Comparison of Cervical Laminectomy to Laminoplasty

NCT ID: NCT01324622

Last Updated: 2017-12-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-01
• Study Completion Date: 2010-11-01

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)

Conditions

Spinal Cord Diseases

Keywords

Spinal Cord Diseases; Myelopathy; Myeloradiculopathy; Laminectomy; Laminoplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laminectomy

Control

Group Type: ACTIVE_COMPARATOR

laminectomy

Intervention Type: PROCEDURE

standard procedure

Laminoplasty

Treatment group

Group Type: ACTIVE_COMPARATOR

Laminoplasty

Intervention Type: DEVICE

Utilizing the ARCH Fixation System (Study device)

Interventions

Laminoplasty

Utilizing the ARCH Fixation System (Study device)

Intervention Type: DEVICE

laminectomy

standard procedure

Intervention Type: PROCEDURE

Other Intervention Names

ARCH Fixation System

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synthes USA HQ, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carl Lauryssen, MD

Role: PRINCIPAL_INVESTIGATOR

Tower Orthopaedics

Daniel Riew, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 14589250 (View on PubMed)

Other Identifiers

2442

Identifier Type: -

Identifier Source: org_study_id