Laminectomy Alone Versus Laminectomy and Fusion for Traumatic Cervical Spinal Cord Injury Without Instability

June 24, 2022 updated by: Mahmoud Sayed Hamed Mohammed, Assiut University

Laminectomy Alone Versus Laminectomy and Fusion for Traumatic Cervical Spinal Cord Injury Without Instability: A Randomized Controlled Trial

The aim of study is to compare clinical and radiological outcomes of laminectomy alone to laminectomy and fusion in the treatment of traumatic cervical spinal cord injury without instability.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Cervical spinal cord injury (CSCI) without instability tends to be caused by a hyperextension force to the neck. This type of injury has been increasing as the elderly population is dramatically increasing.

Although surgery has become the preferred method for management of traumatic unstable cervical spine injury, the treatment of spinal cord injury (SCI) without instability such as fracture, dislocation, and ligamentous injury, however, remains controversial.

Before deciding for surgical or conservative treatment, one should understand the pathophysiology of SCI. Traumatic SCI is dependent on primary damage, such as the dynamic mechanistic force and static pre-existing or concurrent cord compression, and secondary damage, such as edema, ischemia, and inflammation, which lead to demyelination of axons, apoptosis of neural cells, and glial scar formation in the spinal cord.

Advocates of conservative treatment believe that decompression is not effective here, because the compression may have existed before the injury in asymptomatic patients. Therefore, the symptoms develop after a CSCI without instability are probably not a result of the compression itself. On the other hands advocates of surgical treatment believe that decompression could prevent secondary cord damage due to the vicious cycle of "ischemia-edema-ischemia". However, faced with a patient with neurologic dysfunction MRI evidence of cervical spinal cord compression, decompressive surgery is a practical treatment option.

Since these injuries are stable, why to add fusion to laminectomy when it is possible to perform laminectomy only with expected less operative time, blood loss and restriction of neck motion (compared to laminectomy with fusion). Instrumented fusions also entail the risks of screw misplacement, pseudoarthrosis, distal junction kyphosis, and adjacent segment pathology.

Multi-level laminectomy compromises the posterior tension band and increases the mobility of the neck, resulting in post laminectomy kyphosis and potential dynamic injury to the spinal cord . In contrast, spinal instrumentation and fusion helps to eliminate movement at the treated levels and reduce spinal cord tension with less incidence of kyphosis.

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 199093
        • Faculty of Medicine Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with traumatic cervical spine cord injury admitted to Assiut University Hospital - Department of Orthopaedic and Trauma Surgery regardless of age, mechanism of injury or neurological status changes.

Exclusion Criteria:

  1. Associated cervical spine bony or ligamentous injury.
  2. Associated primary focal anterior compression of the cervical spinal cord (clear disc herniation).
  3. Associated head injury.
  4. Kyphotic cervical spine as measured by C2-C7 Cobb angle on X-ray.
  5. Previous surgery of the cervical spine.
  6. Patients who refuse to participate in the study
  7. Patients who are mentally incompetent or unable to comply with the one year follow up regimen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laminectomy alone in patients with traumatic cervical spinal cord injury without instability
laminectomy only with expected less operative time, blood loss and restriction of neck motion (compared to laminectomy with fusion). Instrumented fusions also entail the risks of screw misplacement, pseudoarthrosis, distal junction kyphosis, and adjacent segment pathology.
Procedure: Laminectomy alone versus laminectomy and fusion

laminectomy only with expected less operative time, blood loss and restriction of neck motion (compared to laminectomy with fusion). Instrumented fusions also entail the risks of screw misplacement, pseudoarthrosis, distal junction kyphosis, and adjacent segment pathology.

Multi-level laminectomy compromises the posterior tension band and increases the mobility of the neck, resulting in post laminectomy kyphosis and potential dynamic injury to the spinal cord . In contrast, spinal instrumentation and fusion helps to eliminate movement at the treated levels and reduce spinal cord tension with less incidence of kyphosis.
Active Comparator: Laminectomy and fusion in patients with traumatic cervical spinal cord injury without instability
Multi-level laminectomy compromises the posterior tension band and increases the mobility of the neck, resulting in post laminectomy kyphosis and potential dynamic injury to the spinal cord . In contrast, spinal instrumentation and fusion helps to eliminate movement at the treated levels and reduce spinal cord tension with less incidence of kyphosis.
Procedure: Laminectomy alone versus laminectomy and fusion

laminectomy only with expected less operative time, blood loss and restriction of neck motion (compared to laminectomy with fusion). Instrumented fusions also entail the risks of screw misplacement, pseudoarthrosis, distal junction kyphosis, and adjacent segment pathology.

Multi-level laminectomy compromises the posterior tension band and increases the mobility of the neck, resulting in post laminectomy kyphosis and potential dynamic injury to the spinal cord . In contrast, spinal instrumentation and fusion helps to eliminate movement at the treated levels and reduce spinal cord tension with less incidence of kyphosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological recovery.
Time Frame: 3, 6 and 12 month after treatment.
It is assessed by the improvement (changes) in American Spinal Injury Association (ASIA) motor score). it is based on the motor function score of the 10 pairs of key muscles in the upper and lower limbs, with 5 points for each muscle and 100 points in total.
3, 6 and 12 month after treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck pain .
Time Frame: 3, 6 and 12 month after treatment.
It is assessed by the 100 mm visual analog scale (VAS) score (neck).
3, 6 and 12 month after treatment.
C2-C7 Cobb angle
Time Frame: 3, 6 and 12 month after treatment.
C2-C7 Cobb angle< 10°
3, 6 and 12 month after treatment.
C7 slope
Time Frame: 3, 6 and 12 month after treatment
C7 slope <10°, the angle between the horizontal plane and the plane of the superior endplate of the C7 vertebral body.
3, 6 and 12 month after treatment
C2-C7 sagittal vertical axis
Time Frame: 3, 6 and 12 month after treatment
C2-C7 sagittal vertical axis < 4cm, the anterior offset of C2 from C7.
3, 6 and 12 month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Khaled Mohamed Hassan, Professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Anticipated)

November 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

April 5, 2022

First Submitted That Met QC Criteria

April 29, 2022

First Posted (Actual)

May 4, 2022

Study Record Updates

Last Update Posted (Actual)

June 29, 2022

Last Update Submitted That Met QC Criteria

June 24, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Laminectomy vs fusion

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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