Opioid Use Prior to Adult Spine Deformity Correction Surgery is Associated With Worse Pre- and Postoperative Back Pain and Prolonged Opioid Demands.

STUDY DESIGN: Prospective multicenter database post-hoc analysis. OBJECTIVES: 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. METHODS: 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. RESULT: 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. CONCLUSIONS: 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.

Independent Prognostic Factors Associated With Improved Patient-Reported Outcomes in the Prospective Evaluation of Elderly Deformity Surgery (PEEDS) Study.

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.

Stratifying outcome based on the Oswestry Disability Index for operative treatment of adult spinal deformity on patients 60 years of age or older: a multicenter, multi-continental study on Prospective Evaluation of Elderly Deformity Surgery (PEEDS).

BACKGROUND CONTEXT: Patients with adult spinal deformity suffer from disease related disability as measured by the Oswestry Disability Index (ODI) for which surgery can result in significant improvements. PURPOSE: The purpose of this study was to show the change in overall and individual components of the ODI in patients aged 60 years or older following multi-level spinal deformity surgery. STUDY DESIGN: Prospective, multicenter, multi-continental, observational longitudinal cohort study PATIENT SAMPLE: Patients ≥60 years undergoing primary spinal fusion surgery of ≥5 levels for coronal, sagittal or combined deformity. OUTCOME MEASURES: Oswestry Disability Index (ODI) METHODS: : Patients completed the ODI pre-operatively for baseline, then at 10 weeks, 12 months and 24 months post-operatively. ODI scores were grouped into deciles, and change was calculated with numerical score and improvement or worsening was further categorized from baseline as substantial (≥20%), marginal (≥10-<20%) or no change (within 10%). RESULTS: Two-hundred nineteen patients met inclusion criteria for the study. The median number of spinal levels fused was 9 [Q1=5.0, Q3=12.0]. Two-year mean (95% CI) ODI improvement was 19.3% (16.7%; 21.9%; p<.001) for all age groups, with mean scores improved from a baseline of 46.3% (44.1%; 48.4%) to 41.1% (38.5%; 43.6%) at 10 weeks (p<.001), 28.1% (25.6%; 30.6%) at 12 months (p<.001), and 27.0% (24.4%; 29.5%) at 24 months (p<.001). At 2 years, 45.5% of patients showed 20% or greater improvement in ODI, 23.7% improved between 10% and 20%, 26.3% reported no change (defined as±10% from baseline), 4.5% of patients reported a worsening between 10% to 20%, and none reported worsening greater than 20%. 59.0% of patients were severely disabled (ODI >40%) pre-operatively, which decreased to 20.2% at 2 years. Significant improvement was observed across all 10 ODI items at 12 and 24 months. The largest improvements were seen in pain, walking, standing, sex life, social life and traveling. CONCLUSIONS: In this prospective, multicenter, multi-continental study of patients 60 years or older undergoing multi-level spinal deformity surgery, almost 70% of patients reported significant improvements in ODI without taking into account surgical indications, techniques or complications. Clear data is presented demonstrating the particular change from baseline for each decile of pre-operative ODI score, for each sub-score, and for each age group.

Impact of New Motor Deficit on HRQOL After Adult Spinal Deformity Surgery: Subanalysis From Scoli Risk 1 Prospective Study.

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.

Are Higher Global Alignment and Proportion Scores Associated With Increased Risks of Mechanical Complications After Adult Spinal Deformity Surgery? An External Validation.

BACKGROUND: The Global Alignment and Proportion (GAP) score, based on pelvic incidence-based proportional parameters, was recently developed to predict mechanical complications after surgery for spinal deformities in adults. However, this score has not been validated in an independent external dataset. QUESTIONS/PURPOSES: After adult spinal deformity surgery, is a higher GAP score associated with (1) an increased risk of mechanical complications, defined as rod fractures, implant-related complications, proximal or distal junctional kyphosis or failure; (2) a higher likelihood of undergoing revision surgery to treat a mechanical complication; and (3) is a lower (more proportioned) GAP score category associated with better validated outcomes scores using the Oswestry Disability Index (ODI), Scoliosis Research Society-22 (SRS-22) and the Short Form-36 questionnaires? METHODS: A total of 272 patients who had undergone corrective surgeries for complex spinal deformities were enrolled in the Scoli-RISK-1 prospective trial. Patients were included in this secondary analysis if they fulfilled the original inclusion criteria by Yilgor et al. From the original 272 patients, 14% (39) did not satisfy the radiographic inclusion criteria, the GAP score could not be calculated in 14% (37), and 24% (64) did not have radiographic assessment at postoperative 2 years, leaving 59% (159) for analysis in this review of data from the original trial. A total of 159 patients were included in this study,with a mean age of 58 ± 14 years at the time of surgery. Most patients were female (72%, 115 of 159), the mean number of levels involved in surgery was 12 ± 4, and three-column osteotomy was performed in 76% (120 of 159) of patients. The GAP score was calculated using parameters from early postoperative radiographs (between 3 and 12 weeks) including pelvic incidence, sacral slope, lumbar lordosis, lower arc lordosis and global tilt, which were independently obtained from a computer software based on centralized patient radiographs. The GAP score was categorized as proportional (scores of 0 to 2), moderately disproportional (scores of 3 to 6), or severely disproportional (scores higher than 7 to 13). Receiver operating characteristic area under curve (AUC) was used to assess associations between GAP score and risk of mechanical complications and risk of revision surgery. An AUC of 0.5 to 0.7 was classified as "no or low associative power", 0.7 to 0.9 as "moderate" and greater than 0.9 as "high". We analyzed differences in validated outcome scores between the GAP categories using Wilcoxon rank sum test. RESULTS: At a minimum of 2 years' follow-up, a higher GAP score was not associated with increased risks of mechanical complications (AUC = 0.60 [95% CI 0.50 to 0.70]). A higher GAP score was not associated with a higher likelihood of undergoing a revision surgery to treat a mechanical complication (AUC = 0.66 [95% 0.53 to 0.78]). However, a moderately disproportioned GAP score category was associated with better SF-36 physical component summary score (36 ± 10 versus 40 ± 11; p = 0.047), better SF-36 mental component summary score (46 ± 13 versus 51 ± 12; p = 0.01), better SRS-22 total score (3.4 ± 0.8 versus 3.7 ± 0.7, p = 0.02) and better ODI score (35 ± 21 versus 25 ± 20; p = 0.003) than severely disproportioned GAP score category. CONCLUSION: Based on the findings of this external validation study, we found that alignment targets based on the GAP score alone were not associated with increased risks of mechanical complications and mechanical revisions in patients with complex adult spinal disorders. Parameters not included in the original GAP score needed to be considered to reduce the likelihood of mechanical complications. LEVEL OF EVIDENCE: Level III, diagnostic study.

Clinical Effectiveness of S2-Alar Iliac Screws in Spinopelvic Fixation in Pediatric Neuromuscular Scoliosis: Systematic Literature Review.

STUDY DESIGN: Systematic literature review. OBJECTIVES: To comprehensively review the S2-alar iliac (S2-AI) screw technique for pelvic fixation in pediatric neuromuscular scoliosis. METHODS: Articles identified from the PubMed and EMBASE databases were reviewed for relevance and applicability, and the studies were summarized. RESULTS: Eight articles met the inclusion criteria. A total of 277 pediatric patients underwent spinopelvic fixation using S2-AI fixation for neuromuscular scoliosis; the mean follow-up was 3 years (range = 0.75-6 years). Six articles had level III evidence (5 retrospective cohort studies, 1 observational study), and 2 articles had level IV evidence (case series). Wound complications occurred in 34 (12.2%) patients. Instrumentation complications occurred in 36 patients (13.0%), including lucency around the screw (6.5%), screw fracture (3.6%), disengaging of the set/screw or rod from the tulip head (2.8%), and screw displacement (0.7%). Three patients (1.1%) required reoperation for instrumentation failures. The overall reoperation rate-including 3 hardware replacements and 3 cases of L5-S1 pseudarthrosis-was 2.1%. The mean Cobb angle correction was 51.4°, and the mean pelvic obliquity correction was 14.8°; deformity correction was maintained at 3- and 5-year follow-ups. There were 10 (3.6%) cases of implant prominence/implant-related pain, 1 case of sacroiliac joint pain (resolved with longer screw placement), and no major neurological or vascular complications secondary to S2-AI screw placement. CONCLUSIONS: This review suggests that the use of S2-AI screws in pediatric neuromuscular scoliosis is efficacious with a reasonable safety profile and provides a useful technique for pelvic fixation in children with scoliosis.

Impact of scoliosis surgery on pulmonary function in patients with muscular dystrophies and spinal muscular atrophy.

BACKGROUND: Scoliosis is a common complication of severe neuromuscular diseases. The aim of this study is to determine the impact of posterior spinal fusion on pulmonary function parameters in patients with severe neuromuscular disease at our medical center. METHODS: Retrospective chart review of all patients with severe neuromuscular disease who had posterior spinal fusion between 2012 and 2017 at Texas Children's Hospital. Patients with growing rods, brain injury or malformation, and/or spina bifida were excluded. Pulmonary function measures before and after spinal surgery were determined. RESULTS: A total of 20 eligible patients were identified, 7 with Duchenne muscular dystrophy, 6 with spinal muscular atrophy, 3 with merosin deficient muscular dystrophy, 2 with Charcot-Marie-Tooth, 1 with central core disease, and 1 with dystroglycanopathy. The mean change in vital capacity from pre- to postspine surgery was a loss of 0.63 L for the spinal muscular atrophy patients, a loss of 0.36 L for the Duchenne muscular dystrophy patients, and a gain of 0.23 L for the merosin deficient patients. The difference between spinal muscular atrophy and merosin deficient patients was statistically significant (P = .02) CONCLUSION: In this single-center retrospective study, we found that after spine surgery for scoliosis, all patients with spinal muscular atrophy and most patients with Duchenne muscular dystrophy lost vital capacity, while the patients with merosin deficient muscular dystrophy gained vital capacity. These differences were not associated with differences is respiratory strength, body mass index, or surgical outcomes.

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.

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.

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?

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.

Non-neurologic adverse events after complex adult spinal deformity surgery: results from the prospective, multicenter Scoli-RISK-1 study.

PURPOSE: Accurate information regarding the expected complications of complex adult spinal deformity (ASD) is important for shared decision making and informed consent. The purpose of the present study was to investigate the rate and types of non-neurologic adverse events after complex ASD surgeries, and to identify risk factors that affect their occurrence. METHODS: The details and occurrence of all non-neurologic adverse events were reviewed in a prospective cohort of 272 patients after complex ASD surgical correction in a mulitcentre database of the Scoli-RISK-1 study with a planned follow-up of 2 years. Logistic regression analyses were used to identify potential risk factors for non-neurologic adverse events. RESULTS: Of the 272 patients, 184 experienced a total of 515 non-neurologic adverse events for an incidence of 67.6%. 121 (44.5%) patients suffered from more than one adverse event. The most frequent non-neurologic adverse events were surgically related (27.6%), of which implant failure and dural tear were most common. In the unadjusted analyses, significant factors for non-neurologic adverse events were age, previous spine surgery performed, number of documented non-neurologic comorbidities and ASA grade. On multivariable logistic regression analysis, previous spine surgery was the only independent risk factor for non-neurologic adverse events. CONCLUSIONS: The incidence of non-neurologic adverse events for patients undergoing corrective surgeries for ASD was 67.6%. Previous spinal surgery was the only independent risk factor predicting the occurrence of non-neurologic adverse events. These findings complement the earlier report of neurologic complications after ASD surgeries from the Scoli-RISK-1 study. These slides can be retrieved under Electronic Supplementary Material.

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.

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.

External Validation of the Adult Spinal Deformity (ASD) Frailty Index (ASD-FI) in the Scoli-RISK-1 Patient Database.

STUDY DESIGN: Analysis of a prospective multicenter database. OBJECTIVE: To assess the ability of the recently created Adult Spinal Deformity (ASD) Frailty Index (ASD-FI) to predict odds of major complications and length of hospital stay for patients who had more severe preoperative deformity and underwent more invasive ASD surgery compared with patients in the database used to create the index. SUMMARY OF BACKGROUND DATA: Accurate preoperative estimates of risk are necessary given the high complication rates currently associated with ASD surgery. METHODS: Patients were enrolled by participating institutions in Europe, Asia, and North America from 2009 to 2011. ASD-FI scores were used to classify 267 patients as not frail (NF) (<0.3), frail (0.3-0. 5), or severely frail (SF) (>0.5). Multivariable logistic regression, adjusted for preoperative and surgical covariates such as operative time and blood loss, was performed to determine the relationship between ASD-FI category and incidence of major complications, overall incidence of complications, and length of hospital stay. RESULTS: The mean ASD-FI score was 0.3 (range, 0-0.7). We categorized 105 patients as NF, 103 as frail, and 59 as SF. The adjusted odds of developing a major complication were higher for SF patients (odds ratio = 4.4; 95% CI 2.0, 9.9) compared with NF patients. After adjusting for covariates, length of hospital stay for SF patients increased by 19% (95% CI 1.4%, 39%) compared with NF patients. The odds of developing a major complication or having increased length of stay were similar between frail and NF patients. CONCLUSION: Greater patient frailty, as measured by the ASD-FI, is associated with a longer hospital stay and greater risk of major complications among patients who have severe preoperative deformity and undergo invasive surgical procedures. LEVEL OF EVIDENCE: 2.

Lower Extremity Motor Function Following Complex Adult Spinal Deformity Surgery: Two-Year Follow-up in the Scoli-RISK-1 Prospective, Multicenter, International Study.

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.

Incidence and risk factors of postoperative neurologic decline after complex adult spinal deformity surgery: results of the Scoli-RISK-1 study.

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.

Kinematic efficacy of supplemental anterior lumbar interbody fusion at lumbosacral levels in thoracolumbosacral deformity correction with and without pedicle subtraction osteotomy at L3: an in vitro cadaveric study.

PURPOSE: Pedicle subtraction osteotomy (PSO) is performed to treat rigid, sagittal spinal deformities, but high rates of implant failure are reported. Anterior lumbar interbody fusion has been proposed to reduce this risk, but biomechanical investigation is lacking. The goal of this study was to quantify the (1) destabilizing effects of a lumbar osteotomy and (2) contribution of anterior lumbar interbody fusion (ALIF) at the lumbosacral junction as recommended in literature. METHODS: Fourteen fresh human thoracolumbosacral spines (T12-S1) were tested in flexion-extension (FE), lateral bending (LB), and axial rotation (AR). Bilateral pedicle screws/rods (BPS) were inserted at T12-S1, cross connectors (CC) at T12-L1 and L5-S1, and anterior interbody spacers (S) at L4-5 and L5-S1. In one group, PSO was performed in seven specimens at L3. All specimens were sequentially tested in (1) Intact; (2) BPS; (3) BPS + CC; (4) BPS + S; and (5) BPS + S + CC; a second group of seven spines were tested in the same sequence without PSO. Mixed-model ANOVA with repeated measures was performed (p ≤ 0.05). RESULTS: At the osteotomy site (L2-L4), in FE, BPS, BPS + CC, BPS + S, BPS + CC + S reduced motion to 11.2, 12.9, 10.9, and 11.4%, respectively, with significance only found in BPS and BPS + S construction (p ≤ 0.05). All constructs significantly reduced motion across L2-L4 in the absence of PSO, across all loading modes (p ≤ 0.05). PSO significantly destabilized L2-L4 axial rotational stability, regardless of operative construction (p ≤ 0.05). Across L4-S1 and L2-S1, all instrumented constructs significantly reduced motion, in both PSO- and non-PSO groups, during all loading modes (p ≤ 0.05). CONCLUSIONS: These findings suggest anterior interbody fusion minimally immobilizes motion segments, and interbody devices may primarily act to maintain disc height. Additionally, lumbar osteotomy destabilizes axial rotational stability at the osteotomy site, potentially further increasing mechanical demand on posterior instrumentation. Clinical studies are needed to assess the impact of this treatment strategy.

Neurologic Outcomes of Complex Adult Spinal Deformity Surgery: Results of the Prospective, Multicenter Scoli-RISK-1 Study.

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.