Comparison of Cervical Laminectomy to Laminoplasty

• Neurological Status using the Modified Japanese Orthopaedic Assessment (mJOA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Success defined as mJOA recovery rate ≥ 0%
  
  
• Sagittal Angle [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Success defined as ≤ +15º (kyphosis) as indicated by a neutral lateral radiograph
  
  
• Incidence of Surgical Interventions [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  Success defined as a lack of revision, removal or addition of supplemental fixation.
  
  

• Pain Scores on the Visual Analog Scale [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  
• Functional improvement using the Neck Disability Index (NDI) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  
• Quality of Life improvement using the SF-12 Scale [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  
• Motor Deficit [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  
• Reflex Evaluation [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  
• Sensory Deficit [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  
• Range of Motion [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  
• Sagittal Canal Diameter [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  
• Extent of Spinal Canal/Cord Decompression [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  

Historically, cervical laminectomy has been proven to be effective in the treatment of symptomatic patients with cervical myelopathy. This standard procedure is employed to accomplish posterior decompression of the cervical spinal cord in patients with multi-level cervical spinal stenosis who have normal or near normal cervical spinal curvature and alignment without associated instability. Laminoplasty was developed in Japan as an alternative to the laminectomy procedure with the intent to reduce post-operative morbidity after dorsal cervical spinal cord decompression, neck pain and to maintain the relative stability of the cervical spine after multi-level decompression.

The goal of both the laminoplasty and laminectomy procedures is to provide spinal cord decompression by enlargement of the spinal canal. A potential benefit of laminoplasty compared to laminectomy is to preserve stability and range of motion of the cervical spine without complete disruption/removal of the posterior laminae, spinous processes and interspinous ligamentous structures. Various authors have described different laminoplasty techniques; all preserve the lamina and expand the size of the spinal canal by fixing the freed or partially freed lamina in a more posterior position.

The primary study hypothesis is that, patients treated with laminoplasty with ARCH fixation (Treatment Group) have clinical and radiographic outcomes as assessed by valid outcomes measures, is not inferior to patients treated with laminectomy (Control Group)