Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy: A Randomized Clinical Trial.
Aged
Aged, 80 and over
Cervical Vertebrae
/ diagnostic imaging
Follow-Up Studies
Humans
Laminectomy
/ methods
Magnetic Resonance Imaging
Middle Aged
Patient Reported Outcome Measures
Postoperative Complications
Radiography
Spinal Cord
/ diagnostic imaging
Spinal Cord Diseases
/ surgery
Spinal Fusion
/ methods
Spondylosis
/ surgery
Treatment Outcome
Journal
JAMA
ISSN: 1538-3598
Titre abrégé: JAMA
Pays: United States
ID NLM: 7501160
Informations de publication
Date de publication:
09 03 2021
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
942-951Subventions
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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