The CSM Trial: A Multicenter Study Comparing Ventral to Dorsal Surgery for Cervical Spondylotic Myelopathy
Completed · Phase 3
Conditions studied: Cervical Spondylotic Myelopathy
In brief
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.
Key facts
- Study ID
- NCT00506558
- Run by
- Greenwich Hospital
- People needed
- 103
- Starts
- 2006-11-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2012-08-29
Who can join
Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- degenerative cervical spondylotic myelopathy (2 or more levels of spinal cord compression)
You may not qualify if…
- 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 C7.
- Ossification of posterior longitudinal ligament (OPLL)
- Developmental narrow canal (<12 mm-canal diameter measured on lateral plain cervical spine film)
Where it is running
- Danbury Hospital — Danbury, Connecticut, United States
- Greenwich Hospital — Greenwich, Connecticut, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Lahey Clinic — Burlington, Massachusetts, United States
- University of Medicine and Dentistry - New Jersey — Newark, New Jersey, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- University of Utah HSC — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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