Clinical Trial

Cervical Spondylotic Myelopathy Surgical Trial

Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 28 amendments
This ClinicalTrials.gov record has been amended 28 times since 2014-02-28; most recent amendment 2026-02-03.
Status change: Recruiting → Active, Not Recruiting 2017-09-26
Status change: Not Yet Recruiting → Recruiting 2014-04-05
Trial Details
NCT Number NCT02076113
Lead Sponsor Lahey Clinic
Collaborators: Patient-Centered Outcomes Research Institute
Conditions Cervical Spondylosis With Myelopathy
Enrollment 269 participants
Start Date 2014-04-01
Primary Completion 2018-03-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-20