Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT07177651
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-17
First Post:
2025-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laminoplasty Versus Laminectomy With Lateral Mass Fixation in Management of Degenerative Cervical Canal Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D065406', 'term': 'Laminoplasty'}, {'id': 'D007796', 'term': 'Laminectomy'}], 'ancestors': [{'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019299', 'term': 'Decompression, Surgical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2025-07-02', 'studyFirstSubmitQcDate': '2025-09-16', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in modified Japanese Orthopaedic Association (mJOA) score from baseline to 6 months (neurological function; range 0-17; higher = better function)', 'timeFrame': 'Baseline and 6 months postoperatively', 'description': 'Neurological outcome will be assessed using the modified Japanese Orthopaedic Association (mJOA) score, which evaluates motor and sensory function of the upper and lower extremities, as well as bladder function. Scores range from 0-17, with higher scores indicating better neurological function. Assessments will be performed at baseline (pre-operative), and at 6 months postoperatively by a blinded clinician.'}], 'secondaryOutcomes': [{'measure': 'Complication rate within 90 days postoperatively', 'timeFrame': 'Within 90 days postoperatively', 'description': 'All perioperative complications will be recorded within 90 days of surgery, including but not limited to surgical site infection (CDC criteria), C5 palsy (new postoperative motor deficit in deltoid/biceps), cerebrospinal fluid leak, and reoperation for any cause.'}, {'measure': 'Length of hospital stay (days)', 'timeFrame': 'Perioperative period', 'description': 'Length of hospital stay will be recorded as the number of days from surgery to hospital discharge.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laminoplasty', 'Lateral mass fixation'], 'conditions': ['Cervical Stenosis', 'Degenerative Cervical Spinal Stenosis']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'https://www.asianspinejournal.org/journal/view.php?doi=10.4184%2Fasj.2016.10.3.536'}], 'seeAlsoLinks': [{'url': 'https://www.nature.com/articles/3101477', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Cervical canal stenosis (CCS) is a condition characterized by the narrowing of the spinal canal in the cervical spine, leading to compression of the spinal cord and nerve roots. This can result in a variety of neurological deficits, including myelopathy, radiculopathy, and motor dysfunction. The primary goal of treatment is to relieve neural compression and improve or preserve neurological function. Surgical decompression, such as laminoplasty, is a common procedure to treat this condition, as it decompresses the spinal canal to relieve pressure on the spinal cord. Laminectomy with lateral mass fixation is another option of management.', 'detailedDescription': 'Cervical canal stenosis (CCS) is a condition characterized by the narrowing of the spinal canal in the cervical spine, leading to compression of the spinal cord and nerve roots. This can result in a variety of neurological deficits, including myelopathy, radiculopathy, and motor dysfunction. The primary goal of treatment is to relieve neural compression and improve or preserve neurological function. Surgical decompression, such as laminoplasty, is a common procedure to treat this condition, as it decompresses the spinal canal to relieve pressure on the spinal cord.\n\nLaminoplasty is a posterior approach that involves the surgical widening of the spinal canal by reshaping or repositioning the lamina. However, some patients with cervical stenosis, particularly those with accompanying spinal instability or degenerative changes, may not achieve satisfactory outcomes with laminoplasty alone. In such cases, lateral mass fixation is often added to provide supplemental stability to the spine, potentially preventing postoperative deformities and enhancing long-term outcomes\n\nLateral mass fixation is often combined with posterior decompression and typically done as part of a posterior cervical fusion where screws are placed into the lateral masses (bony structures on the sides of the vertebrae) to stabilize the cervical spine after decompression, such as through a laminectomy. This procedure sacrifices some motion for stability.\n\nA comparative study is needed to better understand the advantages and disadvantages of each approach, in order to guide clinical decision-making and improve patient outcomes.\n\nThe general aim is to evaluate and compare the clinical outcomes, safety, and effectiveness of both surgical techniques in managing this condition.\n\nThe specific aim is to compare the clinical efficacy, assess the radiological outcomes, evaluate the surgical and postoperative complication and investigate long-term outcomes and instability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 40 ≥ years with clinically significant cervical canal stenosis (based on imaging and neurological symptoms).\n* Surgical indication for cervical decompression.\n* Adequate follow up data (minimum 1 year).\n* Patients fit for surgery.\n\nExclusion Criteria:\n\n* Patients unfit for surgery or contraindication to general anaesthesia.\n* Congenital deformities or significant spinal deformities unrelated to stenosis.\n* Patients with cervical kyphosis, active infection or known allergy to titanium.\n* Previous cervical spine surgery.'}, 'identificationModule': {'nctId': 'NCT07177651', 'briefTitle': 'Laminoplasty Versus Laminectomy With Lateral Mass Fixation in Management of Degenerative Cervical Canal Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparative Study Between Laminoplasty Versus Laminectomy With Lateral Mass Fixation in Management of Degenerative Cervical Canal Stenosis', 'orgStudyIdInfo': {'id': 'Posterior cervical approaches'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laminoplasty', 'interventionNames': ['Procedure: Laminoplasty']}, {'type': 'EXPERIMENTAL', 'label': 'Laminectomy with lateral mass fixation', 'interventionNames': ['Procedure: Laminectomy with lateral mass fixation']}], 'interventions': [{'name': 'Laminoplasty', 'type': 'PROCEDURE', 'description': 'Is a posterior approach that involves the surgical widening of the spinal canal by reshaping or repositioning the lamina. However, some patients with cervical stenosis', 'armGroupLabels': ['Laminoplasty']}, {'name': 'Laminectomy with lateral mass fixation', 'type': 'PROCEDURE', 'description': 'Posterior cervical decompression with lateral mass screw insertion', 'armGroupLabels': ['Laminectomy with lateral mass fixation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Fahd Abdel sabour Ahmed Fahd Abdel Sabour Ahmed, Master degree in neurosurgery', 'role': 'CONTACT', 'email': 'Dfahd81@gmail.com', 'phone': '00201029522851'}], 'overallOfficials': [{'name': 'Mahmoud Hassan Ragab', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University hospital, neurosurgery department'}, {'name': 'Abdel Hakeem Abdel Sattar', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University, neurosurgery department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, specialist , neurosurgery department', 'investigatorFullName': 'Fahd Abdel Sabour Ahmed Mohammed', 'investigatorAffiliation': 'Assiut University'}}}}