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

NCT ID: NCT06045663

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-01-09

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.

Conditions

Degenerative Cervical Myelopathy (DCM)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 .

Group Type: ACTIVE_COMPARATOR

laminectomy without lateral mass fixation

Intervention Type: PROCEDURE

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

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 .

Group Type: ACTIVE_COMPARATOR

laminectomy with lateral mass fixation

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Moustafa ElBadry Alrabyi Ahmed

Resident of neurosurgery department, Sohag University Hospitals

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag University

Sohag, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 24353945 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29200481 (View on PubMed)

Other Identifiers

Soh-Med-23-09-02MS

Identifier Type: -

Identifier Source: org_study_id