Cervical Spondylotic Myelopathy Surgical Trial

NAActive, not recruitingINTERVENTIONAL
Enrollment

269

Participants

Timeline

Start Date

April 1, 2014

Primary Completion Date

March 30, 2018

Study Completion Date

December 30, 2025

Conditions
Cervical Spondylosis With Myelopathy
Interventions
PROCEDURE

Ventral (Front) decompression with Fusion

Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.

PROCEDURE

Dorsal (Back) Decompression with Fusion

Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.

PROCEDURE

Dorsal (back) Laminoplasty

Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.

Trial Locations (16)

10021

Hospital for Special Surgery, New York

10032

Columbia, New York

15213

University of Pittsburgh Medical Center, Pittsburgh

19107

Thomas Jefferson University Hospital, Philadelphia

30329

Emory, Atlanta

44106

Cleveland Clinic Foundation, Cleveland

44109

MetroHealth, Cleveland

53226

Medical College of Wisconsin, Milwaukee

53792

University of Wisconsin, Madison

63110

Washington University School of Medicine- St. Louis, St Louis

66160

University of Kansas Medical Center, Kansas City

84132

University of Utah Health Sciences, Salt Lake City

94143

University of California- San Francisco, San Francisco

01805

Lahey Hospital and Medical Center, Burlington

07103

Rutgers-New Jersey Medical School, Newark

M5T2S8

University Health Network-University of Toronto, Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Patient-Centered Outcomes Research Institute

OTHER

lead

Lahey Clinic

OTHER