Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:28 AM
Study NCT ID:
NCT07443267
Status:
COMPLETED
Last Update Posted:
2026-03-02
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy in Pain Reduction of CT-Guided Screw Fixation for Post-laminectomy Surgery Segment Spinal Instability: A Monocentric Study of 24 Patients (2023-2026)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013122', 'term': 'Spinal Diseases'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-17', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain levels between pre-intervention and post-intervention measurements.', 'timeFrame': 'Baseline) , 1 month post-intervention, 6 months post-intervention, and 1 year post-intervention.', 'description': 'Pain assessed using the Visual Analog Scale (VAS) from 1 to 10,'}], 'secondaryOutcomes': [{'measure': 'Improvement in quality of life following the intervention.', 'timeFrame': 'Baseline ) 1 month post-intervention 6 months post-intervention and 1 year post-intervention.', 'description': 'EQ-5D-3L questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Disease', 'Adjacent Segment Disease']}, 'descriptionModule': {'briefSummary': 'Segmental instability of the spine following laminectomy or surgical arthrodesis is a common complication that often requires additional surgical intervention. CT-guided trans-facet screw fixation (TFF), performed under local anesthesia, is an innovative and minimally invasive technique that offers an alternative to open surgery under general anesthesia. This study aims to evaluate the effectiveness of CT-guided TFF fixation in reducing pain and improving daily activities in a population of 43 patients who have undergone prior spinal surgeries'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '93 Years', 'minimumAge': '41 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients consulting at the University Hospital of Nice (CHU de Nice).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treated at the University Hospital of Nice between march 2023 and january 2026 with trans-facet arthrodesis for persistent lumbar segment instability following previous laminectomy surgery.\n* MRI or scintigraphy imaging showed signs suggestive of instability\n* Newly developed or worsening spondylolisthesis on successive examinations\n* Congestive arthropathy\n* Facet dislocation\n* Inflammatory disc disease (MODIC type 1 changes)\n\nExclusion Criteria:\n\n* Inability to tolerate the prone position under local anesthesia.\n* Presence of anatomical variants precluding the technical feasibility of transfacet fixation.'}, 'identificationModule': {'nctId': 'NCT07443267', 'briefTitle': 'Safety and Efficacy in Pain Reduction of CT-Guided Screw Fixation for Post-laminectomy Surgery Segment Spinal Instability: A Monocentric Study of 24 Patients (2023-2026)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Post Laminectomy Spinal Instability: the Role of CT Guided Screw Fixation to Avoid New Surgery', 'orgStudyIdInfo': {'id': '24Radiointerv01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohorte', 'description': 'Patients diagnosed with segment lumbar instability following spinal surgical procedures such as laminectomy .', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Cohorte']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0600', 'city': 'Nice', 'state': 'Alpes Maritimes', 'country': 'France', 'facility': 'CHU NICE', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}