<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/NCT04402567</url>
  </required_header>
  <id_info>
    <org_study_id>HGADFS19052020-01</org_study_id>
    <nct_id>NCT04402567</nct_id>
  </id_info>
  <brief_title>Impact and Burden of Rugby Injuries in Argentina. A Complete Season Retrospective Multicentric Study.</brief_title>
  <acronym>ARugby</acronym>
  <official_title>&quot;Showing the Truth&quot;: Impact and Burden of Rugby Injuries in Argentina. A Complete Season Retrospective Multicentric Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Donación Francisco Santojanni</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Donación Francisco Santojanni</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 aim of this study was to describe the prevalence, incidence and injury load suffered in&#xD;
      male amateur rugby players from Argentina during a competitive season in 2019.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction:&#xD;
&#xD;
      Currently, Rugby is a sport that is giving priority to the well-being of the player. Players&#xD;
      are subjected to high training and match loads exposing them to constant stress that can lead&#xD;
      to overload injuries in addition to frequent contact injuries. Despite knowing what the&#xD;
      situation is like at the international and national level, the &quot;Unión Argentina de Rugby&quot;&#xD;
      lacks conclusive epidemiological data.&#xD;
&#xD;
      Our main purpose was to describe the prevalence, incidence and injury load suffered in male&#xD;
      amateur rugby players from Argentina during a competitive season in 2019.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Observational, descriptive, retrospective and multicenter study.&#xD;
&#xD;
      Participants:&#xD;
&#xD;
      250 male amateur rugby players belonging to three clubs from three rugby unions (Buenos&#xD;
      Aires, Córdoba and Rosario) of Argentina.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Registration methods were applied according to the consensus of the World Rugby by a single&#xD;
      observer per center. Injuries occurred in players from top rosters of 3 amateur rugby clubs&#xD;
      (data collection centers) as well as the number of matches and hours of training were&#xD;
      recorded. Medical diagnoses were classified under the rules of the OSIICS classification&#xD;
      system. The incidence (injuries / 1000 hours-game-player), prevalences (point and period),&#xD;
      the severity (days of absence) and the injury load will be calculated as well as the&#xD;
      location, type, nature. This study followed the guidelines of the STROBE-SIIS Initiative&#xD;
      Declaration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 20, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Injury Incidence</measure>
    <time_frame>9 months</time_frame>
    <description>injuries/1000 hours-player</description>
  </primary_outcome>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Injuries</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Intervention</intervention_name>
    <description>Not Apply</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male Argentine amateur rugby players of the 2019 season&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years&#xD;
&#xD;
          -  Participation in more than 80% during training and matches of the competitive season.&#xD;
&#xD;
          -  First, intermediate, Pre-intermediate A and Pre-intermediate B categories of the&#xD;
             University teams of Córdoba, Old Resian and Los Matreros, belonging to UAR member&#xD;
             unions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Lost patient data&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mauro Andreu, BSc</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Donación Francisco Santojanni</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eduardo Tondelli, BSc</last_name>
    <phone>+54 11 68994582</phone>
    <email>edutondelli@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mauro Andreu, BSc</last_name>
    <phone>+54 11 68788298</phone>
    <email>mfandreu@gmail.com</email>
  </overall_contact_backup>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 17, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 20, 2020</last_update_submitted>
  <last_update_submitted_qc>May 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Donación Francisco Santojanni</investigator_affiliation>
    <investigator_full_name>Mauro Andreu</investigator_full_name>
    <investigator_title>Prof. Lic. Klgo. Ftra. Mauro Andreu</investigator_title>
  </responsible_party>
  <keyword>epidemiology</keyword>
  <keyword>Incidence</keyword>
  <keyword>Injury severity</keyword>
  <keyword>Football</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04402567
org study id: HGADFS19052020-01
nct id: NCT04402567
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to describe the prevalence, incidence and injury load suffered in
      male amateur rugby players from Argentina during a competitive season in 2019.
Introduction:

      Currently, Rugby is a sport that is giving priority to the well-being of the player. Players
      are subjected to high training and match loads exposing them to constant stress that can lead
      to overload injuries in addition to frequent contact injuries. Despite knowing what the
      situation is like at the international and national level, the "Unión Argentina de Rugby"
      lacks conclusive epidemiological data.

      Our main purpose was to describe the prevalence, incidence and injury load suffered in male
      amateur rugby players from Argentina during a competitive season in 2019.

      Design:

      Observational, descriptive, retrospective and multicenter study.

      Participants:

      250 male amateur rugby players belonging to three clubs from three rugby unions (Buenos
      Aires, Córdoba and Rosario) of Argentina.

      Methods:

      Registration methods were applied according to the consensus of the World Rugby by a single
      observer per center. Injuries occurred in players from top rosters of 3 amateur rugby clubs
      (data collection centers) as well as the number of matches and hours of training were
      recorded. Medical diagnoses were classified under the rules of the OSIICS classification
      system. The incidence (injuries / 1000 hours-game-player), prevalences (point and period),
      the severity (days of absence) and the injury load will be calculated as well as the
      location, type, nature. This study followed the guidelines of the STROBE-SIIS Initiative
      Declaration.
observational model: Other
time perspective: Retrospective
measure: Injury Incidence
time frame: 9 months
description: injuries/1000 hours-player
intervention type: Other
intervention name: No Intervention
description: Not Apply
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mauro Andreu, BSc
role: Study Director
affiliation: Hospital Donación Francisco Santojanni
last name: Eduardo Tondelli, BSc
phone: +54 11 68994582
email: edutondelli@gmail.com
last name: Mauro Andreu, BSc
phone: +54 11 68788298
email: mfandreu@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Hospital Donación Francisco Santojanni
investigator full name: Mauro Andreu
investigator title: Prof. Lic. Klgo. Ftra. Mauro Andreu
mesh term: Wounds and Injuries
sharing ipd: Undecided