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

NCT00506558 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2012-08-29

No results posted yet for this study

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.

Conditions

  • Cervical Spondylotic Myelopathy

Interventions

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.

PROCEDURE

Dorsal Decompression With or Without Fusion

Dorsal decompressive laminectomy, laminoplasty, or laminectomy with lateral mass instrumented fusion

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • Greenwich Hospital

    lead OTHER

Principal Investigators

  • Zoher Ghogawala, MD, FACS · Greenwich Hospital - Yale Universtiy School of Medicine

  • Edward C. Benzel, MD · The Cleveland Clinic

  • Robert Heary, MD · University of Medicine and Dentistry of New Jersey

  • Ronald Apfelbaum · University of Utah

  • Jean-Valery Coumans, MD · Massachusetts General Hospital

  • Subu N Magge, MD · Lahey Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00506558 on ClinicalTrials.gov