Cervical Spondylotic Myelopathy Surgical Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Lahey Clinic
Sponsor:
Collaborator:
Patient Centered Outcome Research Institute
Information provided by (Responsible Party):
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT02076113
First received: February 26, 2014
Last updated: March 25, 2015
Last verified: March 2015
  Purpose

The purpose of the study is to determine the optimal surgical approach (ventral vs dorsal) for patients with multi-level cervical spondylotic myelopathy (CSM). There are no established guidelines for the management of patients with CSM, which represents the most common cause of spinal cord injury and dysfunction in the US and in the world.

This study aims to test the hypothesis that ventral surgery is associated with superior Short Form-36 physical component Score (SF-36 PCS) outcome at one year follow-up compared to dorsal approaches and that both ventral and dorsal surgery improve symptoms of spinal cord dysfunction measured using the modified Japanese Orthopedic Association Score (mJOA). A secondary hypothesis is that health resource utilization for ventral surgery, dorsal fusion, and laminoplasty surgery are different. A third hypothesis is that cervical sagittal balance post-operatively is a significant predictor of SF-36 PCS outcome.


Condition Intervention
Cervical Spondylosis With Myelopathy
Procedure: Ventral (Front) decompression with Fusion
Procedure: Dorsal (Back) Decompression with Fusion
Procedure: Dorsal (back) Laminoplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cervical Spondylotic Myelopathy Surgical Trial

Resource links provided by NLM:


Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • Measurement of change in Short Form 36 (SF 36) physical component score (PCS) from baseline to 1 year [ Time Frame: Pre-operatively and 1 year ] [ Designated as safety issue: No ]
    Standardized measure of patient's functional health and well being as reported by the patient


Secondary Outcome Measures:
  • modified Japanese Orthopedic Association Score mJOA [ Time Frame: Pre-operatively, 3 and 6 months and 1 year ] [ Designated as safety issue: No ]
    Short instrument for the functional assessment of patients

  • Oswestry Neck Disability Index (NDI) [ Time Frame: Pre-operatively, 3 and 6 months and 1 year ] [ Designated as safety issue: No ]
    Standard instrument for measuring self-rated disability secondary to neck pain

  • EuroQol-5 D [ Time Frame: Pre-operatively, 3 and 6 months and 1 year ] [ Designated as safety issue: No ]
    Standardized measure of health related quality of life.

  • Number of participants with 30 day complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Complications are considered Hospital Readmission, Re-operation or Death within 30 days of initial surgery

  • Health resource utilization [ Time Frame: Pre-operatively, 1, 3 and 6 months and 1 year ] [ Designated as safety issue: No ]
    patient diary capturing out of pocket health expenses related to cervical surgery

  • Work Status [ Time Frame: pre-operative, 1, 3 and 6 months and 1 year ] [ Designated as safety issue: No ]
  • Sagittal Balance Measurements [ Time Frame: Pre-op and 1 year ] [ Designated as safety issue: No ]
    standing cervical-thoracic-lumbar-sacral xrays


Estimated Enrollment: 250
Study Start Date: April 2014
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ventral
Ventral Decompression with Fusion
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.
Other Name: Anterior Cervical Discectomy and Fusion (ACDF)
Active Comparator: Dorsal
Dorsal Decompression with Fusion or Dorsal Laminoplasty
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.
Other Name: Posterior decompression and fusion
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.

Detailed Description:

Patients' images will be transmitted electronically (without identifying information) to a group of 15 CSM surgeon investigators for their expert opinion. They will provide their opinion on surgical strategy. Equipoise for randomization will be established using this spinal experts network polling mechanism.

If randomized, the patient will be randomized to one of the two treatment approaches - either Ventral (front) (treatment A) or Dorsal (back) (treatment B) approach. If randomized to treatment A (front surgery), the patient will receive decompression/fusion from the front of the neck. If randomized to treatment B (dorsal/back surgery), then the patient and their surgeon will select which posterior procedure they will receive (either dorsal decompression/fusion or dorsal laminoplasty).

Treatment A: Decompression/fusion from the front of the neck.

Treatment B: Dorsal/posterior neck surgery (one of the two surgical procedures listed below):

Dorsal decompression/fusion or dorsal laminoplasty (no fusion)

Functional outcomes will be determined using well-known quantitative scales (SF-36, Oswestry Neck Disability Index (NDI), mJOA, and EuroQol-5D). These instruments will be administered pre-op, 3 months, 6 months, and at 1 year. Additionally, functional outcomes instruments (SF-36, Oswestry Neck Disability Index, and EuroQol-5D) will be collected annually at years 2,3,4 and 5.

Pre-op imaging will include a cervical MRI and cervical CT as well as cervical flexion/extension films and standing cervical-thoracic-lumbar-sacral x-ray . A cervical MRI will be performed at 3 months. At 1 year (randomized patients only) will undergo cervical flexion/ extension xrays and standing cervical-thoracic-lumbar-sacral x-ray . A cervical CT will be performed only if the Oswestry NDI score is > 30.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CSM (≥2 levels of spinal cord compression from C3 to C7)
  • Present with ≥2 of the following symptoms/signs: clumsy hands, gait disturbance, hyperreflexia, up going toes, bladder dysfunction.

Exclusion Criteria:

  • C2-C7 kyphosis>5º (measured in standing neutral cervical spine radiograph),
  • Segmental kyphotic deformity (defined by ≥3 osteophytes extending dorsal to a C2-C7 dorsal-caudal line measured on cervical spine CT),
  • Structurally significant ossification of posterior longitudinal ligament (OPLL - measured on cervical spine CT),
  • Previous cervical spine surgery
  • Significant active health-related co-morbidity (Anesthesia Class IV or higher).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02076113

Contacts
Contact: Susan R Christopher, RN 781-744-7904 susan.r.christopher@lahey.org

Locations
United States, California
University of California- San Francisco Not yet recruiting
San Francisco, California, United States, 94143
Contact: Erika Cavallone       erika.cavallone@ucsf.edu   
Principal Investigator: Sanjay Dhall, MD         
Sub-Investigator: Praveen Mummaneni, MD         
United States, Georgia
Emory Recruiting
Atlanta, Georgia, United States, 30329
Contact: Ericka Brewer    404-778-6857    ericka.brewer@emory.edu   
Principal Investigator: John G Heller, MD         
Sub-Investigator: John Rhee, MD         
Sub-Investigator: Scott Boden, MD         
Sub-Investigator: Tim Yoon, MD         
Sub-Investigator: Keith Michael, MD         
Sub-Investigator: Daniel Refai, MD         
United States, Massachusetts
Massachusetts General Hospital Withdrawn
Boston, Massachusetts, United States, 02114
Lahey Hospital and Medical Center Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Susan R Christopher, RN    781-744-7904    susan.r.christopher@lahey.org   
Contact: Jill N Curran, MS       jill.n.curran@lahey.org   
Principal Investigator: Subu N Magge, MD         
Sub-Investigator: Robert G. Whitmore, MD         
United States, Missouri
Washington University School of Medicine- St. Louis Recruiting
St. Louis, Missouri, United States, 63110
Contact: Colleen Peters    314-747-2994    petersc@wudosis.wustl.edu   
Principal Investigator: Daniel Riew, MD         
Sub-Investigator: Jacob Buchowski, MD         
Sub-Investigator: Michael Kelly, MD         
Sub-Investigator: Lukas Zebala, MD         
United States, New Jersey
Rutgers-New Jersey Medical School Recruiting
Newark, New Jersey, United States, 07103
Contact: Lorelei Pratt, RN    973-972-4702    lpratt@njms.rutgers.edu   
Principal Investigator: Robert F Heary, MD         
Sub-Investigator: Ira Goldstein, MD         
Sub-Investigator: Michael Vives, MD         
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Jennifer Shue    212-774-7183    shuej@hss.edu   
Principal Investigator: Todd J Albert, MD         
Sub-Investigator: Frank P Cammissa, MD         
Sub-Investigator: Alexander P Hughes, MD         
Sub-Investigator: Han Jo Kim, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44106
Contact: Michael Zeleny    216-445-1861    zelenym@ccf.org   
Principal Investigator: Edward C Benzel, MD         
Sub-Investigator: Ajit Krishnaney, MD         
Sub-Investigator: Thomas Mroz, MD         
Sub-Investigator: Michael Steinmetz, MD         
MetroHealth Active, not recruiting
Cleveland, Ohio, United States, 44109
United States, Pennsylvania
Rothman Spine Institute- thomas jefferson University Withdrawn
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Michelle Orlando    215-503-5646    michelle.orlando@jefferson.edu   
Contact: Alberto Montano    215-955-2173    alberto.montano@jefferson.edu   
Principal Investigator: James S. Harrop, MD         
Sub-Investigator: Ashwini Sharan, MD         
Sub-Investigator: Srivivas Prasad, MD         
Sub-Investigator: Joshua Heller, MD         
United States, Utah
University of Utah Health Sciences Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Holly Hill, RN    801-581-6908    holly.hill@hsc.utah.edu   
Contact: Sara McEvoy, PA    801-581-6908    sara.mcevoy@hsc.utah.edu   
Principal Investigator: Erica F Bisson, MD         
Sub-Investigator: Meic Schmidt, MD         
Sub-Investigator: Andrew Daily, MD         
Sub-Investigator: Daniel Brodke, MD         
Sub-Investigator: William Spiker, MD         
United States, Wisconsin
University of Wisconsin Not yet recruiting
Madison, Wisconsin, United States, 53792
Contact: Niki Virnig       virnig@neurosurgery.wisc.edu   
Principal Investigator: Daniel K Resnick, MD         
Sub-Investigator: Nathaniel Brooks, MD         
Medical College of Wisconsin Active, not recruiting
Milwaukee, Wisconsin, United States, 53226
Canada, Ontario
University Health Network-University of Toronto Not yet recruiting
Toronto, Ontario, Canada, M5T2S8
Contact: Yuriy Petrenko, MD    416-603-5285    yuriy.petrenko@uhn.ca   
Principal Investigator: Michael G Fehlings, MD         
Sub-Investigator: Mohammed Shamji, MD         
Sponsors and Collaborators
Lahey Clinic
Patient Centered Outcome Research Institute
Investigators
Principal Investigator: Zoher Ghogawala, MD Lahey Clinic, Inc.
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT02076113     History of Changes
Other Study ID Numbers: LCID: 2013-085, CE-1304-6173
Study First Received: February 26, 2014
Last Updated: March 25, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Lahey Clinic:
cervical spondylotic myelopathy
degenerative cervical spondylosis
spinal fusion

Additional relevant MeSH terms:
Bone Marrow Diseases
Spinal Cord Diseases
Spinal Osteophytosis
Bone Diseases
Central Nervous System Diseases
Hematologic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Spinal Diseases

ClinicalTrials.gov processed this record on March 26, 2015