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The Effect of Bracing on Sagittal Balance in Scoliosis

The Effect of Bracing on Sagittal Balance in Scoliosis, Are we Doing the Right Thing?

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04633031
Enrollment
0
Registered
2020-11-17
Start date
2012-10-31
Completion date
2013-06-30
Last updated
2021-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Scoliosis

Keywords

bracing, sagittal balance

Brief summary

The goal of the study is to analyze the influence of bracing on sagittal balance in scoliosis. In special we want to observe if there is a difference between two types of TLSO-brace, namely boston and cheneau. Retrospective analyses of Full Spine X-rays of patients who underwent bracing-therapy in the context of scoliosis. Different spinopelvic parameters will be analyzed: pelvic incidence, pelvic tilt, sacral slope, lumbar lordosis, spinopelvic angle, spinosacral angle, thoracal kyphosis. Four different X-rays will be reviewed for these parameters: 1. Profile before bracing therapy 2. Profile after initiation of bracing therapy 3. Profile immediately after termination of bracing therapy 4. Profile more than 3 months after termination of brace It concerns patients with idiopathic scoliosis (exclusion of congenital scoliosis, neuromuscular scoliosis and associated spondylolisthesis). Goal of the study is to check if treatment with TLSO-brace has a delordosing effect on sagittal balance (decrease of lumbar lordosis). The zero-hypothesis: TLSO causes no decrease in lumbar lordosis. Secondary goal is to compare the effect of the BOSTON TSLO-brace and otherwise the CHENEAU TLSO-brace on spinopelvic parameters and lumbar lordosis in special.

Interventions

DEVICEBoston
DEVICECheneau

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* late onset idiopathic scoliosis * non-operative indication

Exclusion criteria

* early onset idiopathic scoliosis * neuromuscular scoliosis * congenital scoliosis * associated spondylolisthesis * operative indication

Design outcomes

Primary

MeasureTime frame
Delordosing effect of TLSO brace3 years

Secondary

MeasureTime frame
Difference between Boston and Cheneau brace concerning delordosing effect3 years

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026