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Purpose To evaluate the effect of a programme of active self-correction and task-oriented exercises on spinal deformities and health-related quality of life (HRQL) in patients with mild adolescent idiopathic scoliosis (AIS) (Cobb angle <25°). Methods This was a parallel-group, randomised, superiority-controlled study in which 110 patients were randomly assigned to a rehabilitation programme consisting of active self-correction, task-oriented spinal exercises and education (experimental group, 55 subjects) or traditional spinal exercises (control group, 55 subjects). Before treatment, at the end of treatment (analysis at skeletal maturity), and 12 months later (follow-up), all of the patients underwent radiological deformity (Cobb angle), surface deformity (angle of trunk rotation) and HRQL evaluations (SRS-22 questionnaire). A linear mixed model for repeated measures was used for each outcome measure. Results There were main effects of time ( p  < 0.001), group ( p  < 0.001) and time by group interaction ( p  < 0.001) on radiological deformity: training in the experimental group led to a significant improvement (decrease in Cobb angle of >5°), whereas the control group remained stable. Analysis of all of the secondary outcome measures revealed significant effects of time, group and time by group interaction in favour of the experimental group. Conclusions The programme of active self-correction and task-oriented exercises was superior to traditional exercises in reducing spinal deformities and enhancing the HRQL in patients with mild AIS. The effects lasted for at least 1 year after the intervention ended.

Background The Cobb angle is proposed as the “disease process” outcome for scoliosis research because therapies aim to correct or stop curve progression. While the Scoliosis Research Society recommends the Cobb angle as the primary outcome, the Society on Scoliosis Orthopaedic and Rehabilitation Treatment prioritises, as a general goal, patient related outcomes over Cobb angle progression. Objective To determine the threshold of change in the Cobb angle in adolescents with idiopathic scoliosis (AIS) who perceive improvement in a 6-months randomized controlled trial comparing a Schroth exercise intervention added to the standard of care to the standard of care alone. Methods This is a secondary analysis of data from a randomized controlled trial of 50 patients with AIS, with curves ranging from 10° to 45°, with or without a brace. Participants with diagnoses other than AIS, surgical candidates or patients who had scoliosis surgery were excluded. The 6-month interventions consisted of Schroth exercises added to standard-of-care (observation or bracing) with daily home exercises and weekly therapy sessions (Schroth) or standard-of-care alone (Control). The anchor method for estimating the minimal important difference (MID) in the largest Cobb angles (LC) was used. Patient-reported change in back status over the 6-month treatment period was measured using the Global Rating of Change (GRC) scale as anchor varying from − 7 (“great deal worse”) to + 7 (“great deal better”). Participants were divided into two groups based on GRC scores: Improved (GRC ≥2) or Stable/Not Improved (GRC ≤1). MID was defined as the change in the LC that most accurately predicted the GRC classification as per the receiver operating characteristic curve (ROC). Results The average age was 13.4 ± 1.6 years and the average LC was 28.5 ± 8.8 °s. The average GRC in the control group was − 0.1 ± 1.6, compared to + 4.4 ± 2.2 in the Schroth group. The correlation between LC and GRC was adequate (r = − 0.34, p  < 0.05). The MID for the LC was 1.0 °. The area under the ROC was 0.69 (0.52–0.86), suggesting a 70% chance to properly classify a patient as perceiving No Improvement/Stable or Improvement based on the change in the LC. Conclusion Patients undergoing Schroth treatment perceived improved status of their backs even if the Cobb angle did not improve beyond the conventionally accepted threshold of 5°. Standard of care aims to slow/stop progression while Schroth exercises aim to improve postural balance, signs and symptoms of scoliosis. Given the very small MID, perceived improvement in back status is likely due to something other than the Cobb angle. This study warrants investigating alternatives to the Cobb angle that might be more relevant to patients. Trial registration ClinicalTrials.gov , NCT01610908 . Retrospectively registered on April 2, 2012 (first posted on June 4, 2012 - https://clinicaltrials.gov/ct2/keydates/NCT01610908 )

Purpose To assess the accuracy of O-arm-navigation-based pedicle screw insertion in dystrophic scoliosis secondary to NF-1 and compare it with free-hand pedicle screw insertion technique. Methods 32 patients with dystrophic NF-1-associated scoliosis were divided into two groups. A total of 92 pedicle screws were implanted in apical region (two vertebrae above and below the apex each) in 13 patients using O-arm-based navigation (O-arm group), and 121 screws were implanted in 19 patients using free-hand technique (free-hand group). The postoperative CT images were reviewed and analyzed for pedicle violation. The screw penetration was divided into four grades: grade 0 (ideal placement), grade 1 (penetration <2 mm), grade 2 (penetration between 2 and 4 mm), and grade 3 (penetration >4 mm). Results The accuracy rate of pedicle screw placement (grade 0, 1) was significantly higher in the O-arm group (79 %, 73/92) compared to 67 % (81/121) of the free-hand group ( P  = 0.045). Meanwhile, a significantly lower prevalence of grade 2–3 perforation was observed in the O-arm group (21 vs. 33 %, P  < 0.05), and the incidence of medial perforation was significantly minimized by using O-arm navigation compared to free-hand technique (2 vs. 15 %, P  < 0.01). Moreover, the implant density in apical region was significantly elevated by using O-arm navigation (58 vs. 42 %, P  < 0.001). Conclusion We reported 79 % accuracy of O-arm-based pedicle screw placement in dystrophic NF-1-associated scoliosis. O-arm navigation system does facilitate pedicle screw insertion in dystrophic NF-1-associated scoliosis, demonstrating superiorities in the safety and accuracy of pedicle screw placement in comparison with free-hand technique.

Purpose This study aimed to evaluate the efficacy of selecting the lowest instrumented vertebra (LIV) with extended upper instrumented vertebra (UIV) using the direct vertebral rotation (DVR) technique in patients with adolescent idiopathic scoliosis (AIS) Lenke type 5 C. Materials and methods A total of 120 patients with AIS Lenke 5 C with a lower-end vertebra (LEV) at L4 were prospectively enrolled and randomized into two groups based on the planned LIV: L3 ( n  = 44) or L4 ( n  = 50). All patients underwent posterior instrumentation with the DVR technique, with the upper instrumented vertebra (UIV) positioned at the upper end vertebra (UEV) + 1 or + 2. The final LIV was determined intraoperatively based on fluoroscopic assessment of disc alignment after DVR correction. Clinical and radiographic outcomes, including coronal balance, sagittal alignment, and complications, were evaluated preoperatively, at six months post-surgery, and at a minimum three-year follow-up. Result The mean follow-up duration was 39.8 ± 3 months for both groups, with no significant difference between them ( P  = 0.782). Coronal balance correction rates were comparable between the L3 and L4 groups, showing no significant differences at the final follow-up ( P  > 0.05). However, the number of fused segments differed significantly, with an average of 7.8 levels in the L3 group and 8.7 levels in the L4 group ( P  = 0.001). The distance between the central sacral vertical line (CSVL) and the L3 inner pedicle on convex side-bending films was the primary parameter for selecting L3 as the lowest instrumented vertebra (LIV). Notably, no complications such as adding-on or distal junctional kyphosis were observed in both groups. Conclusion Selecting the LIV at L3, when feasible based on intraoperative disc alignment, can preserve spinal mobility and reduce the number of fused segments without compromising correction outcomes. The CSVL-L3 inner pedicle distance on preoperative convex side-bending films is a useful predictor for the selection of appropriate LIV level for AIS Lenke 5 C with DVR. These findings highlight the importance of individualized LIV selection and intraoperative assessment in optimizing outcomes for patients with AIS Lenke 5 C. Additionally, raising the upper instrumented vertebra (UIV) enhances the correction of the thoracic curve, levels the rib hump, and improves shoulder balance in patients with AIS Lenke 5 C.

Adolescent Idiopathic Scoliosis (AIS) is a 3D deformity of the spine that affects 3% of the adolescent population. Conservative treatments like bracing aim to halt the progression of the curve to the surgical threshold. Computer-aided design and manufacturing (CAD/CAM) methods for brace design and manufacturing are becoming increasingly used. Linked to CAD/CAM and 3D radiographic reconstruction techniques, we developed a finite element model (FEM) enabling to simulate the brace effectiveness before its fabrication, as well as a semi-automatic design processes. The objective of this randomized controlled trial is to compare and validate such FEM semi-automatic algorithm used to design nighttime Providence-type braces. Fifty-eight patients with AIS aged between 10 to 16-years and skeletally immature will be recruited. At the delivery stage, all patients will receive both a Providence-type brace optimized by the semi-automatic algorithm leveraging a patient-specific FEM (Test) and a conventional Providence-type brace (Control), both designed using CAD/CAM methods. Biplanar radiographs will be taken for each patient with both braces in a randomized crossover approach to evaluate immediate correction. Patients will then be randomized to keep either the Test or Control brace as prescribed with a renewal if necessary, and will be followed over two years. The primary outcome will be the change in Cobb angle of the main curve after two years. Secondary outcomes will be brace failure rate, quality of life (QoL) and immediate in-brace correction. This is a single-centre study, double-blinded (participant and outcome assessor) randomized controlled trial (RCT). ClinicalTrials.gov: NCT05001568.

Idiopathic scoliosis is the most common spinal deformity in children. Treatment strategies aim to halt progression of the curve. Mild scoliosis is in many cases observed or, in some cases, treated with scoliosis-specific exercises. More severe curves are treated mainly with a brace. The aim of this study is to investigate the effectiveness of scoliosis-specific exercises compared to observation in adolescents with mild idiopathic scoliosis. Subjects. Previously untreated and skeletally immature children aged 9-15 years of age with idiopathic scoliosis (curve magnitude Cobb 15-24 degrees) will be included. A total of 90 subjects will be included to receive one of two possible interventions. Interventions. Both groups will receive a physical activity prescription according to the World Health Organization recommendations. The intervention group will receive an additional active self-correction treatment strategy for curve correction and will have outpatient sessions once every two weeks for the first three months. They will be prescribed to do the exercises at least three times per week. The intervention will be performed until skeletal maturity or progression of the curve. Outcome. The subjects will participate in the study until curve progression or until skeletal maturity (defined as less than 1 cm growth for six months). The primary outcome variable is failure of treatment, defined as progression of the Cobb angle more than 6 degrees on two consecutive x-rays compared to the baseline x-ray. Secondary outcome measures include patient-reported outcomes, clinical characteristics (i.e. angle of trunk rotation and trunk asymmetry) and number requiring brace treatment. Clinical follow-ups will be performed every six months and radiographs will be taken annually. This study will compare effectiveness of an active self-corrective exercise strategy in mild idiopathic scoliosis with observation in terms of halting curve progression.

IntroductionAdolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine. Brace treatment is effective for eligible patients with AIS and the effectiveness is significantly correlated with the average brace-wear time per day. Three-dimensional (3D) printing technology is a recent advancement that offers unique opportunities for biomedical applications, and customisation of scoliosis braces might lead to greater patient satisfaction and improved compliance. We present here the design of a randomised controlled trial on the clinical effectiveness of 3D-printed braces versus thoracolumbosacral orthoses (TLSO) for patients with AIS.Methods and analysisPatients with AIS (age 10–16 years) with Risser sign 0-II, Cobb angle of main curve of 20°−40°, premenarchal or no more than 1-year postmenarchal (for women), and no history of treatment are eligible, unless they are unable to tolerate the treatment or refuse participation. A total of 88 patients will be randomised into either the 3D group or TLSO group on a 1:1 basis. Participants in the 3D group will choose between a 3D-printed brace and TLSO, according to the Zelen’s design of the trial. Primary outcome measures will include the average brace-wear time per day, health-related quality of life and Cobb angle progression of the primary curve. Secondary outcome measures will include immediate in-brace correction of Cobb angle of the primary curve, rate of conversion to surgery and incidence of any adverse events. This study is designed as a single-centre, two-arm, superiority and open-label randomised controlled trial. The sample size is calculated with reference to the preliminary study and based on the sample size calculation formula.Ethics and disseminationThis study was approved by the Peking University Third Hospital Medicine Science Research Ethics Committee (No: 2019-017-02). Results of the trial will be submitted for publication in a peer-reviewed journal and as conference presentations.Trial registration numberChiCTR1900027379, pre-results.

Objective. Adolescent idiopathic scoliosis (AIS) affects 1%-4% of adolescents in the early stages of puberty, but there is still no effective prediction method. This study aimed to establish a prediction model and validated the accuracy and efficacy of this model in predicting the occurrence of AIS. Methods. Data was collected from a population-based school scoliosis screening program for AIS in China. A sample of 884 children and adolescents with the radiological lateral Cobb angle≥10° was classified as an AIS case, and 895 non-AIS subjects with a Cobb angle<10° were randomly selected from the screening system. All selected subjects were screened by visual inspection of clinical signs, the Adam’s forward-bending test (FBT), and the measurement of angle of trunk rotation (ATR). LR and receiver operating characteristic (ROC) curves were used to preliminarily screen the influential factors, and LR models with different adjusted weights were established to predict the occurrence of AIS. Results. Multivariate LR and ROC curves indicated that angle of thoracic rotation (adjusted odds ratios AOR=5.18−10.06), angle of thoracolumbar rotation (AOR=4.67−7.22), angle of lumbar rotation (AOR=6.97−8.09), scapular tilt (area under the curve AUC=0.77, 95% CI: 0.75-0.80), shoulder-height difference, lumbar concave, and pelvic tilt were the risk predictors for AIS. LR models with different adjusted weights (by AOR, AUC, and AOR+AUC) performed similarly in predicting the occurrence of AIS compared with multivariate LR. The sensitivity (82.55%-83.27%), specificity (82.59%-83.33%), Youden’s index (0.65-0.67), positive predictive value (82.85%-83.58%), negative predictive value (82.29%-83.03%), and total accuracy (82.57%-83.30%) manifested that LR could accurately identify patients with AIS. Conclusions. LR model is a relatively high accurate and feasible method for predicting AIS. Increased performance of LR models using clinically relevant variables offers the potential to early identify high-risk groups of AIS.

IntroductionMinimally invasive spine surgery (MISS) has been shown to be safe and effective in adolescent idiopathic scoliosis (AIS) correction, even though there is no consensus on which treatment provides the best results.Methods and analysisThe present study will be a randomised controlled trial with allocation 1:1. We will enrol 126 patients with Cobb≤70° undergoing AIS surgery. Patients will be divided into two groups, according to a randomisation list unknown to the surgeons. Group 1 will be treated with posterior spine fusion and group 2 with MISS. MISS technique: two midline noncontiguous skin incisions of 3 cm in length, 3–4 segments (6–8 pedicles screws) instrumented per skin incision, uniplanar and polyaxial pedicle screws inserted bilaterally on each side of the proximal and distal levels, rod translation manoeuvre and C–D manoeuvre performed on the distal part. Clinical and radiological follow-ups will be performed for 5 years. Values of Cobb angles degrees will be collected to study the correction rate of the structural major curve. Postoperative and preoperative anterior-posterior (AP) direct radiography will be compared with the last follow-up examination. Operative time, preoperative haemoglobin (Hb) and second postoperative day Hb, full length of hospitalisation, time to achieve verticalisation and time to remove the drainage will be recorded. Numeric Rating Scale (NRS) medium score will be assessed immediately after surgery and during the whole postoperative rehabilitation treatment to estimate pain reduction. Complications will be collected postoperatively and throughout the whole follow-up period.Moreover, questionnaires will be administered at follow-up (NRS, Scoliosis Research Society-22 and Oswestry Disability Index) for the clinical assessment.Ethics and disseminationThe study protocol has been approved by the local ethic committee Area Vasta Emilia Romagna Centro. Written informed consent will be collected for all the participants. Findings of this study will be disseminated through peer-reviewed publications and conference presentations.Trial registration number NCT05860673.

Purpose A hands-on-wall (HOW) position for low-dose stereoradiography of adolescent idiopathic scoliosis (AIS) patients would allow for skeletal maturity assessment of the hand and wrist. Our aims were twofold: confirm the reliability and validity of skeletal maturity assessment using the HOW radiographs and compare the spinal and pelvic 3D parameters to those of standard hands-on-cheeks (HOC) stereoradiographs. Methods Seventy AIS patients underwent two successive stereoradiographs and a standard hand and wrist radiograph on the same day. Patients were randomly assigned to begin with HOW and follow with HOC, or vice versa. Raters assessed digital skeletal age (DSA), Sanders Simplified Skeletal Maturity (SSMS) and Thumb Ossification Composite Index (TOCI). 3D reconstructions of the spine and pelvis bones were performed for each stereoradiograph to measure nine clinically relevant spinal and pelvic 3D parameters. Results Inter-rater and intra-rater reliabilities were excellent for DSA, SSMS and TOCI with both standard radiographs and HOW (ICC > 0.95). Strong correlation was found between ratings of both imaging types (ICC > 0.95). In the 3D reconstructions, kyphosis and sacral slope were slightly decreased in the HOW position, but within the clinical margin of error. All other parameters did not differ significantly between positions ( p  < 0.05). Conclusion The results suggest that HOW stereoradiographs allow clinicians to assess skeletal maturity of the hand and wrist with adequate reliability and validity. We recommend that scoliosis clinics adopt the HOW position to assess skeletal maturity because there is no significant clinical impact on the spinal and pelvic evaluation, and on radiation exposure, cost or time.