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WithdrawnNCT04633031Updated Mar 2, 2021

The Effect of Bracing on Sagittal Balance in Scoliosis

An observational study in Idiopathic Scoliosis, sponsored by Universitaire Ziekenhuizen KU Leuven. Withdrawn at 1 site in Belgium. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-03-02.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Why this study was withdrawn
never approved
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
0
Ages
5 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Idiopathic Scoliosis

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Keywords

  • bracing
  • sagittal balance
03

In context

Scoliosis

594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.

Browse Scoliosis studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Female and male subjects who underwent bracing therapy for an idiopathic scoliosis

Inclusion criteria

  • late onset idiopathic scoliosis
  • non-operative indication

Exclusion criteria

Exclusion Criteria:

  • early onset idiopathic scoliosis
  • neuromuscular scoliosis
  • congenital scoliosis
  • associated spondylolisthesis
  • operative indication
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
0 participants (actual)

Groups and cohorts

  • Group 1

    Cheneau brace

    Device: Cheneau

  • Group 2

    Boston brace

    Device: Boston

Interventions

  • DeviceBoston
  • DeviceCheneau
06

What researchers measure

Primary outcomes

  1. Delordosing effect of TLSO brace

    Time frame: 3 years

Secondary outcomes

  1. Difference between Boston and Cheneau brace concerning delordosing effect

    Time frame: 3 years

07

Study locations

1 site
  • UZ Pellenberg
    Pellenberg, 3212, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04633031
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
Nov 17, 2020
Start date
Oct 2012 (estimated)
Primary completion
Jun 2013 (estimated)
Completion
Jun 2013 (estimated)
Last update
Mar 2, 2021

Study contacts

Pierre Moens, Dr
principal investigator · UZ Leuven

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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