NCT00506558

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2007

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

August 29, 2012

Status Verified

August 1, 2012

Enrollment Period

5.5 years

First QC Date

July 24, 2007

Last Update Submit

August 28, 2012

Conditions

Cervical Spondylotic Myelopathy

Keywords

cervical spondylotic myelopathydegenerative cervical spondylosisspinal fusion

Outcome Measures

Primary Outcomes (1)

  • Oswestry Neck Disability Index, mJOA, major complication rate

    1 year

Secondary Outcomes (1)

  • SF-36 physical component summary (PCS), EuroQol-5D

    1 year

Study Arms (2)

A

EXPERIMENTAL

Ventral Decompression and Instrumented Fusion

Procedure: Ventral Surgical Decompression with Instrumented Fusion

B

ACTIVE COMPARATOR

Dorsal Decompression with or without fusion

Procedure: Dorsal Decompression With or Without Fusion

Interventions

Ventral Surgical Decompression with Instrumented FusionPROCEDURE

Multi-level discectomy or Corpectomy are performed at surgeon's discretion. After decompression an instrumented fusion is performed.

A
Dorsal Decompression With or Without FusionPROCEDURE

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

B

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

Greenwich Hospital

Greenwich, Connecticut, 06830, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

University of Medicine and Dentistry - New Jersey

Newark, New Jersey, 07103, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Utah HSC

Salt Lake City, Utah, 84132-2303, United States

Location

Related Publications (3)

  • Fessler RG, Steck JC, Giovanini MA. Anterior cervical corpectomy for cervical spondylotic myelopathy. Neurosurgery. 1998 Aug;43(2):257-65; discussion 265-7. doi: 10.1097/00006123-199808000-00044.

    PMID: 9696078BACKGROUND

  • Edwards CC 2nd, Heller JG, Murakami H. Corpectomy versus laminoplasty for multilevel cervical myelopathy: an independent matched-cohort analysis. Spine (Phila Pa 1976). 2002 Jun 1;27(11):1168-75. doi: 10.1097/00007632-200206010-00007.

    PMID: 12045513BACKGROUND

  • 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 (Phila Pa 1976). 2007 Feb 15;32(4):429-36. doi: 10.1097/01.brs.0000255068.94058.8a.

    PMID: 17304133RESULT

MeSH Terms

Interventions

Gene Fusion

Intervention Hierarchy (Ancestors)

Recombination, GeneticGenetic Phenomena

Study Officials

  • Zoher Ghogawala, MD, FACS

    Greenwich Hospital - Yale Universtiy School of Medicine

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2007

First Posted

July 25, 2007

Study Start

November 1, 2006

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

August 29, 2012

Record last verified: 2012-08

Locations

US(7)