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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cervical Spinal Cord Injury

Intervention / Treatment
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* Procedure: Laminectomy alone versus laminectomy and fusion


Participation Criteria
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Eligibility Criteria
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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: Associated cervical spine bony or ligamentous injury. Associated primary focal anterior compression of the cervical spinal cord (clear disc herniation). Associated head injury. Kyphotic cervical spine as measured by C2-C7 Cobb angle on X-ray. Previous surgery of the cervical spine. Patients who refuse to participate in the study Patients who are mentally incompetent or unable to comply with the one year follow up regimen
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention 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<br>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<br>* 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.<br>|
| Active Comparator: Laminectomy and fusion in patients with traumatic cervical spinal cord injury without instability<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological recovery. | 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 . | It is assessed by the 100 mm visual analog scale (VAS) score (neck). | 3, 6 and 12 month after treatment. | 
| C2-C7 Cobb angle | C2-C7 Cobb angle< 10° | 3, 6 and 12 month after treatment. | 
| C7 slope | 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 | C2-C7 sagittal vertical axis < 4cm, the anterior offset of C2 from C7. | 3, 6 and 12 month after treatment |