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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Recruitment Status : Withdrawn (never approved)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
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen 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.


Condition or disease Intervention/treatment
Idiopathic Scoliosis Device: Boston Device: Cheneau

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Group/Cohort Intervention/treatment
Group 1
Cheneau brace
Device: Cheneau
Group 2
Boston brace
Device: Boston



Primary Outcome Measures :
  1. Delordosing effect of TLSO brace [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Difference between Boston and Cheneau brace concerning delordosing effect [ Time Frame: 3 years ]


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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Female and male subjects who underwent bracing therapy for an idiopathic scoliosis
Criteria

Inclusion Criteria:

  • late onset idiopathic scoliosis
  • non-operative indication

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Locations
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Belgium
UZ Pellenberg
Pellenberg, Belgium, 3212
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Pierre Moens, Dr UZ Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04633031    
Other Study ID Numbers: Sxxxxx
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: March 2021
Keywords provided by Universitaire Ziekenhuizen Leuven:
bracing
sagittal balance
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases