Cervical Spondylotic Myelopathy Surgical Trial

Study Overview
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Brief Summary
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The purpose of the study is to determine the optimal surgical approach (ventral vs dorsal) for patients with multi-level cervical spondylotic myelopathy (CSM). There are no established guidelines for the management of patients with CSM, which represents the most common cause of spinal cord injury and dysfunction in the US and in the world. This study aims to test the hypothesis that ventral surgery is associated with superior Short Form-36 physical component Score (SF-36 PCS) outcome at one year follow-up compared to dorsal approaches and that both ventral and dorsal surgery improve symptoms of spinal cord dysfunction measured using the modified Japanese Orthopedic Association Score (mJOA). A secondary hypothesis is that health resource utilization for ventral surgery, dorsal fusion, and laminoplasty surgery are different. A third hypothesis is that cervical sagittal balance post-operatively is a significant predictor of SF-36 PCS outcome.

Detailed Description
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Patients' images will be transmitted electronically (without identifying information) to a group of 15 CSM surgeon investigators for their expert opinion. They will provide their opinion on surgical strategy. Equipoise for randomization will be established using this spinal experts network polling mechanism. If randomized, the patient will be randomized to one of the two treatment approaches - either Ventral (front) (treatment A) or Dorsal (back) (treatment B) approach. If randomized to treatment A (front surgery), the patient will receive decompression/fusion from the front of the neck. If randomized to treatment B (dorsal/back surgery), then the patient and their surgeon will select which posterior procedure they will receive (either dorsal decompression/fusion or dorsal laminoplasty). Treatment A: Decompression/fusion from the front of the neck. Treatment B: Dorsal/posterior neck surgery (one of the two surgical procedures listed below): Dorsal decompression/fusion or dorsal laminoplasty (no fusion) Functional outcomes will be determined using well-known quantitative scales (SF-36, Oswestry Neck Disability Index (NDI), mJOA, and EuroQol-5D). These instruments will be administered pre-op, 3 months, 6 months, and at 1 year. Additionally, functional outcomes instruments (SF-36, Oswestry Neck Disability Index, and EuroQol-5D) will be collected annually at years 2,3,4 and 5. Pre-op imaging will include a cervical MRI and cervical CT as well as cervical flexion/extension films and standing cervical-thoracic-lumbar-sacral x-ray . A cervical MRI will be performed at 3 months. At 1 year (randomized patients only) will undergo cervical flexion/ extension xrays and standing cervical-thoracic-lumbar-sacral x-ray . A cervical CT will be performed only if the Oswestry NDI score is > 30.

Official Title
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Cervical Spondylotic Myelopathy Surgical Trial

Conditions
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Cervical Spondylosis With Myelopathy

Intervention / Treatment
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* Procedure: Ventral (Front) decompression with Fusion
* Procedure: Dorsal (Back) Decompression with Fusion
* Procedure: Dorsal (back) Laminoplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CSM (≥2 levels of spinal cord compression from C3 to C7) Present with ≥2 of the following symptoms/signs: clumsy hands, gait disturbance, hyperreflexia, up going toes, bladder dysfunction. Exclusion Criteria: C2-C7 kyphosis>5º (measured in standing neutral cervical spine radiograph), Segmental kyphotic deformity (defined by ≥3 osteophytes extending dorsal to a C2-C7 dorsal-caudal line measured on cervical spine CT), Structurally significant ossification of posterior longitudinal ligament (OPLL - measured on cervical spine CT), Previous cervical spine surgery Significant active health-related co-morbidity (Anesthesia Class IV or higher).

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 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: Ventral<br>Ventral Decompression with Fusion | Procedure: Ventral (Front) decompression with Fusion<br>* Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.<br>* Other names: Anterior Cervical Discectomy and Fusion (ACDF);|
| Active Comparator: Dorsal<br>Dorsal Decompression with Fusion or Dorsal Laminoplasty | Procedure: Dorsal (Back) Decompression with Fusion<br>* Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.<br>* Other names: Posterior decompression and fusion;Procedure: Dorsal (back) Laminoplasty<br>* Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Change in Short Form 36 (SF 36) Physical Component Score (PCS) From Baseline to 1 Year and 2 Year | Standardized measure of patient's functional health and well being as reported by the patient. The SF-36 physical component summary (PCS) scores range from 0 to 100, with higher scores representing better quality of life. | 1 year and 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form-36 (SF-36) Physical Component Summary (PCS) Score | Standardized measure of patient's functional health and well being as reported by the patient. The SF-36 physical component summary (PCS) scores range from 0 to 100, with higher scores representing better quality of life. A typical patient with cervical myelopathy who is being recommended surgery would have a score between 30 and 40. | Pre-operative, 1 year and 2 year | 
| Oswestry Neck Disability Index (NDI) | Standard instrument for measuring self-rated disability secondary to neck pain. The NDI ranges from 0 to 100, with lower scores representing less disability. A typical patient with moderate neck pain and disability would have a score between 20 and 40. | Pre-operative, 1 year and 2 year | 
| EuroQol-5D | Standardized measure of health related quality of life. For the EQ-5D score, 0 indicates death and 1 indicates a perfect health state. EQ-5D scores between 0.6 and 0.7 represent a moderate but significant reduction in overall health-related quality of life. | Pre-operative, 1 year and 2 year | 
| Modified Japanese Orthopedic Association Score mJOA | Short instrument for the functional assessment of patients. The scale ranges from 0 to 17, with higher scores representing less dysfunction due to myelopathy. A typical patient with moderate cervical myelopathy has an mJOA score between 12 and 14. | Pre-operative and 1 year | 
| Sagittal Balance Measurements | Sagittal vertical axis was measured at 1 year postoperatively. | 1 year | 
| Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Patient diary capturing out of pocket health utilization related to cervical surgery. The cumulative health resource utilization over 1-year is reported for the 'as treated' cohorts. Patients reported diagnostic imaging (MRI, x-ray, or CT), along with physical therapy and ongoing (at 1 year) physical therapy, opioid use and ongoing (at 1 year) opioid use, along with appointments with physicians. Data was collected at 1, 3, and 6 months and 1 year after surgery. The data presented is accumulative over the 1 year after surgery. | Within 1 year of surgery | 
| Number of Participants With Continued Full or Part Time Work Status at Each Follow Up Time Point by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Work status was recorded for all patients (working full-time; working part-time; not working, unable to work; not working, but able to work; or retired) at each follow-up through 1 year. | Pre-operative, 1, 3 and 6 months and 1 year | 
| Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. | Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years. | 
| Number of Participants With Unresolved Swallowing Difficulty (Complication) at 3 Months | Dysphagia is considered swallowing difficulty. Difficulty swallowing that resolved within 3 months was considered a minor complication, while prolonged (on going after 3 months) dysphagia was considered a major complication. | 3 months, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical spondylotic myelopathy, degenerative cervical spondylosis, spinal fusion