Browsing by Author "Lurie, Jon D"

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    ItemOpen Access
    Baseline Patient-Reported Outcomes Correlate Weakly With Radiographic Parameters: A Multicenter, Prospective NIH Adult Symptomatic Lumbar Scoliosis Study of 286 Patients.
    (Spine, 2016-11) Chapman, Todd M; Baldus, Christine R; Lurie, Jon D; Glassman, Steven D; Schwab, Frank J; Shaffrey, Christopher I; Lafage, Virginie; Boachie-Adjei, Oheneba; Kim, Han J; Smith, Justin S; Crawford, Charles H; Lenke, Lawrence G; Buchowski, Jacob M; Edwards, Charles; Koski, Tyler; Parent, Stefan; Lewis, Stephen; Kang, Daniel G; McClendon, Jamal; Metz, Lionel; Zebala, Lukas P; Kelly, Michael P; Spratt, Kevin F; Bridwell, Keith H

    Study design

    Prospective, cross-sectional study.

    Objective

    The aim of the study was to determine which radiographic parameters drive patient-reported outcomes (PROs) in primary presentation adult symptomatic lumbar scoliosis (ASLS).

    Summary of background data

    Previous literature suggests correlations between PROs and sagittal plane deformity (sagittal vertical axis [SVA], pelvic incidence-lumbar lordosis [PI-LL] mismatch, pelvic tilt [PT]). Prior work included revision and primary adult spinal deformity patients. The present study addresses only primary presentation ASLS.

    Methods

    Prospective baseline data were analyzed on 286 patients enrolled in an NIH RO1 clinical trial by nine centers from 2010 to 2014.

    Inclusion criteria

    40 to 80 years old, lumbar Cobb (LC) 30° or higher and Scoliosis Research Society-23 score 4.0 or less in Pain, Function or Self-Image domains, or Oswestry Disability Index (ODI) 20 or higher. Patients were primary presentation (no prior spinal deformity surgery) and had complete baseline data: standing coronal/sagittal 36" radiographs and PROs (ODI, Scoliosis Research Society-23, Short Form-12). Correlation coefficients were calculated to evaluate relations between radiographic parameters and PROs for the study population and a subset of patients with ODI 40 or higher. Analysis of variance was used to identify differences in PROs for radiographic modifier groups.

    Results

    Mean age was 60.3 years. Mean spinopelvic parameters were: LL = -39.2°; SVA = 3.1 cm; sacral slope = 32.5°; PT = 23.9°; PI-LL mismatch = 16.8°. Only weak correlations (0.2-0.4) were identified between population sacral slope, SVA and SVA modifiers, and SRS function. SVA and SVA modifiers were weakly associated with ODI. Although there were more correlations in subset analysis of high-symptom patients, all were weak. Analysis of variance identified significant differences in ODI reported by SVA modifier groups.

    Conclusion

    In primary presentation patients with ASLS and a subset of "high-symptom" patients (ODI ≥ 40), only weak associations between baseline PROs and radiographic parameters were identified. For this patient population, these results suggest regional radiographic parameters (LC, LL, PT, PI-LL mismatch) are not drivers of PROs and cannot be used to extrapolate effect on patient-perceived pathology.

    Level of evidence

    2.
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    ItemOpen Access
    Cost-effectiveness Improves for Operative vs Nonoperative Treatment of Adult Symptomatic Lumbar Scoliosis at Eight-Year Follow-up.
    (Spine, 2024-10) Carreon, Leah Y; Glassman, Steven D; Smith, Justin S; Kelly, Michael P; Yanik, Elizabeth L; Baldus, Christine R; Lurie, Jon D; Edwards, Charles; Lenke, Lawrence G; Buchowski, Jacob M; Crawford, Charles H; Koski, Tyler; Lafage, Virginie; Gupta, Munish; Kim, Han Jo; Ames, Christopher P; Bess, Shay; Schwab, Frank J; Shaffrey, Christopher I; Bridwell, Keith H

    Study design

    Secondary data analysis of the NIH sponsored study on Adult Symptomatic Lumbar Scoliosis (ASLS).

    Objectives

    The purpose of this study is to perform a cost-effectiveness analysis comparing operative versus non-operative care for ASLS eight years after enrollment.

    Summary of background data

    A prior cost-effectiveness analysis of the current cohort comparing operative to non-operative care at five years after enrollment showed and ICER of $44,033 in the As-Treated analysis and a ICER of $27,480 in the Intent-to-treat analysis.

    Methods

    Data was collected every three months for the first two years, then every six months for the remainder of the study. Data included use of non-operative modalities, medications and employment status. Costs for index and revision surgeries and non-operative modalities were determined using Medicare Allowable rates. Medication costs were determined using the RedBook and indirect costs were calculated based on reported employment status and income. Quality Adjusted Life Years (QALY) was determined using the SF6D.

    Results

    There were 101 cases in the Operative (Op) and 103 in the Non-operative (Non-Op) group with complete eight year data. Thirty-eight patients (37%) in the Non-Op group had surgery from 3 to 72 months after enrollment. An As-Treated analysis including only cases who never had surgery (N=65) or cases with complete eight-year post-operative data (N=101) showed that operative treatment was favored with an ICER of $20,569 per QALY gained which is within Willingness-to-Pay (WTP) thresholds. An Intent-to-Treat analysis demonstrated greater QALY gains and lower cost in the Op group (ICER = $-13,911). However, Intent-to-Treat analysis is influenced by Non-Op patients who crossed over to operative treatment at variable times during follow-up.

    Conclusion

    Operative treatment was more cost-effective than non-operative treatment for ASLS at eight-year follow-up. The ICER continued to improve as compared to the five-year values ($20,569 vs. $44,033).
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    ItemOpen Access
    Cost-effectiveness of adult lumbar scoliosis surgery: an as-treated analysis from the adult symptomatic scoliosis surgery trial with 5-year follow-up.
    (Spine deformity, 2020-12) Glassman, Steven D; Carreon, Leah Y; Shaffrey, Christopher I; Kelly, Michael P; Crawford, Charles H; Yanik, Elizabeth L; Lurie, Jon D; Bess, R Shay; Baldus, Christine R; Bridwell, Keith H

    Study design

    Longitudinal comparative cohort.

    Objective

    The purpose of this study is to report on the cost-effectiveness of surgical versus non-surgical treatment for Adult Symptomatic Lumbar Scoliosis (ASLS) using the as-treated data and provide a comparison to previously reported intent-to-treat (ITT) analysis. Adult spinal deformity is a relatively prevalent condition for which surgical treatment has become increasingly common but concerns surrounding complications, revision rates and cost-effectiveness remain unresolved. Of these issues, cost-effectiveness is perhaps the most difficult to quantify as the requisite data is difficult to obtain. The purpose of this study is to report on the cost-effectiveness of surgical versus non-surgical treatment for ASLS using the as-treated data and provide a comparison to previously reported ITT analysis.

    Methods

    Patients with at least 5-year follow-up data within the same treatment arm were included. Data collected every 3 months included use of nonoperative modalities, medications and employment status. Costs for surgeries and non-operative modalities were determined using Medicare Allowable rates. Medication costs were determined using the RedBook and indirect costs were calculated based on the reported employment status and income. Quality-Adjusted Life Years (QALY) was determined using the SF-6D.

    Results

    Of 226 patients, 195 patients (73 Non-op, 122 Op) met inclusion criteria. At 5 years, 29 (24%) patients in the Op group had a revision surgery of whom two had two revisions and one had three revisions. The cumulative cost for the Op group was $111,451 with a cumulative QALY gain of 2.3. The cumulative cost for the Non-Op group was $29,124 with a cumulative QALY gain of 0.4. This results in an ICER of $44,033 in favor of Op treatment.

    Conclusion

    This as-treated cost-effectiveness analysis demonstrates that surgical treatment for adult lumbar scoliosis becomes favorable at year-three, 1 year earlier than suggested by a previous intent-to-treat analysis.

    Level of evidence

    II.
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    ItemOpen Access
    Effect modifiers for patient-reported outcomes in operatively and nonoperatively treated patients with adult symptomatic lumbar scoliosis: a combined analysis of randomized and observational cohorts.
    (Journal of neurosurgery. Spine, 2020-03) Yanik, Elizabeth L; Kelly, Michael P; Lurie, Jon D; Baldus, Christine R; Shaffrey, Christopher I; Schwab, Frank J; Bess, Shay; Lenke, Lawrence G; LaBore, Adam; Bridwell, Keith H
    OBJECTIVE:Adult symptomatic lumbar scoliosis (ASLS) is a common and disabling condition. The ASLS-1 was a multicenter, dual-arm study (with randomized and observational cohorts) examining operative and nonoperative care on health-related quality of life in ASLS. An aim of ASLS-1 was to determine patient and radiographic factors that modify the effect of operative treatment for ASLS. METHODS:Patients 40-80 years old with ASLS were enrolled in randomized and observational cohorts at 9 North American centers. Primary outcomes were the differences in mean change from baseline to 2-year follow-up for the SRS-22 subscore (SRS-SS) and the Oswestry Disability Index (ODI). Analyses were performed using an as-treated approach with combined cohorts. Factors examined were prespecified or determined using regression tree analysis. For each potential effect modifier, subgroups were created using clinically relevant cutoffs or via regression trees. Estimates of within-group and between-group change were compared using generalized linear mixed models. An effect modifier was defined as a treatment effect difference greater than the minimal detectable measurement difference for both SRS-SS (0.4) and ODI (7). RESULTS:Two hundred eighty-six patients were enrolled and 256 (90%) completed 2-year follow-up; 171 received operative treatment and 115 received nonoperative treatment. Surgery was superior to nonoperative care for all effect subgroups considered, with the exception of those with nearly normal pelvic incidence-lumbar lordosis (PI-LL) match (≤ 11°). Male patients and patients with more (> 11°) PI-LL mismatch at baseline had greater operative treatment effects on both the SRS-SS and ODI compared to nonoperative treatment. No other radiographic subgroups were associated with treatment effects. High BMI, lower socioeconomic status, and poor mental health were not related to worse outcomes. CONCLUSIONS:Numerous factors previously related to poor outcomes with surgery, such as low mental health, lower socioeconomic status, and high BMI, were not related to outcomes in ASLS in this exploratory analysis. Those patients with higher PI-LL mismatch did improve more with surgery than those with normal alignment. On average, none of the factors considered were associated with a worse outcome with operative treatment versus nonoperative treatment. These findings may guide future prospective analyses of factors related to outcomes in ASLS care.
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    ItemOpen Access
    Effect of Serious Adverse Events on Health-related Quality of Life Measures Following Surgery for Adult Symptomatic Lumbar Scoliosis.
    (Spine, 2019-09) Smith, Justin S; Shaffrey, Christopher I; Kelly, Michael P; Yanik, Elizabeth L; Lurie, Jon D; Baldus, Christine R; Edwards, Charles; Glassman, Steven D; Lenke, Lawrence G; Boachie-Adjei, Oheneba; Buchowski, Jacob M; Carreon, Leah Y; Crawford, Charles H; Errico, Thomas J; Lewis, Stephen J; Koski, Tyler; Parent, Stefan; Kim, Han Jo; Ames, Christopher P; Bess, Shay; Schwab, Frank J; Bridwell, Keith H

    Study design

    Secondary analysis of prospective multicenter cohort.

    Objective

    To assess effect of serious adverse events (SAEs) on 2- and 4-year patient-reported outcomes measures (PROMs) in patients surgically treated for adult symptomatic lumbar scoliosis (ASLS).

    Summary of background data

    Operative treatment for ASLS can improve health-related quality of life, but has high rates of SAEs. How these SAEs effect health-related quality of life remain unclear.

    Methods

    The ASLS study assessed operative versus nonoperative ASLS treatment, with randomized and observational arms. Patients were 40- to 80-years-old with ASLS, defined as lumbar coronal Cobb ≥30° and Oswestry Disability Index (ODI) ≥20 or Scoliosis Research Society-22 (SRS-22) ≤4.0 in pain, function, and/or self-image domains. SRS-22 subscore and ODI were compared between operative patients with and without a related SAE and nonoperative patients using an as-treated analysis combining randomized and observational cohorts.

    Results

    Two hundred eighty-six patients were enrolled, and 2- and 4-year follow-up rates were 90% and 81%, respectively, although at the time of data extraction not all patients were eligible for 4-year follow-up. A total of 97 SAEs were reported among 173 operatively treated patients. The most common were implant failure/pseudarthrosis (n = 25), proximal junctional kyphosis/failure (n = 10), and minor motor deficit (n = 8). At 2 years patients with an SAE improved less than those without an SAE based on SRS-22 (0.52 vs. 0.79, P = 0.004) and ODI (-11.59 vs. -17.34, P = 0.021). These differences were maintained at 4-years for both SRS-22 (0.51 vs. 0.86, P = 0.001) and ODI (-10.73 vs. -16.69, P = 0.012). Despite this effect, patients sustaining an operative SAE had greater PROM improvement than nonoperative patients (P<0.001).

    Conclusion

    Patients affected by SAEs following surgery for ASLS had significantly less improvement of PROMs at 2- and 4-year follow-ups versus those without an SAE. Regardless of SAE occurrence, operatively treated patients had significantly greater improvement in PROMs than those treated nonoperatively.

    Level of evidence

    2.
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    ItemOpen Access
    Health-Related Quality of Life Scores Underestimate the Impact of Major Complications in Lumbar Degenerative Scoliosis Surgery.
    (Spine deformity, 2018-01) Glassman, Steven D; Bridwell, Keith H; Shaffrey, Christopher I; Edwards, Charles C; Lurie, Jon D; Baldus, Christine R; Carreon, Leah Y

    Study design

    Retrospective cohort.

    Objective

    To examine Charlson Comorbidity Index (CCMI) as a marker for deterioration in health status not reflected in standard Health Related Quality of Life (HRQOL) measures.

    Summary of background data

    HRQOL has become a primary metric for assessing outcomes following spinal deformity surgery. However, studies have reported limited impact of complications on postoperative HRQOL outcomes.

    Methods

    We examined serial CCMI, complications, and HRQOL outcomes for 138 adult lumbar deformity patients treated surgically with a minimum two-year follow-up that included 126 females (91%) with a mean age of 59.8 years (range, 40.2-78.5). Patients with no, minor, or major complications were compared at baseline and at one and two years postoperation.

    Results

    Minor complications were observed in 26 patients (19%) and major complications in 15 (11%). Major complications included motor deficit (7), deep vein thrombosis (4), and respiratory failure (3). There was no difference in preoperative SF-36 Physical Component Summary or Scoliosis Research Society-22R (SRS-22R) scores among the groups at baseline. Preoperative CCMI was lowest in the No Complication group (3.52 ± 1.70) followed by the Major (4.00 ± 1.13) and Minor Complication groups (4.15 ± 1.71, p = .165). At one year, there was a significantly greater CCMI deterioration in the Major Complication group (0.80 ± 1.01) compared to both the Minor (0.08 ± 0.27) and No Complication groups (0.27 ± 0.47, p < .001). There was no significant difference in SF-36 Physical Component Summary or SRS-22R scores among the three groups. Similar findings were observed at two years.

    Conclusions

    Despite similar one- and two-year HRQOL improvement, patients with major complications had greater deterioration in CCMI. As CCMI is predictive of medical and surgical risk, patients who sustained a major complication now carry a greater likelihood of adverse outcomes with future interventions, including any subsequent spinal surgery. Although this increased risk may not alter the patient's perception of his or her current health status, it may be important, and should be recognized as part of the shared decision-making process.

    Level of evidence

    Level II, high-quality prognostic study.
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    ItemOpen Access
    Neurologic Deficits Have a Negative Impact on Patient-Related Outcomes in Primary Presentation Adult Symptomatic Lumbar Scoliosis Surgical Treatment at One-Year Follow-up.
    (Spine, 2017-04) Kang, Daniel G; Baldus, Christine; Glassman, Steven D; Shaffrey, Christopher I; Lurie, Jon D; Bridwell, Keith H

    Study design

    A retrospective analysis of prospective, multicenter National Institute of Health clinical trial.

    Objective

    The aim of this study was to assess the rate of neurologic complications and impact of new neurologic deficits on 1-year postoperative patient-reported outcomes (PROs).

    Summary of background data

    There are limited studies evaluating the impact of new neurologic deficits on PROs following surgery for primary presentation adult lumbar scoliosis.

    Methods

    Patients were divided into two groups: new postoperative neurological deficit (Def) or no deficit (NoDef). Preoperative and 1-year follow-up PROs were analyzed [Scoliosis Research Society (SRS) Questionnaire, Oswestry Disability Index (ODI), Short Form-12 Physical/Mental Health Composite Scores (PCS/MCS), and back/leg pain Numerical Rating Scale (NRS)].

    Results

    One hundred forty-one patients: 14 Def (9.9%), 127 NoDef (90.1%). No differences were observed in demographic, radiographic, or PRO data between groups preoperatively. Def group had longer surgical procedures (8.3 vs. 6.9 hours, P = 0.030), greater blood loss (2832 vs. 2606 mL, P = 0.022), and longer hospitalizations (10.6 vs. 7.8 days, P = 0.004). NoDef group reported significant improvement in all PROs from preop to 1-year postoperative. Def group only had improvement in SRS Pain (2.7 preop to 3.4 postop, P = 0.037) and self-image domains (2.7 to 3.6, p = 0.004), and NRS back pain (6.6 to 3.2, P = 0.004) scores with significant worsening of NRS leg pain (4.1 to 6.1, P = 0.045). Group comparisons of 1-year postop PROs found that Def group reported more NRS leg pain (6.1 vs. 1.7, P < 0.001) and worse outcomes than NoDef group for ODI (35.7 vs. 23.1, P = 0.016) and PCS (32.6 vs. 41.9, P = 0.007).

    Conclusion

    We found a 9.9% rate of new neurologic deficits following surgery for symptomatic primary presentation adult lumbar scoliosis, much higher than previous studies. Most neurologic deficits improved by 1-year follow-up, but appeared to have a dramatic negative impact on PROs, with increased postoperative leg pain and greater patient-perceived pathology reported in patients experiencing neurological deficits compared with those who did not.

    Level of evidence

    3.
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    ItemOpen Access
    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.
    (Journal of neurosurgery. Spine, 2021-04) Smith, Justin S; Kelly, Michael P; Yanik, Elizabeth L; Baldus, Christine R; Buell, Thomas J; Lurie, Jon D; Edwards, Charles; Glassman, Steven D; Lenke, Lawrence G; Boachie-Adjei, Oheneba; Buchowski, Jacob M; Carreon, Leah Y; Crawford, Charles H; Errico, Thomas J; Lewis, Stephen J; Koski, Tyler; Parent, Stefan; Lafage, Virginie; Kim, Han Jo; Ames, Christopher P; Bess, Shay; Schwab, Frank J; Shaffrey, Christopher I; Bridwell, Keith H

    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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    ItemOpen Access
    Operative Versus Nonoperative Treatment for Adult Symptomatic Lumbar Scoliosis.
    (The Journal of bone and joint surgery. American volume, 2019-02) Kelly, Michael P; Lurie, Jon D; Yanik, Elizabeth L; Shaffrey, Christopher I; Baldus, Christine R; Boachie-Adjei, Oheneba; Buchowski, Jacob M; Carreon, Leah Y; Crawford, Charles H; Edwards, Charles; Errico, Thomas J; Glassman, Steven D; Gupta, Munish C; Lenke, Lawrence G; Lewis, Stephen J; Kim, Han Jo; Koski, Tyler; Parent, Stefan; Schwab, Frank J; Smith, Justin S; Zebala, Lukas P; Bridwell, Keith H

    Background

    The effectiveness of operative compared with nonoperative treatment at initial presentation (no prior fusion) for adult lumbar scoliosis has not, to our knowledge, been evaluated in controlled trials. The goals of this study were to evaluate the effects of operative and nonoperative treatment and to assess the benefits of these treatments to help treating physicians determine whether patients are better managed operatively or nonoperatively.

    Methods

    Patients with adult symptomatic lumbar scoliosis (aged 40 to 80 years, with a coronal Cobb angle measurement of ≥30° and an Oswestry Disability Index [ODI] score of ≥20 or Scoliosis Research Society [SRS]-22 score of ≤4.0) from 9 North American centers were enrolled in concurrent randomized or observational cohorts to evaluate operative versus nonoperative treatment. The primary outcomes were differences in the mean change from baseline in the SRS-22 subscore and ODI at 2-year follow-up. For the randomized cohort, the initial sample-size calculation estimated that 41 patients per group (82 total) would provide 80% power with alpha equal to 0.05, anticipating 10% loss to follow-up and 20% nonadherence in the nonoperative arm. However, an interim sample-size calculation estimated that 18 patients per group would be sufficient.

    Results

    Sixty-three patients were enrolled in the randomized cohort: 30 in the operative group and 33 in the nonoperative group. Two hundred and twenty-three patients were enrolled in the observational cohort: 112 in the operative group and 111 in the nonoperative group. The intention-to-treat analysis of the randomized cohort found that, at 2 years of follow-up, outcomes did not differ between the groups. Nonadherence was high in the randomized cohort (64% nonoperative-to-operative crossover). In the as-treated analysis of the randomized cohort, operative treatment was associated with greater improvement at the 2-year follow-up in the SRS-22 subscore (adjusted mean difference, 0.7 [95% confidence interval (CI), 0.5 to 1.0]) and in the ODI (adjusted mean difference, -16 [95% CI, -22 to -10]) (p < 0.001 for both). Surgery was also superior to nonoperative care in the observational cohort at 2 years after treatment on the basis of SRS-22 subscore and ODI outcomes (p < 0.001). In an overall responder analysis, more operative patients achieved improvement meeting or exceeding the minimal clinically important difference (MCID) in the SRS-22 subscore (85.7% versus 38.7%; p < 0.001) and the ODI (77.4% versus 38.3%; p < 0.001). Thirty-four revision surgeries were performed in 24 (14%) of the operative patients.

    Conclusions

    On the basis of as-treated and MCID analyses, if a patient with adult symptomatic lumbar scoliosis is satisfied with current spine-related health, nonoperative treatment is advised, with the understanding that improvement is unlikely. If a patient is not satisfied with current spine health and expects improvement, surgery is preferred.

    Level of evidence

    Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
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    ItemOpen Access
    Orthopedic disease burden in adult patients with symptomatic lumbar scoliosis: results from a prospective multicenter study.
    (Journal of neurosurgery. Spine, 2021-08) Smith, Justin S; Shaffrey, Christopher I; Baldus, Christine R; Kelly, Michael P; Yanik, Elizabeth L; Lurie, Jon D; Ames, Christopher P; Bess, Shay; Schwab, Frank J; Bridwell, Keith H

    Objective

    Although the health impact of adult symptomatic lumbar scoliosis (ASLS) is substantial, these patients often have other orthopedic problems that have not been previously quantified. The objective of this study was to assess disease burden of other orthopedic conditions in patients with ASLS based on a retrospective review of a prospective multicenter cohort.

    Methods

    The ASLS-1 study is an NIH-sponsored prospective multicenter study designed to assess operative versus nonoperative treatment for ASLS. Patients were 40-80 years old with ASLS, defined as a lumbar coronal Cobb angle ≥ 30° and Oswestry Disability Index ≥ 20, or Scoliosis Research Society-22 questionnaire score ≤ 4.0 in pain, function, and/or self-image domains. Nonthoracolumbar orthopedic events, defined as fractures and other orthopedic conditions receiving surgical treatment, were assessed from enrollment to the 4-year follow-up.

    Results

    Two hundred eighty-six patients (mean age 60.3 years, 90% women) were enrolled, with 173 operative and 113 nonoperative patients, and 81% with 4-year follow-up data. At a mean (± SD) follow-up of 3.8 ± 0.9 years, 104 nonthoracolumbar orthopedic events were reported, affecting 69 patients (24.1%). The most common events were arthroplasty (n = 38), fracture (n = 25), joint ligament/cartilage repair (n = 13), and cervical decompression/fusion (n = 7). Based on the final adjusted model, patients with a nonthoracolumbar orthopedic event were older (HR 1.44 per decade, 95% CI 1.07-1.94), more likely to have a history of tobacco use (HR 1.63, 95% CI 1.00-2.66), and had worse baseline leg pain scores (HR 1.10, 95% CI 1.01-1.19).

    Conclusions

    Patients with ASLS have high orthopedic disease burden, with almost 25% having a fracture or nonthoracolumbar orthopedic condition requiring surgical treatment during the mean 3.8 years following enrollment. Comparisons with previous studies suggest that the rate of total knee arthroplasty was considerably greater and the rates of total hip arthroplasty were at least as high in the ASLS-1 cohort compared with the similarly aged general US population. These conditions may further impact health-related quality of life and outcomes assessments of both nonoperative and operative treatment approaches in patients with ASLS.