Browsing by Author "Cheung, Kenneth MC"

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    ItemOpen Access
    A Radiographic Analysis of Lumbar Fusion Status and Instrumentation Failure After Complex Adult Spinal Deformity Surgery With Spinopelvic Fixation: Two-Year Follow-up From the Scoli-Risk-1 Prospective Database.
    (Clinical spine surgery, 2020-12) Shimizu, Takayoshi; Lenke, Lawrence G; Cerpa, Meghan; Beauchamp, Eduardo C; Carreon, Leah Y; Shaffrey, Christopher I; Cheung, Kenneth MC; Fehlings, Michael G

    Study design

    A retrospective review of prospectively collected data.

    Objective

    The objective of this study was to investigate the fusion status of the lumbar spine and lumbosacral junction at 2 years postoperatively after complex adult spinal deformity (ASD) surgery.

    Summary of background data

    Achieving fusion is crucial for maintaining optimal alignment in ASD surgery. However, prospective data assessing fusion status using large patient populations are lacking in this patient population.

    Materials and methods

    Postoperative radiographs of 162 patients from the Scoli-Risk-1 database, who underwent complex ASD surgery with fusion to the sacrum, were evaluated by 3 independent spine surgeons at 6-week, 6-month, and 2-year follow-up. The fusion rate of the lumbar spine segments at a 2-year follow-up was determined by using previously published radiographic grading criteria. We also assessed the prevalence of instrumentation failures.

    Results

    The interrater reliabilities for grading the fusion status were overall fair at each level evaluated (Fleiss κ, 0.337-0.439). Overall, 70.3% (114/162) demonstrated the solid fusion of the entire lumbar spine at a 2-year follow-up. The fusion rates of each segment were L1/L2: 87.0%, L2/L3: 82.0%, L3/L4: 83.9%, L4/L5: 89.5%, and L5/S1: 89.5%. Pedicle screw loosening was the most frequent implant failure throughout the observation period (9.2%, 11.6%, and 11.0% at 6-wk, 6-mo, and 2-y follow-up, respectively). No rod breakage was observed at 6 weeks, increasing to 9.8% at 2-year follow-up. The prevalence of postoperative proximal junctional kyphosis was 5.5% at 6 weeks, showing no difference at 2 years postoperative.

    Conclusions

    In this series of complex ASD surgeries often requiring 3-column osteotomies, 70.3% showed solid fusion of the entire lumbar spine, including the lumbosacral junction. The lumbosacral segments showed a relatively high fusion rate at a 2-year follow-up likely due to the frequent use of anterior column support and graft. The prevalence of rod breakage increased as follow-up proceeded to 9.8%, which was most commonly observed at the lumbosacral junction.

    Level of evidence

    Level IV.
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    ItemOpen Access
    An Analysis of the Incidence and Outcomes of Major Versus Minor Neurological Decline After Complex Adult Spinal Deformity Surgery: A Subanalysis of Scoli-RISK-1 Study.
    (Spine, 2018-07) Kato, So; Fehlings, Michael G; Lewis, Stephen J; Lenke, Lawrence G; Shaffrey, Christopher I; Cheung, Kenneth MC; Carreon, Leah Y; Dekutoski, Mark B; Schwab, Frank J; Boachie-Adjei, Oheneba; Kebaish, Khaled M; Ames, Christopher P; Qiu, Yong; Matsuyama, Yukihiro; Dahl, Benny T; Mehdian, Hossein; Pellisé, Ferran; Berven, Sigurd H

    Study design

    A subanalysis from a prospective, multicenter, international cohort study in 15 sites (Scoli-RISK-1).

    Objective

    To report detailed information regarding the severity of neurological decline related to complex adult spine deformity (ASD) surgery and to examine outcomes based on severity.

    Summary of background data

    Postoperative neurological decline after ASD surgeries can occur due to nerve root(s) or spinal cord dysfunction. The impact of decline and the pattern of recovery may be related to the anatomic location and the severity of the injury.

    Methods

    An investigation of 272 prospectively enrolled complex ASD surgical patients with neurological status measured by American Spinal Injury Association Lower Extremity Motor Scores (LEMS) was undertaken. Postoperative neurological decline was categorized into "major" (≥5 points loss) versus "minor" (<5 points loss) deficits. Timing and extent of recovery in LEMS were investigated for each group.

    Results

    Among the 265 patients with LEMS available at discharge, 61 patients (23%) had neurological decline, with 20 (33%) experiencing major decline. Of note, 90% of the patients with major decline had deficits in three or more myotomes. Full recovery was seen in 24% at 6 weeks and increased to 65% at 6 months. However, 34% continued to experience some neurological decline at 24 months, with 6% demonstrating no improvement. Of 41 patients (67%) with minor decline, 73% had deficits in one or two myotomes. Full recovery was seen in 49% at 6 weeks and increased to 70% at 6 months. Of note, 26% had persistence of some neurological deficit at 24 months, with 18% demonstrating no recovery.

    Conclusion

    In patients undergoing complex ASD correction, a rate of postoperative neurological decline of 23% was noted with 33% of these being "major." Although most patients showed substantial recovery by 6 months, approximately one-third continued to experience neurological dysfunction.

    Level of evidence

    2.
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    ItemOpen Access
    Impact of New Motor Deficit on HRQOL After Adult Spinal Deformity Surgery: Subanalysis From Scoli Risk 1 Prospective Study.
    (Spine, 2021-04) Saigal, Rajiv; Lau, Darryl; Berven, Sigurd H; Carreon, Leah; Dekutoski, Mark B; Kebaish, Khaled M; Qiu, Yong; Matsuyama, Yukihiro; Kelly, Michael; Dahl, Benny T; Mehdian, Hossein; Pellisé, Ferran; Lewis, Stephen J; Cheung, Kenneth MC; Shaffrey, Christopher I; Fehlings, Michael G; Lenke, Lawrence G; Ames, Christopher P; AOSpine Knowledge Forum Deformity

    Study design

    International, multicenter, prospective, longitudinal observational cohort.

    Objective

    To assess how new motor deficits affect patient reported quality of life scores after adult deformity surgery.

    Summary of background data

    Adult spinal deformity surgery is associated with high morbidity, including risk of new postoperative motor deficit. It is unclear what effect new motor deficit has on Health-related Quality of Life scores (HRQOL) scores.

    Methods

    Adult spinal deformity patients were enrolled prospectively at 15 sites worldwide. Other inclusion criteria included major Cobb more than 80°, C7-L2 curve apex, and any patient undergoing three column osteotomy. American Spinal Injury Association (ASIA) scores and standard HRQOL scores were recorded pre-op, 6 weeks, 6 months, and 2 years.

    Results

    Two hundred seventy two complex adult spinal deformity (ASD) patients enrolled. HRQOL scores were worse for patients with lower extremity motor score (LEMS). Mean HRQOL changes at 6 weeks and 2 years compared with pre-op for patients with motor worsening were: ODI (+12.4 at 6 weeks and -4.7 at 2 years), SF-36v2 physical (-4.5 at 6 weeks and +2.3 at 2 years), SRS-22r (0.0 at 6 weeks and +0.4 at 2 years). Mean HRQOL changes for motor-neutral patients were: ODI (+0.6 at 6 weeks and -12.1 at 2 years), SF-36v2 physical (-1.6 at 6 weeks and +5.9 at 2 years), and SRS-22r (+0.4 at 6 weeks and +0.7 at 2 years). For patients with LEMS improvement, mean HRQOL changes were: ODI (-0.6 at 6 weeks and -16.3 at 2 years), SF-36v2 physical (+1.0 at 6 weeks and +7.0 at 2 years), and SRS-22r (+0.5 at 6 weeks and +0.9 at 2 years).

    Conclusion

    In the subgroup of deformity patients who developed a new motor deficit, total HRQOLs and HRQOL changes were negatively impacted. Patients with more than 2 points of LEMS worsening had the worst changes, but still showed overall HRQOL improvement at 6 months and 2 years compared with pre-op baseline.Level of Evidence: 3.
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    ItemOpen Access
    Incidence and risk factors of postoperative neurologic decline after complex adult spinal deformity surgery: results of the Scoli-RISK-1 study.
    (The spine journal : official journal of the North American Spine Society, 2018-10) Fehlings, Michael G; Kato, So; Lenke, Lawrence G; Nakashima, Hiroaki; Nagoshi, Narihito; Shaffrey, Christopher I; Cheung, Kenneth MC; Carreon, Leah; Dekutoski, Mark B; Schwab, Frank J; Boachie-Adjei, Oheneba; Kebaish, Khaled M; Ames, Christopher P; Qiu, Yong; Matsuyama, Yukihiro; Dahl, Benny T; Mehdian, Hossein; Pellisé-Urquiza, Ferran; Lewis, Stephen J; Berven, Sigurd H

    Background context

    Significant variability in neurologic outcomes after surgical correction for adult spinal deformity (ASD) has been reported. Risk factors for decline in neurologic motor outcomes are poorly understood.

    Purpose

    The objective of the present investigation was to identify the risk factors for postoperative neurologic motor decline in patients undergoing complex ASD surgery.

    Study design/setting

    This is a prospective international multicenter cohort study.

    Patient sample

    From September 2011 to October 2012, 272 patients undergoing complex ASD surgery were prospectively enrolled in a multicenter, international cohort study in 15 sites.

    Outcome measures

    Neurologic decline was defined as any postoperative deterioration in American Spinal Injury Association lower extremity motor score (LEMS) compared with preoperative status.

    Methods

    To identify risk factors, 10 candidate variables were selected for univariable analysis from the dataset based on clinical relevance, and a multivariable logistic regression analysis was used with backward stepwise selection.

    Results

    Complete datasets on 265 patients were available for analysis and 61 (23%) patients showed a decline in LEMS at discharge. Univariable analysis showed that the key factors associated with postoperative neurologic deterioration included older age, lumbar-level osteotomy, three-column osteotomy, and larger blood loss. Multivariable analysis revealed that older age (odds ratio [OR]=1.5 per 10 years, 95% confidence interval [CI] 1.1-2.1, p=.005), larger coronal deformity angular ratio [DAR] (OR=1.1 per 1 unit, 95% CI 1.0-1.2, p=.037), and lumbar osteotomy (OR=3.3, 95% CI 1.2-9.2, p=.022) were the three major predictors of neurologic decline.

    Conclusions

    Twenty-three percent of patients undergoing complex ASD surgery experienced a postoperative neurologic decline. Age, coronal DAR, and lumbar osteotomy were identified as the key contributing factors.
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    ItemOpen Access
    Independent Prognostic Factors Associated With Improved Patient-Reported Outcomes in the Prospective Evaluation of Elderly Deformity Surgery (PEEDS) Study.
    (Global spine journal, 2023-05) Hassan, Fthimnir M; Lenke, Lawrence G; Berven, Sigurd H; Kelly, Michael P; Smith, Justin S; Shaffrey, Christopher I; Dahl, Benny T; de Kleuver, Marinus; Spruit, Maarten; Pellise, Ferran; Cheung, Kenneth MC; Alanay, Ahmet; Polly, David W; Sembrano, Jonathan; Matsuyama, Yukihiro; Qiu, Yong; Lewis, Stephen J; AO Spine Knowledge Forum Deformity

    Study design

    Prospective, multicenter, international, observational study.

    Objective

    Identify independent prognostic factors associated with achieving the minimal clinically important difference (MCID) in patient reported outcome measures (PROMs) among adult spinal deformity (ASD) patients ≥60 years of age undergoing primary reconstructive surgery.

    Methods

    Patients ≥60 years undergoing primary spinal deformity surgery having ≥5 levels fused were recruited for this study. Three approaches were used to assess MCID: (1) absolute change:0.5 point increase in the SRS-22r sub-total score/0.18 point increase in the EQ-5D index; (2) relative change: 15% increase in the SRS-22r sub-total/EQ-5D index; (3) relative change with a cut-off in the outcome at baseline: similar to the relative change with an imposed baseline score of ≤3.2/0.7 for the SRS-22r/EQ-5D, respectively.

    Results

    171 patients completed the SRS-22r and 170 patients completed the EQ-5D at baseline and at 2 years postoperative. Patients who reached MCID in the SRS-22r self-reported more pain and worse health at baseline in both approaches (1) and (2). Lower baseline PROMs ((1) - OR: .01 [.00-.12]; (2)- OR: .00 [.00-.07]) and number of severe adverse events (AEs) ((1) - OR: .48 [.28-.82]; (2)- OR: .39 [.23-.69]) were the only identified risk factors. Patients who reached MCID in the EQ-5D demonstrated similar characteristics regarding pain and health at baseline as the SRS-22r using approaches (1) and (2). Higher baseline ODI ((1) - OR: 1.05 [1.02-1.07]) and number of severe AEs (OR: .58 [.38-.89]) were identified as predictive variables. Patients who reached MCID in the SRS22r experienced worse health at baseline using approach (3). The number of AEs (OR: .44 [.25-.77]) and baseline PROMs (OR: .01 [.00-.22] were the only identified predictive factors. Patients who reached MCID in the EQ-5D experienced less AEs and a lower number of actions taken due to the occurrence of AEs using approach (3). The number of actions taken due to AEs (OR: .50 [.35-.73]) was found to be the only predictive variable factor. No surgical, clinical, or radiographic variables were identified as risk factors using either of the aforementioned approaches.

    Conclusion

    In this large multicenter prospective cohort of elderly patients undergoing primary reconstructive surgery for ASD, baseline health status, AEs, and severity of AEs were predictive of reaching MCID. No clinical, radiological, or surgical parameters were identified as factors that can be prognostic for reaching MCID.
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    ItemOpen Access
    Lower Extremity Motor Function Following Complex Adult Spinal Deformity Surgery: Two-Year Follow-up in the Scoli-RISK-1 Prospective, Multicenter, International Study.
    (The Journal of bone and joint surgery. American volume, 2018-04) Lenke, Lawrence G; Shaffrey, Christopher I; Carreon, Leah Y; Cheung, Kenneth MC; Dahl, Benny T; Fehlings, Michael G; Ames, Christopher P; Boachie-Adjei, Oheneba; Dekutoski, Mark B; Kebaish, Khaled M; Lewis, Stephen J; Matsuyama, Yukihiro; Mehdian, Hossein; Pellisé, Ferran; Qiu, Yong; Schwab, Frank J; AO Spine International and SRS Scoli-RISK-1 Study Group
    BACKGROUND:The reported neurologic complication rate following surgery for complex adult spinal deformity (ASD) is variable due to several factors. Most series have been retrospective with heterogeneous patient populations and use of nonuniform neurologic assessments. The aim of this study was to prospectively document lower extremity motor function by means of the American Spinal Injury Association (ASIA) lower extremity motor score (LEMS) before and through 2 years after surgical correction of complex ASD. METHODS:The Scoli-RISK-1 study enrolled 272 patients with ASD, from 15 centers, who had undergone primary or revision surgery for a major Cobb angle of ≥80°, corrective osteotomy for congenital spinal deformity or as a revision procedure for any type of deformity, and/or a complex 3-column osteotomy. RESULTS:One of 272 patients lacked preoperative data and was excluded from the analysis, and 62 (22.9%) of the remaining 271 patients, who were included, lacked a 2-year postoperative assessment. Patients with no preoperative motor impairment (normal LEMS group; n = 203) had a small but significant decline from the mean preoperative LEMS value (50) to that at 2 years postoperatively (49.66 [95% confidence interval = 49.46 to 49.85]; p = 0.002). Patients who did have a motor deficit preoperatively (n = 68; mean LEMS, 43.79) had significant LEMS improvement at 6 months (47.21, p < 0.001) and 2 years (46.12, p = 0.003) postoperatively. The overall percentage of patients (in both groups combined) who had a postoperative LEMS decline, compared with the preoperative value, was 23.0% at discharge, 17.1% at 6 weeks, 9.9% at 6 months, and 10.0% at 2 years. CONCLUSIONS:The percentage of patients who had a LEMS decline (compared with the preoperative score) after undergoing complex spinal reconstructive surgery for ASD was 23.0% at discharge, which improved to 10.0% at 2 years postoperatively. These rates are higher than previously reported, which we concluded was due to the prospective, strict nature of the LEMS testing of patients with these challenging deformities. LEVEL OF EVIDENCE:Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
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    ItemOpen Access
    Neurologic Outcomes of Complex Adult Spinal Deformity Surgery: Results of the Prospective, Multicenter Scoli-RISK-1 Study.
    (Spine, 2016-02) Lenke, Lawrence G; Fehlings, Michael G; Shaffrey, Christopher I; Cheung, Kenneth MC; Carreon, Leah; Dekutoski, Mark B; Schwab, Frank J; Boachie-Adjei, Oheneba; Kebaish, Khaled M; Ames, Christopher P; Qiu, Yong; Matsuyama, Yukihiro; Dahl, Benny T; Mehdian, Hossein; Pellisé-Urquiza, Ferran; Lewis, Stephen J; Berven, Sigurd H

    Study design

    Prospective, multicenter, international observational study.

    Objective

    To evaluate motor neurologic outcomes in patients undergoing surgery for complex adult spinal deformity (ASD).

    Summary of background data

    The neurologic outcomes after surgical correction for ASD have been reported with significant variability and have not been measured as a primary endpoint in any prospective, multicenter, observational study.

    Methods

    The primary outcome measure was the change in American Spinal Injury Association (ASIA) Lower Extremity Motor Scores (LEMS) obtained preoperatively, and at hospital discharge, 6 weeks and 6 months postoperatively.

    Results

    A total of 273 patients with complex ASD underwent surgery at 15 sites worldwide. One patient was excluded for lack of preoperative LEMS. The remaining 272 patients were divided into two groups: normal preoperative LEMS (=50) (Preop NML, N = 204, 75%) and abnormal preoperative LEMS (<50) (Preop ABNML, N = 68, 25%). At hospital discharge, 22.18% of patients showed a decline in LEMS compared with 12.78% who showed an improvement. At 6 weeks, there was a significant change compared with discharge: 17.91% patients showed a decline in LEMS and 16.42% showed an improvement. At 6 months, 10.82% patients showed a decline in preoperative LEMS, 20.52% improvement, and 68.66% maintenance. This was a significant change compared with 6 weeks and at discharge.

    Conclusion

    Although complex ASD surgery can restore neurologic function in patients with a preoperative neurologic deficit, a significant portion of patients with ASD experienced postoperative decline in LEMS. Measures that can anticipate and reduce the risk of postoperative neurologic complications are warranted.

    Level of evidence

    3.
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    ItemOpen Access
    Opioid Use Prior to Adult Spine Deformity Correction Surgery is Associated With Worse Pre- and Postoperative Back Pain and Prolonged Opioid Demands.
    (Global spine journal, 2024-06) Sardi, Juan P; Smith, Justin S; Gum, Jeffrey L; Rocos, Brett; Charalampidis, Anastasios; Lenke, Lawrence G; Shaffrey, Christopher I; Cheung, Kenneth MC; Qiu, Yong; Matsuyama, Yukihiro; Pellisé, Ferran; Polly, David W; Sembrano, Jonathan N; Dahl, Benny T; Kelly, Michael P; de Kleuver, Marinus; Spruit, Maarten; Alanay, Ahmet; Berven, Sigurd H; Lewis, Stephen J; AO Spine Knowledge Forum Deformity
    Prospective multicenter database post-hoc analysis. Opioids are frequently prescribed for painful spinal conditions to provide pain relief and to allow for functional improvement, both before and after spine surgery. Amidst a current opioid epidemic, it is important for providers to understand the impact of opioid use and its relationship with patient-reported outcomes. The purpose of this study was to evaluate pre-/postoperative opioid consumption surrounding ASD and assess patient-reported pain outcomes in older patients undergoing surgery for spinal deformity. Patients ≥60 years of age from 12 international centers undergoing spinal fusion of at least 5 levels and a minimum 2-year follow-up were included. Patient-reported outcome scores were collected using the Numeric Rating Scale for back and leg pain (NRS-B; NRS-L) at baseline and at 2 years following surgery. Opioid use, defined based on a specific question on case report forms and question 11 from the SRS-22r questionnaire, was assessed at baseline and at 2-year follow-up. Of the 219 patients who met inclusion criteria, 179 (81.7%) had 2-year data on opioid use. The percentages of patients reporting opioid use at baseline (n = 75, 34.2%) and 2 years after surgery (n = 55, 30.7%) were similar (P = .23). However, at last follow-up 39% of baseline opioid users (Opi) were no longer taking opioids, while 14% of initial non-users (No-Opi) reported opioid use. Regional pre- and postoperative opioid use was 5.8% and 7.7% in the Asian population, 58.3% and 53.1% in the European, and 50.5% and 40.2% in North American patients, respectively. Baseline opioid users reported more preoperative back pain than the No-Opi group (7.0 vs 5.7, P = .001), while NRS-Leg pain scores were comparable (4.8 vs 4, P = .159). Similarly, at last follow-up, patients in the Opi group had greater NRS-B scores than Non-Opi patients (3.2 vs 2.3, P = .012), but no differences in NRS-Leg pain scores (2.2 vs 2.4, P = .632) were observed. In this study, almost one-third of surgical ASD patients were consuming opioids both pre- and postoperatively world-wide. There were marked international variations, with patients from Asia having a much lower usage rate, suggesting a cultural influence. Despite both opioid users and nonusers benefitting from surgery, preoperative opioid use was strongly associated with significantly more back pain at baseline that persisted at 2-year follow up, as well as persistent postoperative opioid needs.
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    ItemOpen Access
    Patient-Reported Outcomes After Complex Adult Spinal Deformity Surgery: 5-Year Results of the Scoli-Risk-1 Study.
    (Global spine journal, 2022-10) Zuckerman, Scott L; Cerpa, Meghan; Lenke, Lawrence G; Shaffrey, Christopher I; Carreon, Leah Y; Cheung, Kenneth MC; Kelly, Michael P; Fehlings, Michael G; Ames, Christopher P; Boachie-Adjei, Oheneba; Dekutoski, Mark B; Kabeaish, Khaled M; Lewis, Stephen J; Matsuyama, Yukihiro; Pellisé, Ferran; Qiu, Yong; Schwab, Frank J; Smith, Justin S; AO Spine Knowledge Forum Deformity and SRS Scoli-RISK-1 Study Group

    Study design

    Prospective cohort.

    Objective

    To prospectively evaluate PROs up to 5-years after complex ASD surgery.

    Methods

    The Scoli-RISK-1 study enrolled 272 ASD patients undergoing surgery from 15 centers. Inclusion criteria was Cobb angle of >80°, corrective osteotomy for congenital or revision deformity, and/or 3-column osteotomy. The following PROs were measured prospectively at intervals up to 5-years postoperative: ODI, SF36-PCS/MCS, SRS-22, NRS back/leg. Among patients with 5-year follow-up, comparisons were made from both baseline and 2-years postoperative to 5-years postoperative. PROs were analyzed using mixed models for repeated measures.

    Results

    Seventy-seven patients (28.3%) had 5-year follow-up data. Comparing baseline to 5-year data among these 77 patients, significant improvement was seen in all PROs: ODI (45.2 vs. 29.3, P < 0.001), SF36-PCS (31.5 vs. 38.8, P < 0.001), SF36-MCS (44.9 vs. 49.1, P = 0.009), SRS-22-total (2.78 vs. 3.61, P < 0.001), NRS-back pain (5.70 vs. 2.95, P < 0.001) and NRS leg pain (3.64 vs. 2.62, P = 0.017). In the 2 to 5-year follow-up period, no significant changes were seen in any PROs. The percentage of patients achieving MCID from baseline to 5-years were: ODI (62.0%) and the SRS-22r domains of function (70.4%), pain (63.0%), mental health (37.5%), self-image (60.3%), and total (60.3%). Surprisingly, mean values (P > 0.05) and proportion achieving MCID did not differ significantly in patients with major surgery-related complications compared to those without.

    Conclusions

    After complex ASD surgery, significant improvement in PROs were seen at 5-years postoperative in ODI, SF36-PCS/MCS, SRS-22r, and NRS-back/leg pain. No significant changes in PROs occurred during the 2 to 5-year postoperative period. Those with major surgery-related complications had similar PROs and proportion of patients achieving MCID as those without these complications.
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    ItemOpen Access
    Predictors of Health-Related Quality-of-Life After Complex Adult Spinal Deformity Surgery: A Scoli-RISK-1 Secondary Analysis.
    (Spine deformity, 2017-03) Carreon, Leah Y; Glassman, Steven D; Shaffrey, Christopher I; Fehlings, Michael G; Dahl, Benny; Ames, Christopher P; Matsuyama, Yukihiro; Qiu, Yong; Mehdian, Hossein; Cheung, Kenneth MC; Schwab, Frank J; Pellisé, Ferran; Kebaish, Khaled M; Lenke, Lawrence G

    Study design

    Longitudinal cohort.

    Objectives

    To identify variables that predict 2-year Short Form-36 Physical Composite Summary Score (SF-36PCS) and the Scoliosis Research Society-22R (SRS22-R) Total score after surgery for complex adult spinal deformity.

    Summary of background data

    Increasingly, treatment effectiveness is assessed by the extent to which the procedure improves a patient's health-related quality of life (HRQOL). This is especially true in patients with complex adult spinal deformity.

    Methods

    The data set from the Scoli-Risk-1 study was queried for patients with complete 2-year SF-36 and SRS-22R. Regression analysis was performed to determine predictors of 2-year SF-36PCS and SRS-22R Total scores. Factors included were sex, age, smoking status, body mass index, American Society of Anesthesiologists (ASA) grade, Lower Extremity Motor Score improvement, indication for surgery, preoperative and 2-year maximum coronal Cobb angles, number of prior spine surgeries, number of three-column osteotomies, number of surgical levels, number of surgical stages, lowest instrumented level, presence and type of neurologic complication, and number of reported serious adverse events.

    Results

    Of 272 cases enrolled, 206 (76%) cases were included in this analysis, 143 (69%) females, and mean age of 57.69 years. Factors that were significantly associated with of 2-year SF-36PCS were age (p < .001), ASA grade (p < .001), maximum preoperative Cobb angle (p = .007), number of three-column osteotomies (p = .049) and type of neurologic complication (p = .068). Factors predictive of 2-year SRS-22R Total scores were maximum preoperative Cobb angle (p = .001) and the number of serious adverse events (p = .071).

    Conclusions

    Factors predictive of lower 2-year HRQOLs after surgery for complex adult spinal deformity were older age, higher ASA grade, larger preoperative Cobb angle, larger numbers of three-column osteotomies, and the occurrence of both neurologic and nonneurologic complications. Most of these factors are beyond the control of surgeons. Still, surgeons should medically optimize a patient prior to surgery to minimize the risk of complications and offer the best chance of improving a patient's quality of life.

    Level of evidence

    Level II. Prospective cohort.
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    ItemOpen Access
    Spinal cord injury in high-risk complex adult spinal deformity surgery: review of incidence and outcomes from the Scoli-RISK-1 study
    (Spinal Cord Series and Cases, 2024) Jiang, Fan; Joshi, Hetshree; Badhiwala, Jetan H; Wilson, Jamie RF; Lenke, Lawrence G; Shaffrey, Christopher I; Cheung, Kenneth MC; Carreon, Leah Y; Dekutoski, Mark B; Schwab, Frank J; Boachie-Adjei, Oheneba; Kebaish, Khaled M; Ames, Christopher P; Berven, Sigurd H; Qiu, Yong; Matsuyama, Yukihiro; Dahl, Benny T; Mehdian, Hossein; Pellisé, Ferran; Lewis, Stephen J; Fehlings, Michael G
    Abstract Study design Clinical case series. Objective To describe the cause, treatment and outcome of 6 cases of perioperative spinal cord injury (SCI) in high-risk adult deformity surgery. Setting Adult spinal deformity patients were enrolled in the multi-center Scoli-RISK-1 cohort study. Methods A total of 272 patients who underwent complex adult deformity surgery were enrolled in the prospective, multi-center Scoli-RISK-1 cohort study. Clinical follow up data were available up to a maximum of 2 years after index surgery. Cases of perioperative SCI were identified and an extensive case review was performed. Results Six individuals with SCI were identified from the Scoli-RISK-1 database (2.2%). Two cases occurred intraoperatively and four cases occurred postoperatively. The first case was an incomplete SCI due to a direct intraoperative insult and was treated postoperatively with Riluzole. The second SCI case was caused by a compression injury due to overcorrection of the deformity. Three cases of incomplete SCI occurred; one case of postoperative hematoma, one case of proximal junctional kyphosis (PJK) and one case of adjacent segment disc herniation. All cases of post-operative incomplete SCI were managed with revision decompression and resulted in excellent clinical recovery. One case of incomplete SCI resulted from infection and PJK. The patient’s treatment was complicated by a delay in revision and the patient suffered persistent neurological deficits up to six weeks following the onset of SCI. Conclusion Despite the low incidence in high-risk adult deformity surgeries, perioperative SCI can result in devastating consequences. Thus, appropriate postoperative care, follow up and timely management of SCI are essential.
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    ItemOpen Access
    The Effect of Tobacco Smoking on Adverse Events Following Adult Complex Deformity Surgery: Analysis of 270 Patients From the Prospective, Multicenter Scoli-RISK-1 Study.
    (Spine, 2020-01) Wilson, Jamie RF; Jiang, Fan; Badhiwala, Jetan H; Shaffrey, Christopher I; Carreon, Leah Y; Cheung, Kenneth MC; Dahl, Benny T; Ames, Christopher P; Boachie-Adjei, Oheneba; Dekutoski, Mark B; Lewis, Stephen J; Matsuyama, Yukihiro; Mehdian, Hossein; Pellisé, Ferran; Qiu, Yong; Schwab, Frank J; Lenke, Lawrence G; Fehlings, Michael G

    Study design

    Post-hoc analysis of a prospective, multicenter cohort study.

    Objective

    To analyze the impact of smoking on rates of postoperative adverse events (AEs) in patients undergoing high-risk adult spine deformity surgery.

    Summary of background data

    Smoking is a known predictor of medical complications after adult deformity surgery, but the effect on complications, implant failure and other AEs has not been adequately described in prospective studies.

    Methods

    Twenty-six patients with a history of current smoking were identified out of the 272 patients enrolled in the SCOLI-RISK-1 study who underwent complex adult spinal deformity surgery at 15 centers, with 2-year follow-up. The outcomes and incidence of AEs in these patients were compared to the nonsmoking cohort (n = 244) using univariate analysis, with additional multivariate regression to adjust for the effect of patient demographics, complexity of surgery, and other confounders.

    Results

    The number of levels and complexity of surgery in both cohorts were comparable. In the univariate analysis, the rates of implant failure were almost double (odds ratio 2.28 [0.75-6.18]) in smoking group (n = 7; 26.9%)) that observed in the nonsmoking group (n = 34; 13.9%), but this was not statistically significant (P = 0.088). Surgery-related excessive bleeding (>4 L) was significantly higher in the smoking group (n = 5 vs. n = 9; 19.2% vs. 3.7%; OR 6.22[1.48 - 22.75]; P = 0.006). Wound infection rates and respiratory complications were similar in both groups. In the multivariate analysis, the smoking group demonstrated a higher incidence of any surgery-related AEs over 2 years (n = 13 vs. n = 95; 50.0% vs. 38.9%; OR 2.12 [0.88-5.09]) (P = 0.094).

    Conclusion

    In this secondary analysis of patients from the SCOLI-RISK-1 study, a history of smoking significantly increased the risk of excessive intraoperative bleeding and nonsignificantly increased the rate of implant failure or surgery-related AEs over 2 years. The authors therefore advocate a smoking cessation program in patients undergoing complex adult spine deformity surgery.

    Level of evidence

    2.
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    The Influence of Multilevel Spinal Deformity Surgery on the EuroQol 5 Dimensions' (EQ-5D) Questionnaire and Residential Status in the Elderly: A Prospective, Observational, Multicenter Study.
    (Global spine journal, 2023-03) Jentzsch, Thorsten; Lewis, Stephen J; Oitment, Colby; Rienmüller, Anna; Martin, Allan R; Nielsen, Christopher J; Shear-Yashuv, Hananel; de Kleuver, Marinus; Qiu, Yong; Matsuyama, Yukihiro; Lenke, Lawrence G; Alanay, Ahmet; Pellisé-Urquiza, Ferran; Cheung, Kenneth MC; Spruit, Maarten; Polly, David W; Sembrano, Jonathan N; Shaffrey, Christopher I; Smith, Justin S; Kelly, Michael P; Dahl, Benny; Berven, Sigurd H; AO Spine Knowledge Forum Deformity

    Study design

    Multicenter, international prospective study.

    Objective

    This study investigated the clinical outcome up to 2 years after multi-level spinal deformity surgery in the elderly by reporting the minimal clinically important difference (MCID) of EuroQol 5-dimensions (EQ-5D), EQ-VAS, and residential status.

    Methods

    As an ancillary study of 219 patients ≥60 years with spinal deformity undergoing primary instrumented fusion surgery of ≥5 levels, this study focuses on EQ-5D (3-L) as the primary outcome and EQ-VAS and residential status as secondary outcomes. Data on EQ-5D were compared between pre-operatively and postoperatively at 10 weeks, 12 months, and 24 months. An anchor-based approach was used to calculate the MCID.

    Results

    The EQ-5D index and EQ-VAS, respectively, improved significantly at each time point compared to pre-operatively (from .53 (SD .21) and 55.6 (SD 23.0) pre-operatively to .64 (SD .18) and 65.8 (SD 18.7) at 10 weeks, .74 (SD .18) and 72.7 (SD 18.1) at 12 months, and .73 (SD .20) and 70.4 (SD 20.4) at 24 months). 217 (99.1%) patients lived at home pre-operatively, while 186 (88.6%), 184 (98.4%), and 172 (100%) did so at 10 weeks, 12 months, and 24 months, respectively. Our calculated MCID for the EQ-5D index at 1 year was .22 (95% CI .15-.29).

    Conclusions

    The EQ-5D index significantly increased at each time point over 24 months after ≥5 level spinal deformity surgery in elderly patients. The MCID of the EQ-5D-3 L was .22. Patients living at home pre-operatively can expect to be able to live at home 2 years postoperatively.
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    The Scoli-RISK 1 results of lower extremity motor function 5 years after complex adult spinal deformity surgery.
    (European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2021-11) Lenke, Lawrence G; Zuckerman, Scott L; Cerpa, Meghan; Shaffrey, Christopher I; Carreon, Leah Y; Cheung, Kenneth MC; Kelly, Michael P; Fehlings, Michael G; Ames, Christopher P; Boachie-Adjei, Oheneba; Dekutoski, Mark B; Kebaish, Khaled M; Lewis, Stephen J; Matsuyama, Yukihiro; Pellisé, Ferran; Qiu, Yong; Schwab, Frank J; Smith, Justin S; AO Spine Knowledge Forum Deformity and SRS Scoli-RISK-1 Study Group

    Introduction

    Neurologic complications after complex adult spinal deformity (ASD) surgery are important, yet outcomes are heterogeneously reported, and long-term follow-up of actual lower extremity motor function is unknown.

    Objective

    To prospectively evaluate lower extremity motor function scores (LEMS) before and at 5 years after surgical correction of complex ASD.

    Design

    Retrospective analysis of a prospective, multicenter, international observational study.

    Methods

    The Scoli-RISK-1 study enrolled 272 ASD patients undergoing surgery from 15 centers around the world. Inclusion criteria were Cobb angle of > 80°, corrective osteotomy for congenital or revision deformity and/or 3-column osteotomy. Among patients with 5-year follow-up, comparisons of LEMS to baseline and within each follow-up period were made via documented neurologic exams on each patient.

    Results

    Seventy-seven (28.3%) patients had 5-year follow-up. Among these 77 patients with 5-year follow-up, rates of postoperative LEMS deterioration were: 14.3% hospital discharge, 10.7% at 6 weeks, 6.5% at 6 months, 9.5% at 2 years and 9.3% at 5 years postoperative. During the 2-5 year window, while mean LEMS did not change significantly (-0.5, p = 0.442), eight (11.1%) patients deteriorated (of which 3 were ≥ 4 motor points), and six (8.3%) patients improved (of which 2 were ≥ 4 points). Of the 14 neurologic complications, four (28.6%) were surgery-related, three of which required reoperation. While mean LEMS were not impacted in patients with a major surgery-related complication, mean LEMS were significantly lower in patients with neurologic surgery-related complications at discharge (p = 0.041) and 6 months (p = 0.008) between the two groups as well as the change from baseline to 5 years (p = 0.041).

    Conclusions

    In 77 patients undergoing complex ASD surgery with 5-year follow-up, while mean LEMS did not change from 2 to 5 years, subtle neurologic changes occurred in approximately 1 in 5 patients (11.1% deteriorated; 8.3% improved). Major surgery-related complication did not result in decreased LEMS; however, those with neurologic surgery-related complications continued to have decreased lower extremity motor function at 5 years postoperative. These results underscore the importance of long-term follow-up to 5 years, using individual motor scores rather than group averages, and comparing outcomes to both baseline and last follow-up.
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    Unilateral versus bilateral lower extremity motor deficit following complex adult spinal deformity surgery: is there a difference in recovery up to 2-year follow-up?
    (The spine journal : official journal of the North American Spine Society, 2019-03) Tuchman, Alexander; Lenke, Lawrence G; Cerpa, Meghan; Fehlings, Michael G; Lewis, Stephen J; Shaffrey, Christopher I; Cheung, Kenneth MC; Carreon, Leah Yacat; Dekutoski, Mark B; Schwab, Frank J; Boachie-Adjei, Oheneba; Kebaish, Khaled; Ames, Christopher P; Qiu, Yong; Matsuyama, Yukihiro; Dahl, Benny T; Mehdian, Hossein; Pellisé, Ferran; Berven, Sigurd H

    Background context

    Scoli-RISK-1 is a multicenter prospective cohort designed to study neurologic outcomes following complex adult spinal deformity (ASD). The effect of unilateral versus bilateral postoperative motor deficits on the likelihood of long-term recovery has not been previously studied in this population.

    Purpose

    To evaluate whether bilateral postoperative neurologic deficits have a worse recovery than unilateral deficits.

    Study design

    Secondary analysis of a prospective, multicenter, international cohort study.

    Methods

    In a cohort of 272 patients, neurologic decline was defined as deterioration of the American Spinal Injury Association Lower Extremity Motor Scores (LEMS) following surgery. Patients with lower extremity neurologic decline were grouped into unilateral and bilateral cohorts. Differences in demographics, surgical variables, and patient outcome measures between the two cohorts were analyzed.

    Results

    A total of 265 patients had LEMS completed at discharge. Unilateral decline was seen in 32 patients (12%), while 29 (11%) had bilateral symptoms. At 2 years, there was no significant difference in either median LEMS (unilateral 50.0, interquartile range [IQR] 47.5-50.0; bilateral 50.0, IQR 48.0-50.0, p=.939) or change in LEMS from baseline (unilateral 0.0, IQR -1.0 to 0.0; bilateral 0.0, IQR -1.0 to 0.0, p=.920). In both groups, approximately two-thirds of patients saw recovery to at least their preoperative baseline by 2 years postoperatively (unilateral n=15, 63%; bilateral n=14, 67%). The mean Scoliosis Research Society-22R (SRS-22R) score at 2 years was 3.7±0.6 versus 3.2±0.6 (p=.009) for unilateral and bilateral groups, respectively.

    Conclusions

    The prognosis for neurologic recovery of new motor deficits following complex adult spinal deformity is similar with both unilateral and bilateral weaknesses. Despite similar rates of neurologic recovery, patient reported outcomes for those with bilateral motor decline measured by SRS-22R are worse at 2 years after surgery.