Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT01994512
Status:
COMPLETED
Last Update Posted:
2015-12-17
First Post:
2013-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Swedish Spinal Stenosis Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013130', 'term': 'Spinal Stenosis'}, {'id': 'D013168', 'term': 'Spondylolisthesis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013169', 'term': 'Spondylolysis'}, {'id': 'D055009', 'term': 'Spondylosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003664', 'term': 'Decompression'}, {'id': 'D050939', 'term': 'Gene Fusion'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011312', 'term': 'Pressure'}, {'id': 'D055595', 'term': 'Mechanical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011995', 'term': 'Recombination, Genetic'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 245}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-16', 'studyFirstSubmitDate': '2013-11-19', 'studyFirstSubmitQcDate': '2013-11-22', 'lastUpdatePostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': '2 years', 'description': 'A difference in ODI of 12 at follow up between the two interventions is considered as significant.'}], 'secondaryOutcomes': [{'measure': 'Back pain', 'timeFrame': '2 years', 'description': 'The visual analog scale (VAS 0-100) is used the evaluate pain. A difference of 20 between the interventions is considered significant.'}, {'measure': 'Leg pain', 'timeFrame': '2 years', 'description': 'The visual analog scale (VAS 0-100) is used the evaluate pain. A difference of 20 between the interventions is considered significant.'}, {'measure': 'EuroQol (EQ-5D)', 'timeFrame': '2 years', 'description': 'Measurement of quality of life'}, {'measure': 'Swiss Spinal Stenosis Questionnaire', 'timeFrame': '2 years', 'description': "A disease-specific self-report outcome instrument commonly used in trials to measure treatment outcomes in patients with lumbar spinal stenosis. The Swiss Spinal Stenosis Questionnaire quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment. It was designed to complement existing generic measures of lumbar spine disability and health status in the evaluation of patients with lumbar spinal stenosis."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Spinal stenosis', 'Decompression', 'Fusion', 'Olisthesis'], 'conditions': ['Lumbar Spinal Stenosis']}, 'referencesModule': {'references': [{'pmid': '27074066', 'type': 'DERIVED', 'citation': 'Forsth P, Olafsson G, Carlsson T, Frost A, Borgstrom F, Fritzell P, Ohagen P, Michaelsson K, Sanden B. A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis. N Engl J Med. 2016 Apr 14;374(15):1413-23. doi: 10.1056/NEJMoa1513721.'}]}, 'descriptionModule': {'briefSummary': 'A national randomized multicentre trial (RCT) where decompression is compared with decompression with simultaneous fusion in 245 patients with spinal stenosis on one or two adjacent lumbar levels with or without degenerative olisthesis. The material is stratified for the existence of degenerative olisthesis \\>3mm. Monitoring is performed with clinical results from patient surveys after 2 and five years, and with radiological follow-up (MRI, CT and plain X-ray) and an objective function test (6 min walking test) after 2 years. The null hypothesis is that there is no difference in results between the two interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pseudoclaudication in one or both legs and backpain (VAS\\>30)\n* MRI with 1-2 adjacent stenotic segments (area \\<0.75 mm2)between L2 and sacrum\n* Duration of symptoms \\>6 months\n* Informed consent\n\nExclusion Criteria:\n\n* Spondylolysis\n* Degenerative lumbar scoliosis (Cobb angle \\>20 deg)\n* History of lumbar spinal surgery for spinal stenosis or instability\n* Stenosis not caused by degenerative changes\n* Stenosis caused by herniated disc\n* Other specific spinal conditions, Mb Bechterew, malignancy, neurologic disorders\n* History of vertebral compression fractures in affected segments\n* Psychological disorders where the surgeon considers participation inappropriate(dementia, drug abuse)'}, 'identificationModule': {'nctId': 'NCT01994512', 'acronym': 'SSSS', 'briefTitle': 'Swedish Spinal Stenosis Study', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Swedish Spinal Stenosis Study. An RCT Comparing Decompression With Fusion to Decompression Only in Lumbar Spinal Stenosis With or Without Degenerative Olisthesis.', 'orgStudyIdInfo': {'id': 'SS 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Decompression without fusion', 'description': 'Surgery of the stenotic spinal segments with decompression of the neural elements without concommitant fusion.', 'interventionNames': ['Procedure: Decompression without fusion']}, {'type': 'EXPERIMENTAL', 'label': 'Decompression with fusion', 'description': 'Surgery of the stenotic spinal segments with decompression of the neural elements with concommitant fusion.', 'interventionNames': ['Procedure: Decompression with fusion']}], 'interventions': [{'name': 'Decompression without fusion', 'type': 'PROCEDURE', 'description': 'Decompressive surgery of both central and lateral component of the stenosis.', 'armGroupLabels': ['Decompression without fusion']}, {'name': 'Decompression with fusion', 'type': 'PROCEDURE', 'description': 'Decompressive surgery of both central and lateral component of the stenosis AND concomitant instrumented or uninstrumented posterior fusion of decompressed segments.', 'armGroupLabels': ['Decompression with fusion']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}