Comparison of Cervical Laminectomy to Laminoplasty

This study has been terminated.
(terminated due to failure to meet enrolment goals)
Sponsor:
Information provided by (Responsible Party):
Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier:
NCT01324622
First received: March 23, 2011
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Spinal Cord Diseases
Device: Laminoplasty
Procedure: laminectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Synthes USA HQ, Inc.:

Primary Outcome Measures:
  • Neurological Status using the Modified Japanese Orthopaedic Assessment (mJOA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Success defined as mJOA recovery rate ≥ 0%

  • Sagittal Angle [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Success defined as ≤ +15º (kyphosis) as indicated by a neutral lateral radiograph

  • Incidence of Surgical Interventions [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Success defined as a lack of revision, removal or addition of supplemental fixation.


Secondary Outcome Measures:
  • Pain Scores on the Visual Analog Scale [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Functional improvement using the Neck Disability Index (NDI) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  • Quality of Life improvement using the SF-12 Scale [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  • Motor Deficit [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  • Reflex Evaluation [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  • Sensory Deficit [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  • Range of Motion [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  • Sagittal Canal Diameter [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  • Extent of Spinal Canal/Cord Decompression [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2006
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Laminectomy
Control
Procedure: laminectomy
standard procedure
Active Comparator: Laminoplasty
Treatment group
Device: Laminoplasty
Utilizing the ARCH Fixation System (Study device)
Other Name: ARCH Fixation System

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01324622

Locations
United States, California
Tower Orthopaedics
Beverly Hills, California, United States, 90211
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, Missouri
Research Medical Center
Kansas City, Missouri, United States, 64132
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Synthes USA HQ, Inc.
Investigators
Principal Investigator: Carl Lauryssen, MD Tower Orthopaedics
Principal Investigator: Daniel Riew, MD Washington University
  More Information

Publications:
Responsible Party: Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier: NCT01324622     History of Changes
Other Study ID Numbers: 2442
Study First Received: March 23, 2011
Last Updated: June 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Synthes USA HQ, Inc.:
Spinal Cord Diseases
Myelopathy
Myeloradiculopathy
Laminectomy
Laminoplasty

Additional relevant MeSH terms:
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014