The Effect of Bracing on Sagittal Balance in Scoliosis

Withdrawn

• Conditions: Idiopathic Scoliosis
• Interventions: Device: Cheneau; Device: Boston

• Registration Number: NCT04633031
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-16
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-17
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• late onset idiopathic scoliosis
• non-operative indication

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Cheneau	Cheneau brace
Group 2	Boston	Boston brace

Primary Outcome Measures

Name	Time	Method
Delordosing effect of TLSO brace	3 years

Secondary Outcome Measures

Name	Time	Method
Difference between Boston and Cheneau brace concerning delordosing effect	3 years

Trial Locations

Locations (1)

UZ Pellenberg; 🇧🇪 Pellenberg, Belgium