Clinical trial NCT03298256: Three-dimensional Effects of Bracing in Adolescent Idiopathic Scoliosis
Official title: Three-dimensional Effects of Bracing in Adolescent Idiopathic Scoliosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Idiopathic Scoliosis
Keywords: AIS
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 53
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted in the Department of Orthopaedics and Traumatology, The University of Hong Kong.

Brief summary: This study intends to investigate the three dimensional (3D) effect of bracing on the adolescent idiopathic scoliosis (AIS). In particular, it will look at the relationship between frontal deformity correction and changes in the sagittal profile and apical vertebral rotation (AVR) during bracing. The investigators hypothesise that if the thoracic frontal deformity can be controlled with bracing, there will be spontaneous correction of the sagittal plane and rotation deformity through coupling.

Detailed description: Scoliosis is a 3D deformity of the spine with curvatures occurring in three planes.

The efficacy of bracing in correcting the frontal deformity is now well-accepted after the Bracing in Adolescent Idiopathic Scoliosis Trial (BRAIST). Restoration of the sagittal alignment is one of the fundamental goals in scoliosis treatment. The investigators have previously demonstrated on fulcrum bending radiographs that there is coupling between the frontal deformity, thoracic kyphosis and apical vertebral derotation. The investigators' findings suggest that there may be natural coupling of the frontal and sagittal deformities towards "self-normalisation" during correction of the curves. The effect of bracing on the sagittal alignment and 3D deformity in scoliosis is currently not well-understood. If there is a tendency for the natural curve behaviour to return towards a more normal sagittal alignment, then bracing may exert a similar effect on the 3D profile. Understanding how the 3D deformity is affected by bracing allows further insight into curve progression and brace effectiveness.

Few studies in the literature have addressed the sagittal profile and 3D correction by bracing. Of those, the findings were based on vertebral reconstructions obtained from CT-scan, finite element analysis modelling, or studying the changes in the rib cage rotation. However, the investigators propose to measure the 3D profile using the modern EOS ® system, which allows biplanar radiography and 3D calculations and a more accurate measurement of vertebral wedging.

Eligibility criteria: Inclusion Criteria:

-Diagnosis of Lenke type 1 AIS who fulfil the normal criteria for bracing

Exclusion Criteria:

* if the aetiology of the scoliosis is not idiopathic
* does not belong to Lenke type 1
* previous treatment with a brace
* severe presentation requiring surgical intervention
* unavailable for regular follow-up
* parents are unable to give informed consent

Primary outcomes:
measure: Compare change in three dimensional (3D) effect of bracing on the adolescent idiopathic scoliosis (AIS) using the EOS Imaging System
timeFrame: Follow-up to 3 years
Secondary outcomes:
measure: Measure health-related quality of life outcome by the 22-item Scoliosis Research Society questionnaire (SRS-22) of patients with adolescent idiopathic scoliosis (AIS)
timeFrame: Follow-up to 3 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Duchess of Kent Children's Hospital
Study officials:
affiliation: The University of Hong Kong
name: Dr Kenny Kwan, BMBCh(Oxon)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. 2013 Oct 17;369(16):1512-21. doi: 10.1056/NEJMoa1307337. Epub 2013 Sep 19.
citation: Luk KD, Cheung WY, Wong Y, Cheung KM, Wong YW, Samartzis D. The predictive value of the fulcrum bending radiograph in spontaneous apical vertebral derotation in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2012 Jul 1;37(15):E922-6. doi: 10.1097/BRS.0b013e31824f108f.
citation: Luk KD, Vidyadhara S, Lu DS, Wong YW, Cheung WY, Cheung KM. Coupling between sagittal and frontal plane deformity correction in idiopathic thoracic scoliosis and its relationship with postoperative sagittal alignment. Spine (Phila Pa 1976). 2010 May 15;35(11):1158-64. doi: 10.1097/BRS.0b013e3181bb49f3.
citation: Parent S, Labelle H, Skalli W, de Guise J. Vertebral wedging characteristic changes in scoliotic spines. Spine (Phila Pa 1976). 2004 Oct 15;29(20):E455-62. doi: 10.1097/01.brs.0000142430.65463.3a.
citation: Masharawi Y, Salame K, Mirovsky Y, Peleg S, Dar G, Steinberg N, Hershkovitz I. Vertebral body shape variation in the thoracic and lumbar spine: characterization of its asymmetry and wedging. Clin Anat. 2008 Jan;21(1):46-54. doi: 10.1002/ca.20532.