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Cervical Spondylotic Myelopathy Surgical Trial
Sponsor: Lahey Clinic
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.
Key Details
Gender
All
Age Range
45 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
269
Start Date
2014-04-01
Completion Date
2026-12-30
Last Updated
2026-02-20
Healthy Volunteers
No
Conditions
Interventions
Ventral (Front) decompression with Fusion
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.
Dorsal (Back) Decompression with Fusion
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.
Dorsal (back) Laminoplasty
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.
Locations (16)
University of California- San Francisco
San Francisco, California, United States
Emory
Atlanta, Georgia, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Washington University School of Medicine- St. Louis
St Louis, Missouri, United States
Rutgers-New Jersey Medical School
Newark, New Jersey, United States
Hospital for Special Surgery
New York, New York, United States
Columbia
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
MetroHealth
Cleveland, Ohio, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Utah Health Sciences
Salt Lake City, Utah, United States
University of Wisconsin
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
University Health Network-University of Toronto
Toronto, Ontario, Canada