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The CSM Trial: A Multicenter Study Comparing Ventral to Dorsal Surgery for Cervical Spondylotic Myelopathy (CSM)

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ClinicalTrials.gov Identifier: NCT00506558
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : August 29, 2012
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Greenwich Hospital

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.


Condition or disease Intervention/treatment Phase
Cervical Spondylotic Myelopathy Procedure: Ventral Surgical Decompression with Instrumented Fusion Procedure: Dorsal Decompression With or Without Fusion Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The CSM Trial: A Multicenter Study Comparing Ventral to Dorsal Surgery for Cervical Spondylotic Myelopathy
Study Start Date : November 2006
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Ventral Decompression and Instrumented Fusion
Procedure: Ventral Surgical Decompression with Instrumented Fusion
Multi-level discectomy or Corpectomy are performed at surgeon's discretion. After decompression an instrumented fusion is performed.
Active Comparator: B
Dorsal Decompression with or without fusion
Procedure: Dorsal Decompression With or Without Fusion
Dorsal decompressive laminectomy, laminoplasty, or laminectomy with lateral mass instrumented fusion



Primary Outcome Measures :
  1. Oswestry Neck Disability Index, mJOA, major complication rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. SF-36 physical component summary (PCS), EuroQol-5D [ Time Frame: 1 year ]


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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 C7.
  • Ossification of posterior longitudinal ligament (OPLL)
  • Developmental narrow canal (<12 mm-canal diameter measured on lateral plain cervical spine film)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506558


Locations
United States, Connecticut
Danbury Hospital
Danbury, Connecticut, United States, 06810
Greenwich Hospital
Greenwich, Connecticut, United States, 06830
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, New Jersey
University of Medicine and Dentistry - New Jersey
Newark, New Jersey, United States, 07103
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Utah
University of Utah HSC
Salt Lake City, Utah, United States, 84132-2303
Sponsors and Collaborators
Greenwich Hospital
Yale University
Investigators
Study Director: Zoher Ghogawala, MD, FACS Greenwich Hospital - Yale Universtiy School of Medicine
Principal Investigator: Edward C. Benzel, MD The Cleveland Clinic
Principal Investigator: Robert Heary, MD University of Medicine and Dentistry of New Jersey
Principal Investigator: Ronald Apfelbaum University of Utah
Principal Investigator: Jean-Valery Coumans, MD Massachusetts General Hospital
Principal Investigator: Subu N Magge, MD Lahey Clinic