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Operative versus nonoperative treatment for adult symptomatic lumbar scoliosis at 5-year follow-up: durability of outcomes and impact of treatment-related serious adverse events.

Publication ,  Journal Article
Smith, JS; Kelly, MP; Yanik, EL; Baldus, CR; Buell, TJ; Lurie, JD; Edwards, C; Glassman, SD; Lenke, LG; Boachie-Adjei, O; Buchowski, JM ...
Published in: J Neurosurg Spine
April 30, 2021

OBJECTIVE: Although short-term adult symptomatic lumbar scoliosis (ASLS) studies favor operative over nonoperative treatment, longer outcomes are critical for assessment of treatment durability, especially for operative treatment, because the majority of implant failures and nonunions present between 2 and 5 years after surgery. The objectives of this study were to assess the durability of treatment outcomes for operative versus nonoperative treatment of ASLS, to report the rates and types of associated serious adverse events (SAEs), and to determine the potential impact of treatment-related SAEs on outcomes. METHODS: The ASLS-1 (Adult Symptomatic Lumbar Scoliosis-1) trial is an NIH-sponsored multicenter prospective study to assess operative versus nonoperative ASLS treatment. Patients were 40-80 years of age and had ASLS (Cobb angle ≥ 30° and Oswestry Disability Index [ODI] ≥ 20 or Scoliosis Research Society [SRS]-22 subscore ≤ 4.0 in the Pain, Function, and/or Self-Image domains). Patients receiving operative and nonoperative treatment were compared using as-treated analysis, and the impact of related SAEs was assessed. Primary outcome measures were ODI and SRS-22. RESULTS: The 286 patients with ASLS (107 with nonoperative treatment, 179 with operative treatment) had 2-year and 5-year follow-up rates of 90% (n = 256) and 74% (n = 211), respectively. At 5 years, compared with patients treated nonoperatively, those who underwent surgery had greater improvement in ODI (mean difference -15.2 [95% CI -18.7 to -11.7]) and SRS-22 subscore (mean difference 0.63 [95% CI 0.48-0.78]) (p < 0.001), with treatment effects (TEs) exceeding the minimum detectable measurement difference (MDMD) for ODI (7) and SRS-22 subscore (0.4). TEs at 5 years remained as favorable as 2-year TEs (ODI -13.9, SRS-22 0.52). For patients in the operative group, the incidence rates of treatment-related SAEs during the first 2 years and 2-5 years after surgery were 22.38 and 8.17 per 100 person-years, respectively. At 5 years, patients in the operative group who had 1 treatment-related SAE still had significantly greater improvement, with TEs (ODI -12.2, SRS-22 0.53; p < 0.001) exceeding the MDMD. Twelve patients who received surgery and who had 2 or more treatment-related SAEs had greater improvement than nonsurgically treated patients based on ODI (TE -8.34, p = 0.017) and SRS-22 (TE 0.32, p = 0.029), but the SRS-22 TE did not exceed the MDMD. CONCLUSIONS: The significantly greater improvement of operative versus nonoperative treatment for ASLS at 2 years was durably maintained at the 5-year follow-up. Patients in the operative cohort with a treatment-related SAE still had greater improvement than patients in the nonoperative cohort. These findings have important implications for patient counseling and future cost-effectiveness assessments.

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Published In

J Neurosurg Spine

DOI

EISSN

1547-5646

Publication Date

April 30, 2021

Volume

35

Issue

1

Start / End Page

67 / 79

Location

United States

Related Subject Headings

  • Orthopedics
  • 3209 Neurosciences
  • 1109 Neurosciences
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Smith, J. S., Kelly, M. P., Yanik, E. L., Baldus, C. R., Buell, T. J., Lurie, J. D., … Bridwell, K. H. (2021). Operative versus nonoperative treatment for adult symptomatic lumbar scoliosis at 5-year follow-up: durability of outcomes and impact of treatment-related serious adverse events. J Neurosurg Spine, 35(1), 67–79. https://doi.org/10.3171/2020.9.SPINE201472
Smith, Justin S., Michael P. Kelly, Elizabeth L. Yanik, Christine R. Baldus, Thomas J. Buell, Jon D. Lurie, Charles Edwards, et al. “Operative versus nonoperative treatment for adult symptomatic lumbar scoliosis at 5-year follow-up: durability of outcomes and impact of treatment-related serious adverse events.J Neurosurg Spine 35, no. 1 (April 30, 2021): 67–79. https://doi.org/10.3171/2020.9.SPINE201472.
Smith, Justin S., et al. “Operative versus nonoperative treatment for adult symptomatic lumbar scoliosis at 5-year follow-up: durability of outcomes and impact of treatment-related serious adverse events.J Neurosurg Spine, vol. 35, no. 1, Apr. 2021, pp. 67–79. Pubmed, doi:10.3171/2020.9.SPINE201472.
Smith JS, Kelly MP, Yanik EL, Baldus CR, Buell TJ, Lurie JD, Edwards C, Glassman SD, Lenke LG, Boachie-Adjei O, Buchowski JM, Carreon LY, Crawford CH, Errico TJ, Lewis SJ, Koski T, Parent S, Lafage V, Kim HJ, Ames CP, Bess S, Schwab FJ, Shaffrey CI, Bridwell KH. Operative versus nonoperative treatment for adult symptomatic lumbar scoliosis at 5-year follow-up: durability of outcomes and impact of treatment-related serious adverse events. J Neurosurg Spine. 2021 Apr 30;35(1):67–79.

Published In

J Neurosurg Spine

DOI

EISSN

1547-5646

Publication Date

April 30, 2021

Volume

35

Issue

1

Start / End Page

67 / 79

Location

United States

Related Subject Headings

  • Orthopedics
  • 3209 Neurosciences
  • 1109 Neurosciences
  • 1103 Clinical Sciences