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

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  • 1 Department of Neurosurgery, University of Virginia Health System, Charlottesville, Virginia;
  • 2 Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, Missouri;
  • 3 Department of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire;
  • 4 Mercy Medical Center, Baltimore, Maryland;
  • 5 Norton Leatherman Spine Center, Louisville, Kentucky;
  • 6 Department of Orthopedic Surgery, Columbia University, New York, New York;
  • 7 FOCOS Orthopedic Hospital, Accra, Ghana;
  • 8 Department of Orthopedic Surgery, Nicklaus Children's Hospital, Miami, Florida;
  • 9 UHN-Orthopedics, University of Toronto, Toronto Western Hospital, Toronto, Ontario, Canada;
  • 10 Department of Neurological Surgery, Northwestern University, Chicago, Illinois;
  • 11 Sainte-Justine University Hospital, Montréal, Quebec, Canada;
  • 12 Hospital for Special Surgery, New York, New York;
  • 13 Department of Neurosurgery, University of California, San Francisco, California
  • 14 Denver International Spine Center, Presbyterian St. Luke's/Rocky Mountain Hospital for Children, Denver, Colorado; and
  • 15 Departments of Neurosurgery and Orthopedic Surgery, Duke University, Durham, North Carolina
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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.

ABBREVIATIONS ASD = adult spinal deformity; ASLS = adult symptomatic lumbar scoliosis; GLMM = generalized linear mixed model; MDMD = minimum detectable measurement difference; NRS = numeric rating scale; ODI = Oswestry Disability Index; PRO = patient-reported outcome; SAE = serious adverse event; SRS = Scoliosis Research Society; TE = treatment effect.

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Contributor Notes

Correspondence Justin S. Smith: University of Virginia Health Sciences Center, Charlottesville, VA. jss7f@virginia.edu.

INCLUDE WHEN CITING Published online April 30, 2021; DOI: 10.3171/2020.9.SPINE201472.

Disclosures Dr. Smith reports consultancy fees from Zimmer Biomet, NuVasive, DePuy Synthes, Stryker, and Carlsmed; receives royalties from Zimmer Biomet, NuVasive, and Thieme; holds stock in Alphatec; receives research funding to his institution from DePuy Synthes, International Spine Study Group Foundation (ISSGF), and AO Spine; receives fellowship grant funding to his institution from AO Spine and Neurosurgery Research and Education Foundation; serves on the editorial boards of Journal of Neurosurgery Spine, Neurosurgery, Operative Neurosurgery, and Spine Deformity; and serves on the board of directors of SRS, outside the submitted work. Dr. Kelly reports grants from NIH and SRS during the conduct of the study; and grants from Setting Scoliosis Straight Foundation, ISSGF, and AO Spine, outside the submitted work. Dr. Yanik reports grants from SRS during the conduct of the study. Dr. Lurie reports grants from NIH and SRS during the conduct of the study, grants from PCORI and FDA, personal fees from Spinol, and personal fees from UpToDate, outside the submitted work. Dr. Glassman reports grants from NuVasive, Intellrod, Integra, Pfizer, ISSG, and Norton Healthcare during the conduct of the study; is an employee of Norton Healthcare; reports personal fees from K2M/Stryker and Medtronic; is co-chair of American Spine Registry; and is ethics chair for SRS, outside the submitted work. In addition, he has patents with royalties paid with K2M/Stryker, Medtronic, and Springer, outside the submitted work. Dr. Lenke reports personal fees from Medtronic, K2M, Fox Rothschild, LLC, and Quality Medical Publishing; grants and personal fees from DePuy Synthes Spine; nonfinancial support from Broadwater, Seattle Science Foundation, Stryker Spine, and the Spinal Research Foundation; grants and nonfinancial support from SRS; grants from EOS and Setting Scoliosis Straight Foundation; and grants and nonfinancial support from AO Spine, outside the submitted work. Dr. Boachie-Adjei is a consultant for Stryker and is also on their speakers bureau. Dr. Buchowski reports personal fees from Globus, K2M/Stryker, and Wolters Kluwer; grants from AO Spine; and grants from OMeGA, outside the submitted work. Dr. Carreon reports research grants to her institution from Orthopaedic Research and Education Foundation, NIH, ISSG, SRS, TSRH, Pfizer, Lifesciences Corporation, IntelliRod, Cerapedics, Medtronic, Empirical Spine, and NeuroPoint Alliance, outside the submitted work; reports consulting work for National Spine Health Foundation; serves on the editorial advisory boards for Spine, The Spine Journal, and Spine Deformity; and serves as a member on the University of Louisville IRB, SRS Research Committee, and American Spine Registry, outside the submitted work. She is employed by Norton Healthcare and the University of Southern Denmark. Dr. Crawford reports grants from NIH during the conduct of the study; and personal fees from Alphatec, DePuy Synthes, Medtronic, NuVasive, and Springer, outside the submitted work. Dr. Errico reports consulting fees and royalties from Stryker Spine, and royalties from Altus Spine, outside the submitted work. Dr. Lewis reports honoraria from Medtronic and Stryker, and he is a consultant for Stryker and L&K Biomed. He reports program and fellowship support with fees paid to his institution by Spine Vision, DePuy Synthes, Medtronic, and Stryker, outside the submitted work. He has ownership in Augmedics. Dr. Koski reports grants and personal fees from NuVasive, personal fees from Medtronic, and personal fees from Spinewave, outside the submitted work. Dr. Parent reports grants and personal fees from EOS imaging; personal fees from Spinologics and K2M; grants, fellowship support, and personal fees from DePuy Synthes Spine; endowments from academic research chair in spine deformities of the CHU Sainte-Justine (DePuy); grants from Canadian Institutes of Health Research, Pediatric Orthopaedic Society of North America, SRS, Canadian Foundation for Innovation, Setting Scoliosis Straight Foundation, and Natural Sciences and Engineering Council of Canada; fellowship support from Medtronic and Orthopaediatrics, outside the submitted work. Dr. Lafage is a consultant for Globus Medical; receives royalties from NuVasive; has ownership in Nemaris, Inc.; and receives honoraria from DePuy Synthes Spine, Implanet, and The Permanente Medical Group, outside the submitted work. Dr. Kim reports royalties from Zimmer Biomet and K2M/Stryker and personal fees from Alphatec, outside the submitted work. Dr. Ames reports personal fees from Stryker, Zimmer Biomet Spine, DePuy Synthes, NuVasive, Next Orthosurgical, K2M, Medicrea, DePuy Synthes, Medtronic, Titan Spine, ISSG, Operative Neurosurgery, SRS, ISSG, Global Spinal Analytics, and UCSF, outside the submitted work. Dr. Bess is a consultant for Stryker, has direct stock ownership with Carlsmed, and is a patent holder with Stryker. He has received clinical or research support for the study described (includes equipment or material) from ISSGF. He has received support of a non–study-related clinical or research effort overseen by him from ISSGF, DePuy Synthes, K2M/Stryker, NuVasive, Medtronic, Globus, Mirus, and SI Bone. He is on the speakers bureau for Stryker and receives royalties from Stryker and NuVasive. Dr. Schwab is a consultant for Zimmer Biomet and Medtronic, and he receives royalties from Zimmer Biomet, Medtronic, and Medicrea. He has ownership interest in VFT Solutions and SeaSpine (noncompensated), and he is on the executive committee for ISSG (noncompensated). Dr. Shaffrey reports grants from NIH during the conduct of the study; and personal fees from NuVasive, Medtronic, Zimmer Biomet, and SI Bone, outside the submitted work. Dr. Bridwell reports grants from SRS during the conduct of the study.

  • 1

    Lutz W, Sanderson W, Scherbov S. The coming acceleration of global population ageing. Nature. 2008;451(7179):716719.

  • 2

    Department of Economic and Social Affairs, Population Division. World Population Ageing 2017 (ST/ESA/SER.A/408). United Nations; 2017.Accessed November 10, 2020. https://www.un.org/en/development/desa/population/publications/pdf/ageing/WPA2017_Report.pdf

    • Search Google Scholar
    • Export Citation
  • 3

    Fehlings MG, Tetreault L, Nater A, . The aging of the global population: the changing epidemiology of disease and spinal disorders. Neurosurgery. 2015;77(suppl 4):S1S5.

    • Search Google Scholar
    • Export Citation
  • 4

    Diebo BG, Shah NV, Boachie-Adjei O, . Adult spinal deformity. Lancet. 2019;394(10193):160172.

  • 5

    Schwab F, Dubey A, Gamez L, . Adult scoliosis: prevalence, SF-36, and nutritional parameters in an elderly volunteer population. Spine (Phila Pa 1976).2005;30(9):10821085.

    • Search Google Scholar
    • Export Citation
  • 6

    Bess S, Line B, Fu KM, . The health impact of symptomatic adult spinal deformity: comparison of deformity types to United States population norms and chronic diseases. Spine (Phila Pa 1976).2016;41(3):224233.

    • Search Google Scholar
    • Export Citation
  • 7

    Acaroglu E, Yavuz AC, Guler UO, . A decision analysis to identify the ideal treatment for adult spinal deformity: is surgery better than non-surgical treatment in improving health-related quality of life and decreasing the disease burden?. Eur Spine J. 2016;25(8):23902400.

    • Search Google Scholar
    • Export Citation
  • 8

    Bridwell KH, Glassman S, Horton W, . Does treatment (nonoperative and operative) improve the two-year quality of life in patients with adult symptomatic lumbar scoliosis: a prospective multicenter evidence-based medicine study. Spine (Phila Pa 1976).2009;34(20):21712178.

    • Search Google Scholar
    • Export Citation
  • 9

    Glassman SD, Carreon LY, Shaffrey CI, . The costs and benefits of nonoperative management for adult scoliosis. Spine (Phila Pa 1976).2010;35(5):578582.

    • Search Google Scholar
    • Export Citation
  • 10

    Kelly MP, Lurie JD, Yanik EL, . Operative versus nonoperative treatment for adult symptomatic lumbar scoliosis. J Bone Joint Surg Am. 2019;101(4):338352.

    • Search Google Scholar
    • Export Citation
  • 11

    Smith JS, Lafage V, Shaffrey CI, . Outcomes of operative and nonoperative treatment for adult spinal deformity: a prospective, multicenter, propensity-matched cohort assessment with minimum 2-year follow-up. Neurosurgery. 2016;78(6):851861.

    • Search Google Scholar
    • Export Citation
  • 12

    Smith JS, Shaffrey CI, Glassman SD, . Risk-benefit assessment of surgery for adult scoliosis: an analysis based on patient age. Spine (Phila Pa 1976).2011;36(10):817824.

    • Search Google Scholar
    • Export Citation
  • 13

    McCarthy IM, Hostin RA, Ames CP, . Total hospital costs of surgical treatment for adult spinal deformity: an extended follow-up study. Spine J. 2014;14(10):23262333.

    • Search Google Scholar
    • Export Citation
  • 14

    McCarthy IM, Hostin RA, O’Brien MF, . Analysis of the direct cost of surgery for four diagnostic categories of adult spinal deformity. Spine J. 2013;13(12):18431848.

    • Search Google Scholar
    • Export Citation
  • 15

    Smith JS, Klineberg E, Lafage V, . Prospective multicenter assessment of perioperative and minimum 2-year postoperative complication rates associated with adult spinal deformity surgery. J Neurosurg Spine. 2016;25(1):114.

    • Search Google Scholar
    • Export Citation
  • 16

    Pellisé F, Serra-Burriel M, Smith JS, . Development and validation of risk stratification models for adult spinal deformity surgery. J Neurosurg Spine. 2019;31(4):587599.

    • Search Google Scholar
    • Export Citation
  • 17

    Ames CP, Smith JS, Pellisé F, . Artificial intelligence based hierarchical clustering of patient types and intervention categories in adult spinal deformity surgery: towards a new classification scheme that predicts quality and value. Spine (Phila Pa 1976).2019;44(13):915926.

    • Search Google Scholar
    • Export Citation
  • 18

    Li G, Passias P, Kozanek M, . Adult scoliosis in patients over sixty-five years of age: outcomes of operative versus nonoperative treatment at a minimum two-year follow-up. Spine (Phila Pa 1976).2009;34(20):21652170.

    • Search Google Scholar
    • Export Citation
  • 19

    Kim YJ, Bridwell KH, Lenke LG, . Pseudarthrosis in adult spinal deformity following multisegmental instrumentation and arthrodesis. J Bone Joint Surg Am. 2006;88(4):721728.

    • Search Google Scholar
    • Export Citation
  • 20

    Dawson L, Zarin DA, Emanuel EJ, . Considering usual medical care in clinical trial design. PLoS Med. 2009;6(9):e1000111.

  • 21

    Weinstein JN, Lurie JD, Tosteson TD, . Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007;356(22):22572270.

    • Search Google Scholar
    • Export Citation
  • 22

    Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976).2000;25(22):29402952.

  • 23

    Bridwell KH, Cats-Baril W, Harrast J, . The validity of the SRS-22 instrument in an adult spinal deformity population compared with the Oswestry and SF-12: a study of response distribution, concurrent validity, internal consistency, and reliability. Spine (Phila Pa 1976).2005;30(4):455461.

    • Search Google Scholar
    • Export Citation
  • 24

    National Institute of Arthritis and Musculoskeletal and Skin Diseases. Template and Guidelines for Developing a Multi-Site Manual of Operations and Procedures (MOOP). National Institutes of Health; 2017.Accessed November 11, 2020.https://www.niams.nih.gov/sites/default/files/multisite_moop_0.pdf

    • Search Google Scholar
    • Export Citation
  • 25

    Baldus C, Kelly MP, Yanik EL, . Incidence of cancer in spinal deformity patients receiving high-dose (≥40 mg) bone morphogenetic protein (rhBMP-2). Spine (Phila Pa 1976).2017;42(23):17851791.

    • Search Google Scholar
    • Export Citation
  • 26

    Kelly MP, Kim HJ, Ames CP, . Minimum detectable measurement difference for health-related quality of life measures varies with age and disability in adult spinal deformity: implications for calculating minimal clinically important difference. Spine (Phila Pa 1976).2018;43(13):E790E795.

    • Search Google Scholar
    • Export Citation
  • 27

    Carreon LY, Glassman SD, Lurie J, . Cost-effectiveness of operative versus nonoperative treatment of adult symptomatic lumbar scoliosis an intent-to-treat analysis at 5-year follow-up. Spine (Phila Pa 1976).2019;44(21):14991506.

    • Search Google Scholar
    • Export Citation
  • 28

    Smith JS, Shaffrey CI, Berven S, . Operative versus nonoperative treatment of leg pain in adults with scoliosis: a retrospective review of a prospective multicenter database with two-year follow-up. Spine (Phila Pa 1976).2009;34(16):16931698.

    • Search Google Scholar
    • Export Citation
  • 29

    Smith JS, Shaffrey CI, Berven S, . Improvement of back pain with operative and nonoperative treatment in adults with scoliosis. Neurosurgery. 2009;65(1):8694.

    • Search Google Scholar
    • Export Citation
  • 30

    Smith JS, Shaffrey CI, Ames CP, Lenke LG. Treatment of adult thoracolumbar spinal deformity: past, present, and future. J Neurosurg Spine. 2019;30(5):551567.

    • Search Google Scholar
    • Export Citation
  • 31

    Buell TJ, Buchholz AL, Quinn JC, . A pilot study on posterior polyethylene tethers to prevent proximal junctional kyphosis after multilevel spinal instrumentation for adult spinal deformity. Oper Neurosurg (Hagerstown). 2019;16(2):256266.

    • Search Google Scholar
    • Export Citation
  • 32

    Gupta S, Eksi MS, Ames CP, . A novel 4-rod technique offers potential to reduce rod breakage and pseudarthrosis in pedicle subtraction osteotomies for adult spinal deformity correction. Oper Neurosurg (Hagerstown). 2018;14(4):449456.

    • Search Google Scholar
    • Export Citation
  • 33

    Line BG, Bess S, Lafage R, . Effective prevention of proximal junctional failure in adult spinal deformity surgery requires a combination of surgical implant prophylaxis and avoidance of sagittal alignment overcorrection. Spine (Phila Pa 1976).2020;45(4):258267.

    • Search Google Scholar
    • Export Citation
  • 34

    Smith JS, Shaffrey CI, Bess S, . Recent and emerging advances in spinal deformity. Neurosurgery. 2017;80(3S):S70S85.

  • 35

    Buell TJ, Bess S, Xu M, . Optimal tether configurations and preload tensioning to prevent proximal junctional kyphosis: a finite element analysis. J Neurosurg Spine. 2019;30(5):574584.

    • Search Google Scholar
    • Export Citation
  • 36

    Buell TJ, Chen CJ, Nguyen JH, . Surgical correction of severe adult lumbar scoliosis (major curves ≥ 75°): retrospective analysis with minimum 2-year follow-up. J Neurosurg Spine. 2019;31(4):548561.

    • Search Google Scholar
    • Export Citation
  • 37

    Buell TJ, Chen CJ, Quinn JC, . Alignment risk factors for proximal junctional kyphosis and the effect of lower thoracic junctional tethers for adult spinal deformity. World Neurosurg. 2019;121:e96e103.

    • Search Google Scholar
    • Export Citation
  • 38

    Buell TJ, Mullin JP, Nguyen JH, . A novel junctional tether weave technique for adult spinal deformity: 2-dimensional operative video. Oper Neurosurg (Hagerstown). 2019;16(2):4546.

    • Search Google Scholar
    • Export Citation
  • 39

    Nguyen JH, Buell TJ, Wang TR, . Low rates of complications after spinopelvic fixation with iliac screws in 260 adult patients with a minimum 2-year follow-up. J Neurosurg Spine. 2019;30(5):635643.

    • Search Google Scholar
    • Export Citation
  • 40

    Buell TJ, Buchholz AL, Mazur MD, . Kickstand rod technique for correcting coronal imbalance in adult scoliosis: 2-dimensional operative video. Oper Neurosurg (Hagerstown). 2020;19(2):E163E164.

    • Search Google Scholar
    • Export Citation
  • 41

    Buell TJ, Christiansen PA, Nguyen JH, . Coronal correction using kickstand rods for adult thoracolumbar/lumbar scoliosis: case series with analysis of early outcomes and complications. Oper Neurosurg (Hagerstown). 2020;19(4):403413.

    • Search Google Scholar
    • Export Citation
  • 42

    Buell TJ, Yener U, Wang TR, . Sacral insufficiency fractures after lumbosacral arthrodesis: salvage lumbopelvic fixation and a proposed management algorithm. J Neurosurg Spine. 2020;33(2):225236.

    • Search Google Scholar
    • Export Citation

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