Three-dimensional Effects of Bracing in Adolescent Idiopathic Scoliosis

NCT03298256 | Completed

• 1 other identifier: UW 15-493
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

AIS

Outcome Measures

Primary Outcomes (1)

• Compare change in three dimensional (3D) effect of bracing on the adolescent idiopathic scoliosis (AIS) using the EOS Imaging System

  To compare change in full length, orthogonal anteroposterior and lateral X-rays in a standardised standing position after the brace is applied, and at intervals of no fewer than 6 months until the brace is weaned off, or if surgical intervention is required

  Follow-up to 3 years

Secondary Outcomes (1)

• Measure health-related quality of life outcome by the 22-item Scoliosis Research Society questionnaire (SRS-22) of patients with adolescent idiopathic scoliosis (AIS)

  Follow-up to 3 years

Study Arms (1)

Lenke type 1 AIS

Patients will be given a new prescription for a custom made Boston type thoracic-lumbo- sacral-orthosis (TLSO) braces. All patients will undergo low dose biplanar X-rays using the EOS ® machine system.

Radiation: EOS X-rays

Interventions

EOS X-rays RADIATION

Full length, orthogonal anteroposterior and lateral X-rays will be taken simultaneously in a standardised standing position, with arms folded anteriorly in 45 degrees . All radiographs will include C7 proximally and the femoral heads distally. 3D reconstruction of the spine can be performed. X-rays will be repeated after the brace is applied, and at intervals of no fewer than 6 months until the brace is weaned off, or if surgical intervention is required. Coronal, sagittal and axial parameters will be calculated from the reconstruction. 3D vertebral wedging will be calculated in the posterofrontal, sagittal and diagonal planes at the apex, 3 superior and 3 inferior vertebrae, as described by Scherrer et al. Changes in the pre- and post-bracing and follow-up parameters can be calculated.

Lenke type 1 AIS

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted in the Department of Orthopaedics and Traumatology, The University of Hong Kong.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Duchess of Kent Children's Hospital

Hong Kong, Hong Kong

Location

Related Publications (5)

• 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.

  PMID: 24047455 BACKGROUND

• 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.

  PMID: 22744400 BACKGROUND

• 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.

  PMID: 20118836 BACKGROUND

• 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.

  PMID: 15480123 BACKGROUND

• 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.

  PMID: 17729333 BACKGROUND

Study Officials

• Dr Kenny Kwan, BMBCh(Oxon)

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 2, 2017
• Study Start: November 1, 2015
• Primary Completion: May 31, 2019
• Study Completion: December 31, 2021
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)