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DOI 10.1001/jama.2021.1233

Медицинская библиотека · JAMA · 2021

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

Ghogawala Zoher, Terrin Norma, Dunbar Melissa R, Breeze Janis L, Freund Karen M, Kanter Adam S, Mummaneni Praveen V, Bisson Erica F, Barker Fred G, Schwartz J Sanford, Harrop James S, Magge Subu N, Heary Robert F, Fehlings Michael G, Albert Todd J, Arnold Paul M, Riew K Daniel, Steinmetz Michael P, Wang Marjorie C, Whitmore Robert G, Heller John G, Benzel Edward C

Сравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка NIH: внешняя программаПоддержка исследования: вне правительства СШАПеревод в очереди

Аннотация

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.

Для цитирования: Ghogawala Zoher, Terrin Norma, Dunbar Melissa R, Breeze Janis L, Freund Karen M, Kanter Adam S, Mummaneni Praveen V, Bisson Erica F, Barker Fred G, Schwartz J Sanford, Harrop James S, Magge Subu N, Heary Robert F, Fehlings Michael G, Albert Todd J, Arnold Paul M, Riew K Daniel, Steinmetz Michael P, Wang Marjorie C, Whitmore Robert G, Heller John G, Benzel Edward C. Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy: A Randomized Clinical Trial.. JAMA. 2021. DOI: 10.1001/jama.2021.1233.

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