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. 2020 Nov 27;10(11):e038373.
doi: 10.1136/bmjopen-2020-038373.

3D-printed brace in the treatment of adolescent idiopathic scoliosis: a study protocol of a prospective randomised controlled trial

Youyu Zhang #  1 , Junyang Liang #  2 , Nanfang Xu  3 , Lin Zeng  4 , Chaojun Du  5 , Yaoxu Du  5 , Yan Zeng  1 , Miao Yu  1 , Zhongjun Liu  1
Affiliations

3D-printed brace in the treatment of adolescent idiopathic scoliosis: a study protocol of a prospective randomised controlled trial

Youyu Zhang et al. BMJ Open. .

Abstract

Introduction: Adolescent 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 analysis: Patients 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 dissemination: This 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 number: ChiCTR1900027379, pre-results.

Keywords: clinical trials; paediatric orthopaedics; scoliosis.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Study design. 3D, three-dimensional; TLSO, thoracolumbosacral orthoses.
Figure 2
Figure 2
Three-dimensional-printed brace design.
Figure 3
Figure 3
Immediate correction of three-dimensional-printed brace.
See this image and copyright information in PMC

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References

    1. Negrini S, Minozzi S, Bettany-Saltikov J, et al. . Braces for idiopathic scoliosis in adolescents. Spine 2016;41:1813–25. 10.1097/BRS.0000000000001887 - DOI - PubMed
    1. Kalichman L, Kendelker L, Bezalel T. Bracing and exercise-based treatment for idiopathic scoliosis. J Bodyw Mov Ther 2016;20:56–64. 10.1016/j.jbmt.2015.04.007 - DOI - PubMed
    1. Negrini S, Donzelli S, Aulisa AG, et al. . 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord 2018;13:3. 10.1186/s13013-017-0145-8 - DOI - PMC - PubMed
    1. Vigneswaran HT, Grabel ZJ, Eberson CP, et al. . Surgical treatment of adolescent idiopathic scoliosis in the United States from 1997 to 2012: an analysis of 20,346 patients. J Neurosurg Pediatr 2015;16:322–8. 10.3171/2015.3.PEDS14649 - DOI - PubMed
    1. Nachemson AL, Peterson LE. Effectiveness of treatment with a brace in girls who have adolescent idiopathic scoliosis. A prospective, controlled study based on data from the brace study of the scoliosis research Society. J Bone Joint Surg Am 1995;77:815–22. 10.2106/00004623-199506000-00001 - DOI - PubMed

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