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Comparison of Cervical Laminectomy to Laminoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01324622
Recruitment Status : Terminated (terminated due to failure to meet enrolment goals)
First Posted : March 29, 2011
Results First Posted : April 17, 2017
Last Update Posted : December 7, 2017
Information provided by (Responsible Party):
Synthes USA HQ, Inc.

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Diseases Device: Laminoplasty Procedure: laminectomy Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : January 1, 2006
Actual Primary Completion Date : November 1, 2010
Actual Study Completion Date : November 1, 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Laminectomy
Procedure: laminectomy
standard procedure

Active Comparator: Laminoplasty
Treatment group
Device: Laminoplasty
Utilizing the ARCH Fixation System (Study device)
Other Name: ARCH Fixation System

Primary Outcome Measures :
  1. Imrovement in Modified Japanese Orthopaedic Assessment (mJOA) Recovery Rate [ Time Frame: 12 months ]
    Number of participants who have mJOA Recovery Rate ≥0%. mJOA Recovery Rate is defined as: mJOA Recovery Rate = ((PostOp Score-PreOp Score)/(17 - Pre-Op Score))*100

  2. Sagittal Angle Success [ Time Frame: 12 months ]
    Success defined as ≤ +15º (kyphosis) as indicated by a neutral lateral radiograph

  3. Incidence of Surgical Interventions [ Time Frame: up to 24 months ]
    Success defined as a lack of revision, removal or addition of supplemental fixation.

Secondary Outcome Measures :
  1. Pain Scores on the Visual Analog Scale [ Time Frame: Up to 24 months ]
  2. Functional Improvement Using the Neck Disability Index (NDI) [ Time Frame: up to 24 months ]
  3. Quality of Life Improvement Using the SF-12 Scale [ Time Frame: up to 24 months ]
  4. Motor Deficit [ Time Frame: up to 24 months ]
  5. Reflex Evaluation [ Time Frame: up to 24 months ]
  6. Sensory Deficit [ Time Frame: up to 24 months ]
  7. Range of Motion [ Time Frame: up to 24 months ]
  8. Sagittal Canal Diameter [ Time Frame: up to 24 months ]
  9. Extent of Spinal Canal/Cord Decompression [ Time Frame: up to 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01324622

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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
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Synthes USA HQ, Inc.
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Principal Investigator: Carl Lauryssen, MD Tower Orthopaedics
Principal Investigator: Daniel Riew, MD Washington University School of Medicine
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Responsible Party: Synthes USA HQ, Inc. Identifier: NCT01324622    
Other Study ID Numbers: 2442
First Posted: March 29, 2011    Key Record Dates
Results First Posted: April 17, 2017
Last Update Posted: December 7, 2017
Last Verified: October 2017
Keywords provided by Synthes USA HQ, Inc.:
Spinal Cord Diseases
Additional relevant MeSH terms:
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Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases