Cervical Spondylotic Myelopathy Surgical Trial
a study on Cervical Spondylotic Myelopathy
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.
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.
Cervical Spondylosis With Myelopathy cervical spondylotic myelopathy degenerative cervical spondylosis spinal fusion
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).
- University of California- San Francisco accepting new patients
San Francisco, California, 94143, United States
- 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
- accepting new patients
- Start Date
- Completion Date
- Lahey Clinic
- Patient Centered Outcomes Research Institute
- Study website for the Cervical Spondylotic Myelopathy Surgical Study
- Lead Scientist
- Praveen Mummaneni
- Study Type
- Last Updated
- December 1, 2016
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02076113.