Clinical trial NCT01324622: Comparison of Cervical Laminectomy to Laminoplasty
Official title: Comparison of Cervical Laminectomy to Cervical Laminoplasty* in Patients With Cervical Myelopathy or Myeloradiculopathy Due to Multiple Level Cervical Spinal Canal Stenosis * ARCH™ Fixation System by SYNTHES
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Diseases
Keywords: Spinal Cord Diseases
Myelopathy
Myeloradiculopathy
Laminectomy
Laminoplasty
Lead sponsor: Synthes USA HQ, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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)

Eligibility 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

Primary outcomes:
measure: Imrovement in Modified Japanese Orthopaedic Assessment (mJOA) Recovery Rate
timeFrame: 12 months
measure: Sagittal Angle Success
timeFrame: 12 months
measure: Incidence of Surgical Interventions
timeFrame: up to 24 months
Secondary outcomes:
measure: Pain Scores on the Visual Analog Scale
timeFrame: Up to 24 months
measure: Functional Improvement Using the Neck Disability Index (NDI)
timeFrame: up to 24 months
measure: Quality of Life Improvement Using the SF-12 Scale
timeFrame: up to 24 months
measure: Motor Deficit
timeFrame: up to 24 months
measure: Reflex Evaluation
timeFrame: up to 24 months
measure: Sensory Deficit
timeFrame: up to 24 months
measure: Range of Motion
timeFrame: up to 24 months
measure: Sagittal Canal Diameter
timeFrame: up to 24 months
measure: Extent of Spinal Canal/Cord Decompression
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Tower Orthopaedics
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Tower Orthopaedics
name: Carl Lauryssen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Daniel Riew, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edwards CC 2nd, Riew KD, Anderson PA, Hilibrand AS, Vaccaro AF. Cervical myelopathy. current diagnostic and treatment strategies. Spine J. 2003 Jan-Feb;3(1):68-81. doi: 10.1016/s1529-9430(02)00566-1.