Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-01-02 @ 11:11 AM
Study NCT ID:
NCT06847503
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-26
First Post:
2025-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Outcome After Combined Posterior Laminectomy and Anterior Cervical Discectomy and Fusion for Large Cervical Disc Prolapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2025-02-21', 'studyFirstSubmitQcDate': '2025-02-21', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of improvement in the modified Japanese Orthopaedic AssociationmJOA-AR scale.', 'timeFrame': '30 day', 'description': 'It is an 18-point scale that addresses upper (5 points) and lower extremity (7 points) motor function, sensation (3 points) and micturition (3 points). A score of 18 reflects no neurological deficits whereas a lower score indicates a greater degree of disability and functional impairment. The mJOA is the second most commonly used outcome measure to quantify severity in patients with DCM'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Posterior Laminectomy', 'Anterior Cervical Discectomy'], 'conditions': ['Cervical Disc Prolapse']}, 'descriptionModule': {'briefSummary': 'Cervical disc herniation (CDH) is the result of the displacement of the nucleus pulposus of the intervertebral disc, which may result in impingement of the traversing nerves as they exit the neural foramen or directly compressing the spinal cord contained within the spinal canal.\\[1\\] Eventually symptoms may arise because of a CDH with compression of the rootlet or spinal cord.\\[2\\] When conservative treatment for CDH fails, surgical treatment may be considered.\\[3\\] The main goals of surgical treatment are to remove pressure from the nerves, restore the alignment of the vertebrae, to stabilize the spine \\[3\\] and to prevent progression of neurological deficit in case of myelopathy.\\[4\\] Anterior cervical discectomy and fusion (ACDF) has proven to be an effective surgical intervention for both cervical radiculopathy and myelopathy and has become standard treatment for both of these disease states over the last half-century.\\[5\\] Certain reports have indicated that various complications are associated with ACDF namely, incomplete decompression, recurrence of myelopathy due to adjacent segment degeneration.\\[6\\] In cases where the stenosis is extensive, or attributed in part to congenital stenosis, the posterior approach may be advantageous to achieve more extensive decompression that would otherwise not be possible through an anterior approach.\\[7\\] Given that most stenosis occurs from anterior pathology, a posterior decompression works to indirectly relieve pressure on the spinal cord.\\[8\\] Misalignment and large anterior compression of the spinal cord can be risk factors for insufficient functional recovery in patients treated with posterior decompression alone.\\[9\\] In a study of 428 patients that were enrolled in a prospective cohort study to investigate the incidence, etiology, and outcomes of patients who experience neurological deterioration after surgery for degenerative cervical myelopathy(DCM), Evaniew et al\\[10\\] reported the incidence of deterioration after surgery for DCM was approximately one in ten (12%).\n\nIn this study we will perform combined posterior laminectomy and ACDF to avoid incomplete decompression and neurological deterioration after surgery. We aim to assess the functional outcome after combined posterior laminectomy and ACDF in patients with large cervical disc prolapse.\n\nIn this study we will perform combined posterior laminectomy and ACDF to avoid incomplete decompression and neurological deterioration after surgery. We aim to assess the functional outcome after combined posterior laminectomy and ACDF in patients with large cervical disc prolapse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with degenerative large cervical disc prolapse and canal stenosis with myelopathy.\n\n(we defined large cervical disc prolapse as any cervical disc prolapse occupying 40% or more of the cervical spinal canal)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with degenerative large cervical disc prolapse and canal stenosis with myelopathy.\n\n(we defined large cervical disc prolapse as any cervical disc prolapse occupying 40% or more of the cervical spinal canal)\n\nExclusion Criteria:\n\n* Cervical disc prolapse with wide canal\n* Cervical disc prolapse with radiculopathy\n* Traumatic Cervical disc prolapse\n* Patients with ossification of the posterior longitudinal ligament (OPLL)'}, 'identificationModule': {'nctId': 'NCT06847503', 'briefTitle': 'Functional Outcome After Combined Posterior Laminectomy and Anterior Cervical Discectomy and Fusion for Large Cervical Disc Prolapse', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Functional Outcome After Combined Posterior Laminectomy and Anterior Cervical Discectomy and Fusion for Large Cervical Disc Prolapse', 'orgStudyIdInfo': {'id': 'Post Laminectomy Ant Cervical'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'Patients with degenerative large cervical disc prolapse and canal stenosis with myelopathy.\n\n(we defined large cervical disc prolapse as any cervical disc prolapse occupying 40% or more of the cervical spinal canal)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'residant doctor', 'investigatorFullName': 'Mohamed Abdelrahman Zakaria Abdelrahman', 'investigatorAffiliation': 'Assiut University'}}}}