https://www.ipd.gu.se/digitalAssets/1252/1252566_Artikel_sept_Aina_Lancet_2_.pdf

Adolescent idiopathic scoliosis.

Study Design. Literature review. Objective. To establish consistent parameters for future adolescent idiopathic scoliosis bracing studies so that valid and reliable comparisons can be made. of Background Data. Current bracing literature lacks consistency for both inclusion criteria and the definitions of brace effectiveness. Methods. A total of 32 brace treatment studies and the current bracing in adolescent idiopathic scoliosis proposal were analyzed to: (1) determine inclusion criteria that will best identify those patients most at risk for progression, (2) determine the most appropriate definitions for bracing effectiveness, and (3) identify additional variables that would provide valuable information. Results. Early brace studies lacked clarity in their inclusion criteria. In more recent studies, inclusion criteria have narrowed considerably to include primarily those patients most at risk for curve progression who may benefit from the use of a brace. Brace effectiveness was usually defined by various degrees of curve progression at maturity. Less frequently, it was defined by the resultant curve magnitude at maturity, whether or not surgical intervention was needed, or if there was change to another brace. Conclusions. Optimal inclusion criteria for future adolescent idiopathic scoliosis brace studies consist of: age is 10 years or older when brace is prescribed, Risser 0-2, primary curve angles 25°-40°, no prior treatment, and, if female, either premenarchal or less than 1 year postmenarchal. Assessment of brace effectiveness should include: (1) the percentage of patients who have ≤5° curve progression and the percentage of patients who have a6° progression at maturity, (2) the percentage of patients with curves exceeding 45° at maturity and the percentage who have had surgery recommended/undertaken, and (3) 2-year follow-up beyond maturity to determine the percentage of patients who subsequently undergo surgery. All patients, regardless of subjective reports on compliance, should be included in the results (intent to treat). Every study should provide results stratified by curve type and size grouping.

/pdf/standardization-of-criteria-for-adolescent-idiopathic-5gspg2h4gm.pdf

Standardization of criteria for adolescent idiopathic scoliosis brace studies: SRS Committee on Bracing and Nonoperative Management.

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.

Surgical rates after observation and bracing for adolescent idiopathic scoliosis: an evidence-based review.

Background: The efficacy of brace treatment for patients with adolescent idiopathic scoliosis remains controversial, and effectiveness remains unproven. We accurately measured the number of hours of brace wear for patients with this condition to determine if increased wear correlated with lack of curve progression.

Methods: Of 126 patients with adolescent idiopathic scoliosis curves measuring between 25° and 45°, 100 completed a prospective study in which they were managed with a Boston brace fitted with a heat sensor that measured the exact number of hours of brace wear. Orthopaedic teams prescribed either sixteen or twenty-three hours of brace wear and were blinded to the wear data. At the completion of treatment, the number of hours of brace wear were compared with the frequency of curve progression of ≥6° and with curve progression requiring surgery.

Results: The total number of hours of brace wear correlated with the lack of curve progression. This effect was most significant in patients who were at Risser stage 0 (p = 0.0003) or Risser stage 1 (p = 0.07) at the beginning of treatment and in patients with an open triradiate cartilage at the beginning of treatment. Logistic regression analyses showed a “dose-response” curve in which the greater number of hours of brace wear correlated with lack of curve progression. Brace wear to school and immediately afterward was most successful. Curves did not progress in 82% of patients who wore the brace more than twelve hours per day, compared with only 31% of those who wore the brace fewer than seven hours per day (p = 0.0005). The number of hours of brace wear also correlated inversely with the need for surgical treatment (p = 0.0005). The number of hours of wear were similar for the patients who were advised to wear the brace sixteen or twenty-three hours daily.

Conclusions: The Boston brace is an effective means of controlling curve progression in patients with adolescent idiopathic scoliosis when worn for more than twelve hours per day.

Level of Evidence: Therapeutic Level II. See Instructions to Authors for a complete description of levels of evidence.

Brace Wear Control of Curve Progression in Adolescent Idiopathic Scoliosis

#### Summary points

Scoliosis is a three dimensional deformity of the spine defined as a lateral curvature of the spine in the coronal plane of more than 10°.1 It can be categorised into three major types—congenital, syndromic, and idiopathic. Congenital scoliosis refers to spinal deformity caused by abnormally formed vertebrae. Syndromic scoliosis is associated with a disorder of the neuromuscular, skeletal, or connective tissue systems; neurofibromatosis; or other important medical condition. Idiopathic scoliosis has no known cause and can be subdivided based on the age of onset—infantile idiopathic scoliosis includes patients aged 0-3 years, juvenile idiopathic scoliosis includes patients aged 4-10 years, and adolescent idiopathic scoliosis affects people aged >10 years.

Adolescent idiopathic scoliosis (AIS) is the most common spinal deformity seen by primary care physicians, paediatricians, and spinal surgeons.2 This review is focused on AIS and reviews the diagnosis, management, and controversies surrounding this condition based on the available literature.

#### Sources and selection criteria

We searched Medline and the Cochrane Library using MeSH terms “adolescent idiopathic scoliosis”, and “scoliosis bracing”. We included systematic reviews, randomised controlled trials, and good quality prospective observational studies mainly from the past 15 years but did not …

Study design A prospective study was conducted of 102 consecutive female patients with adolescent idiopathic scoliosis. Those patients with Risser 0, 1, and 2 met the criteria for inclusion and were treated only with the Providence brace. Objectives To report the authors' experience with a hypercorrective nighttime brace and to evaluate the results with respect to risk factors for progression. Second, the study compares results with expectations from the natural history as reported by others. Summary of background data Compliance with full-time brace treatment for adolescent idiopathic scoliosis has been a problem. Since the introduction of the Milwaukee brace, alternatives such as low-profile braces, reduced wearing schedules, and nighttime only bracing have been tried. However, many factors influence the success or failure besides compliance. These include in-brace correction, brace design, and the orthotist's skills. This is the first report of the results of treatment with a new nighttime brace that is made with CAD/CAM technology that can achieve higher initial in-brace corrections than other reported methods. Methods Results were analyzed with respect to curve size, curve pattern, maturity, and level of the primary curve apex. Both compliant and noncompliant patients were included in the analysis. A univariate analysis was done on those factors thought to influence success with bracing using the Pearson chi2 test. Results The average initial in-brace correction with a supine radiograph was 96% for major curves and 98% for minor curves. Seventy-five patients (74%) did not progress >5 degrees and 27 patients (26%) progressed > or =6 degrees or went on to surgery. Twenty-nine percent of Risser 0 or 1 patients progressed and 17% of patients Risser 2 progressed. The risk of progression anticipated by natural history data, which included all curve patterns, was 68% for Risser 0 and 1 and 23% for Risser 2. Risser 3 and 4 patients were excluded from the study. Seventy-six percent of patients with curve apexes between T8 and L1 had successful outcomes using the Providence brace. This is compared with a 74% success rate in the prospective Scoliosis Research Society study of patients wearing a thoraco lumbar sacral orthosis for 16 hours per day with curve apexes between T8 and L1. With the Providence brace, 63% of thoracic curves and 65% of double curves were successful. Ninety-four percent of lumbar curves and 93% of thoracolumbar curves were successful. Conclusion Excellent initial in-brace correction of adolescent idiopathic scoliosis was observed with this computer-designed and manufactured recumbent brace. Patients with high apex curves cephalad to T8 (n = 31) had a success rate of 61% compared with a success rate of 79% (n = 71) if the apex was at or below T9. Compared with previous natural history and the prospective study data, the Providence brace is effective in preventing progression of adolescent idiopathic scoliosis for curves 35 degrees (n = 8) is too small to validate its effectiveness for larger curves with a higher apex.

Barry McCoy

Papers

Nighttime bracing with the Providence brace in adolescent girls with idiopathic scoliosis.