A pilot study on the “ScoliBrace” in the treatment of adolescent idiopathic scoliosis

• Published in: European journal of orthopaedic surgery & traumatology 2024-05, Vol.34 (4), p.1803-1809
• Main Authors: Lim, Kevin Boon Leong, Mak, Heidi Ka Wing, Abdul Rahaman, Siti Hauzah, Ong, Ling Ling, Ooi, Shi Yang Jess, Lee, Nicole Kim Luan
• Format: Article
• Language: English
• Subjects: Medicine; Medicine & Public Health; Original Article; Patient satisfaction; Pilot projects; Scoliosis; Surgical Orthopedics; Traumatic Surgery
• ISSN: 1432-1068; 1633-8065; 1432-1068
• DOI: 10.1007/s00590-024-03845-6

Purpose Bracing for adolescents with idiopathic scoliosis (AIS) is a treatment option to prevent curve progression to surgical level. This study aimed to assess the efficacy of a 3D fully customized over corrective brace, “ScoliBrace,” an orthosis treatment for AIS. Methods This was a prospective pilot study of AIS female patients with inclusion criteria followed recommended Scoliosis Research Society (SRS) Guidelines. Cobb angles measured at: baseline (T0), 21 months (T5-2), skeletal maturity (T6), 6 months post-brace (T7), along with hours of brace wear using a thermal sensor and health-related quality of life (HRQoL) using the SRS-22r questionnaire. Results A total of 30 female AIS patients with mean age 11.85 ± 0.68 years, predominantly Risser 0 (70%), and median Cobb angle 29° were recruited; 21 patients were included for the final analysis. Results showed significant difference in Cobb angle between T0 and T5-2 (median = 22.5° vs. 28.5°, p  = 0.0082). 57.14% had reduction in Cobb angle by ≥ 5° at skeletal maturity. Cobb angle reduced 0.794° for each additional hour of dosage ( p  = 0.036, 95% CI =  − 1.532°, − 0.056°). Although pain level was increased at T6 (4.37 ± 0.51vs.4.70 ± 0.41, p  = 0.014), patients reported significantly greater satisfaction with management of their condition (3.90 ± 0.90vs.3.29 ± 0.88, p  = 0.020). Conclusion Results show similar findings to the BRAIST study, whereby curves remained under surgical threshold and showed improvement. More than half had curve reduction of ≥ 5° at skeletal maturity. Increased dose was also associated with improved outcomes. Using “ScoliBrace” as a non-surgical treatment, maintained curves below surgical threshold and showed curve reduction, improving patient satisfaction with management.