Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-05 @ 11:37 AM
Study NCT ID:
NCT07200557
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2025-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reassessing the Role of Routine Radiographs After Spinal Fusion Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 978}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2025-09-10', 'studyFirstSubmitQcDate': '2025-09-26', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of radiographs that led to further diagnostic tests or therapeutic interventions within 12 months post-surgery', 'timeFrame': 'Within 12 months after spinal fusion surgery', 'description': 'Percentage of follow-up visits with routine radiographs in which the radiograph resulted in further diagnostic testing (e.g., CT, MRI) or a therapeutic intervention (e.g., medication change, reoperation).'}], 'secondaryOutcomes': [{'measure': 'Proportion of abnormal versus normal radiographs', 'timeFrame': 'Within 12 months after spinal fusion surgery', 'description': 'Percentage of routine postoperative radiographs classified as abnormal compared to those classified as normal, based on radiologist or surgeon interpretation.'}, {'measure': 'Correlation between clinical course and management decisions', 'timeFrame': 'Within 12 months after spinal fusion surgery', 'description': 'Percentage of follow-up visits in which the patient was symptomatic versus asymptomatic, compared to the percentage of those visits that resulted in further diagnostic testing or therapeutic intervention.'}, {'measure': 'Correlation of demographic factors with radiographic utility', 'timeFrame': 'Within 12 months after spinal fusion surgery', 'description': 'Percentage of radiographs leading to additional diagnostic tests or therapeutic interventions, stratified by demographic variables (age in years, sex, body mass index in kg/m²).'}, {'measure': 'Correlation of surgical factors with radiographic utility', 'timeFrame': 'Within 12 months after spinal fusion surgery', 'description': 'Percentage of radiographs leading to additional diagnostic tests or therapeutic interventions, stratified by surgical variables (fusion level: cervical, thoracic, lumbar; number of fused segments; type of instrumentation).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Routine radiographs', 'Spinal fusion', 'Clinical utility', 'Spinal fusion surgery', 'Radiographs'], 'conditions': ['Radiography', 'Spinal Fusion']}, 'descriptionModule': {'briefSummary': 'Routine radiographs are commonly obtained after spinal fusion surgery to monitor postoperative evolution and detect complications. However, the actual contribution of these radiographs to clinical decision-making remains unclear. This retrospective cohort study evaluates the frequency and clinical impact of routine postoperative radiographs in patients undergoing spinal fusion surgery at University Hospitals Leuven.', 'detailedDescription': 'Routine radiographs are commonly obtained after spinal fusion surgery to assess implant position, fusion progress, and potential complications. Yet, their actual contribution to patient care remains uncertain, and routine use may expose patients to unnecessary radiation and increase healthcare costs.\n\nIn this retrospective cohort study, the investigators will evaluate the clinical utility of routine radiographs during the first postoperative year after spinal fusion surgery at University Hospitals Leuven (2011-2021).\n\nThe investigators will review each follow-up visit to record the clinical course, radiographic findings, and whether these influenced further diagnostic tests or therapeutic interventions.\n\nThe investigators will primarily assess how often radiographs lead to a change in management. Secondary analyses will determine the proportion of abnormal versus normal radiographs, the relationship between clinical course and imaging results, and whether demographic or surgical factors predict radiographic utility.\n\nBy analyzing nearly 1,000 patients and more than 2,800 visits, the investigators will provide one of the most comprehensive evaluations of routine postoperative radiographs to date, aiming to guide more efficient, evidence-based follow-up strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing spinal fusion surgery (2011-2021) for degenerative conditions at University Hospitals Leuven', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent spinal fusion surgery at UZ Leuven, including the cervical, thoracic and lumbar spine for a degenerative condition\n* Adults of 18 years and older\n* Follow up at least 3 months after surgery\n\nExclusion Criteria:\n\n* Non-degenerative (kypho) scoliosis\n* Indications other than degenerative conditions and (adult) isthmic spondylolisthesis (e.g. tumor, septic arthritis, trauma,…)\n* Chronic neuromuscular disease'}, 'identificationModule': {'nctId': 'NCT07200557', 'acronym': 'RRASP', 'briefTitle': 'Reassessing the Role of Routine Radiographs After Spinal Fusion Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Reassessing the Role of Routine Radiographs After Spinal Fusion Surgery', 'orgStudyIdInfo': {'id': 'S68783'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing spinal fusion surgery (2011-2021) at University Hospitals Leuven', 'description': 'Retrospective cohort of adult patients (≥18 years) who underwent spinal fusion surgery for degenerative spinal conditions at University Hospitals Leuven between 2011 and 2021. Patients were followed for at least 12 months after surgery, with data collected from postoperative follow-up visits, including clinical course, radiographic findings, and subsequent management decisions.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Sofie Rummens, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is a retrospective, single-center study. No individual participant data will be made publicly available. Summary results will be reported in peer-reviewed publications.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}