Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-02 @ 6:08 AM
Study NCT ID:
NCT07001969
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-03
First Post:
2025-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percutaneous Trans-facet Spine Fixation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013130', 'term': 'Spinal Stenosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 77}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-07-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-24', 'studyFirstSubmitDate': '2025-02-13', 'studyFirstSubmitQcDate': '2025-05-24', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain relief', 'timeFrame': '3 months', 'description': 'Relief of pain from neuralgia (sciatica \\& brachialgia) also claudication pain assessment by visual analogue scale 1-10'}], 'secondaryOutcomes': [{'measure': 'Functional recovery', 'timeFrame': '3 months', 'description': 'functional improvement postoperatively. Secondary outcomes include functional recovery (Oswestry Disability Index score)'}, {'measure': 'Less complications', 'timeFrame': '1 year', 'description': 'fusion rates (CT scan), and complication rates, assessing both efficacy and safety.\n\nAdditional measures like hospital stay duration and patient satisfaction provide insights into procedural efficiency and patient-reported outcomes.'}, {'measure': 'Spinal stability', 'timeFrame': '6 months', 'description': 'By CT spine we can assess facet fusion, stabilization of spine segmental instability'}, {'measure': 'Neurological decompression indirectly', 'timeFrame': '6 months', 'description': 'Early by position of patients intraoperative and stabilization, late by healing of pathological state of ligament flavum hypertrophic changes, disc degeneration, spinal canal stenosis by Magnetic resonance imaging follow-up'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Percutaneous', 'Trans-facet', 'Fixation', 'Massoud-Goel', 'Technique and Theory for Treatment of Degenerative Spine'], 'conditions': ['Degenerative Spine', 'Degeneration of Lumbar Intervertebral Disc', 'Degenerative Cervical Disc Disease', 'Ligamentum Flavum Hypertrophy', 'Spinal Canal Stenosis', 'Spine Instability']}, 'referencesModule': {'availIpds': [{'url': 'https://t.me/drmassoud77/24301', 'type': 'Individual Participant Data Set', 'comment': 'Book of author about technique'}], 'references': [{'pmid': '15257485', 'type': 'BACKGROUND', 'citation': 'Borm W, Konig RW, Albrecht A, Richter HP, Kast E. Percutaneous transarticular atlantoaxial screw fixation using a cannulated screw system and image guidance. Minim Invasive Neurosurg. 2004 Apr;47(2):111-4. doi: 10.1055/s-2004-818449.'}, {'pmid': '6478690', 'type': 'BACKGROUND', 'citation': 'Magerl FP. Stabilization of the lower thoracic and lumbar spine with external skeletal fixation. Clin Orthop Relat Res. 1984 Oct;(189):125-41.'}, {'pmid': '13641310', 'type': 'BACKGROUND', 'citation': 'BOUCHER HH. A method of spinal fusion. J Bone Joint Surg Br. 1959 May;41-B(2):248-59. doi: 10.1302/0301-620X.41B2.248. No abstract available.'}, {'pmid': '18109577', 'type': 'BACKGROUND', 'citation': 'KING D. Internal fixation for lumbosacral fusion. J Bone Joint Surg Am. 1948 Jul;30A(3):560-5. No abstract available.'}, {'pmid': '25013340', 'type': 'BACKGROUND', 'citation': 'Goel A. Goel\'s classification of atlantoaxial "facetal" dislocation. J Craniovertebr Junction Spine. 2014 Jan;5(1):3-8. doi: 10.4103/0974-8237.135206. No abstract available.'}, {'pmid': '25558146', 'type': 'BACKGROUND', 'citation': 'Satoskar SR, Goel AA, Mehta PH, Goel A. Quantitative morphometric analysis of the lumbar vertebral facets and evaluation of feasibility of lumbar spinal nerve root and spinal canal decompression using the Goel intraarticular facetal spacer distraction technique: A lumbar/cervical facet comparison. J Craniovertebr Junction Spine. 2014 Oct;5(4):157-62. doi: 10.4103/0974-8237.147079.'}, {'pmid': '30783342', 'type': 'BACKGROUND', 'citation': 'Goel A. From "only decompression" to "only fixation:" A century-long journey of surgical treatment for spinal spondylosis. J Craniovertebr Junction Spine. 2018 Oct-Dec;9(4):219-220. doi: 10.4103/jcvjs.JCVJS_118_18. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://t.me/drmassoud77/24301', 'label': 'Collection of auther about the theory and the technique'}]}, 'descriptionModule': {'briefSummary': 'Percutaneous Trans-facet Fixation Massoud-Goel Technique and Theory for Treatment of Degenerative Spine', 'detailedDescription': "Massoud-Goel' as rationale treatment for treatment spinal degeneration affected spinal segments using trans-articular screws, without physically distracting the facets, or removal of any part of the bone or ligament.\n\nFollowing fixing of the segment, all the secondary phenomenon reverse, effectively increasing the canal size and reversing the effects of spinal degeneration and spinal canal stenosis.\n\nStabilizes the region and provides an environment for resorption of the herniated disc and ultimate arthrodesis of the spinal segments."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor Lumbar Sub-axial cervical instability Clinical radicular symptoms can indicate the level of spinal instability. The presence of osteophytes. Reduction of the intervertebral disc space. Disc prolapse. Ligamentum flavum buckling. For atlantoaxial instability Cervical myelopathy clinical Alteration of atlantodental interval on dynamic flexion-extension images.\n\nExclusion Criteria:\n\n1. Cauda equine syndrome\n2. Progressive motor weakness\n3. Failed damage control method\n4. Spondylolisthesis, Spondyolysis.'}, 'identificationModule': {'nctId': 'NCT07001969', 'acronym': 'Massoud-Goel', 'briefTitle': 'Percutaneous Trans-facet Spine Fixation', 'organization': {'class': 'OTHER', 'fullName': 'Armed Forces College of Medicine, Cairo, Egypt'}, 'officialTitle': 'Massoud-Goel Technique and Theory: Percutaneous Trans-facet Fixation for Treatment of Degenerative Spine', 'orgStudyIdInfo': {'id': 'EGY-2025-PTFF-MGT-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Percutaneous Trans-Facet Fixation Using the Massoud-Goel Technique and Theory for Degenerative Spine', 'description': 'This study arm involves the use of Percutaneous Trans-Facet Fixation (PTFF) with the Massoud-Goel Technique and Theory (MGT) for the treatment of degenerative spine conditions, Looking for signs of instability. In this arm will undergo minimally invasive trans-facet screw fixation to provide spinal stability while preserving mobility and reducing soft tissue disruption.\n\nThe intervention includes:\n\n* Preoperative Assessment: MRI and CT scans to evaluate facet joint degeneration and spinal instability.\n* Surgical Technique: Percutaneous placement of facet screws under fluoroscopic guidance, following the principles of the Massoud-Goel Technique.\n* Postoperative Care: Patients will follow a structured rehabilitation program, including pain management and physiotherapy, to assess functional recovery and long-term outcomes.\n\nThe study aims to evaluate radiological fusion rates, pain relief (VAS scores), functional improvement (ODI scores), and complication rates associations.', 'interventionNames': ['Procedure: Massoud-Goel Technique and Theory', 'Procedure: Percutaneous Trans-facet Fixation for Treatment of Degenerative Spine']}], 'interventions': [{'name': 'Massoud-Goel Technique and Theory', 'type': 'PROCEDURE', 'description': 'Percutaneous Trans-facet Fixation Massoud-Goel Technique and Theory for Treatment of Degenerative Spine', 'armGroupLabels': ['Percutaneous Trans-Facet Fixation Using the Massoud-Goel Technique and Theory for Degenerative Spine']}, {'name': 'Percutaneous Trans-facet Fixation for Treatment of Degenerative Spine', 'type': 'PROCEDURE', 'description': 'Percutaneous Trans-facet Fixation (Developmental of Dr Atul goel technique of transfacet fixation by open surgery using Magrel technique) Massoud-Goel Technique and Theory for Treatment of Degenerative Spine', 'armGroupLabels': ['Percutaneous Trans-Facet Fixation Using the Massoud-Goel Technique and Theory for Degenerative Spine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41639', 'city': 'Cairo', 'state': 'Shorouk', 'country': 'Egypt', 'facility': '434', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '7 years', 'ipdSharing': 'YES', 'description': 'New researches', 'accessCriteria': 'IPD Sharing Access Criteria for the Study:\\*\\*\n\n\\*\\*"Percutaneous Trans-Facet Fixation Using the Massoud-Goel Technique for Treatment of Degenerative Spine"\n\n1. Data Availability:\n\n * De-identified Individual Participant Data (IPD) will be made available for academic and research purposes.\n * Shared data will include patient demographics, radiographic outcomes, clinical assessments (VAS, ODI scores), and surgical parameters\\*\\*.\n2. Access Requirements:\n\n * Researchers must submit a formal request with a brief research proposal outlining the intended use of the data.\n * Approval from an \\*\\*Institutional Review Board (IRB) or Ethics Committee is mandatory.\n * A Data Use Agreement (DUA) must be signed to ensure compliance with ethical and legal regulations.\n3. Timing of Data Sharing:\n\n * Data will be available 6 months after the primary publication of study results.\n * The sharing period will extend for 5 years post-publ'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahmoud Massoud', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}, {'name': 'Military Academy for Medical Sciences', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer Orthopedic surgery department Orthopedic Surgery AFCM Cairo Egypt, Consultant spine surgery Helmya Military hospital, Spine unit.', 'investigatorFullName': 'Mahmoud Massoud', 'investigatorAffiliation': 'Armed Forces College of Medicine, Cairo, Egypt'}}}}