Comparison of Cervical Laminectomy to Laminoplasty
Primary Purpose
Spinal Cord Diseases
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laminoplasty
laminectomy
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Diseases focused on measuring Spinal Cord Diseases, Myelopathy, Myeloradiculopathy, Laminectomy, Laminoplasty
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
Sites / Locations
- Tower Orthopaedics
- Yale University School of Medicine
- Research Medical Center
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Laminectomy
Laminoplasty
Arm Description
Control
Treatment group
Outcomes
Primary Outcome Measures
Imrovement in Modified Japanese Orthopaedic Assessment (mJOA) Recovery Rate
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
Sagittal Angle Success
Success defined as ≤ +15º (kyphosis) as indicated by a neutral lateral radiograph
Incidence of Surgical Interventions
Success defined as a lack of revision, removal or addition of supplemental fixation.
Secondary Outcome Measures
Pain Scores on the Visual Analog Scale
Functional Improvement Using the Neck Disability Index (NDI)
Quality of Life Improvement Using the SF-12 Scale
Motor Deficit
Reflex Evaluation
Sensory Deficit
Range of Motion
Sagittal Canal Diameter
Extent of Spinal Canal/Cord Decompression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01324622
Brief Title
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
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
terminated due to failure to meet enrolment goals
Study Start Date
January 1, 2006 (Actual)
Primary Completion Date
November 1, 2010 (Actual)
Study Completion Date
November 1, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synthes USA HQ, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Diseases
Keywords
Spinal Cord Diseases, Myelopathy, Myeloradiculopathy, Laminectomy, Laminoplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laminectomy
Arm Type
Active Comparator
Arm Description
Control
Arm Title
Laminoplasty
Arm Type
Active Comparator
Arm Description
Treatment group
Intervention Type
Device
Intervention Name(s)
Laminoplasty
Other Intervention Name(s)
ARCH Fixation System
Intervention Description
Utilizing the ARCH Fixation System (Study device)
Intervention Type
Procedure
Intervention Name(s)
laminectomy
Intervention Description
standard procedure
Primary Outcome Measure Information:
Title
Imrovement in Modified Japanese Orthopaedic Assessment (mJOA) Recovery Rate
Description
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
Time Frame
12 months
Title
Sagittal Angle Success
Description
Success defined as ≤ +15º (kyphosis) as indicated by a neutral lateral radiograph
Time Frame
12 months
Title
Incidence of Surgical Interventions
Description
Success defined as a lack of revision, removal or addition of supplemental fixation.
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Pain Scores on the Visual Analog Scale
Time Frame
Up to 24 months
Title
Functional Improvement Using the Neck Disability Index (NDI)
Time Frame
up to 24 months
Title
Quality of Life Improvement Using the SF-12 Scale
Time Frame
up to 24 months
Title
Motor Deficit
Time Frame
up to 24 months
Title
Reflex Evaluation
Time Frame
up to 24 months
Title
Sensory Deficit
Time Frame
up to 24 months
Title
Range of Motion
Time Frame
up to 24 months
Title
Sagittal Canal Diameter
Time Frame
up to 24 months
Title
Extent of Spinal Canal/Cord Decompression
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl Lauryssen, MD
Organizational Affiliation
Tower Orthopaedics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Riew, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tower Orthopaedics
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
14589250
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.
Results Reference
background
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Comparison of Cervical Laminectomy to Laminoplasty
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