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<PubmedArticle><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">33930859</PMID><DateRevised><Year>2024</Year><Month>08</Month><Day>13</Day></DateRevised><Article PubModel="Electronic-Print"><Journal><ISSN IssnType="Electronic">1547-5646</ISSN><JournalIssue CitedMedium="Internet"><Volume>35</Volume><Issue>1</Issue><PubDate><Year>2021</Year><Month>Jul</Month><Day>01</Day></PubDate></JournalIssue><Title>Journal of neurosurgery. Spine</Title><ISOAbbreviation>J Neurosurg Spine</ISOAbbreviation></Journal><ArticleTitle>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.</ArticleTitle><Pagination><StartPage>67</StartPage><EndPage>79</EndPage><MedlinePgn>67-79</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">2020.9.SPINE201472</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.3171/2020.9.SPINE201472</ELocationID><Abstract><AbstractText Label="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.</AbstractText><AbstractText Label="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 &#x2265; 30&#xb0; and Oswestry Disability Index [ODI] &#x2265; 20 or Scoliosis Research Society [SRS]-22 subscore &#x2264; 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.</AbstractText><AbstractText Label="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 &lt; 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 &lt; 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.</AbstractText><AbstractText Label="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.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Smith</LastName><ForeName>Justin S</ForeName><Initials>JS</Initials><AffiliationInfo><Affiliation>1Department of Neurosurgery, University of Virginia Health System, Charlottesville, Virginia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kelly</LastName><ForeName>Michael P</ForeName><Initials>MP</Initials><AffiliationInfo><Affiliation>2Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, Missouri.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yanik</LastName><ForeName>Elizabeth L</ForeName><Initials>EL</Initials><AffiliationInfo><Affiliation>2Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, Missouri.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Baldus</LastName><ForeName>Christine R</ForeName><Initials>CR</Initials><AffiliationInfo><Affiliation>2Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, Missouri.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Buell</LastName><ForeName>Thomas J</ForeName><Initials>TJ</Initials><AffiliationInfo><Affiliation>1Department of Neurosurgery, University of Virginia Health System, Charlottesville, Virginia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lurie</LastName><ForeName>Jon D</ForeName><Initials>JD</Initials><AffiliationInfo><Affiliation>3Department of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Edwards</LastName><ForeName>Charles</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>4Mercy Medical Center, Baltimore, Maryland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Glassman</LastName><ForeName>Steven D</ForeName><Initials>SD</Initials><AffiliationInfo><Affiliation>5Norton Leatherman Spine Center, Louisville, Kentucky.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lenke</LastName><ForeName>Lawrence G</ForeName><Initials>LG</Initials><AffiliationInfo><Affiliation>6Department of Orthopedic Surgery, Columbia University, New York, New York.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Boachie-Adjei</LastName><ForeName>Oheneba</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>7FOCOS Orthopedic Hospital, Accra, Ghana.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Buchowski</LastName><ForeName>Jacob M</ForeName><Initials>JM</Initials><AffiliationInfo><Affiliation>2Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, Missouri.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Carreon</LastName><ForeName>Leah Y</ForeName><Initials>LY</Initials><AffiliationInfo><Affiliation>5Norton Leatherman Spine Center, Louisville, Kentucky.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Crawford</LastName><ForeName>Charles H</ForeName><Initials>CH</Initials><AffiliationInfo><Affiliation>5Norton Leatherman Spine Center, Louisville, Kentucky.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Errico</LastName><ForeName>Thomas J</ForeName><Initials>TJ</Initials><AffiliationInfo><Affiliation>8Department of Orthopedic Surgery, Nicklaus Children's Hospital, Miami, Florida.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lewis</LastName><ForeName>Stephen J</ForeName><Initials>SJ</Initials><AffiliationInfo><Affiliation>9UHN-Orthopedics, University of Toronto, Toronto Western Hospital, Toronto, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Koski</LastName><ForeName>Tyler</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>10Department of Neurological Surgery, Northwestern University, Chicago, Illinois.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Parent</LastName><ForeName>Stefan</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>11Sainte-Justine University Hospital, Montr&#xe9;al, Quebec, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lafage</LastName><ForeName>Virginie</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>12Hospital for Special Surgery, New York, New York.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kim</LastName><ForeName>Han Jo</ForeName><Initials>HJ</Initials><AffiliationInfo><Affiliation>12Hospital for Special Surgery, New York, New York.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ames</LastName><ForeName>Christopher P</ForeName><Initials>CP</Initials><AffiliationInfo><Affiliation>13Department of Neurosurgery, University of California, San Francisco, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bess</LastName><ForeName>Shay</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>14Denver International Spine Center, Presbyterian St. Luke's/Rocky Mountain Hospital for Children, Denver, Colorado; and.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schwab</LastName><ForeName>Frank J</ForeName><Initials>FJ</Initials><AffiliationInfo><Affiliation>12Hospital for Special Surgery, New York, New York.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Shaffrey</LastName><ForeName>Christopher I</ForeName><Initials>CI</Initials><AffiliationInfo><Affiliation>15Departments of Neurosurgery and Orthopedic Surgery, Duke University, Durham, North Carolina.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bridwell</LastName><ForeName>Keith H</ForeName><Initials>KH</Initials><AffiliationInfo><Affiliation>2Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, Missouri.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2021</Year><Month>04</Month><Day>30</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>J Neurosurg Spine</MedlineTA><NlmUniqueID>101223545</NlmUniqueID><ISSNLinking>1547-5646</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">adult</Keyword><Keyword MajorTopicYN="N">lumbar</Keyword><Keyword MajorTopicYN="N">nonoperative treatment</Keyword><Keyword MajorTopicYN="N">outcomes</Keyword><Keyword MajorTopicYN="N">scoliosis</Keyword><Keyword MajorTopicYN="N">spine deformity</Keyword><Keyword MajorTopicYN="N">surgery</Keyword></KeywordList><CoiStatement>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 <i>Journal of Neurosurgery Spine, Neurosurgery, Operative Neurosurgery</i>, and <i>Spine Deformity</i>; 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 <i>Spine, The Spine Journal</i>, and <i>Spine Deformity</i>; 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&amp;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, <i>Operative Neurosurgery</i>, 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&#x2013;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. 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