Summary

Eligibility
for people ages 45-80 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

Details

Keywords

Cervical Spondylosis With Myelopathy, cervical spondylotic myelopathy, degenerative cervical spondylosis, spinal fusion, Spondylosis, Spinal Cord Diseases, Bone Marrow Diseases, Ventral (Front) decompression with Fusion, Dorsal (Back) Decompression with Fusion, Dorsal (back) Laminoplasty, Ventral, Dorsal

Eligibility

Locations

  • UCSF
    San Francisco California 94143 United States
  • University of Utah Health Sciences
    Salt Lake City Utah 84132 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Lahey Clinic
Links
Patient Centered Outcomes Research Institute
ID
NCT02076113
Study Type
Interventional
Participants
About 269 people participating
Last Updated