<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/NCT04470232</url>
  </required_header>
  <id_info>
    <org_study_id>20_RIPH3-03</org_study_id>
    <nct_id>NCT04470232</nct_id>
  </id_info>
  <brief_title>Transcultural and Psychometric Validation of SUSHI and HOOS-12 Scores in Patients With Coxofemoral Pathologies</brief_title>
  <acronym>HIP</acronym>
  <official_title>Transcultural and Psychometric Validation of SUSHI and HOOS-12 Scores in Patients With Coxofemoral Pathologies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Center of Martinique</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lariboisière Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Saint-Gregoire Private Hospital Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Center of Martinique</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 management of coxofemoral pathologies is constantly increasing.&#xD;
&#xD;
      In addition to degenerative hip pathology, the orthopedic surgeon is now confronted with&#xD;
      pathologies such as femoro-acetabular conflict, pathologies of the gluteus medius and&#xD;
      pathologies of the labrum whose early management limits arthritis degeneration. These&#xD;
      pathologies are mainly encountered in young subjects (&lt;60 years).&#xD;
&#xD;
      Self-questionnaires play an important role in understanding patients' point of view on the&#xD;
      impact of their coxofemoral pathologies and also allow an assessment of their condition after&#xD;
      treatment.&#xD;
&#xD;
      For the evaluation of coxofemoral pathologies in the young subject (&lt;60 years) the Super&#xD;
      Simple Hip score (SUSHI-score) was developed and validated.&#xD;
&#xD;
      In the elderly subject with hip osteoarthritis, the HOOS score has the advantage of&#xD;
      specifically measuring pain, symptoms, function and quality of life, but is made up of 40&#xD;
      items and is often considered rather heavy to submit. However, it has recently been&#xD;
      simplified and the HOOS-12 (HOOS score with 12 items) has been developed and validated.&#xD;
&#xD;
      These two scores are useful in current clinical practice but they are only validated in&#xD;
      English.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 11, 2020</start_date>
  <completion_date type="Anticipated">March 2023</completion_date>
  <primary_completion_date type="Anticipated">September 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Transcultural validation of the SUSHI-score and HOOS-12 score questionnaire</measure>
    <time_frame>1 month</time_frame>
    <description>It will be a question of obtaining a version translated into French. The translated version tested on a small group of patients (15) will be submitted to the author of the original version of the tool, along with a report highlighting and explaining all the modifications and difficulties noted by a group of experts.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Psychometric validation of the SUSHI-score and HOOS-12 score questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>Questionnaires will be passed by 120 subjects. Following parameters will be measured: feasibility and acceptability, validity, reliability, and sensitivity to change.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Coxofemoral Pathologies</condition>
  <arm_group>
    <arm_group_label>Patients with coxofemoral pathologies</arm_group_label>
    <description>For the transcultural validation, a french version of the 2 self-assessment questionnaires, SUSHI-score and the HOOs-12 score will be produced.&#xD;
For the psychometric validation, 120 patients with coxofemoral pathologies will pass the two questionnaires. The HAGOS (Hip and Groin Score) questionnaire will be also passed by the subject, for the convergent validity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self-assessment questionnaires</intervention_name>
    <description>120 patients with coxofemoral pathologies will pass the SUSHI-score and the HOOS-12 score questionnaires.&#xD;
The HAGOS (Hip and Groin Score) questionnaire will be also passed by the subject, for the convergent validity.</description>
    <arm_group_label>Patients with coxofemoral pathologies</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a coxofemoral pathology.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient (age greater than or equal to 18 years old),&#xD;
&#xD;
          -  Patient with coxofemoral pathology,&#xD;
&#xD;
          -  Patient having been informed of the research,&#xD;
&#xD;
          -  Patient agreeing to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor patient,&#xD;
&#xD;
          -  Pregnant woman,&#xD;
&#xD;
          -  Patient out of state to agree to participate in the study,&#xD;
&#xD;
          -  Patient unable to answer a self-assessment questionnaire,&#xD;
&#xD;
          -  Patient under justice, guardianship or curatorship,&#xD;
&#xD;
          -  Patient who refused to participate in the study.&#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_contact>
    <last_name>Mathieu SEVERYNS, MD</last_name>
    <phone>05 96 55 22 21</phone>
    <phone_ext>+596</phone_ext>
    <email>mathieu.severyns@chu-martinique.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hôpital Lariboisière - AP-HP</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guillaume ODRI, MD</last_name>
      <phone>01 49 95 91 51</phone>
      <phone_ext>+33</phone_ext>
      <email>guillaume.odri@ap-hp.fr</email>
    </contact>
    <investigator>
      <last_name>Guillaume ODRI, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Privé Saint-Grégoire</name>
      <address>
        <city>Saint-Grégoire</city>
        <zip>35760</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Charles KAJETANEK, MD</last_name>
      <phone>02 23 25 30 85</phone>
      <phone_ext>+33</phone_ext>
      <email>charles.kajetanek@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Charles KAJETANEK, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU of Martinique</name>
      <address>
        <city>Fort-de-France</city>
        <zip>97261</zip>
        <country>Martinique</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mathieu SEVERYNS, MD</last_name>
      <phone>05 96 55 22 21</phone>
      <phone_ext>+596</phone_ext>
      <email>mathieu.severyns@chu-martinique.fr</email>
    </contact>
    <investigator>
      <last_name>Mathieu SEVERYNS, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lucas MATTESI, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
    <country>Martinique</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>June 10, 2022</last_update_submitted>
  <last_update_submitted_qc>June 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coxofemoral pathologies</keyword>
  <keyword>Self assessment questionnaire</keyword>
  <keyword>Super Simple Hip score (SUSHI-score)</keyword>
  <keyword>Hip disability and Osteoarthritis Outcome Score (HOOS score)</keyword>
  <keyword>Transcultural validation</keyword>
  <keyword>Psychometric validation</keyword>
  <keyword>Hip and Groin score (HAGOS)</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT04470232
org study id: 20_RIPH3-03
nct id: NCT04470232
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The management of coxofemoral pathologies is constantly increasing.

      In addition to degenerative hip pathology, the orthopedic surgeon is now confronted with
      pathologies such as femoro-acetabular conflict, pathologies of the gluteus medius and
      pathologies of the labrum whose early management limits arthritis degeneration. These
      pathologies are mainly encountered in young subjects (<60 years).

      Self-questionnaires play an important role in understanding patients' point of view on the
      impact of their coxofemoral pathologies and also allow an assessment of their condition after
      treatment.

      For the evaluation of coxofemoral pathologies in the young subject (<60 years) the Super
      Simple Hip score (SUSHI-score) was developed and validated.

      In the elderly subject with hip osteoarthritis, the HOOS score has the advantage of
      specifically measuring pain, symptoms, function and quality of life, but is made up of 40
      items and is often considered rather heavy to submit. However, it has recently been
      simplified and the HOOS-12 (HOOS score with 12 items) has been developed and validated.

      These two scores are useful in current clinical practice but they are only validated in
      English.
observational model: Cohort
time perspective: Prospective
measure: Transcultural validation of the SUSHI-score and HOOS-12 score questionnaire
time frame: 1 month
description: It will be a question of obtaining a version translated into French. The translated version tested on a small group of patients (15) will be submitted to the author of the original version of the tool, along with a report highlighting and explaining all the modifications and difficulties noted by a group of experts.
measure: Psychometric validation of the SUSHI-score and HOOS-12 score questionnaire
time frame: 12 months
description: Questionnaires will be passed by 120 subjects. Following parameters will be measured: feasibility and acceptability, validity, reliability, and sensitivity to change.
arm group label: Patients with coxofemoral pathologies
description: For the transcultural validation, a french version of the 2 self-assessment questionnaires, SUSHI-score and the HOOs-12 score will be produced.
For the psychometric validation, 120 patients with coxofemoral pathologies will pass the two questionnaires. The HAGOS (Hip and Groin Score) questionnaire will be also passed by the subject, for the convergent validity.
intervention type: Other
intervention name: Self-assessment questionnaires
description: 120 patients with coxofemoral pathologies will pass the SUSHI-score and the HOOS-12 score questionnaires.
The HAGOS (Hip and Groin Score) questionnaire will be also passed by the subject, for the convergent validity.
arm group label: Patients with coxofemoral pathologies
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mathieu SEVERYNS, MD
phone: 05 96 55 22 21
phone ext: +596
email: mathieu.severyns@chu-martinique.fr
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: France
country: Martinique
responsible party type: Sponsor
sharing ipd: No