Comparison of Cervical Laminectomy to Laminoplasty

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Spinal Cord Diseases

Intervention / Treatment
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* Device: Laminoplasty
* Procedure: laminectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laminectomy<br>Control | Procedure: laminectomy<br>* standard procedure<br>|
| Active Comparator: Laminoplasty<br>Treatment group | Device: Laminoplasty<br>* Utilizing the ARCH Fixation System (Study device)<br>* Other names: ARCH Fixation System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 
| Sagittal Angle Success | Success defined as ≤ +15º (kyphosis) as indicated by a neutral lateral radiograph | 12 months | 
| Incidence of Surgical Interventions | Success defined as a lack of revision, removal or addition of supplemental fixation. | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores on the Visual Analog Scale |  | Up to 24 months | 
| Functional Improvement Using the Neck Disability Index (NDI) |  | up to 24 months | 
| Quality of Life Improvement Using the SF-12 Scale |  | up to 24 months | 
| Motor Deficit |  | up to 24 months | 
| Reflex Evaluation |  | up to 24 months | 
| Sensory Deficit |  | up to 24 months | 
| Range of Motion |  | up to 24 months | 
| Sagittal Canal Diameter |  | up to 24 months | 
| Extent of Spinal Canal/Cord Decompression |  | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Diseases, Myelopathy, Myeloradiculopathy, Laminectomy, Laminoplasty