The CSM Trial: A Multicenter Study Comparing Ventral to Dorsal Surgery for Cervical Spondylotic Myelopathy - Full Text View

Sponsor:	Greenwich Hospital
Collaborator:	Yale University
Information provided by:	Greenwich Hospital
ClinicalTrials.gov Identifier:	NCT00506558

Purpose

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	Intervention	Phase
Cervical Spondylotic Myelopathy	Procedure: Ventral Surgical Decompression with Instrumented Fusion Procedure: Dorsal Decompression With or Without Fusion	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The CSM Trial: A Multicenter Study Comparing Ventral to Dorsal Surgery for Cervical Spondylotic Myelopathy

Resource links provided by NLM:

MedlinePlus related topics: Surgery

U.S. FDA Resources

Further study details as provided by Greenwich Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	100
Study Start Date:	November 2006
Estimated Study Completion Date:	July 2009

Arms	Assigned Interventions
A: Experimental 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.
B: Active Comparator Dorsal Decompression with or without fusion	Procedure: Dorsal Decompression With or Without Fusion Dorsal decompressive laminectomy, laminoplasty, or laminectomy with lateral mass instrumented fusion

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Eligibility

Ages Eligible for Study:	40 Years to 85 Years
Genders Eligible for Study:	Both
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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506558

Contacts

Contact: Zoher Ghogawala, MD, FACS	203-863-3474	zoher.ghogawala@yale.edu
Contact: Ellyn Wasserberger	203-863-3474	ellynw@greenhosp.org

Locations

United States, Connecticut
Greenwich Hospital	Recruiting
Greenwich, Connecticut, United States, 06830
Contact: Zoher Ghogawala, MD 203-863-3474
Contact: Ellyn Wasserberger 203-863-3474 ellynw@greenhosp.org
Principal Investigator: Zoher Ghogawala, MD
Danbury Hospital	Recruiting
Danbury, Connecticut, United States, 06810
Contact: Kent Kilbourn 203-856-4049 kentkilbourn@yahoo.com
Principal Investigator: Javed Shahid, MD
United States, Massachusetts
Lahey Clinic	Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Christine Gould 781-744-3956 Christine.A.Gould@lahey.org
Principal Investigator: Subu N Magge, MD
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Elba Montanez 617-726-3511 emontanez@partners.org
Principal Investigator: Jean-Valery Coumans, MD
United States, New Jersey
University of Medicine and Dentistry - New Jersey	Recruiting
Newark, New Jersey, United States, 07103
Contact: Carolyn Rogers 973-972-8291 rogerscj@umdnj.edu
Principal Investigator: Robert Heary, MD
Sub-Investigator: Ira M Goldstein, MD
United States, Ohio
Cleveland Clinic Foundation	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Diane Fabec 216-445-7744 Fabecd@ccf.org
Principal Investigator: Edward C Benzel, MD
United States, Utah
University of Utah HSC	Recruiting
Salt Lake City, Utah, United States, 84132-2303
Contact: Holly Hill 801-581-6908 holly.hill@hsc.utah.edu
Principal Investigator: Ronald Apfelbaum, MD

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 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

More Information

Additional Information:

Overall CSM Study Organizational Website This link exits the ClinicalTrials.gov site

Publications:

Ghogawala Z, Coumans JV, Benzel EC, Stabile LM, Barker FG 2nd. Ventral versus dorsal decompression for cervical spondylotic myelopathy: surgeons' assessment of eligibility for randomization in a proposed randomized controlled trial: results of a survey of the Cervical Spine Research Society. Spine. 2007 Feb 15;32(4):429-36.

Fessler RG, Steck JC, Giovanini MA. Anterior cervical corpectomy for cervical spondylotic myelopathy. Neurosurgery. 1998 Aug;43(2):257-65; discussion 265-7.

Edwards CC 2nd, Heller JG, Murakami H. Corpectomy versus laminoplasty for multilevel cervical myelopathy: an independent matched-cohort analysis. Spine. 2002 Jun 1;27(11):1168-75.

Study ID Numbers:	GH-CSM-382, GH-CSM-382
Study First Received:	July 24, 2007
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00506558 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Greenwich Hospital:

cervical spondylotic myelopathy
degenerative cervical spondylosis
spinal fusion

Additional relevant MeSH terms:

Spinal Cord Diseases
Nervous System Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on November 09, 2009