Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy: A Randomized Clinical Trial.


Journal

JAMA
ISSN: 1538-3598
Titre abrégé: JAMA
Pays: United States
ID NLM: 7501160

Informations de publication

Date de publication:
09 03 2021
Historique:
entrez: 9 3 2021
pubmed: 10 3 2021
medline: 20 3 2021
Statut: ppublish

Résumé

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. 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. 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%). 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.

Identifiants

pubmed: 33687463
pii: 2777236
doi: 10.1001/jama.2021.1233
pmc: PMC7944378
doi:

Banques de données

ClinicalTrials.gov
['NCT02076113']

Types de publication

Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

942-951

Subventions

Organisme : NIAMS NIH HHS
ID : R13 AR065834
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002544
Pays : United States

Commentaires et corrections

Type : CommentIn
Type : CommentIn
Type : CommentIn

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Auteurs

Zoher Ghogawala (Z)

Department of Neurosurgery, Lahey Hospital and Medical Center, Burlington, Massachusetts.

Norma Terrin (N)

Tufts Clinical and Translational Science Institute, Tufts University, and Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.

Melissa R Dunbar (MR)

Department of Neurosurgery, Lahey Hospital and Medical Center, Burlington, Massachusetts.

Janis L Breeze (JL)

Tufts Clinical and Translational Science Institute, Tufts University, and Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.

Karen M Freund (KM)

Tufts Clinical and Translational Science Institute, Tufts University, and Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.

Adam S Kanter (AS)

Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburg, Pennsylvania.

Praveen V Mummaneni (PV)

Department of Neurological Surgery, University of California, San Francisco.

Erica F Bisson (EF)

Department of Neurosurgery Clinical Neurosciences Center, University of Utah School of Medicine, Salt Lake City.

Fred G Barker (FG)

Massachusetts General Hospital Brain Tumor Center, Boston.

J Sanford Schwartz (JS)

University of Pennsylvania Perelman School of Medicine, Philadelphia.
University of Pennsylvania Wharton School, Philadelphia.

James S Harrop (JS)

Thomas Jefferson University, Philadelphia, Pennsylvania.

Subu N Magge (SN)

Department of Neurosurgery, Lahey Hospital and Medical Center, Burlington, Massachusetts.

Robert F Heary (RF)

Department of Neurological Surgery, Hackensack Meridian School of Medicine, Nutley, New Jersey.

Michael G Fehlings (MG)

Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.
Division of Neurosurgery, Krembil Neuroscience Centre, University Health Network, Toronto, Ontario, Canada.

Todd J Albert (TJ)

Department of Orthopedic Surgery, Hospital for Special Surgery, New York, New York.
Department of Neurosurgery, Weill Cornell Medicine, New York, New York.

Paul M Arnold (PM)

Carle Neuroscience Institute, Carle Foundation Hospital, Urbana, Illinois.

K Daniel Riew (KD)

Columbia University Irving Medical Center, New York, New York.

Michael P Steinmetz (MP)

Neurosurgery, Cleveland Clinic Foundation, Cleveland, Ohio.

Marjorie C Wang (MC)

Department of Neurosurgery, Medical College of Wisconsin, Milwaukee.

Robert G Whitmore (RG)

Department of Neurosurgery, Lahey Hospital and Medical Center, Burlington, Massachusetts.

John G Heller (JG)

Emory Orthopaedics & Spine Center, Emory University School of Medicine, Atlanta, Georgia.

Edward C Benzel (EC)

Neurosurgery, Cleveland Clinic Foundation, Cleveland, Ohio.

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