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

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European Journal of Orthopaedic Surgery & Traumatology Aims and scope Submit manuscript

Abstract

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.

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Data availability

The datasets generated during an/or analyzed during the current study are available from the corresponding author on reasonable request.

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Funding

This research was funded by KKH Health Endowment Fund Research Grant (Grant Number: KKHHEF/2016/11).

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Authors and Affiliations

  1. Department of Orthopaedic Surgery, KK Women’s and Children’s Hospital, Singapore, Singapore

    Kevin Boon Leong Lim

  2. Division of Surgery, KK Women’s and Children’s Hospital, Singapore, Singapore

    Kevin Boon Leong Lim & Nicole Kim Luan Lee

  3. Orthopaedia Singapore, Singapore, Singapore

    Heidi Ka Wing Mak

  4. Speciality & Ambulatory Services Division, KK Women’s and Children’s Hospital, Singapore, Singapore

    Siti Hauzah Abdul Rahaman, Ling Ling Ong & Shi Yang Jess Ooi

Authors
  1. Kevin Boon Leong Lim
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  2. Heidi Ka Wing Mak
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  3. Siti Hauzah Abdul Rahaman
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  4. Ling Ling Ong
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  5. Shi Yang Jess Ooi
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  6. Nicole Kim Luan Lee
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Contributions

All authors contributed to the study conception and design. Material presentation, data collection and analysis were performed by Kevin Boon Leong Lim, Heidi Ka Wing Mak, Siti Hauzah Abdul Rahaman, Ling Ling Ong, Jess Shi Yang Ooi, and Nicole Kim Luan Lee. The first draft of the manuscript was written by Kevin Boon Leong Lim, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Nicole Kim Luan Lee.

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Conflict of interest

The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Ethics approval

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by SingHealth Centralized Institutional Review Board (CIRB) (Reference Number: 2016/3074).

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Lim, K.B.L., Mak, H.K.W., Abdul Rahaman, S.H. et al. A pilot study on the “ScoliBrace” in the treatment of adolescent idiopathic scoliosis. Eur J Orthop Surg Traumatol (2024). https://doi.org/10.1007/s00590-024-03845-6

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  • DOI: https://doi.org/10.1007/s00590-024-03845-6

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