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In patients with cervical spondylotic myelopathy, does a ventral surgical approach, compared with a dorsal surgical approach, improve patient-reported physical functioning at 1 year?
In this randomized clinical trial that included 163 patients, mean improvement in the Short Form 36 physical component summary score (range, 0-100) was 5.9 points in the ventral surgery group and 6.2 points in the dorsal surgery group at 1 year, a difference that was not statistically significant.
Among patients with cervical spondylotic myelopathy undergoing cervical spinal surgery, a ventral approach did not significantly improve patient-reported physical functioning at 1 year compared with outcomes after a dorsal approach.
Cervical spondylotic myelopathy is the most common cause of spinal cord dysfunction worldwide. It remains unknown whether a ventral or dorsal surgical approach provides the best results.
To determine whether a ventral surgical approach compared with a dorsal surgical approach for treatment of cervical spondylotic myelopathy improves patient-reported physical functioning at 1 year.
Design, Setting, and Participants
Randomized clinical trial of patients aged 45 to 80 years with multilevel cervical spondylotic myelopathy enrolled at 15 large North American hospitals from April 1, 2014, to March 30, 2018; final follow-up was April 15, 2020.
Patients were randomized to undergo ventral surgery (n = 63) or dorsal surgery (n = 100). Ventral surgery involved anterior cervical disk removal and instrumented fusion. Dorsal surgery involved laminectomy with instrumented fusion or open-door laminoplasty. Type of dorsal surgery (fusion or laminoplasty) was at surgeon’s discretion.
Main Outcomes and Measures
The primary outcome was 1-year change in the Short Form 36 physical component summary (SF-36 PCS) score (range, 0 [worst] to 100 [best]; minimum clinically important difference = 5). Secondary outcomes included 1-year change in modified Japanese Orthopaedic Association scale score, complications, work status, sagittal vertical axis, health resource utilization, and 1- and 2-year changes in the Neck Disability Index and the EuroQol 5 Dimensions score.
Among 163 patients who were randomized (mean age, 62 years; 80 [49%] women), 155 (95%) completed the trial at 1 year (80% at 2 years). All patients had surgery, but 5 patients did not receive their allocated surgery (ventral: n = 1; dorsal: n = 4). One-year SF-36 PCS mean improvement was not significantly different between ventral surgery (5.9 points) and dorsal surgery (6.2 points) (estimated mean difference, 0.3; 95% CI, −2.6 to 3.1; P = .86). Of 7 prespecified secondary outcomes, 6 showed no significant difference. Rates of complications in the ventral and dorsal surgery groups, respectively, were 48% vs 24% (difference, 24%; 95% CI, 8.7%-38.5%; P = .002) and included dysphagia (41% vs 0%), new neurological deficit (2% vs 9%), reoperations (6% vs 4%), and readmissions within 30 days (0% vs 7%).
Conclusions and Relevance
Among patients with cervical spondylotic myelopathy undergoing cervical spinal surgery, a ventral surgical approach did not significantly improve patient-reported physical functioning at 1 year compared with outcomes after a dorsal surgical approach.
ClinicalTrials.gov Identifier: NCT02076113
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Corresponding Author: Zoher Ghogawala, MD, Department of Neurosurgery, Lahey Hospital and Medical Center, 41 Mall Rd, Burlington, MA 01805 (firstname.lastname@example.org).
Accepted for Publication: January 29, 2021.
Author Contributions: Dr Ghogawala and Ms Breeze had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Ghogawala, Terrin, Freund, Barker, Schwartz, Harrop, Heary, Albert, Riew, Heller, Benzel.
Acquisition, analysis, or interpretation of data: Ghogawala, Terrin, Dunbar, Breeze, Freund, Kanter, Mummaneni, Bisson, Barker, Schwartz, Harrop, Magge, Heary, Fehlings, Albert, Arnold, Riew, Steinmetz, Wang, Whitmore, Benzel.
Drafting of the manuscript: Ghogawala, Terrin, Dunbar, Barker, Schwartz, Harrop, Heary, Albert, Benzel.
Critical revision of the manuscript for important intellectual content: Ghogawala, Terrin, Breeze, Freund, Kanter, Mummaneni, Bisson, Barker, Schwartz, Harrop, Magge, Heary, Fehlings, Albert, Arnold, Riew, Steinmetz, Wang, Whitmore, Heller, Benzel.
Statistical analysis: Ghogawala, Terrin, Breeze, Freund, Barker, Schwartz.
Obtained funding: Ghogawala, Freund, Schwartz, Arnold.
Administrative, technical, or material support: Ghogawala, Dunbar, Kanter, Harrop, Magge, Heary, Fehlings, Albert, Riew, Whitmore, Benzel.
Supervision: Ghogawala, Kanter, Mummaneni, Barker, Schwartz, Harrop, Magge, Heary, Albert, Riew, Steinmetz, Benzel.
Conflict of Interest Disclosures: Dr Kanter reported receipt of personal fees and royalties from Zimmer Biomet and NuVasive. Dr Mummaneni reported receipt of personal fees from DePuy Synthes, Globus, and Stryker; holding stock in Spinicity/ISD; receipt of grants from the Neurosurgery Research and Education Foundation, the International Spine Study Group, AO Spine, and the National Institutes of Health; and receipt of book royalties from Thieme and Springer. Dr Bisson reported receipt of personal fees from Stryker and MiRus and grants from the Neurosurgery Research and Education Foundation. Dr Schwartz reported receipt of personal fees from Allergan, Bayer, Blue Cross and Blue Shield Associations, and Pfizer. Dr Harrop reported receipt of personal consulting fees from DePuy Synthes and Ethicon. Dr Albert reported consultancy for NuVasive; board of directorship for Back Story, the American Orthopaedic Association (past relationship), and the Scoliosis Research Society; ownership interest in Augmedics, Bonovo Orthopedics, CytoDyn, HS2, Innovative Surgical Designs, InVivo Therapeutics, Morphogenesis, Paradigm Spine, Physician Recommended Nutriceuticals, Parvizi Surgical Innovations, Precision Orthopedics, Pulse Equity, Spinicity, Strathspey Crown, and Surg.io; and receipt of royalties from DePuy Synthes Spine, Zimmer Biomet, Elsevier, JP Medical Publishers, Springer, and Thieme. Dr Riew reported receipt of personal fees from Biomet and Medtronic and stock ownership in Amedica, Axiomed, Benvenue, Expanding Orthopedics, Osprey, Paradigm Spine, Spinal Kinetics, Spineology, and Vertiflex. Dr Steinmetz reported receipt of royalties from Zimmer Biomet and Elsevier and consultancy and receipt of an honorarium from Globus. Dr Wang reported consultancy for Zimmer Biomet, Medtronic, and Titan Biologics. Dr Whitmore reported receipt of personal fees from Intrinsic Therapeutics and DePuy Synthes and stock ownership in Theseus. Dr Heller reported receipt of personal fees and royalties from Medtronic and holding a patent for laminoplasty plates issued by Medtronic. No other disclosures were reported.
Funding/Support: This study was supported by the National Institutes of Health (grant R13AR065834-01), the Patient-Centered Outcomes Research Institute (grant CE 1304-6173), and the Tufts Clinical and Translational Science Institute (grant UL 1TR002544). Additional financial support was provided by the Alan L. and Jacqueline B. Stuart Spine Outcomes Research Center at Lahey Hospital and Medical Center.
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
Group Information: A list of the CSM-S trial investigators appears in Supplement 3.
Data Sharing Statement: See Supplement 4.
Additional Contributions: We acknowledge the following contributions: from Lahey Hospital and Medical Center, Jill Curran, MS, was the national data manager; Susan Christopher, RN, BSN, was the patient-reported outcomes manager; and Juan Small, MD, and Aaron Paul, MD, served as independent radiology reviewers. Spinal expert panel reviewers included the 15 site investigators plus 9 auxiliary expert members: Paul C. McCormick, MD (Columbia-Presbyterian Hospital, New York, New York), Sigurd Berven, MD (University of California, San Francisco), Tanvir Choudhri, MD (Mt Sinai Medical Center, New York, NY), Asdrubal Falavigna, MD (University of Caxias do Sul, Caxias do Sul, Brazil), Alan Hilibrand, MD (Rothman Institute, Thomas Jefferson University, Philadelphia, Pennsylvania), Vedantam Rajshekhar, MD (Christian Medical College, Vellore, India), Daniel K. Resnick, MD (University of Wisconsin, Madison), Jeffrey Wang, MD (Keck School of Medicine, University of Southern California, Los Angeles), and Jean-Valery Coumans, MD (Massachusetts General Hospital, Boston). The data and safety monitoring board was chaired by Tamsin A. Knox, MD, MPH (Tufts University School of Medicine, Boston, Massachusetts), with Paul C. McCormick, MD, Jeffrey Wang, MD, Langston Holly, MD (University of California, Los Angeles), and Farzad Noubary, PhD (Tufts University School of Medicine) as members. Surgeons who randomized patients into the CSM-S trial included the 15 site investigators listed as authors along with the following surgeons: Rachid Assina, MD (Hackensack Meridian School of Medicine, Nutley, New Jersey), Sanjay Dhall, MD (University of California, San Francisco), Joshua Heller, MD (Thomas Jefferson University), Jeremy Amps, MD (Cleveland Clinic Foundation, Cleveland, Ohio), Shekar Kurpad, MD, PhD (Medical College of Wisconsin, Milwaukee), Jack Jallo, MD, PhD (Thomas Jefferson University), Keith Michael, MD (Emory University School of Medicine, Atlanta, Georgia), Srinivas Prasad, MD (Thomas Jefferson University), and Ajit Krishnaney, MD (Cleveland Clinic Foundation). None of these individuals received any personal compensation for their role in the study.
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