The objective of this study is to compare the clinical and radiographic outcomes of multi-level laminectomy to multi-level laminoplasty in the treatment of patients with cervical myelopathy or myeloradiculopathy. The hypothesis for the study is that the laminoplasty group is not inferior to the laminectomy group.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Utilizing the ARCH Fixation System (Study device)
standard procedure
Tower Orthopaedics
Beverly Hills, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Research Medical Center
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Imrovement in Modified Japanese Orthopaedic Assessment (mJOA) Recovery Rate
Number of participants who have mJOA Recovery Rate ≥0%. mJOA Recovery Rate is defined as: mJOA Recovery Rate = ((PostOp Score-PreOp Score)/(17 - Pre-Op Score))\*100
Time frame: 12 months
Sagittal Angle Success
Success defined as ≤ +15º (kyphosis) as indicated by a neutral lateral radiograph
Time frame: 12 months
Incidence of Surgical Interventions
Success defined as a lack of revision, removal or addition of supplemental fixation.
Time frame: up to 24 months
Pain Scores on the Visual Analog Scale
Time frame: Up to 24 months
Functional Improvement Using the Neck Disability Index (NDI)
Time frame: up to 24 months
Quality of Life Improvement Using the SF-12 Scale
Time frame: up to 24 months
Motor Deficit
Time frame: up to 24 months
Reflex Evaluation
Time frame: up to 24 months
Sensory Deficit
Time frame: up to 24 months
Range of Motion
Time frame: up to 24 months
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Sagittal Canal Diameter
Time frame: up to 24 months
Extent of Spinal Canal/Cord Decompression
Time frame: up to 24 months