In this study comparing bracing with observation for treatment of adolescent idiopathic scoliosis (including a randomized cohort and a cohort treated according to patient preference), bracing was ...associated with significantly less progression to a curve requiring surgery.
Adolescent idiopathic scoliosis is characterized by a lateral curvature of the spine with a Cobb angle of more than 10 degrees and vertebral rotation. Whereas scoliosis develops in approximately 3% of children younger than 16 years of age, only 0.3 to 0.5% have progressive curves requiring treatment.
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Curves larger than 50 degrees are associated with a high risk of continued worsening throughout adulthood and thus usually indicate the need for surgery.
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In the United States in 2009, there were more than 3600 hospital discharges for spinal surgery to correct adolescent idiopathic scoliosis, the total costs of which (approximately $514 million) . . .
Adolescent idiopathic scoliosis Weinstein, Stuart L, Dr; Dolan, Lori A, PhD; Cheng, Jack CY, MD ...
The Lancet (British edition),
05/2008, Letnik:
371, Številka:
9623
Journal Article
Recenzirano
Summary 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.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.SampleBraced patients, aged 10 to 15, Risser <3, Cobb 20°- to 40°, observed to Cobb ≥40° and/or ≥Risser 4 selected from prospective databases. ComparatorsBracing 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.” OutcomeTreatment failure (Cobb ≥40 before Risser 4). StatisticsComparison 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 wear18.31 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 Evidence3
BACKGROUND:Despite widespread use of single-stage open reduction and pelvic osteotomy for treatment of developmental dysplasia of the hip (DDH) after walking age, this aggressive strategy remains ...controversial. We directly compared dislocated hips treated with closed reduction (CR) to those treated with open reduction and Salter innominate osteotomy (OR/IO) to estimate the relative hazard of total hip arthroplasty (THA) and the THA-free survival time.
METHODS:In a series of patients 18 to 60 months of age, 45 patients (58 hips) underwent CR and 58 patients (78 hips) were treated with OR/IO and followed to a minimum 40 years post-reduction. Observations in the survival analysis were censored if no THA had occurred by 48 years. Multivariate Cox regression analysis was used to estimate the hazard of THA given treatment, age, and bilaterality. Complications and additional procedures were noted.
RESULTS:At 48 years of follow-up, 29 (50%) of the hips survived after CR compared with 54 (69%) after OR/IO. At 45 years, the survival probability after OR/IO was 0.63 (95% confidence interval CI = 0.50 to 0.78) compared with 0.55 (95% CI = 0.43 to 0.72) after CR. The hazard ratio (HR) of THA was modeled as a function of treatment, age at reduction, and bilaterality. The effect of age and treatment on the outcome of hips in patients with unilateral involvement was minimal. However, age did significantly alter the relationship between treatment and outcome in bilateral cases. In the bilateral group, the predicted HR of THA was lower after CR in hips that were reduced at the age of 18 months (HR = 0.16, 95% CI = 0.04 to 0.64) but higher in those that were reduced at 36 months (HR = 4.23, 95% CI = 2.00 to 8.95). Additional procedures were indicated for 17% and 22% of hips after CR and OR/IO, respectively.
CONCLUSIONS:Osteoarthritis and THA was more likely after CR than OR/IO, but the data do not indicate a difference in unadjusted hip-survival time. In patients with bilateral disease, an older age at reduction was associated with an increased hazard of THA after CR than after OR/IO. Both treatments provided substantial benefit relative to the natural history of DDH, but THA is the expected outcome in middle adulthood.
LEVEL OF EVIDENCE:Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
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 followsmajor 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.
: Systematic review of clinical studies.
: To develop a pooled estimate of the prevalence of surgery after observation and after brace treatment in patients with adolescent idiopathic scoliosis ...(AIS).
: 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.
: 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).
: 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.
: 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.
Descriptive.
To describe the design and development of Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST).
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?
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.
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.
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.
N/A.
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 Evidence2
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