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Summary

for people ages 45–80 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Details

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.

Keywords

Cervical Spondylosis With Myelopathy cervical spondylotic myelopathy degenerative cervical spondylosis spinal fusion

Eligibility

You can join if…

Open to people ages 45–80

  • 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.

You CAN'T join if...

  • 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).

Locations

  • University of Utah Health Sciences accepting new patients
    Salt Lake City, Utah, 84132, United States
  • University of Kansas Medical Center accepting new patients
    Kansas City, Kansas, 66160, United States
  • Washington University School of Medicine- St. Louis in progress, not accepting new patients
    St. Louis, Missouri, 63110, United States
  • University of Wisconsin accepting new patients
    Madison, Wisconsin, 53792, United States
  • Medical College of Wisconsin accepting new patients
    Milwaukee, Wisconsin, 53226, United States
  • Emory accepting new patients
    Atlanta, Georgia, 30329, United States
  • MetroHealth in progress, not accepting new patients
    Cleveland, Ohio, 44109, United States
  • Cleveland Clinic Foundation accepting new patients
    Cleveland, Ohio, 44106, United States
  • University of Pittsburgh Medical Center accepting new patients
    Pittsburgh, Pennsylvania, 15213, United States
  • University Health Network-University of Toronto accepting new patients
    Toronto, Ontario, M5T2S8, Canada
  • Rothman Spine Institute- thomas jefferson University not yet accepting patients
    Philadelphia, Pennsylvania, 19107, United States
  • Thomas Jefferson University Hospital accepting new patients
    Philadelphia, Pennsylvania, 19107, United States
  • Rutgers-New Jersey Medical School accepting new patients
    Newark, New Jersey, 07103, United States
  • Hospital for Special Surgery accepting new patients
    New York, New York, 10021, United States
  • Columbia accepting new patients
    New York, New York, 10032, United States
  • Lahey Hospital and Medical Center accepting new patients
    Burlington, Massachusetts, 01805, United States
  • Massachusetts General Hospital withdrawn
    Boston, Massachusetts, 02114, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Lahey Clinic
Links
Patient Centered Outcomes Research Institute
Study website for the Cervical Spondylotic Myelopathy Surgical Study
ID
NCT02076113
Lead Scientist
Praveen Mummaneni
Study Type
Interventional
Last Updated
December 1, 2016
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