Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT04470232
Status:
UNKNOWN
Last Update Posted:
2022-06-13
First Post:
2020-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcultural and Psychometric Validation of SUSHI and HOOS-12 Scores in Patients With Coxofemoral Pathologies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-10', 'studyFirstSubmitDate': '2020-07-09', 'studyFirstSubmitQcDate': '2020-07-09', 'lastUpdatePostDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transcultural validation of the SUSHI-score and HOOS-12 score questionnaire', 'timeFrame': '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', 'timeFrame': '12 months', 'description': 'Questionnaires will be passed by 120 subjects. Following parameters will be measured: feasibility and acceptability, validity, reliability, and sensitivity to change.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coxofemoral pathologies', 'Self assessment questionnaire', 'Super Simple Hip score (SUSHI-score)', 'Hip disability and Osteoarthritis Outcome Score (HOOS score)', 'Transcultural validation', 'Psychometric validation', 'Hip and Groin score (HAGOS)'], 'conditions': ['Coxofemoral Pathologies']}, 'descriptionModule': {'briefSummary': "The management of coxofemoral pathologies is constantly increasing.\n\nIn 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).\n\nSelf-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.\n\nFor the evaluation of coxofemoral pathologies in the young subject (\\<60 years) the Super Simple Hip score (SUSHI-score) was developed and validated.\n\nIn 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.\n\nThese two scores are useful in current clinical practice but they are only validated in English."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a coxofemoral pathology.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient (age greater than or equal to 18 years old),\n* Patient with coxofemoral pathology,\n* Patient having been informed of the research,\n* Patient agreeing to participate in the study.\n\nExclusion Criteria:\n\n* Minor patient,\n* Pregnant woman,\n* Patient out of state to agree to participate in the study,\n* Patient unable to answer a self-assessment questionnaire,\n* Patient under justice, guardianship or curatorship,\n* Patient who refused to participate in the study.'}, 'identificationModule': {'nctId': 'NCT04470232', 'acronym': 'HIP', 'briefTitle': 'Transcultural and Psychometric Validation of SUSHI and HOOS-12 Scores in Patients With Coxofemoral Pathologies', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Center of Martinique'}, 'officialTitle': 'Transcultural and Psychometric Validation of SUSHI and HOOS-12 Scores in Patients With Coxofemoral Pathologies', 'orgStudyIdInfo': {'id': '20_RIPH3-03'}}, 'armsInterventionsModule': {'armGroups': [{'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.\n\nFor 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.', 'interventionNames': ['Other: Self-assessment questionnaires']}], 'interventions': [{'name': 'Self-assessment questionnaires', 'type': 'OTHER', 'description': '120 patients with coxofemoral pathologies will pass the SUSHI-score and the HOOS-12 score questionnaires.\n\nThe HAGOS (Hip and Groin Score) questionnaire will be also passed by the subject, for the convergent validity.', 'armGroupLabels': ['Patients with coxofemoral pathologies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume ODRI, MD', 'role': 'CONTACT', 'email': 'guillaume.odri@ap-hp.fr', 'phone': '01 49 95 91 51', 'phoneExt': '+33'}, {'name': 'Guillaume ODRI, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Lariboisière - AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35760', 'city': 'Saint-Grégoire', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charles KAJETANEK, MD', 'role': 'CONTACT', 'email': 'charles.kajetanek@gmail.com', 'phone': '02 23 25 30 85', 'phoneExt': '+33'}, {'name': 'Charles KAJETANEK, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Privé Saint-Grégoire', 'geoPoint': {'lat': 48.15101, 'lon': -1.68579}}, {'zip': '97261', 'city': 'Fort-de-France', 'status': 'RECRUITING', 'country': 'Martinique', 'contacts': [{'name': 'Mathieu SEVERYNS, MD', 'role': 'CONTACT', 'email': 'mathieu.severyns@chu-martinique.fr', 'phone': '05 96 55 22 21', 'phoneExt': '+596'}, {'name': 'Mathieu SEVERYNS, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lucas MATTESI, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU of Martinique', 'geoPoint': {'lat': 14.60365, 'lon': -61.07418}}], 'centralContacts': [{'name': 'Mathieu SEVERYNS, MD', 'role': 'CONTACT', 'email': 'mathieu.severyns@chu-martinique.fr', 'phone': '05 96 55 22 21', 'phoneExt': '+596'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Center of Martinique', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lariboisière Hospital', 'class': 'UNKNOWN'}, {'name': 'Saint-Gregoire Private Hospital Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}