelchair&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  patients not walking or rarely walking, long-term users of a wheelchair before the&#xD;
             intervention, and surgery on at least one shoulder by anatomical or reverse prosthesis&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patient walking without aid&#xD;
&#xD;
          -  Shoulder surgery other than arthroplasty&#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>Léo Chiche, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>April 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>paraplegia</keyword>
  <keyword>Shoulder prosthesis</keyword>
  <keyword>spinal cord injury</keyword>
  <keyword>wheelchair</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</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/NCT04418050
org study id: RECHMPL20_0200
nct id: NCT04418050
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Repeated transfers and wheelchair propulsion in patients with neurological deficit of the
      lower limbs leads to a major mechanical overload of the upper limbs, especially on shoulders,
      the "weight-bearing" shoulder. Under these conditions, arthroplasty is subject to significant
      constraints; such an indication in this condition is always discussed. The objective of this
      study was to evaluate the medium-term clinical and functional outcomes of anatomical and
      reverse arthroplasty on the weight-bearing shoulder in individuals with long-term wheelchair
      use.
observational model: Cohort
time perspective: Retrospective
measure: Evolution of joint mobility
time frame: 1 day
description: Evolution of joint mobility
measure: number of searches for early implant loosening
time frame: 1 day
description: number of searches for early implant loosening
intervention type: Procedure
intervention name: Shoulder arthroplasty
description: Surgery consisting in replacement of gleno-humeral joint by a shoulder prosthesis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Léo Chiche, MD
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: NC