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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Degenerative Cervical Myelopathy (DCM)
• Intervention / Treatment: Procedure: laminectomy without lateral mass fixation; Procedure: laminectomy with lateral mass fixation

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mousatafa Elbadry Ahmed, Resident; Phone Number: 01096978493; Email: mousafaelbadry100@gmail.com
• Study Contact Backup: Name: Mohamed A. Abdelaal, Professor; Phone Number: 01212941293

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of cervical spine sagittal alignment	assessment of cervical spine sagittal alignment using (C2-C7) Cobb's angle	6 months

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases; Spinal Cord Diseases; Bone Marrow Diseases
• Other Study ID Numbers: Soh-Med-23-09-02MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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