Cervical Spondylotic Myelopathy Surgical Trial (CSM-S Trial)

Overview

Status: Not yet recruiting
Keywords: Cervical , Spondylotic Myelopathy , Kyphosis , Decompression , Neck , Spinal Cord
IRB Number: 00069689
Specialty: Neurosurgery, Neurosurgery
Sub Specialties: Spine Surgery, Neuro Spine Surgery

Brief Summary

1a. To determine if ventral surgery is associated with superior SF-36 PCS (quality of life) outcome at one year follow-up compared to dorsal (fusion or laminoplasty) surgery.

1b. To determine if, compared to pre-operative baseline status, both ventral and dorsal surgery for CSM improve symptoms of spinal cord dysfunction using mJOA (self assessed functional measure scale).

 2.  To determine if, from a patient perspective, health resource utilization (out-of-pocket expenses and loss of productivity) for ventral surgery, dorsal fusion, and laminoplasty surgery are different.

 3.  To determine if cervical sagittal balance post-operatively is a significant predictor of SF-36 PCS (quality of life) outcome.

Detailed Description

Surgical decompression for CSM can improve its disabling symptoms, but surgical complications are common and many of these complications affect patients’ overall health-related quality of life. The optimal surgical treatment, therefore, remains controversial, with disagreement between three main approaches: ventral decompression and fusion, dorsal decompression and fusion, or dorsal laminoplasty. This study aims to test the hypothesis that ventral surgery is associated with superior 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 using the mJOA score. 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.

Principal Investigator: Erica Bisson
Department: Neurosurgery - Adult
Co Investigator: Andrew Dailey
Co Investigator: Darrel Brodke
Co Investigator: Brandon Lawrence
Co Investigator: Meic Schmidt
Co Investigator: Ryan Spiker

Contact Information

Name:Holly Hill
Phone: 801-581-6908
Email: holly.hill@hsc.utah.edu

Inclusion Criteria

 

Patients aged 45-75 years with CSM (≥2 levels of spinal cord compression from C3 to C7) presenting with ≥2 of the following symptoms/signs: clumsy hands, gait disturbance, hyperreflexia, up going toes, bladder dysfunction.

Exclusion Criteria

Any of the following: C2-C7 kyphosis>5º (measured in extension), segmental kyphotic deformity (defined by ≥3 osteophytes extending dorsal to a C2-C7 dorsal-caudal line measured on cervical spine CT), ossification of posterior longitudinal ligament (OPLL – measured on cervical spine CT), developmental narrow canal (12 mm anterior-posterior canal diameter at the base of C2 measured on cervical spine radiograph), previous cervical spine surgery, or significant active health-related co-morbidity (Anesthesia Class III or higher).