Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT04308018
Status:
UNKNOWN
Last Update Posted:
2020-03-13
First Post:
2019-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Primary Sacroiliac Fusion Versus Fusion to the Sacrum for Degenerative Disease of the Lumbar Spine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 148}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-11', 'studyFirstSubmitDate': '2019-11-21', 'studyFirstSubmitQcDate': '2020-03-11', 'lastUpdatePostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Revision rate', 'timeFrame': '1 year after surgery', 'description': 'Revisions rates between groups 1 year after surgery'}], 'secondaryOutcomes': [{'measure': 'Inter-group Oswestry disability index (ODI)', 'timeFrame': '3, 6, 12, and 24 months after surgery', 'description': 'Difference in Oswestry disability index (ODI) between groups 3, 6, 12, and 24 months after surgery'}, {'measure': 'British Medical Research Council (BMRC) scale', 'timeFrame': '3, 6, 12, and 24 months after surgery', 'description': 'BMRC scale 3, 6, 12, and 24 months after surgery'}, {'measure': 'Severe adverse events', 'timeFrame': '3, 6, 12, and 24 months after surgery', 'description': '(Severe adverse events) SAE due to instrumentation (new neurological deficit, infection, vascular complications, etc.)'}, {'measure': 'Back pain intensity', 'timeFrame': '3, 6, 12, and 24 months after surgery', 'description': 'Back pain intensity at the visual analogue scale (VAS; 0-10; high scores mean a worse outcome) 3, 6, 12, and 24 months after surgery'}, {'measure': 'Health-related quality of life', 'timeFrame': '3, 6, 12, and 24 months after surgery', 'description': 'Health-related quality of life evaluated by the "physical component summary (PCS)" of the short-form (SF)-36 3, 6, 12, and 24 months after surgery'}, {'measure': 'Patient satisfaction', 'timeFrame': '3, 6, 12, and 24 months after surgery', 'description': 'Patient satisfaction index 3, 6, 12, and 24 months after surgery'}, {'measure': 'Intra-group Oswestry disability index (ODI)', 'timeFrame': '3, 6, 12, and 24 months after surgery', 'description': 'Difference in ODI 3, 6, 12, and 24 months after surgery versus preoperatively within the same group'}, {'measure': 'Revision rate II', 'timeFrame': '24 months after surgery', 'description': 'Revisions rates between groups 24 months after surgery'}, {'measure': 'Sacroiliac joint syndrome', 'timeFrame': '3, 6, 12, and 24 months after surgery', 'description': 'Clinically apparent sacroiliac joint syndrome (Definition: Effective infiltration of local anesthetic) 3, 6, 12, and 24 months after surgery'}, {'measure': 'Gluteal pain', 'timeFrame': '3, 6, 12, and 24 months after surgery', 'description': 'Gluteal pain at the visual analogue scale (VAS; 0-10; high scores mean a worse outcome) 3, 6, 12, and 24 months after surgery'}, {'measure': 'Changes in sagittal balance', 'timeFrame': '1 and 2 years after surgery', 'description': 'Changes in sagittal balance (C7 plumb line, pelvic tilt, pelvic incidence, sacral slope, and lumbar lordosis) 1 and 2 years after surgery versus preoperatively within the same group'}, {'measure': 'Progressive degeneration of the adjacent segment', 'timeFrame': '3, 6, 12, and 24 months after surgery', 'description': 'Radiological proof of progressive degeneration of the adjacent segment'}, {'measure': 'Surgery duration', 'timeFrame': 'Surgery', 'description': 'Surgery duration'}, {'measure': 'Intraoperative blood loss', 'timeFrame': 'Intraoperative', 'description': 'Intraoperative blood loss'}, {'measure': 'Adverse events', 'timeFrame': '3, 6, 12, and 24 months after surgery', 'description': 'Adverse events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Degeneration Spine']}, 'descriptionModule': {'briefSummary': 'To prove that the use of additional S2alar-iliac screws for pure lumbar fusions due to degenerative lumbar disease provides superior outcome compared to the standard procedure of fusion to S1.', 'detailedDescription': 'Patients with symptomatic degenerative spine disease with or without spinal stenosis undergoing lumbosacral fusion to S1. Pedicle screws for posterior Instrumentation and fusion of the lumbar spine plus intervertebral fusion L5/S1 (anterior lumbar inter body fusion (ALIF), transforaminal lumbar inter body fusion (TLIF), or posterior lumbar inter body fusion (PLIF)) with\n\n1. Caudal end of the instrumentation at S1\n2. Caudal end of the instrumentation at iliac bone via S2alar-iliac screws\n\nStratification of both groups by:\n\n* Number of instrumented levels\n* Sagittal balance (Roussouly type 1+2 vs. 3+4)\n\nProspective, randomized, controlled, rater-blinded multicentric interventional study with two parallel groups'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with symptomatic degenerative spine disease with or without spinal stenosis undergoing lumbosacral fusion to S1\n* Lumbar or thoracolumbar Instrumentation\n* Planned ventral intervertebral fusion (ALIF, TLIF, PLIF) in L5/S1\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Scoliosis \\>20°\n* Chronic steroid usage\n* Significant co-morbidity influencing the surgical success:\n\n * Osteoporosis\n * Rheumatoid arthritis\n * Mental illness/dementia'}, 'identificationModule': {'nctId': 'NCT04308018', 'acronym': 'PSEUDOLUSE', 'briefTitle': 'Primary Sacroiliac Fusion Versus Fusion to the Sacrum for Degenerative Disease of the Lumbar Spine', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Primary Sacroiliac Fusion Versus Fusion to the Sacrum for Degenerative Disease of the Lumbar Spine', 'orgStudyIdInfo': {'id': '20/20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'S1', 'description': 'Caudal end of the instrumentation at S1', 'interventionNames': ['Procedure: S1 screws']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'S2alar-iliac', 'description': 'Caudal end of the instrumentation at iliac bone via S2alar-iliac screws', 'interventionNames': ['Procedure: S2alar-iliac screws']}], 'interventions': [{'name': 'S2alar-iliac screws', 'type': 'PROCEDURE', 'description': 'Caudal end of the instrumentation at iliac bone via S2alar-iliac screws', 'armGroupLabels': ['S2alar-iliac']}, {'name': 'S1 screws', 'type': 'PROCEDURE', 'description': 'Caudal end of the instrumentation at S1', 'armGroupLabels': ['S1']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sandro Krieg, MD', 'role': 'CONTACT', 'email': 'sandro.krieg@tum.de', 'phone': '8941402151'}, {'name': 'Sebastian Ille, MD', 'role': 'CONTACT', 'email': 'sebastian.ille@tum.de', 'phone': '8941402151'}], 'overallOfficials': [{'name': 'Sandro Krieg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technical University Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}