Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-27 @ 10:14 PM
Study NCT ID:
NCT06815861
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-10
First Post:
2025-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Morbidity in Adult Scoliotic Surgery: Analysis of a Series From Brest (MOSCA-B)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2025-02-04', 'studyFirstSubmitQcDate': '2025-02-06', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of postoperative complications', 'timeFrame': 'at the time of inclusion', 'description': 'Number of complications (raw description), followed by univariate analysis to exclude confounding factors'}], 'secondaryOutcomes': [{'measure': 'ODI SORE', 'timeFrame': 'at the time of inclusion', 'description': 'ODI SCORE after the surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adult scoliosis', 'spine deformity', 'neurosurgery', 'spine surgery'], 'conditions': ['Adult Scoliosis', 'Spine Deformity', 'Neurosurgery']}, 'descriptionModule': {'briefSummary': 'Scoliosis surgery is an invasive procedure essential for alleviating significant pain and improving the physical, psychological, aesthetic, professional, and social well-being of patients. However, it carries a considerable risk of perioperative complications. This retrospective study, conducted at Brest University Hospital since 2017, aims to analyze these complications to provide a detailed assessment, particularly since the introduction of the OARM (intraoperative CT navigation), with the goal of optimizing the safety and effectiveness of surgical interventions. The complications studied include neurological, infectious, mechanical, and cardiopulmonary complications, along with an additional "other" category for rare complications. The period analyzed extends from the immediate postoperative phase to the most recent follow-up consultation with the referring surgeon, which varies depending on the duration of follow-up for each patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient Who underwent scoliosis surgery between 2017 and 2024 at the Brest University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient\n* Patient affiliated with a social security system\n* Who underwent scoliosis surgery between 2017 and 2024 at the Brest University Hospital\n\nExclusion Criteria:\n\nPatients under legal protection (guardianship, curatorship, etc.) Refusal to participate (expressed opposition) History of scoliosis surgery performed by another surgeon, regardless of the center or year'}, 'identificationModule': {'nctId': 'NCT06815861', 'acronym': 'MOSCA-B', 'briefTitle': 'Perioperative Morbidity in Adult Scoliotic Surgery: Analysis of a Series From Brest (MOSCA-B)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Perioperative Morbidity in Adult Scoliotic Surgery: Analysis of a Series From Brest', 'orgStudyIdInfo': {'id': '29BRC24.0313 - MOSCA-B'}}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'Chu Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available beginning three years and ending fifteen years following the final study report completion', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}