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NCT04633031 Clinical Trial

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Clinical Trial Details — Status: Withdrawn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
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design

Related Conditions & MeSH terms

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
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