The Effect of Bracing on Sagittal Balance in Scoliosis

NCT ID: NCT04633031

Last Updated: 2021-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Idiopathic Scoliosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

Cheneau brace

Cheneau

Intervention Type DEVICE

Group 2

Boston brace

Boston

Intervention Type DEVICE

Interventions

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Boston

Intervention Type DEVICE

Cheneau

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* late onset idiopathic scoliosis
* non-operative indication

Exclusion Criteria

* early onset idiopathic scoliosis
* neuromuscular scoliosis
* congenital scoliosis
* associated spondylolisthesis
* operative indication
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Moens, Dr

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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UZ Pellenberg

Pellenberg, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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Sxxxxx

Identifier Type: -

Identifier Source: org_study_id

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