Cervical Spondylotic Myelopathy Surgical Trial

Running, not enrolling · Not applicable

Conditions studied: Cervical Spondylosis With Myelopathy

In brief

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 facts

Study ID

NCT02076113

Run by

Lahey Clinic

People needed

269

Starts

2014-04-01

Expected to finish

2026-12-30

Last updated by the study team

2026-02-20

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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