The CSM Trial: A Multicenter Study Comparing Ventral to Dorsal Surgery for Cervical Spondylotic Myelopathy
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Greenwich Hospital
- Enrollment
- 103
- Locations
- 14
- Primary Endpoint
- Oswestry Neck Disability Index, mJOA, major complication rate
Study Overview
Brief Summary
The purpose of the study is to determine the optimal surgical approach (ventral versus dorsal) for patients with multi-level cervical spondylotic myelopathy (CSM). There are no established guidelines for the management of patients with CSM, which slowly causes spinal cord injury in afflicted patients.
This study aims to test the hypothesis that ventral surgery (decompressing the spinal cord from the front of the neck) and dorsal surgery (decompressing the spinal cord from the back of the neck) might differ in their overall outcome or major complication rate.
Detailed Description
A. Purpose To determine the optimal surgical approach (ventral versus dorsal) for patients with multi-level cervical spondylotic myelopathy (CSM).
B. Background There are no established guidelines for the management of patients with CSM. It is estimated that up to 30 percent of patients have an unsatisfactory outcome after surgery for CSM. It remains uncertain how dorsal and ventral approaches differ in their success rates and in their complication rates. This study aims to test the hypothesis that ventral and dorsal surgical approaches differ in their outcomes or major complication rates. A secondary hypothesis is that fusion might improve outcome by reducing repetitive shear injury to the spinal cord.
C. Specific Location of Study
This is a multi-center trial. Subjects will be entered into the study from 9 separate centers. At this site, subjects will be recruited from the office of Dr. Zoher Ghogawala. All subjects at this site will undergo surgery at Greenwich Hospital.
D. Probable Duration of Project
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •degenerative cervical spondylotic myelopathy (2 or more levels of spinal cord compression)
Exclusion Criteria
- •C2-C7 kyphosis>5˚ (measured on lateral cervical spine image in extension)
- •Segmental kyphotic deformity defined as 3 or more levels of disc-osteophyte extend dorsal to a line drawn from the dorsal caudal point of C2 to the dorsal caudal point of C
- •Ossification of posterior longitudinal ligament (OPLL)
- •Developmental narrow canal (<12 mm-canal diameter measured on lateral plain cervical spine film)
Outcomes
Primary Outcomes
Oswestry Neck Disability Index, mJOA, major complication rate
Time Frame: 1 year
Secondary Outcomes
- SF-36 physical component summary (PCS), EuroQol-5D(1 year)