Cervical Spondylotic Myelopathy Surgical Trial
|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.|
|ClinicalTrials.gov Identifier: NCT02076113|
Recruitment Status : Active, not recruiting
First Posted : March 3, 2014
Last Update Posted : April 3, 2018
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 or disease||Intervention/treatment||Phase|
|Cervical Spondylosis With Myelopathy||Procedure: Ventral (Front) decompression with Fusion Procedure: Dorsal (Back) Decompression with Fusion Procedure: Dorsal (back) Laminoplasty||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cervical Spondylotic Myelopathy Surgical Trial|
|Actual Study Start Date :||April 1, 2014|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2023|
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.
- 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
- 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
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
|United States, California|
|University of California- San Francisco|
|San Francisco, California, United States, 94143|
|United States, Georgia|
|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|
|New York, New York, United States, 10032|
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44106|
|Cleveland, Ohio, United States, 44109|
|United States, Pennsylvania|
|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|
|University Health Network-University of Toronto|
|Toronto, Ontario, Canada, M5T2S8|
|Principal Investigator:||Zoher Ghogawala, MD||Lahey Clinic, Inc.|