Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-06-14 @ 4:17 PM
Study NCT ID:
NCT03271060
Status:
UNKNOWN
Last Update Posted:
2017-09-01
First Post:
2017-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study Between Posterior Lumbar Interbody Fusion(PLIF) and Intertransverse Process Fusion in Treatment of Spodylolithesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013168', 'term': 'Spondylolisthesis'}], 'ancestors': [{'id': 'D013169', 'term': 'Spondylolysis'}, {'id': 'D055009', 'term': 'Spondylosis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Posterior inter body fusion and inter transverse process bone graft'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-31', 'studyFirstSubmitDate': '2017-08-31', 'studyFirstSubmitQcDate': '2017-08-31', 'lastUpdatePostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Back pain', 'timeFrame': '1year postoperative', 'description': 'Back pain severity grading mild, moderate, severe'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Spondylolisthesis']}, 'descriptionModule': {'briefSummary': "The first technique described for interbody fusion was the anterior lumbar interbody fusion (ALIF).(20) For this technique, the intervertebral disc is accessed through a retroperitoneal or transperitoneal approach.\n\nWhile the posterior approach was first described by Russell Hibbs in 1911, in the 1950's, Cloward (7)popularized the posterior approach for a posterior lumbar interbody fusion (PLIF).", 'detailedDescription': 'In this study we will try to identify the benefits and outcome of posterior lumbar interbody fusion and inter transverse process bone graft fusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* lumbar spondylolisthesis\n\nExclusion Criteria:\n\n* infection of lumbar spine'}, 'identificationModule': {'nctId': 'NCT03271060', 'briefTitle': 'Comparative Study Between Posterior Lumbar Interbody Fusion(PLIF) and Intertransverse Process Fusion in Treatment of Spodylolithesis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparative Study Between Posterior Lumbar Interbody Fusion(PLF) and Intertransverse Process Fusion in Treatment of Spodylolithesis', 'orgStudyIdInfo': {'id': 'Lumbar spondylolisthesis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lumbar spondylolisthesis1', 'interventionNames': ['Procedure: Inter transverse bone grafting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lumbar spondylolisthesis 2', 'interventionNames': ['Procedure: Posterior lumbar interbody fusion']}], 'interventions': [{'name': 'Posterior lumbar interbody fusion', 'type': 'PROCEDURE', 'description': 'Lumbar fusion by screws and inter vertebral cage', 'armGroupLabels': ['Lumbar spondylolisthesis 2']}, {'name': 'Inter transverse bone grafting', 'type': 'PROCEDURE', 'description': 'Inter transverse process bone grafting by bone graft from illiac crest or other sites', 'armGroupLabels': ['Lumbar spondylolisthesis1']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mahmoud Garamoun, Resident', 'role': 'CONTACT', 'email': 'Garamoun.mahmoud@yahoo.com', 'phone': '201091123869'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Mahmoud Garamoun Abd El Zaher', 'investigatorAffiliation': 'Assiut University'}}}}