Comparison of Cervical Laminectomy to Laminoplasty

DePuy Synthes

Status

Terminated

Conditions

Spinal Cord Diseases

Treatments

Device: Laminoplasty

Procedure: laminectomy

Study type

Interventional

Funder types

Industry

Identifiers

NCT01324622

2442

Details and patient eligibility

About

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.

Full description

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)

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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