Cervical Spondylotic Myelopathy Surgical Trial



Status:Active, not recruiting
Conditions:Neurology, Hematology
Therapuetic Areas:Hematology, Neurology
Healthy:No
Age Range:45 - 80
Updated:4/17/2018
Start Date:April 1, 2014
End Date:June 2023

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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.

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.

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).
We found this trial at
16
sites
Atlanta, Georgia
Principal Investigator: John G Heller, MD
Phone: 404-778-6857
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Burlington, Massachusetts 01805
Principal Investigator: Subu N Magge, MD
Phone: 781-744-7904
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Burlington, MA
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Edward C Benzel, MD
Phone: 216-445-1861
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, Ohio 44109
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Paul Arnold, MD
Phone: 913-588-3252
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Daniel K Resnick, MD
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Madison, WI
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Marjorie C Wang, MD
Phone: 414-805-5419
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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535 E 70th St
New York, New York 10021
(212) 606-1000
Principal Investigator: Todd J Albert, MD
Phone: 646-714-6663
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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New York, New York 10032
Principal Investigator: Daniel Riew, MD
Phone: 212-305-5036
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Newark, New Jersey 07103
Principal Investigator: Robert F Heary, MD
Phone: 973-972-4702
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Newark, NJ
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: James S. Harrop, MD
Phone: 215-503-4852
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Adam Kanter, MD
Phone: 412-864-2188
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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660 South Euclid Avenue
Saint Louis, Missouri 63110
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Saint Louis, MO
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Salt Lake City, Utah 84132
Principal Investigator: Erica F Bisson, MD
Phone: 801-581-6908
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San Francisco, California 94143
Principal Investigator: Praveen Mummaneni, MD
Phone: 415-353-8197
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Toronto, Ontario
Principal Investigator: Michael G Fehlings, MD
Phone: 416-603-5285
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