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Cervical Spondylotic Myelopathy Surgical Trial

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02076113
First Posted: March 3, 2014
Last Update Posted: September 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Lahey Clinic
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    Short instrument for the functional assessment of patients

  • Oswestry Neck Disability Index (NDI) [ Time Frame: Pre-operatively, 3 and 6 months and 1 year ]
    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 ]
    Standardized measure of health related quality of life.

  • Number of participants with 30 day complications [ Time Frame: 30 days ]
    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 ]
    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 ]
  • Sagittal Balance Measurements [ Time Frame: Pre-op and 1 year ]
    standing cervical-thoracic-lumbar-sacral xrays

  • Number of participants with unresolved swallowing difficulty (complication) at 3 months [ Time Frame: 3 months ]
    Complication is considered swallowing difficulty


Estimated Enrollment: 250
Actual Study Start Date: April 1, 2014
Estimated Study Completion Date: June 2023
Estimated Primary Completion Date: December 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076113


Locations
United States, California
University of California- San Francisco
San Francisco, California, United States, 94143
United States, Georgia
Emory
Atlanta, Georgia, United States, 30329
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
United States, Missouri
Washington University School of Medicine- St. Louis
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Rutgers-New Jersey Medical School
Newark, New Jersey, United States, 07103
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Columbia
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44106
MetroHealth
Cleveland, Ohio, United States, 44109
United States, Pennsylvania
Rothman Spine Institute- thomas jefferson University
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Utah
University of Utah Health Sciences
Salt Lake City, Utah, United States, 84132
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Ontario
University Health Network-University of Toronto
Toronto, Ontario, Canada, M5T2S8
Sponsors and Collaborators
Lahey Clinic
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Zoher Ghogawala, MD Lahey Clinic, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT02076113     History of Changes
Other Study ID Numbers: LCID: 2013-085
CE-1304-6173 ( Other Identifier: Patient-Centered Outcomes Research Institute )
First Submitted: February 26, 2014
First Posted: March 3, 2014
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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