Improvement in axial rotation with bracing reduces the risk of curve progression in patients with adolescent idiopathic scoliosis.

PURPOSE: New evidence highlights the significance of 3D in-brace correction for Adolescent Idiopathic Scoliosis (AIS) patients. This study explores how axial parameters relate to treatment failure in braced AIS patients. METHODS: AIS patients (Sanders 1-5) undergoing Rigo-Chêneau bracing at a single institution were included. Axial vertebral rotation (AVR) was determined by utilizing pre-brace and in-brace 3D reconstructions from EOS® radiographs. The primary outcome was treatment failure: surgery or coronal curve progression > 5°. Minimum follow-up was two years. RESULTS: 75 patients (81% female) were included. Mean age at bracing initiation was 12.8 ± 1.3 years and patients had a pre-brace major curve of 31.0° ± 6.5°. 25 patients (76% female) experienced curve progression > 5°, and 18/25 required surgical intervention. The treatment failure group had larger in-brace AVR than the success group (5.8° ± 4.1° vs. 9.9° ± 7.6°, p = 0.003), but also larger initial coronal curve measures. In-brace AVR did not appear to be associated with treatment failure after adjusting for the pre-brace major curve (Hazard Ratio (HR):0.99, 95% Confidence Interval (CI):0.94-1.05, p = 0.833). Adjusting for pre-brace major curve, patients with AVR improvement with bracing had an 85% risk reduction in treatment failure versus those without (HR:0.15, 95% CI:0.02-1.13, p = 0.066). At the final follow-up, 42/50 (84%) patients without progression had Sanders ≥ 7. CONCLUSIONS: While in-brace rotation was not an independent predictor of curve progression (due to its correlation with curve magnitude), improved AVR with bracing was a significant predictor of curve progression. This study is the first step toward investigating the interplay between 3D parameters, skeletal maturity, compliance, and brace efficacy, allowing a future prospective multicenter study. LEVEL OF EVIDENCE: Retrospective study; Level III.

Utilizing a comprehensive machine learning approach to identify patients at high risk for extended length of stay following spinal deformity surgery in pediatric patients with early onset scoliosis.

PURPOSE: Early onset scoliosis (EOS) patient diversity makes outcome prediction challenging. Machine learning offers an innovative approach to analyze patient data and predict results, including LOS in pediatric spinal deformity surgery. METHODS: Children under 10 with EOS were chosen from the American College of Surgeon's NSQIP database. Extended LOS, defined as over 5 days, was predicted using feature selection and machine learning in Python. The best model, determined by the area under the curve (AUC), was optimized and used to create a risk calculator for prolonged LOS. RESULTS: The study included 1587 patients, mostly young (average age: 6.94 ± 2.58 years), with 33.1% experiencing prolonged LOS (n = 526). Most patients were female (59.2%, n = 940), with an average BMI of 17.0 ± 8.7. Factors influencing LOS were operative time, age, BMI, ASA class, levels operated on, etiology, nutritional support, pulmonary and neurologic comorbidities. The gradient boosting model performed best with a test accuracy of 0.723, AUC of 0.630, and a Brier score of 0.189, leading to a patient-specific risk calculator for prolonged LOS. CONCLUSIONS: Machine learning algorithms accurately predict extended LOS across a national patient cohort and characterize key preoperative drivers of increased LOS after PSIF in pediatric patients with EOS.

Institutional Variability in Anesthesia Time for Mehta Casting in Early-Onset Scoliosis (EOS).

PURPOSE: Mehta casting is a potentially curative intervention for early-onset scoliosis (EOS) that typically requires multiple anesthetics. The Food and Drug Administration (FDA) reported that >3 hours of anesthesia under the age of 3 years old may alter brain development; however, no standard exists for the duration of anesthesia during casting. The purpose of this study is to quantify the variability in anesthesia during Mehta casting. We hypothesize that significant institutional variability exists and may be attributed to modifiable factors. METHODS: An EOS registry was used to identify patients who underwent at least one Mehta casting procedure. Anesthesia exposure was quantified, and site variability was assessed by patient characteristics, cast placement, procedure type, and equipment used. RESULTS: Our cohort consisted of 208 patients from 5 institutions (age 2.6±1.4 y). There were 1097 Mehta casting procedures, with 5.4±3.6 castings per patient. Of these patients, 106 (51%) were female, with an average age of 2.11±1.29 years old at the time casting was initiated. Patient etiologies included 154 idiopathic (74.0%), 22 syndromic (10.6%), 18 congenital (8.7%), 11 neuromuscular (5.3%), and 3 unknown (1.4%). Anesthesia time was 69±31 minutes and varied significantly between sites (59±14 to 117±46 min; P <0.001). Cumulative anesthesia time for patients under 3 years was 320±197 minutes with 120/161 (74.5%) patients exceeding 3 hours. Anesthesia time was lower after the FDA warning in 2016 compared with pre-2016 (71±30 vs. 66±32, P =0.008). CONCLUSIONS: Patients undergoing Mehta casting are at significant risk of exceeding 3 hours of anesthesia, which the FDA has stated may be harmful for children <3 years. Significant site variability indicates that standardization protocols should be developed to encourage best practices and minimize anesthetic times. LEVEL OF EVIDENCE: Prognostic Level II.

Strategies to Avoid Distal Junctional Pathology.

Distal junctional pathology remains an unsolved issue in spine surgery. Distal junctional pathology can occur on a spectrum from asymptomatic radiographic finding to catastrophic distal construct failure. It is significant to address as postoperative sagittal balance has been shown to be correlated with patient-reported outcomes. Current literature and clinical experience suggest there are techniques that can be implemented regardless of setting to avoid distal junctional pathology. Much of the avoidant strategy relies on understanding the deformity pathology, selection of the lowest instrumented vertebra (LIV), health of the segments caudal to the LIV, and methods of fixation.

Development and Validation of a Health-Related Quality-of-Life Measure in Older Children and Adolescents with Early-Onset Scoliosis: Early-Onset Scoliosis Self-Report Questionnaire (EOSQ-SELF).

BACKGROUND: The 24-question Early-Onset Scoliosis Questionnaire (EOSQ-24) is a proxy measure assessing health-related quality of life (HRQoL) among patients with early-onset scoliosis (EOS). There exists an increasing need to assess HRQoL through a child's own perspective, particularly for older children and adolescents with EOS. The purpose of this study was to develop and validate a self-reported questionnaire, the Early-Onset Scoliosis Self-Report Questionnaire (EOSQ-SELF), to assess HRQoL in older children and adolescents with EOS. METHODS: A literature review, an expert focus group, and patient interviews were used to generate a preliminary survey of appropriate domains and question items. This survey was provided to English-speaking patients with EOS who were 8 to 18 years of age and capable of answering survey questions. Content validity was assessed for clarity and relevance of questions. Confirmatory factors analysis was performed to reduce the number of items and determine domains that fit items. Reliability was evaluated by measuring the internal consistency of items and test-retest reliability. Construct validity was evaluated by convergent, discriminant, and known-group validity. RESULTS: The literature review, expert focus group, and patient interviews identified 59 questions in 14 domains. Psychometric analysis reduced these to 30 questions across 12 domains: General Health, Pain/Discomfort, Pulmonary Function, Transfer, Physical Function/Daily Living, Participation, Fatigue/Energy Level, Sleep, Appearance, Relationships, Emotion, and Satisfaction. The final questionnaire was found to have good content and construct validity and adequate reliability. CONCLUSIONS: The EOSQ-SELF is a valid and reliable instrument for measuring self-reported HRQoL among older children and adolescents with EOS (ages 8 to 18 years). This will serve as an important research outcome measure and enhance clinical care by providing a better understanding of HRQoL for these patients. LEVEL OF EVIDENCE: Diagnostic Level II . See Instructions for Authors for a complete description of levels of evidence.

A multicenter study of the 5-year trends in robot-assisted spine surgery outcomes and complications.

Background: Although a growing amount of literature that suggests robots are safe and can achieve comparable outcomes to conventional techniques, much of this literature is limited by small sample sizes and single-surgeon or single center series. Furthermore, it is unclear what the impact of robotic technology has made on operative and clinical outcomes over time. This is the first and largest multicenter study to examine the trends in outcomes and complications after robot-assisted spine surgery over a 5-year period. Methods: Adult (≥18 years old) patients who underwent spine surgery with robot-assistance between 2015 and 2019 at four unique spine centers. The robotic systems used included the Mazor Renaissance, Mazor X, and Mazor Stealth Edition. Patients with incomplete data were excluded from this study. The minimum follow-up was 90 days. Results: A total of 722 adult patients were included (117 Renaissance, 477 X, 128 Stealth). Most patient and operative factors (e.g., sex, tobacco status, total instrumented levels, and pelvic fixation,) were similar across the years. Mean ± standard deviation Charlson comorbidity index (CCI) was 1.5±1.5. The most commonly reported diagnoses included high grade spondylolisthesis (40.6%), degenerative disc disease (18.4%), and degenerative scoliosis (17.6%). Mean (standard deviation) number of instrumented levels was 3.8±3.4. From 2015 to 2019, average robot time per screw improved from 7.2 to 5.5 minutes (P=0.004, R2=0.649). Average fluoroscopy time per screw improved from 15.2 to 9.4 seconds (P=0.002). Rates of both intraoperative screw exchange for misplaced screw (2015-2016: 2.7%, 2019: 0.8%, P=0.0115, R2=0.1316) and robot abandonment (2015-2016: 7.1%, 2019: 1.1%, P=0.011, R2=0.215) improved significantly over time. The incidence of other intraoperative complications (e.g., dural tear, loss of motor/sensory function, blood transfusion) remained consistently low, but similar throughout the years. The length of stay (LOS) decreased by nearly 1 day from 2015 to 2019 (P=0.007, R2=0.779). 90-day reoperation rates did not change significantly. Conclusions: At four institutions among seven surgeons, we demonstrate robot screw accuracy, reliability, operative efficiency, and radiation exposure improved significantly from 2015 to 2019. 90-day complication rates remained low and LOS decreased significantly with time. These findings further validate continued usage of robot-assisted spine surgery and the path toward improved value-based care.

Clinical Trial Quality Assessment in Adult Spinal Surgery: What Do Publication Status, Funding Source, and Result Reporting Tell Us?

STUDY DESIGN: Narrative Review. OBJECTIVES: The objective of this study was to compare publication status of clinical trials in adult spine surgery registered on ClinicalTrials.gov by funding source as well as to identify other trends in clinical trials in adult spine surgery. METHODS: All prospective, comparative, therapeutic (intervention-based) trials of adult spinal disease that were registered on ClinicalTrials.gov with a start date of January 1, 2000 and completion date before December 17, 2018 were included. Primary outcome was publication status of published or unpublished. A bivariate analysis was used to compare publication status to funding source of industry vs non-industry. RESULTS: Our search identified 107 clinical trials. The most common source of funding was industry (62 trials, 57.9% of total), followed by University funding (26 trials, 24.3%). The results of 76 trials (71.0%) were published, with industry-funded trials less likely to be published compared to non-industry-funded trials (62.9% compared to 82.2%, P = .03). Of the 31 unpublished studies, 13 did not report any results on ClinicalTrials.gov, and of those with reported results, none was a positive trial. CONCLUSIONS: Clinician researchers in adult spine surgery should be aware that industry-funded trials are less likely to go on to publication compared to non-industry-funded trials, and that negative trials are frequently not published. Future opportunities include improvement in result reporting and in publishing negative studies.

Resection of congenital hemivertebra in pediatric scoliosis: the experience of a two-specialty surgical team.

OBJECTIVE: Institutions investigating value and quality emphasize utilization of two attending surgeons with different areas of technical expertise to treat complex surgical cases and to minimize complications. Here, the authors chronicle the 12-year experience of using a two-attending surgeon, two-specialty model to perform hemivertebra resection in the pediatric population. METHODS: Retrospective cohort data from 2008 to 2019 were obtained from the NewYork-Presbyterian Morgan Stanley Children's Hospital operative database. This database included all consecutive pediatric patients < 21 years old who underwent hemivertebra resection performed with the two-attending surgeon (neurosurgeon and orthopedic surgeon) model. Demographic information was extracted. Intraoperative complications, including durotomy and direct neurological injury, were queried from the clinical records. Intraoperative neuromonitoring data were evaluated. Postoperative complications were queried, and length of follow-up was determined from the clinical records. RESULTS: From 2008 to 2019, 22 patients with a median (range) age of 9.1 (2.0-19.3) years underwent hemivertebra resection with the two-attending surgeon, two-specialty model. The median (range) number of levels fused was 2 (0-16). The mean (range) operative time was 5 hours and 14 minutes (2 hours and 59 minutes to 8 hours and 30 minutes), and the median (range) estimated blood loss was 325 (80-2700) ml. Navigation was used in 14% (n = 3) of patients. Neither Gardner-Wells tongs nor halo traction was used in any operation. Neuromonitoring signals significantly decreased or were lost in 14% (n = 3) of patients. At a mean ± SD (range) follow-up of 4.6 ± 3.4 (1.0-11.6) years, 31% (n = 7) of patients had a postoperative complication, including 2 instances of proximal junctional kyphosis, 2 instances of distal junctional kyphosis, 2 wound complications, 1 instance of pseudoarthrosis with hardware failure, and 1 instance of screw pullout. The return to the operating room (OR) rate was 27% (n = 6), which included patients with the abovementioned wound complications, distal junctional kyphosis, pseudoarthrosis, and screw pullout, as well as a patient who required spinal fusion after loss of motor evoked potentials during index surgery. CONCLUSIONS: Twenty-two patients underwent hemivertebra resection with a two-attending surgeon, two-specialty model over a 12-year period at a specialized children's hospital, with a 14% rate of change in neuromonitoring, 32% rate of nonneurological complications, and a 27% rate of unplanned return to the OR.

Completion of a formal physiotherapeutic scoliosis-specific exercise training program for adolescent idiopathic scoliosis increases patient compliance to home exercise programs.

INTRODUCTION: Physiotherapeutic Scoliosis-Specific Exercise (PSSE) is a conservative approach for management of adolescent idiopathic scoliosis (AIS). Although there is Level I evidence for the efficacy of PSSE, compliance in the teenage population remains in question. The purpose of this study is to investigate the association between completion of formal PSSE training and compliance to prescribed home exercise programs (HEP). METHODS: Patients with AIS evaluated at our institution between 2013 and 2015 with a minimum of one PSSE session were enrolled. A chart review and questionnaire completed by caregivers was utilized to assess HEP compliance following the final PSSE session at 1 week, 3 months, 1 year, and 2 years. Patients were divided into two groups, those completing formal training (10 or more PSSE sessions), and those who did not complete formal training (fewer than 10 sessions). RESULTS: 81 patients were identified (mean age of 13.1 years; major curve of 31.3°). Patients who completed training demonstrated 50% compliance at 1 week (vs. 25.6% for non-completers, Odds Ratio (OR): 2.9, p = 0.027), 41.2% at 3 months (vs. 18.9% for non-completers, OR: 3.0, p = 0.044), 23.5% at 1 year (vs. 13.5% for non-completers, OR: 2.0, p = 0.281), and 25.7% at 2 years (vs. 13.5% for non-completers, OR: 2.2, p = 0.197). The mean HEP duration (minutes) in patients who completed training was higher at 1 week (80.8 vs. 48, p = 0.010), 3 months (64.6 vs. 23.7, p ≤ 0.001), 1 year (35.3 vs. 22.7, p = 0.270), and 2 years (34.3 vs. 18.9, p = 0.140). CONCLUSION: Patients who completed PSSE training maintained higher HEP compliance.

It is not just about the frontal plane: sagittal parameters impact curve progression in AIS patients undergoing brace treatment.

STUDY DESIGN: Retrospective cohort study. OBJECTIVES: The purpose of this study was to explore the association between pre-brace and in-brace sagittal parameters and curve progression. To date, there has been no published research focused on spinopelvic sagittal parameters and bracing outcomes in AIS. We hypothesize that sagittal spinopelvic parameters are associated with curve progression at 2 years. METHODS: This study included AIS patients with a pre-brace (PB) major curve between 20° and 45°. The outcome was defined as > 10° curve progression or surgery within 2 years of brace initiation. Spinopelvic parameters included C7-Central Sacral Vertebral Line shift (C7-CSVL), thoracic trunk shift, lumbar lordosis (LL), pelvic incidence (PI), T2-T12 thoracic kyphosis (TK) pelvic incidence-lumbar lordosis (PI-LL) mismatch, sagittal vertical axis (SVA), and pelvic tilt (PT). RESULTS: Of 50 patients included in this review, [70% Rigo (RCSO) and 30% Boston (BSO)], 16 (32%) patients demonstrated progression (23% of patients with RCSO vs 53% with BSO; p = 0.034). In patients with more than 30% major coronal curve correction (CCC), 23% had progression. 45% of patients progressed when they achieved ≤ 30% correction (p = 0.108). Among PB sagittal parameters and adjusting for coronal curve, patients with an abnormal PB SVA had 3.1 times increased risk of treatment failure compared with patients who had a normal PB SVA. Patients with PB hypo-LL had a 2.8 times increased risk of treatment failure compared with patients who had normal or hyper-LL. Among IB sagittal parameters, patients who had a normal PB PI-LL had a 3.9 times increased risk of treatment failure when they became mismatched in-brace (IB). Patients who had normal pre-brace kyphosis who became hypo-kyphotic IB had an 8.4 times increased risk of treatment failure compared with patients who maintained normal TK or became hyper-kyphotic. CONCLUSION: These data suggest that we should pay careful attention to sagittal parameters prior to and during brace treatment as braces can control these parameters. LEVEL OF EVIDENCE: Level III.

Risk Factors Associated with Surgical Site Infection in Pediatric Patients Undergoing Spinal Deformity Surgery: A Systematic Review and Meta-Analysis.

BACKGROUND: Considerable variation exists in surgical site infection (SSI) prevention practices for pediatric patients undergoing spinal deformity surgery, but the incidence of SSI has been reported to remain high in the United States. The literature reports various risk factors associated with SSI but findings are inconsistent. The purpose of this systematic review and meta-analysis was to assess the published literature investigating associations between various risk factors and SSI in pediatric patients undergoing spinal surgery. METHODS: The systematic review and the meta-analysis were conducted according to Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) guidelines among peer-reviewed journals published in English between January 2000 and April 2019. Studies that involved pediatric patients with spinal deformity undergoing surgical procedures in North America and assessed risk factors for SSI were included. The quality of individual studies was assessed, and weighted risk ratios and mean differences were calculated for each risk factor. RESULTS: Of 763 potential articles identified, 13 met inclusion criteria; 7 studies were rated as average and 6, as poor quality based on the quality checklist. The meta-analysis demonstrated that the SSI risk increased by the following factors: 2.53 (95% confidence interval [CI], 1.26 to 5.10) for overweight to obese patients compared with patients with normal weight, 2.84 (95% CI, 1.67 to 4.81) for patients with a neuromuscular etiology compared with non-neuromuscular etiology, 1.69 (95% CI, 1.41 to 2.02) for patients with a gastrostomy tube (G-tube) compared with those without, 3.45 (95% CI, 2.08 to 5.72) for nonambulatory patients compared with ambulators, and 3.39 (95% CI, 2.38 to 4.83) for patients with pelvic instrumentation compared with those without. Patients who developed SSI also had 158.38 mL (95% CI, 46.78 to 269.97 mL) greater estimated blood loss compared with those who did not. CONCLUSIONS: Despite the limited quality of the available studies and wide variety of populations and outcome definitions, evidence suggests that overweight to obese status, neuromuscular etiology, use of a G-tube, nonambulatory status, instrumentation to the pelvis, and greater estimated blood loss are risk factors for SSI. The use of a common SSI definition and strong methodology are warranted for future studies. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete list of levels of evidence.

Bigger is better: larger thoracic height is associated with increased health related quality of life at skeletal maturity.

STUDY DESIGN: Cross sectional OBJECTIVES: The purpose of this study is to evaluate the association between thoracic height and health-related quality of life (HRQoL) at skeletal maturity in patients with EOS. Current literature suggests a minimum thoracic height of 18 cm to 22 cm to avoid poor pulmonary function and related health outcomes. METHODS: Patients with EOS who reached skeletal maturity from 2005 to 2018 were identified in two registries including 32 centers. Thoracic height from T1 to T12 at skeletal maturity and Early Onset Scoliosis 24 Item Questionnaire (EOSQ-24) scores were collected. The EOSQ-24 domains included HRQoL of patients, parental impact, financial impact and patient and parental satisfaction. RESULTS: 469 patients (mean age: 14.9, female: 77.4%) were identified. 29% patients were of congenital etiology, 20.3% neuromuscular, 13.6% syndromic, 34.8% idiopathic, and 2.3% other. When patients were grouped by thoracic height at skeletal maturity, all EOSQ-24 domains increased after a threshold of 18 cm. When stratified by etiology, the 18 cm cutoff held for patients with congenital, neuromuscular and syndromic EOS. The cutoff for idiopathic EOS was 20 cm. For all patients, after the threshold was met, HRQoL continued to improve with increases in thoracic height at skeletal maturity. A subset of 169 patients for which arm span measurements were available was also identified and their thoracic heights were normalized. When grouped by the percentage of expected thoracic height attained, EOSQ-24 domains increased after a threshold of 80%. CONCLUSIONS: Once 18 cm of actual thoracic height or 80% of expected thoracic height is achieved, HRQoL continues to improve as thoracic height increases in skeletally mature patients with non-idiopathic EOS. Patients with idiopathic EOS had a higher threshold, possibly due to their larger average size and higher care giver expectations for HRQoL. LEVEL OF EVIDENCE: Level III.

Establishing consensus on the best practice guidelines for the use of bracing in adolescent idiopathic scoliosis.

STUDY DESIGN: Survey. OBJECTIVES: Bracing is the mainstay of conservative treatment in Adolescent Idiopathic Scoliosis (AIS). The purpose of this study was to establish best practice guidelines (BPG) among a multidisciplinary group of international bracing experts including surgeons, physiatrists, physical therapists, and orthotists utilizing formal consensus building techniques. Currently, there is significant variability in the practice of brace treatment for AIS and, therefore, there is a strong need to develop BPG for bracing in AIS. METHODS: We utilized the Delphi process and the nominal group technique to establish consensus among a multidisciplinary group of bracing experts. Our previous work identified areas of variability in brace treatment that we targeted for consensus. Following a review of the literature, three iterative surveys were administered. Topics included bracing goals, indications for starting and discontinuing bracing, brace types, brace prescription, radiographs, physical activities, and physiotherapeutic scoliosis-specific exercises. A face-to-face meeting was then conducted that allowed participants to vote for or against inclusion of each item. Agreement of 80% throughout the surveys and face-to-face meeting was considered consensus. Items that did not reach consensus were discussed and revised and repeat voting for consensus was performed. RESULTS: Of the 38 experts invited to participate, we received responses from 32, 35, and 34 for each survey, respectively. 11 surgeons, 4 physiatrists, 8 physical therapists, 3 orthotists, and 1 research scientist participated in the final face-to-face meeting. Experts reached consensus on 67 items across 10 domains of bracing which were consolidated into the final best practice recommendations. CONCLUSIONS: We believe that adherence to these BPG will lead to fewer sub-optimal outcomes in patients with AIS by reducing the variability in AIS bracing practices, and provide a framework future research. LEVEL OF EVIDENCE: Level IV.