The Effect of Bracing on Sagittal Balance in Scoliosis
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|ClinicalTrials.gov Identifier: NCT04633031|
Recruitment Status : Withdrawn (never approved)
First Posted : November 17, 2020
Last Update Posted : March 2, 2021
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:
- Profile before bracing therapy
- Profile after initiation of bracing therapy
- Profile immediately after termination of bracing therapy
- 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.
|Condition or disease||Intervention/treatment|
|Idiopathic Scoliosis||Device: Boston Device: Cheneau|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||The Effect of Bracing on Sagittal Balance in Scoliosis, Are we Doing the Right Thing?|
|Estimated Study Start Date :||October 2012|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||June 2013|
- Delordosing effect of TLSO brace [ Time Frame: 3 years ]
- Difference between Boston and Cheneau brace concerning delordosing effect [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04633031
|Pellenberg, Belgium, 3212|
|Principal Investigator:||Pierre Moens, Dr||UZ Leuven|