Zoher Ghogawala1, Norma Terrin2, Melissa R Dunbar1, Janis L Breeze2, Karen M Freund2, Adam S Kanter3, Praveen V Mummaneni4, Erica F Bisson5, Fred G Barker6, J Sanford Schwartz7,8, James S Harrop9, Subu N Magge1, Robert F Heary10, Michael G Fehlings11,12, Todd J Albert13,14, Paul M Arnold15, K Daniel Riew16, Michael P Steinmetz17, Marjorie C Wang18, Robert G Whitmore1, John G Heller19, Edward C Benzel17. 1. Department of Neurosurgery, Lahey Hospital and Medical Center, Burlington, Massachusetts. 2. Tufts Clinical and Translational Science Institute, Tufts University, and Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts. 3. Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburg, Pennsylvania. 4. Department of Neurological Surgery, University of California, San Francisco. 5. Department of Neurosurgery Clinical Neurosciences Center, University of Utah School of Medicine, Salt Lake City. 6. Massachusetts General Hospital Brain Tumor Center, Boston. 7. University of Pennsylvania Perelman School of Medicine, Philadelphia. 8. University of Pennsylvania Wharton School, Philadelphia. 9. Thomas Jefferson University, Philadelphia, Pennsylvania. 10. Department of Neurological Surgery, Hackensack Meridian School of Medicine, Nutley, New Jersey. 11. Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada. 12. Division of Neurosurgery, Krembil Neuroscience Centre, University Health Network, Toronto, Ontario, Canada. 13. Department of Orthopedic Surgery, Hospital for Special Surgery, New York, New York. 14. Department of Neurosurgery, Weill Cornell Medicine, New York, New York. 15. Carle Neuroscience Institute, Carle Foundation Hospital, Urbana, Illinois. 16. Columbia University Irving Medical Center, New York, New York. 17. Neurosurgery, Cleveland Clinic Foundation, Cleveland, Ohio. 18. Department of Neurosurgery, Medical College of Wisconsin, Milwaukee. 19. Emory Orthopaedics & Spine Center, Emory University School of Medicine, Atlanta, Georgia.
Abstract
Importance: 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. Objective: 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. Interventions: 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. Results: 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-36PCS 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. Trial Registration: ClinicalTrials.gov Identifier: NCT02076113.
RCT Entities:
Importance: 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. Objective: 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. Interventions: 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. Results: 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. Trial Registration: ClinicalTrials.gov Identifier: NCT02076113.
Authors: Michael G Fehlings; Sean Barry; Branko Kopjar; Sangwook Tim Yoon; Paul Arnold; Eric M Massicotte; Alexander Vaccaro; Darrel S Brodke; Christopher Shaffrey; Justin S Smith; Eric Woodard; Robert J Banco; Jens Chapman; Michael Janssen; Christopher Bono; Rick Sasso; Mark Dekutoski; Ziya L Gokaslan Journal: Spine (Phila Pa 1976) Date: 2013-12-15 Impact factor: 3.468
Authors: Jetan H Badhiwala; Christopher S Ahuja; Muhammad A Akbar; Christopher D Witiw; Farshad Nassiri; Julio C Furlan; Armin Curt; Jefferson R Wilson; Michael G Fehlings Journal: Nat Rev Neurol Date: 2020-01-23 Impact factor: 42.937
Authors: Zoher Ghogawala; James Dziura; William E Butler; Feng Dai; Norma Terrin; Subu N Magge; Jean-Valery C E Coumans; J Fred Harrington; Sepideh Amin-Hanjani; J Sanford Schwartz; Volker K H Sonntag; Fred G Barker; Edward C Benzel Journal: N Engl J Med Date: 2016-04-14 Impact factor: 91.245