Comparison of Cervical Laminectomy to Laminoplasty

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)

Inclusion Criteria: All must be met for inclusion in the study.

- The patient must be at least 18 years of age and have no evidence of developmental
anomaly of the cranial cervical junction and/or cervical spine

- The patient has the diagnosis of cervical myelopathy

- The myelopathy or myeloradiculopathy requires a posterior cervical decompression of
the spinal canal involving two or more contiguous intervertebral levels including and
between C3 and C7

- The patient signs the study informed consent form.

Exclusion Criteria:

- Primary symptoms and signs of cervical radiculopathy (only) without myelopathy.

- Presence of primary focal anterior compression of the cervical spinal cord.

- Ossification of the ligamentum flavum.

- Previous surgery of the cervical spine.

- Tumor, infection, or trauma of the cervical spine or cord.

- Segmental instability - Pregnant or interested in becoming pregnant during the study
follow-up period.

- Known sensitivity to device materials.

- Currently being treated or intends to be treated postoperatively with other devices
for the same disorder (e.g., electrical stimulation devices, pain control devices,
etc.).

- Currently a participant in any other study related to the treatment of cervical spinal
disorders.

- Prisoner

- Mentally incompetent, or unable to comply with the follow up regime