Clinical trial NCT02076113: Cervical Spondylotic Myelopathy Surgical Trial
Official title: Cervical Spondylotic Myelopathy Surgical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cervical Spondylosis With Myelopathy
Keywords: cervical spondylotic myelopathy
degenerative cervical spondylosis
spinal fusion
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-03-03
Enrollment: 269
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Measurement of Change in Short Form 36 (SF 36) Physical Component Score (PCS) From Baseline to 1 Year and 2 Year
timeFrame: 1 year and 2 year
Secondary outcomes:
measure: Short Form-36 (SF-36) Physical Component Summary (PCS) Score
timeFrame: Pre-operative, 1 year and 2 year
measure: Oswestry Neck Disability Index (NDI)
timeFrame: Pre-operative, 1 year and 2 year
measure: EuroQol-5D
timeFrame: Pre-operative, 1 year and 2 year
measure: Modified Japanese Orthopedic Association Score mJOA
timeFrame: Pre-operative and 1 year
measure: Sagittal Balance Measurements
timeFrame: 1 year
measure: Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
timeFrame: Within 1 year of surgery
measure: 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
timeFrame: Pre-operative, 1, 3 and 6 months and 1 year
measure: Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
timeFrame: Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
measure: Number of Participants With Unresolved Swallowing Difficulty (Complication) at 3 Months
timeFrame: 3 months, 1 year
Other outcomes:
measure: Short Form-36 (SF-36) Physical Component Summary (PCS) Score by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
timeFrame: Pre-operative, 1 year and 2 year
Locations:
city: San Francisco
country: United States
facility: University of California- San Francisco
state: California
city: Atlanta
country: United States
facility: Emory
state: Georgia
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine- St. Louis
state: Missouri
city: Newark
country: United States
facility: Rutgers-New Jersey Medical School
state: New Jersey
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Columbia
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences
state: Utah
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Toronto
country: Canada
facility: University Health Network-University of Toronto
state: Ontario
Study officials:
affiliation: Lahey Clinic, Inc.
name: Zoher Ghogawala, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghogawala Z, Martin B, Benzel EC, Dziura J, Magge SN, Abbed KM, Bisson EF, Shahid J, Coumans JV, Choudhri TF, Steinmetz MP, Krishnaney AA, King JT Jr, Butler WE, Barker FG 2nd, Heary RF. Comparative effectiveness of ventral vs dorsal surgery for cervical spondylotic myelopathy. Neurosurgery. 2011 Mar;68(3):622-30; discussion 630-1. doi: 10.1227/NEU.0b013e31820777cf.
citation: Ghogawala Z, Coumans JV, Benzel EC, Stabile LM, Barker FG 2nd. Ventral versus dorsal decompression for cervical spondylotic myelopathy: surgeons' assessment of eligibility for randomization in a proposed randomized controlled trial: results of a survey of the Cervical Spine Research Society. Spine (Phila Pa 1976). 2007 Feb 15;32(4):429-36. doi: 10.1097/01.brs.0000255068.94058.8a.
citation: Ghogawala Z, Benzel EC, Heary RF, Riew KD, Albert TJ, Butler WE, Barker FG 2nd, Heller JG, McCormick PC, Whitmore RG, Freund KM, Schwartz JS. Cervical spondylotic myelopathy surgical trial: randomized, controlled trial design and rationale. Neurosurgery. 2014 Oct;75(4):334-46. doi: 10.1227/NEU.0000000000000479.
citation: Roguski M, Benzel EC, Curran JN, Magge SN, Bisson EF, Krishnaney AA, Steinmetz MP, Butler WE, Heary RF, Ghogawala Z. Postoperative cervical sagittal imbalance negatively affects outcomes after surgery for cervical spondylotic myelopathy. Spine (Phila Pa 1976). 2014 Dec 1;39(25):2070-7. doi: 10.1097/BRS.0000000000000641.
citation: Ghogawala Z, Terrin N, Dunbar MR, Breeze JL, Freund KM, Kanter AS, Mummaneni PV, Bisson EF, Barker FG 2nd, Schwartz JS, Harrop JS, Magge SN, Heary RF, Fehlings MG, Albert TJ, Arnold PM, Riew KD, Steinmetz MP, Wang MC, Whitmore RG, Heller JG, Benzel EC. Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy: A Randomized Clinical Trial. JAMA. 2021 Mar 9;325(10):942-951. doi: 10.1001/jama.2021.1233.