Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT02886260
Status:
UNKNOWN
Last Update Posted:
2021-08-05
First Post:
2016-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishing a Descriptive Cohort of Patients Cared for Operation on the Spine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013124', 'term': 'Spinal Injuries'}, {'id': 'D013122', 'term': 'Spinal Diseases'}], 'ancestors': [{'id': 'D019567', 'term': 'Back Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-04', 'studyFirstSubmitDate': '2016-08-29', 'studyFirstSubmitQcDate': '2016-08-29', 'lastUpdatePostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life measured by the Oswestry Disability Index score', 'timeFrame': '24 months after surgical intervention'}], 'secondaryOutcomes': [{'measure': 'Quality of life measured by the Oswestry Disability Index score', 'timeFrame': '6 weeks, 12 weeks, 6 months, 12 months, 36 months, 48 months after surgical intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Quality of Life', 'Spinal Injuries', 'Spinal Diseases']}, 'descriptionModule': {'briefSummary': 'This study aims to:\n\n1. describe the monitoring of patients treated for spinal disorders.\n2. create a comprehensive database of reliable and readily exploitable quickly to produce a library of cross publications between orthopedic surgery and neurosurgical services. This database will include clinical, functional , radiographic , educational, social and professional data.\n3. obtain a cohort of patients in the comprehensive range of spinal pathologies.\n4. standardize data collection in this cohort with similar national projects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with symptomatic spinal pathology requiring surgical or orthopedic treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must be given free and informed consent and signed the consent\n* The patient must be affiliated or beneficiary of a health insurance plan\n* The patient is available for a 24-month follow-up\n* The patient is at least 18 years old\n* The patient has a symptomatic spinal pathology requiring surgical or orthopedic treatment\n\nExclusion Criteria:\n\n* The patient is under judicial protection, guardianship or curatorship\n* The patient refuses to sign the consent\n* It is not possible to give informed information to the patient\n* The patient does not fluently read French.\n* the patient is not available for a 24-month follow-ip'}, 'identificationModule': {'nctId': 'NCT02886260', 'acronym': 'KEOPS', 'briefTitle': 'Establishing a Descriptive Cohort of Patients Cared for Operation on the Spine', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'orgStudyIdInfo': {'id': 'LOCAL/2011/PK-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '30000', 'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Carey Suehs', 'role': 'CONTACT', 'email': 'carey.suehs@chu-nimes.fr', 'phone': '+33466686788'}], 'facility': 'CHU Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'centralContacts': [{'name': 'CHU Nimes', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}