Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-03-29 @ 4:56 PM
Study NCT ID:
NCT06722859
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-09
First Post:
2024-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between The Results of Open and Microsurgical Decompression in Degenerative Spinal Canal Stenosis in 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'], 'maskingDescription': 'To compare the outcomes of open and microsururgical decompression in degenerative spinal stenosis in lumbar spine'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'To compare the outcomes of open and microsururgical decompression in degenerative spinal stenosis in lumbar spine'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2024-12-04', 'studyFirstSubmitQcDate': '2024-12-04', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clincal evaluation by visual analogue scale back pain and leg pain', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Degenerative Lumbar Canal Stenosis']}, 'descriptionModule': {'briefSummary': 'To compare the outcomes of open and microsururgical decompression in degenerative spinal stenosis in lumbar spine', 'detailedDescription': 'Lumbar spinal stenosis is defined as a circumscribed, osteoligamentous narrowing of the spinal canal. The clinical burden includes backaches and symptoms in the legs that deteriorate upon standing and walking (neurogenic claudication). Lumbar spinal stenosis is the most common cause of lumbar spine diseases in patients \\> 65 years old requiring surgical treatment; it is estimated that ∼0.1% of the population will need some procedure to treat degenerative lumbar spine conditions. Surgical treatment for lumbar spinal stenosis is indicated in cases of conservative treatment failure. It is also indicated in cases with very acute symptoms and radicular involvement associated with dermatome sensorial and motor changes and progressive worsening of severe neurogenic claudication. Vertebral canal decompression can be performed with several techniques. The gold standard is the open technique with laminectomy or laminotomy, in which laminae are resected or opened; next, the ligamentum flavum, usually thickened, is resected, exposing the nervous structures under compression. Laminotomy can be unilateral, bilateral or divide the spinous process. Damaging the paraspinal muscles and liberal removal of posterior bone may cause iatrogenic spinal instability. The Microsurgical spinal canal decompression decreases paravertebral musculature injury, reducing postoperative complications related to hematomas, seromas and infections and trunk extensor musculature atrophy. The dural sac is decompressed after its exposure and removed to allow the resection of the lateral recess and foramen opening to decompress an adjacent and/or emerging nerve root. It is believed that MIS may limit surgery-related morbidity and mortality by reducing the degree of surgical trauma while maintaining similar surgical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients present with degenerative lumber spinal canal stenosis in one or two level\n\nExclusion Criteria:\n\n1. degenrative listhesis.\n2. degenerative scoliosis.\n3. other secondary causes of lumber canal stenosis as tumor , abscesses and infection.\n4. Patients with previous lumbar operation'}, 'identificationModule': {'nctId': 'NCT06722859', 'briefTitle': 'Comparison Between The Results of Open and Microsurgical Decompression in Degenerative Spinal Canal Stenosis in Lumbar Spine', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparison Between The Results of Open and Microsurgical Decompression in Degenerative Spinal Canal Stenosis in Lumbar Spine in Assuit University Hospital', 'orgStudyIdInfo': {'id': 'Lumbar canal stenosis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Open surgical decompression', 'interventionNames': ['Procedure: Open surgical decompression in degenerative lumbar canal stenosis', 'Procedure: Microsurgical decompression']}, {'type': 'OTHER', 'label': 'Microsurgical decompression', 'interventionNames': ['Procedure: Open surgical decompression in degenerative lumbar canal stenosis', 'Procedure: Microsurgical decompression']}], 'interventions': [{'name': 'Open surgical decompression in degenerative lumbar canal stenosis', 'type': 'PROCEDURE', 'description': 'Open surgical decompression in degenerative lumbar canal stenosis', 'armGroupLabels': ['Microsurgical decompression', 'Open surgical decompression']}, {'name': 'Microsurgical decompression', 'type': 'PROCEDURE', 'description': 'Microsurgical decompression of degenerative lumbar canal stenosis', 'armGroupLabels': ['Microsurgical decompression', 'Open surgical decompression']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Shamel Mahmoud Mohamed, Resident', 'role': 'CONTACT', 'email': 'shamel.15259250@med.aun.edu.eg', 'phone': '01028174272'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of orthopedic and trauma surgery Assiut university hospital', 'investigatorFullName': 'Shamel Mahmoud', 'investigatorAffiliation': 'Assiut University'}}}}