The Effect of Bracing on Sagittal Balance in Scoliosis

Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04633031
• Other study ID #: Sxxxxx
• Status: Withdrawn
• Start date: October 2012
• Est. completion date: June 2013

Study information

• Verified date: March 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• late onset idiopathic scoliosis

• non-operative indication

Exclusion Criteria:

• early onset idiopathic scoliosis

• neuromuscular scoliosis

• congenital scoliosis

• associated spondylolisthesis

• operative indication

Related Conditions & MeSH terms

• Idiopathic Scoliosis
• Scoliosis

Intervention

Device:
• Boston

• Cheneau

Locations

Country	Name	City	State
Belgium	UZ Pellenberg	Pellenberg

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delordosing effect of TLSO brace		3 years
Secondary	Difference between Boston and Cheneau brace concerning delordosing effect		3 years