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

Primary Purpose

Degenerative Cervical Myelopathy (DCM)

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laminectomy without lateral mass fixation
laminectomy with lateral mass fixation
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Cervical Myelopathy (DCM)

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    laminectomy group

    laminectomy with lateral mass fixation

    Arm Description

    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 .

    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 .

    Outcomes

    Primary Outcome Measures

    assessment of cervical spine sagittal alignment
    assessment of cervical spine sagittal alignment using (C2-C7) Cobb's angle

    Secondary Outcome Measures

    Full Information

    First Posted
    September 13, 2023
    Last Updated
    September 26, 2023
    Sponsor
    Sohag University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06045663
    Brief Title
    Cervical Laminectomy With or Without Lateral Mass Fixation in Cervical Spondylotic Myelopathy
    Official Title
    Cervical Laminectomy With or Without Lateral Mass Fixation in Cervical Spondylotic Myelopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2024 (Anticipated)
    Study Completion Date
    April 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sohag University

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Degenerative Cervical Myelopathy (DCM)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    laminectomy group
    Arm Type
    Active Comparator
    Arm Description
    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 .
    Arm Title
    laminectomy with lateral mass fixation
    Arm Type
    Active Comparator
    Arm Description
    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 .
    Intervention Type
    Procedure
    Intervention Name(s)
    laminectomy without lateral mass fixation
    Intervention Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    laminectomy with lateral mass fixation
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    assessment of cervical spine sagittal alignment
    Description
    assessment of cervical spine sagittal alignment using (C2-C7) Cobb's angle
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mousatafa Elbadry Ahmed, Resident
    Phone
    01096978493
    Email
    mousafaelbadry100@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed A. Abdelaal, Professor
    Phone
    01212941293

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    24353945
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29200481
    Citation
    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.
    Results Reference
    background

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

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