PReventing Idiopathic SCOliosis PROgression (PRISCOPRO): A protocol for a quadruple-blinded, randomized controlled trial comparing 3D designed Boston brace to standard Boston brace

Introduction Idiopathic scoliosis is the most common spinal deformity in children. Treatment strategies aim to halt progression of the curve. Patients are treated mainly with thoracolumbosacral orthosis (TLSO) if indicated. This form of brace treatment has been shown to be cumbersome and tough on growing individuals. However, computer aided design and manufactured (CAD/CAM) braces might increase comfortability and ultimately outcome if compliance is improved. In a multicenter, randomized controlled trial, we aim to compare CAD/CAM designed Boston 3D-brace to standard Boston brace. Methods Subjects: 170 previously untreated and skeletally immature children diagnosed with idiopathic scoliosis, aged 9–17 years of age (curve magnitude Cobb 25–40 degrees) will be included. Interventions: Both groups will receive a physical activity prescription according to the World Health Organization recommendations. Randomization will be performed 1:1 to a 3D CAD/CAM designed Boston 3D-brace or a standard Boston brace, both with prescribed daily wear time of 20 hours. Outcome: The subjects will participate in the study until curve progression or until skeletal maturity. The primary outcome variable is failure of treatment, defined as progression of the Cobb angle more than 6 degrees compared to the baseline x-ray. The progression is confirmed if seen on two consecutive standing spinal x-rays. Radiographs will be taken at each six-month follow-up. Secondary outcome measures include patient and clinical reported outcomes, including number of individuals requiring surgical intervention. Discussion This study will show if efficacy in brace treatment can be improved with new brace designs. Trial registration The protocol has been registered on ClinicalTrials.gov, identifier: NCT04805437.

Ist eine Verbesserung der Behandlungssicherheit in der Korsettversorgung von Skoliosepatienten durch Anwendung standardisierter CAD-Algorithmen möglich?

Zusammenfassung Hintergrund Die Versorgung von Skoliosepatienten mit korrigierenden Rumpforthesen führt auch heutzutage noch zu recht unterschiedlichen Ergebnissen. Publizierte Erfolgsquoten zwischen 50 und 90 % führen zwangsläufig zu der Frage, wie sich die Erfolgsquoten der Korsettversorgung steigern und vereinheitlichen lassen. Die Ergebnisse einer mit dieser Zielsetzung weiterentwickelten computerunterstützen (CAD/„Computer Aided Design“) Chêneau-Versorgung werden dargestellt. Methodik Am Stichtag (08.12.2019) wurde die prospektiv angelegte Datenbank unserer Abteilung retrospektiv ausgewertet. Es waren ausschließlich unreife Mädchen mit einer Adoleszentenskoliose, Alter 10–14 Jahre, Risser 0–2 in die Datenbank aufgenommen worden. Ergebnisse Sowohl die Gesamtgruppe mit einem Beobachtungszeitraum von mindestens 18 Monaten als auch die Patientinnengruppen mit bereits erreichtem Behandlungsabschluss zeigten Erfolgsraten zwischen 86 und 88 %. Die Ergebnisse insgesamt waren signifikant besser als die Erfolgsrate der Boston-Brace-Kontrollgruppe (BRAIST) von 72 %. Auch im Vergleich mit den Ergebnissen anderer Chêneau-Derivate war die Erfolgsrate unserer Serie teils deutlich besser. Schlussfolgerungen Die Behandlungssicherheit für die Patienten mit Skoliosen sollte verbessert werden. Ein Ansatz hierzu kann die Verwendung standardisierter CAD-Bibliotheken sein. Weitere Untersuchungen mit Studiendesigns höherer Evidenz sind notwendig, um die in unserer Untersuchung gefundenen Ergebnisse zu untermauern.

Radiographic Outcomes of Immobilization using Boston Brace for Pediatric Spondylolysis

Background and Aims: Spondylolysis is a common cause of lower back pain during youth. The aim of this study is to report the bony union rate and risk factors for non-union of the lumbar spondylolysis of pediatric patients treated with a rigid thoracolumbosacral orthosis (Boston brace). Materials and Methods: A retrospective review of 68 children (mean age = 13.9 years) treated for spondylolysis with a thoracolumbosacral orthosis. Patient charts and imaging studies were evaluated to identify the bony union rate of the spondylolysis after a minimum of 3 months of immobilization (mean = 4.2 months). Laterality, grade, level, and presence of high signal intensity in the magnetic resonance imaging were evaluated as prognostic factors. Results: Sixty-eight patients presented with 110 defects. Of them, 46 (42%) were incomplete fractures, 38 (35%) complete fractures, and 26 (24%) pseudoarthrosis. Of these defects, 38 (82.6%), 11 (28.9%), and 0 (0.0%) had bony union at the end of the treatment (p < 0.001). Unilateral defects healed significantly better than bilateral ones (relative risk = 1.71, 95% confidence interval = 1.16–2.54, 17/26 (65%) vs 32/84 (38%), p = 0.014). High signal intensity in the magnetic resonance images before the treatment predicted healing (relative risk = 13.24, 95% confidence interval = 1.93–91.01, 48/87 (55%) vs 1/24 (4.3%), p < 0.001). The level of the spondylolysis (L5 vs above L5) did not affect the healing rate. Conclusion: The union rates of spondylolysis with a thoracolumbosacral orthosis were similar as compared to earlier studies done with a low thoracolumbosacral orthosis. The grade of the defect, laterality, and presence of high signal intensity increased the probability of bony union. A high thoracolumbosacral orthosis (underarm) does not seem to improve the healing rate of pediatric spondylolysis defects.

Conservative treatment of main thoracic adolescent idiopathic scoliosis: Full-time or nighttime bracing?

Purpose: To compare treatment efficacy between the Boston full-time brace and the Providence part-time brace in main thoracic adolescent idiopathic scoliosis (AIS). Methods: Patients were treated with either the Boston brace ( n = 37) or the Providence brace ( n = 40). Inclusion criteria were Risser grade ≤2, major curve between 25° and 40° with the apex of the curve between T7 and T11 vertebrae. Two-year follow-up was available in all patients unless brace treatment had reached endpoint. The primary outcome measure was main curve progression to ≥45°. Results: Median age was 12.6 years and median treatment length at follow-up was 25 months (interquartile range (IQR): 18–32)) with no difference between the groups ( p ≥ 0.116). Initial median main Cobb angle was 29° (IQR: 27–33) and 36° (IQR: 33–38) in the Boston and Providence groups, respectively ( p < 0.001). At follow-up, 13 patients (35%) had progressed to ≥45° in the Boston group versus 16 patients (40%) in the Providence group ( p = 0.838). Twenty-three patients (62%) had progressed by more than 5° in the Boston group versus 22 patients (55%) in the Providence group ( p = 0.685). The secondary thoracolumbar/lumbar curve progressed by more than 5° in 14 (38%) and 18 (45%) in the Boston and Providence groups, respectively ( p = 0.548). Conclusions: Despite a larger initial curve size in the Providence group, progression of more than 5° or to surgical indication area was similar in the Boston group. Our results indicate that nighttime bracing is a viable alternative to full-time bracing also in main thoracic AIS.

RADIOGRAPHIC EVALUATION OF THORACOLUMBAR STABILIZATION USING TWO DIFFERENT ORTHOSIS SYSTEMS

ABSTRACT Objective: To evaluate radiographically the stability of the thoracolumbar junction comparing the two types of thoracolumbosacral orthosis (TLSO) most used in our environment, the Jewett and the Boston braces. Methods: After approval by the institutional review board, nine participants were submitted to X-rays in the profile view, with the beam focused on T12, in the orthostatic position, maximal flexion without brace and maximal flexion with the Jewett and the Boston braces. The Cobb angle of the thoracolumbar junction (T10-L2) was measured and the values compared using the student T test (p <0.05). Results: The Boston brace promoted greater stabilization of the thoracolumbar junction during flexion of the trunk compared to the Jewett brace (p <0.05). In addition, there was no statistical difference in the Cobb angle of the thoracolumbar junction in the orthostatic (neutral) position and in flexion using the Boston brace. Conclusion: The Boston brace presented greater stabilization of the thoracolumbar region during flexion of the trunk compared to the Jewett brace. Level of Evidence II; Prospective comparative study.

The effect of spinal bracing on sitting function in children with neuromuscular scoliosis

Background: Scoliosis is common in children with neuromuscular deficits. It is often associated with an asymmetric sitting position and with poor balance. Many children with neuromuscular scoliosis spend most of their day sitting. Objectives: To describe how sitting function is affected by treatment with a modified custom-moulded Boston brace in children with neuromuscular scoliosis. Study design: Retrospective review of medical records. Methods: A review of medical records from children fitted with scoliosis braces, including analysis of sitting, using a pressure-mapping system. Results: A total of 106 children with a median age of 11.3 (1.7–17.7) years were included. The most frequent diagnoses were cerebral palsy ( n = 33) and myelomeningocele ( n = 17). Around 56 children could sit without support and 24 children were independent walkers. The Cobb angle was between 19° and 126°. Sitting function as noted in medical records improved in 73/105 children and deteriorated in five. The pressure mapping showed that symmetry was improved in 44/86 children, while three deteriorated. Stability improved in 20/40 children and seven decreased. Conclusion: Bracing had a positive effect on sitting function in children with neuromuscular scoliosis. Clinical relevance Bracing can reduce the need for support in sitting. Children with severe scoliosis can get a better sitting function with a brace. Sitting analysis with pressure mapping can identify sitting problems needing correction of the brace and adaptations of the chair.