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Study Design: Prospective multicenter study data were used for model derivation and externally validated using retrospective cohort data., Objective: Derive and validate a prognostic model of benefit from bracing for adolescent idiopathic scoliosis (AIS)., Summary of Background Data: The Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) demonstrated the superiority of bracing over observation to prevent curve progression to the surgical threshold; 42% of untreated subjects had a good outcome, and 28% progressed to the surgical threshold despite bracing, likely due to poor adherence. To avoid over-treatment and to promote patient goal setting and adherence, bracing decisions (who and how much) should be based on physician and patient discussions informed by individual-level data from high-quality predictive models., Materials and Methods: Logistic regression was used to predict curve progression to <45° at skeletal maturity (good prognosis) in 269 BrAIST subjects who were observed or braced. Predictors included age, sex, body mass index, Risser stage, Cobb angle, curve pattern, and treatment characteristics (hours of brace wear and in-brace correction). Internal and external validity were evaluated using jackknifed samples of the BrAIST data set and an independent cohort (n=299) through estimates of discrimination and calibration., Results: The final model included age, sex, body mass index, Risser stage, Cobb angle, and hours of brace wear per day. The model demonstrated strong discrimination ( c -statistics 0.83-0.87) and calibration in all data sets. Classifying patients as low risk (high probability of a good prognosis) at the probability cut point of 70% resulted in a specificity of 92% and a positive predictive value of 89%., Conclusion: This externally validated model can be used by clinicians and families to make informed, individualized decisions about when and how much to brace to avoid progression to surgery. If widely adopted, this model could decrease overbracing of AIS, improve adherence, and, most importantly, decrease the likelihood of spinal fusion in this population., Competing Interests: M.L.S.: consultant to Stryker, Orthofix, and OrthoPediatrics. The remaining authors report no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The institutional standard follow-up schedule for patients undergoing spinal instrumentation and fusion for adolescent idiopathic scoliosis (AIS) is return to clinic at 6-weeks and 3 months post-procedure for radiographs. COVID-19 prompted a change in this practice and most routine post-op visits were performed virtually during that time. The purpose of this study is to estimate the cost and benefit of in-person visits to inform the relative value of in-person follow-up using data from the year prior to COVID changes., Methods: This was a retrospective study including all patients with AIS who underwent spinal instrumentation and fusion in 2019 by a single surgeon at a tertiary medical center. The cost of radiographs, travel, and parental lost wages associated with follow-up visits at 6-weeks and 3-months were estimated. Transportation costs were estimated by multiplying the distance between home and clinic by the standard IRS travel reimbursement rate ($0.58/mile). Parental lost wages were estimated using the average 2019 US census income for men and women. Each patient's electronic medical record was reviewed to see whether radiographs and physical assessment resulted in any changes in orthopaedic management at each visit., Results: The sample included 63 patients (75% female, 94% Caucasian) with an average age of 15.22 years. The average round-trip distance traveled was 94.4 miles (range 3.2-476), resulting in an average travel cost of $109.47. The total time spent for a visit (travel, wayfinding and the clinic visit itself) averaged 330 minutes, resulting in an estimated lost parental wage of $125.47. Estimated cost of radiographs at each visit was $693. This combined cost burden totaled $927.94 for each visit, and no changes in management were prompted by clinical or radiographic findings at any of the 126 visits., Conclusion: COVID-19 presented many new challenges to healthcare, including a necessary increase in virtual healthcare delivery. This study estimated the cost of in-person follow-up visits the year prior to COVID-19. Patients and their families traveled hundreds of miles and spent hundreds of dollars to attend these visits. No changes in clinical management were prompted by findings at these in-person follow-up visits, and implementation of virtual post-operative visits could potentially lead to cost savings for families in these instances. Level of Evidence: III ., Competing Interests: Disclosures: The authors report no potential conflicts of interest related to this study., (Copyright © The Iowa Orthopaedic Journal 2024.)

Purpose: The Morbidity and Mortality (M&M) report of the Scoliosis Research Society (SRS) has been collected since 1965 and since 1968 submission of complications has been required of all members. Since 2009, the SRS has collected information on death, blindness, and neurological deficit, with acute infection being added in 2012 and unintentional return to the operating room (OR) being added in 2017. In this report, we use the most recent data submitted to the SRS M&M database to determine the rate of neurological deficit, blindness, acute infection, unintentional return to the OR, and death, while also comparing this information to previous reports., Methods: The SRS M&M database was queried for all cases from 2013 to 2020. The rates of death, vision loss, neurological deficit, acute infection, and unintentional return to the OR were then calculated and analyzed. The rates were compared to previously published data if available. Differences in complication rates between years were analyzed with Poisson regression with significance set at α = 0.05., Results: The total number of cases submitted per year varied with a maximum of 49,615 in 2018 and a minimum of 40,464 in 2020. The overall reported complication rate from 2013 to 2020 was 2.86%. The overall mortality rate ranged from 0.09% in 2018 to 0.14% in 2015. The number of patients with visual impairment ranged from 4 to 13 between 2013 and 2015 (no data on visual impairment were collected after 2015). The overall infection rate varied from 0.95 in 2020 to 1.30% in 2015. When the infection rate was analyzed based on spinal deformity group, the neuromuscular scoliosis group consistently had the highest infection rate ranging from 3.24 to 3.94%. The overall neurological deficit rate ranged from 0.74 to 0.94%, with the congenital kyphosis and dysplastic spondylolisthesis groups having the highest rates. The rates of unintentional return to the OR ranged from 1.60 to 1.79%. Multiple groups showed a statistically significant decreasing trend for infection, return to the operating room, neurologic deficit, and death., Conclusions: Neuromuscular scoliosis had the highest infection rate among all spinal deformity groups. Congenital kyphosis and dysplastic spondylolisthesis had the highest rate of neurological deficit postoperatively. This is similar to previously published data. Contrary to previous reports, neuromuscular scoliosis did not have the highest annual death rate. Multiple groups showed a statistically significant decreasing trend in complication rates during the reporting period, with only mortality in degenerative spondylolisthesis significantly trending upwards., Level of Evidence: Level III., (© 2022. The Author(s).)

Outcomes of a pilot study of spine growth modulation (GM) were compared to those of untreated and braced patients from a concurrent bracing effectiveness trial (BrAIST). The purpose of this study was to determine probabilities of progression (PP) to fusion indications (≥45°) in a cohort of subjects who underwent GM surgery, and to compare GM outcomes to those of matched BrAIST subjects. Secondary analyses were conducted comparing two prospective longitudinal studies. In one, a vertebral GM system was implanted in 6 highly skeletally immature AIS patients. The control group provided by BrAIST was comprised of a subset of untreated or braced subjects that fit the eligibility criteria of the GM study. GM outcomes were compared to predictions from two prognostic logistic regression models derived from BrAIST to estimate risk of curve progression to ≥45°. If the GM patients were untreated, PPs ranged from 68-98%. If braced for 18 hours/day, progression was expected in two of six, one with a PP of 71%. This latter patient not only did not progress, his curve decreased >20°. In the matched cohort, two were untreated and quickly progressed, whereas two were braced and did not progress. Therefore, the bracing models and matched cohort confirmed the initial assumption that all GM patients were at high risk if untreated. They also supported the probable benefit of the GM system, as 3 of 6 benefited from GM relative to predictions for untreated patients, and one of 6 benefited compared to predictions for highly compliant braced patients.

Purpose: While the Scoliosis Research Society (SRS) has established criteria for brace initiation in adolescent idiopathic scoliosis (AIS), there are no recommendations concerning other management issues. As the BrAIST study reinforced the utility of bracing, the SRS Non-Operative Management Committee decided to evaluate the consensus or discord in AIS brace management., Methods: 1200 SRS members were sent an online survey in 2017, which included 21 items concerning demographics, bracing indications, management, and monitoring. Free-text responses were analyzed and collated into common themes. Data were analyzed using Microsoft Excel 2013., Results: Of 218 respondents; 207 regularly evaluate and manage patients with AIS, and 205 currently prescribe bracing. 99% of respondents use bracing for AIS and the majority (89%) use the published SRS criteria, or a modified version, to initiate bracing. 85% do not use brace monitoring and 66% use both %-Cobb correction and fit criteria to evaluate brace adequacy. In contrast, other aspects of brace management demonstrated a high degree of practice variability. This was seen with a radiographic assessment of maturity level, hours prescribed, timing and frequency of radiographic evaluation, the use of nighttime bracing only, and the method and timing of brace discontinuation., Conclusion: Although there is consensus in brace management amongst SRS members with respect to brace initiation and evaluation of adequacy, there is striking variability in how bracing for AIS is used. This variability may impact the overall efficacy of brace treatment and may be decreased with more robust guidelines from the SRS., Level of Evidence: III.

Study Design: Retrospective., Objectives: Utilize three-dimensional (3D) measurements to assess the relationship between thoracic scoliosis severity and thoracic kyphosis in a large, multicenter cohort, and determine impact of 3D measurements on adolescent idiopathic scoliosis (AIS) curve classification. Research has demonstrated differences in two-dimensional (2D) and 3D assessment of the sagittal plane deformity in AIS. A prior smaller, single-institution study demonstrated an association between scoliosis severity and loss of 3D thoracic kyphosis., Methods: Data included retrospective compilation of prospectively enrolled bracing candidates and prospectively enrolled surgical candidates with thoracic AIS. Analysis included two groups based on thoracic curve magnitude: moderate (20-45°) and severe (> 45°). Imaging was performed using 2D radiographs. 3D thoracic kyphosis was calculated using a 2D to 3D conversion formula. Kyphosis was categorized according to the Lenke classification sagittal plane modifier., Results: Analysis included 3032 patients. 2D kyphosis was significantly less in the moderate group (21 ± 12 vs 23 ± 14, p = 0.028). However, estimated 3D kyphosis was significantly greater in the moderate group (13 ± 10 vs 5 ± 12, p < 0.001). In the moderate group, the rate of normokyphosis was 78% with 2D measures and 61% with 3D measures of T5-T12 kyphosis. In the severe group, this rate changed from 72 to 32% with use of 2D and 3D measures, respectively. In the moderate group, 16% of patients were classified as hypokyphotic using 2D measures while this rate increased 38% with 3D measures (p < 0.001). In the severe group, this rate changed from 18 to 68% using 2D and 3D measures, respectively (p < 0.001)., Conclusions: Increased coronal curve severity was associated with decreased thoracic kyphosis. Hypokyphosis was more pronounced in 3D. 2D radiographs increasingly underestimate kyphosis with increasing coronal severity. Assessment of sagittal alignment from 2D radiographs can be improved with a 2D-3D conversion formula. Findings indicate potential for classification system improvement with use of 3D sagittal plane measurements., Level of Evidence: IV.

The recently developed magnetically controlled growing rod (MCGR) system has gained popularity because it limits additional surgical lengthening procedures and promises reduction of the complication rate previously reported for the traditional growing rods. A retrospective single-center study was performed. Demographic and complications data were recorded. A statistical analysis was conducted to quantify the effect of MCGR placement and of subsequent lengthening on the Cobb angle, T1-T12 kyphosis, and the distances from T1-T12 and T1-S1. Twenty-four patients met the inclusion criteria. Six had idiopathic scoliosis and 18 patients had nonidiopathic scoliosis (neuromuscular and syndromic scoliosis). Nine patients underwent primary MCGR placement, and 15 had the traditional growing rods removed and replaced with MCGRs. The mean age at surgery and at last follow-up was 6.3 years and 8.8 years, respectively. The mean follow-up was 29.2 months. The MCGR placement significantly reduced the Cobb angle and kyphosis by an average of 21.33° and 10.79°, respectively. The T1-T12 and the T1-S1 distances increased an average of 1.19 and 1.89 cm/year, respectively, during the follow-up period. The average percentage of achieved-to-intended distraction was 65% on the concave side and 68% on the convex side at last follow-up. There were 9 postoperative complications in 8 (33%) patients, 6 of whom had nonidiopathic scoliosis. The MCGR system is reliable and effective in the treatment of patients affected by early-onset scoliosis. [Orthopedics. 2020;43(6):e601-e608.]., (Copyright 2020, SLACK Incorporated.)

Study Design: Comparative effectiveness study OBJECTIVE.: To evaluate factors leading to higher percentage of brace failures in a cohort of North American patients with adolescent idiopathic scoliosis relative to their peers in Italy., Summary of Background Data: Studies of bracing in United States have shown worse outcomes than studies from European centers, possibly due to sample characteristics or treatment approaches., Methods: Sample: Braced patients, aged 10 to 15, Risser <3, Cobb 20°- to 40°, observed to Cobb ≥40° and/or ≥Risser 4 selected from prospective databases. Comparators: Bracing per Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) (TLSO) and Italian Scientific Spine Institute (ISICO) protocol (SPoRT braces with or without SEAS exercises). Baseline characteristics (sex, age, BMI, Risser, Cobb, curve type) and average hours of brace wear/day. Differences in programs (e.g., SEAS, type of brace, weaning protocol) were captured by a variable named "SITE.", Outcome: Treatment failure (Cobb ≥40 before Risser 4)., Statistics: Comparison of baseline characteristics, analyses of risk factors, treatment components, and outcomes within and between cohorts using logistic regression., Results: A total of 157 BrAIST and 81 ISICO subjects were included. Cohorts were similar at baseline but differed significantly in terms of average hours of brace wear: 18.31 in the ISICO versus 11.76 in the BrAIST cohort. Twelve percent of the ISICO and 39% of the BrAIST cohort had failed treatment. Age, Risser, Cobb, and a thoracic apex predicted failure in both groups. SITE was related to failure (odds ratio [OR] = 0.19), indicating lower odds of failure with ISICO versus BrAIST approach. With both SITE and wear time in the model, SITE loose significance. In the final model, the adjusted odds of failure were higher in boys (OR = 3.34), and those with lowest BMI (OR = 9.83); the odds increased with the Cobb angle (OR = 1.23), and decreased with age (OR = 0.41) and hours of wear (OR = 0.86)., Conclusion: Treatment at the ISICO resulted in a lower failure rate, primarily explained by longer average hours of brace wear., Level of Evidence: 3.

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.

Study Design: Prognostic study and validation using prospective clinical trial data., Objective: To derive and validate a model predicting curve progression to ≥45° before skeletal maturity in untreated patients with adolescent idiopathic scoliosis (AIS)., Summary of Background Data: Studies have linked the natural history of AIS with characteristics such as sex, skeletal maturity, curve magnitude, and pattern. The Simplified Skeletal Maturity Scoring System may be of particular prognostic utility for the study of curve progression. The reliability of the system has been addressed; however, its value as a prognostic marker for the outcomes of AIS has not. The BrAIST trial followed a sample of untreated AIS patients from enrollment to skeletal maturity, providing a rare source of prospective data for prognostic modeling., Methods: The development sample included 115 untreated BrAIST participants. Logistic regression was used to predict curve progression to ≥45° (or surgery) before skeletal maturity. Predictors included the Cobb angle, age, sex, curve type, triradiate cartilage, and skeletal maturity stage (SMS). Internal and external validity was evaluated using jackknifed samples of the BrAIST data set and an independent cohort (n = 152). Indices of discrimination and calibration were estimated. A risk classification was created and the accuracy evaluated via the positive (PPV) and negative predictive values (NPV)., Results: The final model included the SMS, Cobb angle, and curve type. The model demonstrated strong discrimination (c-statistics 0.89-0.91) and calibration in all data sets. The classification system resulted in PPVs of 0.71-0.72 and NPVs of 0.85-0.93., Conclusions: This study provides the first rigorously validated model predicting a short-term outcome of untreated AIS. The resultant estimates can serve two important functions: 1) setting benchmarks for comparative effectiveness studies and 2) most importantly, providing clinicians and families with individual risk estimates to guide treatment decisions., Level of Evidence: Level 1, prognostic., (Copyright © 2019 Scoliosis Research Society. Published by Elsevier Inc. All rights reserved.)

Background: Adolescent idiopathic scoliosis (AIS) has been associated with unnecessary referrals, but the provider and patient costs associated with these referrals remain unknown. The purpose of this study was to determine the prevalence and associated costs of unnecessary referrals for AIS in a university hospital-based orthopaedic clinic. These data are required to estimate the cost-efficacy of scoliosis screening programs., Methods: We accessed the electronic medical records of all patients referred during 2013-2014 with suspected AIS. Spine radiographs were reviewed to determine whether the referral was "unnecessary," defined as a Cobb angle <20 degrees. Patient and provider costs were estimated. Patient costs included transportation expenses and parental lost wages. Provider costs included orthopaedic evaluation, diagnostic imaging, and overhead. Transportation costs were based on actual driving distances and the Internal Revenue Service standard mileage rate. Parental lost wages and the cost of evaluation by an orthopaedic surgeon were calculated with time-driven activity-based costing. Diagnostic imaging costs were calculated with a traditional activity-based costing methodology., Results: Three hundred thirty-seven patients were included. The prevalence of unnecessary referrals was 39% (n=131). 17% of patients had a Cobb angle <10 degrees and 22% had a Cobb angle between 10-20 degrees. Males were more likely to be referred unnecessarily than females, 49% to 35% (p=0.02) as were non-Caucasians (54% vs. 37%, p=0.04). No difference was noted related to source of insurance (private or public, p=0.18). The average total cost of an unnecessary referral was $782.13 USD, including $231.07 in patient costs and $551.06 in provider costs., Conclusions: Nearly 40% of all referrals for AIS were deemed unnecessary. The average cost of an unnecessary referral is approximately $780, imposing significant costs on both patients and the healthcare system. Level of Evidence: III., Competing Interests: Disclosures: The authors report no potential conflicts of interest related to this study.

Background: Clinical evidence regarding the ability of braces to decrease the risk of curve progression to surgical threshold in patients with adolescent idiopathic scoliosis (AIS) continues to strengthen. Unfortunately, there is still a great deal of uncertainty regarding the impact of brace wear on psychosocial well-being or the impact of psychological well-being on brace wear adherence. The purpose of this study is to evaluate psychosocial well-being, in particular body image and quality of life (QOL), and brace wear adherence in female AIS patients undergoing brace treatment., Methods: The Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) was a multicenter, controlled trial using randomized and preference assignments into an observation or brace treatment group. BrAIST patients were skeletally immature adolescents diagnosed with AIS having moderate curve sizes (20 to 40 degrees). Patients in the bracing group were instructed to wear a thoracolumbosacral orthosis, at least 18 h/d. Scores on the Spinal Appearance Questionnaire and the PedsQL4.0 Generic Scales from 167 female BrAIST patients who were randomized to brace treatment (n=58) and patients who chose brace treatment (n=109) were analyzed., Results: At baseline and at 12 months, no differences were found between the least-adherent brace wear group (<6 h/d) and most-adherent brace wear group (≥12 h/d) patients in terms of major curve, body image, and QOL. In the most-adherent group, poorer body image scores were significantly correlated with poorer QOL scores at baseline, at 6 months, and at 12 months but not at 18 months. In general, body image scores and QOL scores were not significantly correlated in the least-adherent group. When comparing patients that had a ≥6 degree increase of their major curve between baseline and 12 months to patients that did not, there were no significant differences in body image or QOL scores., Conclusions: For females adolescents with AIS, body image and QOL do not have a significant impact on brace wear adherence and are subsequently not significantly impacted by brace wear., Level of Evidence: Level II-therapeutic (prospective comparative study).

Background: Spinal muscular atrophy (SMA) is a progressive neuromuscular disease commonly including progressive scoliosis resulting in severe deformity and negatively affecting pulmonary function. Surgical correction and stabilization of this progressive deformity is generally recommended; however, the timing and method of surgical fixation remains controversial., Methods: Retrospective review of clinical, radiographic, and pulmonary function data from 16 children with SMA and surgically treated scoliosis between 1985 and 2013. Radiographic data included direct measures of major curve, coronal balance, pelvic obliquity, T1-T12 height, T1-S1 height, and T1-rod length. Estimations of rib collapse, thoracic cavity shape, and space-available-for-lung (T6:T12, width ratio; T6:T10, rib-vertebral-angle difference ratios; and lung height) were determined. Eleven patients were able to complete pulmonary function testing. Results were compared with published outcomes for growing rod constructs., Results: Posterior spinal fusion was performed at an average age of 9.8±3.6 years. The mean age at most recent follow-up was 19.4 years (range, 10 to 37 y), with a mean follow-up of 10.1 years (range, 3.1 to 26 y). Radiographic measurements improved from preoperative to latest follow-up as follows: major curve, 78±20 degrees to 27±24 degrees; coronal balance, 4.1±4.0 cm to 1.9±2.2 cm; pelvic obliquity (median), 23 to 5 degrees; T1-T12 height, 19±3 cm to 22±3 cm; T1-S1 height, 31±7 cm to 36±6 cm; T1-rod length, 0.8±1.1 cm (postop) to 2.8±1.6 cm (final); and space-available-for-lung ratio, 0.88±0.26 to 0.95±0.25. Rib collapse continued throughout the follow-up period in all but 1 patient. Pulmonary function testing demonstrated a decrease in rate of decline in forced vital capacity and forced expiratory volume when comparing preoperative with postoperative rates. Mean length of stay was 7.8±4.4 days. Complications included reintubation for low tidal volumes (n=1), pneumonia (n=1), superficial wound breakdown (n=1), and superficial infection (n=1)., Conclusions: Definitive posterior spinal fusion for treatment of scoliosis associated with SMA is effective at controlling curve progression and pelvic obliquity without negatively impacting the space-available-for-lung ratio, trunk height, or pulmonary function at 10 years follow-up., Level of Evidence: Therapeutic Level IV.

Study Design: The Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) included skeletally immature high-risk patients with adolescent idiopathic scoliosis (AIS) with moderate curve sizes (20°- 40°). BrAIST was a multicenter, controlled trial using both randomized and preference treatment arms into either an observation group or a brace treatment group., Objective: The aim of this study was to analyze and compare body image and quality-of-life (QOL) in female AIS patients who were observed or treated with a brace., Summary of Background Data: Brace treatment is an effective means for controlling progressive scoliosis and preventing the need for surgery, but there is no consensus regarding the effect of brace treatment on body image or on QOL in adolescents with AIS., Methods: Data from female BrAIST patients in the randomized (n = 132) or preference (n = 187) arms and were observed (n = 120) or brace treated (n = 199) were analyzed. Patients completed the Spinal Appearance Questionnaire (SAQ) and the Pediatric Quality of Life Inventory (PedsQOL) 4.0 Generic Scales at baseline and 6 month follow-up visits up to 2 years. Items on the SAQ measured three body image constructs (self, ideal, and overall). The PedsQOL measured health, activities, feelings, social factors, and school., Results: . In general, there were no significant differences within or between study arms or treatments regarding body image or QOL through 2 years of follow-up. Poorer body image was significantly correlated with poorer QOL during the first 2 years of follow-up regardless of study arm or treatment. Patients who crossed-over to a different treatment and patients with largest Cobb angles ≥ 40 degrees had significantly poorer body image, in particular self-body image, compared with those that did not., Conclusion: This study does not support findings from previous research indicating that wearing a brace has a negative impact on or is negatively impacted by body image or QOL., Level of Evidence: 2.

Study Design: Descriptive., Objective: To describe the design and development of Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)., Summary of Background Data: Bracing has remained the standard of care for the nonoperative treatment of adolescent idiopathic scoliosis since the introduction of the Milwaukee brace in the late 1940s, but it has never been subjected to a rigorous evaluation of either its efficacy or its effectiveness. The BrAIST was designed to address the primary question: Do braces (specifically a thoracolumbosacral orthosis) lower the risk of curve progression to a surgical threshold (≥50°) in patients with adolescent idiopathic scoliosis relative to watchful waiting alone?, Methods: The authors describe the rationale for BrAIST, including the limitations of the current literature evaluating bracing for adolescent idiopathic scoliosis. Second, the authors describe the preliminary work, including the preparation of the National Institutes of Health clinical trials planning grant. Finally, the authors describe the trial design in detail., Results: BrAIST was conducted in 25 sites in North America. Subjects were treated either with a thoracolumbosacral orthosis or watchful waiting and followed every 6 months until they reached skeletal maturity or the surgical threshold of 50° Cobb angle., Conclusion: Clinical decision making will be improved by translation of the BrAIST results into evidence-based prognosis and estimates of how the prognosis, specifically the risk of progressing to surgery, may be altered by the use of bracing., Level of Evidence: N/A.

Background: Randomized controlled trials are powerful tools to evaluate the outcomes of clinical treatments. However, these trials tend to be expensive and time-consuming, and their conclusions can be threatened by several limitations. This study estimated the strength of three common limitations (underenrollment, selective enrollment, and nonadherence to protocol) in a proposed study of adolescent idiopathic scoliosis., Methods: Patients with scoliosis and their parents were asked to complete a web-based survey about their preferences concerning a hypothetical randomized trial. Adolescents without scoliosis and their parents also participated. Surveys included questions about treatment preference, likelihood of participation, required risk reduction, and propensity to drop out or choose a different treatment while enrolled in the study., Results: Ninety adolescents and eighty-three parents participated. Observation was preferred to bracing by the majority of subjects. Overall, 33% of the parents and adolescents would both agree to participate in the hypothetical trial. Of the subjects who would not agree to participate, the majority would rather share the decision-making responsibility with the physician than have the treatment chosen in a random fashion. Many of the subjects would consider changing treatments during the course of the trial if they were not satisfied with the outcomes; the majority of parents who preferred bracing would consider crossing over to the bracing arm if their children were randomized to observation., Conclusions: Recruitment into a randomized trial of bracing compared with observation for the treatment of adolescent idiopathic scoliosis may well be problematic, considering the relatively small percentage of families who said they would consider randomization. Additionally, the threat of nonadherence to protocol may be strong and must be addressed in the protocol of the trial. Most families wanted to make the treatment decision with the physician in lieu of randomization; therefore, the role of the physician in patient recruitment and retention should not be underestimated.

Adolescent idiopathic scoliosis (AIS) affects 1-3% of children in the at-risk population of those aged 10-16 years. The aetiopathogensis of this disorder remains unknown, with misinformation about its natural history. Non-surgical treatments are aimed to reduce the number of operations by preventing curve progression. Although bracing and physiotherapy are common treatments in much of the world, their effectiveness has never been rigorously assessed. Technological advances have much improved the ability of surgeons to safely correct the deformity while maintaining sagittal and coronal balance. However, we do not have long-term results of these changing surgical treatments. Much has yet to be learned about the general health, quality of life, and self-image of both treated and untreated patients with AIS.

Study Design: : Systematic review of clinical studies., Objectives: : To develop a pooled estimate of the prevalence of surgery after observation and after brace treatment in patients with adolescent idiopathic scoliosis (AIS)., Summary of Background Data: : Critical analysis of the studies evaluating bracing in AIS yields limited evidence concerning the effect of TLSOs on curve progression, rate of surgery, and the burden of suffering associated with AIS. Many patients choose bracing without an evidence-based estimate of their risk of surgery relative to no treatment. Therefore, such an estimate is needed to promote informed decision-making., Methods: : Multiple electronic databases were searched using the key words "adolescent idiopathic scoliosis," "observation," "orthotics," "surgery," and "bracing." The search was limited to the English language. Studies were included if observation or a TLSO was evaluated and if the sample closely matched the current indications for bracing (skeletal immaturity, age <15 years, Cobb angle between 20 degrees and 45 degrees ). One reviewer (L.A.D) selected the articles and abstracted the data, including research design, type of brace, minimum follow-up, and surgical rate. Additional data concerning inclusion criteria and risk factors for surgery included gender, Risser, age and Cobb angle at brace initiation, curve type, and dose (hours of recommended brace wear)., Results: : Eighteen studies were included (observation = 3, bracing = 15). All were Level III or IV clinical series. Despite some uniformity in surgical indications, the surgical rates were extremely variable, ranging from 1 surgery of 72 patients (1%) to 51 of 120 patients (43%) after bracing, and from 2 surgeries of 15 patients (13%) to 18 of 47 patients (28%) after observation. When pooled, the bracing surgical rate was 23% compared with 22% in the observation group. Pooled estimates for surgical rate by type of brace, curve type, Cobb angle, Risser sign, and dose were also calculated., Conclusion: : Comparing the pooled rates for these two interventions shows no clear advantage of either approach. Based on the evidence presented here, one cannot recommend one approach over the other to prevent the need for surgery in AIS. This recommendation carries a grade of D, indicating that the use of bracing relative to observation is supported by "troublingly inconsistent or inconclusive studies of any level." The decision to brace for AIS is often difficult for clinicians and families. An evidence-based estimate of the risk of surgery will provide additional information to use as they weigh the costs and benefits of bracing.

Objective: To determine if community equipoise exists concerning the effectiveness of bracing in adolescent idiopathic scoliosis., Background Data: Bracing is the standard of care for adolescent idiopathic scoliosis despite the lack of strong reasearch evidence concerning its effectiveness. Thus, some researchers support the idea of a randomized trial, whereas others think that randomization in the face of a standard of care would be unethical., Methods: A random of Scoliosis Research Society and Pediatric Orthopaedic Society of North America members were asked to consider 12 clinical profiles and to give their opinion concerning the radiographic outcomes after observation and bracing., Results: An expert panel was created from the respondents. They expressed a wide array of opinions concerning the percentage of patients within each scenario who would benefit from bracing. Agreement was noted concerning the risk due to bracing for post-menarchal patients only., Conclusions: : This study found a high degree of variability in opinion among clinicians concerning the effectiveness of bracing, suggesting that a randomized trial of bracing would be ethical.

Little substantive data is available in the literature on the long-term clinical and radiological results of Cotrel-Dubousset instrumentation (CDI) for the treatment of adolescent idiopathic scoliosis. We therefore retrospectively investigated the long-term clinical and radiographic outcome of patients who underwent (CDI) for right thoracic adolescent idiopathic scoliosis. 54 consecutive patients (45 females, 9 males) who underwent CDI for right thoracic adolescent idiopathic scoliosis with an average age of 14 years (range 10-21 years) at surgery were included in this series. There were 18 King Type II, 19 Type III, 5 Type IV, 3 Type V and 9 double major curves. The average coronal Cobb angle of the primary thoracic curve preoperatively, postoperatively and at latest follow-up was 55 degrees, 17 degrees and 22 degrees, respectively. The lumbar curve (secondary and double major) averaged 40 degrees, 21 degrees and 23 degrees, respectively. Coronal balance (deviation from the central sacral line) was slightly improved from 13 mm to 11 mm. The average shoulder elevation increased from 3 degrees to 5 degrees, presumably as a result of the rod derotation maneuver. Thoracic kyphosis (20 degrees to 22 degrees) and lumbar lordosis (49 degrees to 54 degrees) was preserved or even improved by the instrumentation. All patients were doing well and had no complaints with regard to a substantial limitation of professional or sports activity. There were no apparent non-unions, infections or neurological complications. CDI of adolescent right thoracic idiopathic scoliosis provides encouraging clinical and radiographic results at an average follow-up of 9 years (2 to 16 years). Overall patient satisfaction, functional status and subjective cosmetic improvement is high.

This paper evaluates the efficacy the Moss-Miami System instrumentation for surgical treatment of spinal deformity. Eight-five patients with AIS underwent a posterior spinal fusion with using this system between 1994 and 1998. Radiographs of the spine were taken preoperatively, at discharge, one year after surgery, and at the latest follow-up (average of 2.5 year, range 2 to 6 years). All radiographs were assessed for curve magnitude, coronal balance, kyphosis, lordosis, junctional kyphosis, and sagittal balance. The Scoliosis Research Society instrument was administered at the final follow-up. The average curve correction ranged from 53 to 65 percent. All patients showed solid fusion by final follow-up. Three patients required a second operation for complications related to their scoliosis; two patients showed a rod fracture without evidence of pseudoarthrosis or curve progression. Two transient neurological complications related to the surgery were observed. SRS results were favorable with regard to function and cosmetic appearance.

Study Design: Retrospective chart review., Objectives: To evaluate the efficacy of the Rosenberger thoracic lumbar sacral orthosis in preventing curve progression in adolescent idiopathic scoliosis., Summary of Background Data: Radiographic outcomes of patients using the Rosenberger thoracic lumbar sacral orthosis have never been reported in the literature, but reports of other thoracic lumbar sacral orthoses conflict concerning the ability braces to improve on the natural history of adolescent idiopathic scoliosis., Methods: Seventy-one patients with progressive adolescent idiopathic scoliosis treated with the Rosenberger were evaluated at an average of 2.3 years following brace discontinuation. Initial curves averaged 29 degrees. Braces were prescribed for 16 to 20 hours per day and worn for an average of 3.2 years. Patients were between 9 and 16 years of age, and all were skeletally immature at the time of bracing., Results: Twenty-one patients (30%) underwent instrumentation and arthrodesis despite bracing. Forty (56%) had more than 5 degrees of progression. Overall, 43 (61%) had surgery and/or progressed by the time of follow-up. The average curve correction was 33% in patients who did not have surgery and 21% in those patients who did (P < 0.04). Other significant factors associated with brace failure included absence of menarche before treatment, younger age at presentation and initial bracing, increased apical rotation of the primary curve at presentation, and a thoracic curve pattern., Conclusions: The Rosenberger brace demonstrated an overall failure rate similar to untreated rates from published natural history studies, although subgroups of patients had lower failure rates. These findings suggest the need for further refinement of the indications for the Rosenberger brace.

Study Design: Consecutive series of patients with idiopathic scoliosis with atypical features., Objectives: The purpose of this study is to define a specific yet sensitive set of signs and symptoms to indicate the use of MRI in patients with atypical idiopathic scoliosis. Specifically, this study empirically defines a new diagnostic test for the presence of neurogenic lesions based on clinical and radiologic data and then reports the properties of this test in relation to MRI as the gold standard., Summary of Background Data: The reported prevalence of brain stem and spinal cord abnormalities in patients with idiopathic scoliosis associated with atypical features varies from 0% to 60%. This wide range most likely results from the fact that the samples studied are either not well defined or are heterogeneous across studies. Because of these issues, the likelihood of neurogenic lesions in atypical idiopathic scoliosis is not known; consequently, the decision to order an MRI is controversial.METHODS A total of 1,206 patients coded as having idiopathic scoliosis were identified from our institutional database. Of these, 72 patients had one or more atypical features: early-onset scoliosis, atypical curve, severe curve despite immaturity (>45 degrees ), rapidly progressive curve (>1 degrees per month), back pain, headache, or neurologic abnormalities on clinical examination. All 72 patients underwent brain and spinal cord MRI. Logistic regression was used to determine significant predictors of positive MRI and to define the prognostic model., Results: Eleven patients (15%) had abnormal findings on MRI. Eight had an Arnold-Chiari type I malformation associated with a syrinx; 1 had an Arnold-Chiari type I malformation; 1 a syrinx; and 1 a cervical syrinx with a conus lipoma. MRI was positive in 5 of 9 patients (55%) with severe curves despite immaturity. Twenty patients had one or more abnormal neurologic signs. Of these, 8 (40%) had a positive MRI, while only 3 of the 52 patients (6%) with a normal neurologic examination (but other atypical features) had a positive MRI. The most predictive model included the variables neurologic abnormalities (yes or no) and severe curve despite immaturity (yes or no). Using this model, patients with atypical characteristics other than severe curvatures or abnormal neurologic abnormalities(s) had a 3% probability (95% confidence interval [CI], 1-12%) of having a positive MRI; patients with abnormal neurologic change(s), but a nonsevere curve, had a 29% probability of a positive MRI (95% CI, 12-53%) and patients with severe curves and no neurologic change(s) had a 32% probability of positive MRI (95% CI, 8-71%). Patients with both a severe curve and abnormal neurologic change(s) had an 86% probability of positive MRI (95% CI, 46-98%). Agreement between this test and the MRI was 75%, with a sensitivity of 82% (95% CI, 48-97%) and a specificity of 74% (95% CI, 61-83%)., Conclusions: The model derived in this study indicates that the probability of neurogenic lesions is extremely low in most patients with idiopathic scoliosis with atypical features. However, patients with severe curves despite skeletal immaturity and an abnormal neurologic examination have a significant probability of neurogenic lesions. Therefore, clinical efficiency will be enhanced by narrowing the indications for MRI to those patients with these risk factors.

Psychosocial characteristics of 95 female patients treated with Milwaukee bracing for idiopathic scoliosis were examined using a battery of five psychosocial scales. Sixty-five patients treated with bracing alone and 30 patients who also underwent arthrodesis for curve progression were compared with 49 age-matched female controls. At an average follow-up of 7 years, no differences in depression or health locus of control existed. Significant perceptions of discrimination and a lower satisfaction of overall appearance was recalled during the treatment phase. By final follow-up, there was no longer any difference between the patients and controls in these areas. Significantly, differences in body-image scores persisted at follow-up. Operative patients had a more negative body image of the axial skeleton in comparison with the braced and control groups. We conclude that transient psychological effects are often present during treatment, and a lower body image may persist for several years in surgical patients.

One hundred and two (92 per cent) of 111 immature patients in whom idiopathic scoliosis had been treated with a Milwaukee brace were followed to determine the effectiveness of the brace in preventing progression of the scoliosis. The average time from cessation of bracing until the latest radiographs were made for the patients who were managed non-operatively was six years and four months. The average progression of the curve, from the time of initial bracing until use of the brace was stopped, in the eighty-eight patients who were included in the statistical analysis was 4 degrees. The curve continued to progress an average of 5 degrees after use of the brace was stopped in the patients who did not have an arthrodesis. Forty-two patients (48 percent) had more than 5 degrees of progression at the time that use of the brace was stopped. Thirty-seven patients (42 per cent) had an operation or a curve of sufficient magnitude to warrant operative intervention. The maximum correction of the Cobb angle in the brace had prognostic importance for progression of the curve. The patients in whom the curve did not progress or who did not need operative intervention had had an average correction of 20 per cent, while the patients who had a failure had had an average correction of 8 per cent. The patients who eventually had the indications for an arthrodesis were on the average, one year younger (eleven years and none months) and had a curve of a larger magnitude at the time of bracing than the patients who did not need an arthrodesis. The findings of this study do not agree with previously reported favorable results with bracing and raise questions about whether the natural history of progressive idiopathic scoliosis is truly altered by use of the Milwaukee brace.