Cervical Laminectomy With or Without Lateral Mass Fixation in Cervical Spondylotic Myelopathy

• ClinicalTrials.gov Identifier: NCT06045663
• Recruitment Status: Not yet recruiting
• First Posted: September 21, 2023
• Last Update Posted: September 28, 2023
• Sponsor: Sohag University
• Information provided by (Responsible Party): Moustafa ElBadry Alrabyi Ahmed, Sohag University

Study Description

Brief Summary:

The cervical spine consists of seven cervical vertebrae joined by intervertebral disks and a complex network of ligaments. The cervical spine has a normal lordotic curve, and it is much more mobile than the thoracic or lumbar regions of the spine, which makes it more liable to both degenerative and traumatic disorders .

Degenerative cervical myelopathy (DCM) is the most common form of spinal cord dysfunction in adults. The incidence and prevalence of myelopathy due to degeneration of the spine are estimated at a minimum of 41 and 605 per million in North America and Incidence of cervical spondylotic myelopathy-related hospitalizations has been estimated at 4.04/100,000 person-years.

Degenerative cervical myelopathy (DCM), earlier referred to as cervical spondylotic myelopathy, Patients report neurological symptoms such as pain and numbness in limbs, poor coordination, imbalance, and bladder dysfunction.

Surgical management for patients with multilevel cervical myelopathy aims to decompress the spinal cord and restore the normal sagittal alignment using either an anterior approach or a posterior approach. Multilevel anterior surgery is associated with complications such as increased surgical trauma and increased incidence of pseudarthrosis, graft dislodgement, and implant failure as the number of level increases.The posterior approach is optimal for multilevel stenosis using consecutive laminectomies However, although the effectiveness of cervical laminectomy was documented repeatedly, there were still concerns over postoperative kyphotic deformity, cervical instability, and late deterioration Cervical laminectomy and fusion may be performed to avoid the potential complications of instability and kyphosis associated with cervical laminectomy alone. For the latter, dissection and removal of the posterior elements disrupts the normal biomechanics of the cervical spine, leading to post laminectomy deformity and instability Our study aim to evaluate the multilevel cervical laminectomy alone, and multilevel cervical laminectomy with lateral mass fixation in patients with cervical spondylotic myelopathy regarding the Clinical and radiological outcome for short term follow-up.

Condition or disease	Intervention/treatment	Phase
Degenerative Cervical Myelopathy (DCM)	Procedure: laminectomy without lateral mass fixation; Procedure: laminectomy with lateral mass fixation	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cervical Laminectomy With or Without Lateral Mass Fixation in Cervical Spondylotic Myelopathy
• Estimated Study Start Date: October 1, 2023
• Estimated Primary Completion Date: March 1, 2024
• Estimated Study Completion Date: April 1, 2024

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: laminectomy group; patient will divided into two group the first group will undergo cervical laminectomy while the second group will undergo cervical laminectomy with lateral mass fixation .all surgical related events and comorbidities will be recorded. the patient will examine after 3 months of operation and patient's myelopathy grade and functional status was evaluated after 6 months using modified Japanese orthopedic association (mJAO) score. Radiological Follow-up by using plain X-rays, 6 months follow up assessment of cervical spine sagittal alignment using (C2-C7) Cobb's angle and MRI scan if needed follow up will be at our department follow up clinic .	Procedure: laminectomy without lateral mass fixation; patient will divided into two group the first group will undergo cervical laminectomy without lateral mass fixation while the second group will undergo cervical laminectomy with lateral mass fixation while the second group will undergo cervical laminectomy with lateral mass fixation
Active Comparator: laminectomy with lateral mass fixation; patient will divided into two group the first group will undergo cervical laminectomy while the second group will undergo cervical laminectomy with lateral mass fixation .all surgical related events and comorbidities will be recorded. the patient will examine after 3 months of operation and patient's myelopathy grade and functional status was evaluated after 6 months using modified Japanese orthopedic association (mJAO) score. Radiological Follow-up by using plain X-rays, 6 months follow up assessment of cervical spine sagittal alignment using (C2-C7) Cobb's angle and MRI scan if needed follow up will be at our department follow up clinic .	Procedure: laminectomy with lateral mass fixation; patient will divided into two group the first group will undergo cervical laminectomy without lateral mass fixation while the second group will undergo cervical laminectomy with lateral mass fixation while the second group will undergo cervical laminectomy with lateral mass fixation

Outcome Measures

Primary Outcome Measures :

1. assessment of cervical spine sagittal alignment [ Time Frame: 6 months ]
   assessment of cervical spine sagittal alignment using (C2-C7) Cobb's angle

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Signs and symptoms of spondylotic myelopathy at two or more level cervical canal stenosis after full filling clinical and radiological criteria

Exclusion Criteria:

• History of previous cervical intervention like (anterior cervical approach and laminoplasty ).
• History of cervical trauma.
• History of other neurological disorders such as( Multiple sclerosis , stroke,AML,….ETC).
• patient with insuffient data.
• Uncontrolled DM, hypertension and thyroid disorders.
• Osterpenic or osteoporotic patients

Contacts and Locations

Contacts

Contact: Mousatafa Elbadry Ahmed, Resident; 01096978493; mousafaelbadry100@gmail.com

Contact: Mohamed A. Abdelaal, Professor; 01212941293

Sponsors and Collaborators

Sohag University

More Information

Publications:

Mohamed E, Ihab Z, Moaz A, Ayman N, Haitham AE. Lateral mass fixation in subaxial cervical spine: anatomic review. Global Spine J. 2012 Mar;2(1):39-46. doi: 10.1055/s-0032-1307261.

Singrakhia MD, Malewar NR, Singrakhia SM, Deshmukh SS. Cervical Laminectomy with Lateral Mass Screw Fixation in Cervical Spondylotic Myelopathy: Neurological and Sagittal Alignment Outcome: Do We Need Lateral Mass Screws at each Segment? Indian J Orthop. 2017 Nov-Dec;51(6):658-665. doi: 10.4103/ortho.IJOrtho_266_16.

• Responsible Party: Moustafa ElBadry Alrabyi Ahmed, Resident of neurosurgery department, Sohag University Hospitals, Sohag University
• ClinicalTrials.gov Identifier: NCT06045663
• Other Study ID Numbers: Soh-Med-23-09-02MS
• First Posted: September 21, 2023
• Last Update Posted: September 28, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Spinal Cord Diseases; Bone Marrow Diseases; Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases