The Effect of Bracing on Sagittal Balance in Scoliosis

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04633031
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 0

Study Details

Study Description

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	Phase
Idiopathic Scoliosis	Device: Boston; Device: Cheneau

Study Design

• 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?
• Anticipated Study Start Date: Oct 1, 2012
• Anticipated Primary Completion Date: Jun 1, 2013
• Anticipated Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Group 1 Cheneau brace	Device: Cheneau
Group 2 Boston brace	Device: Boston

Outcome Measures

Primary Outcome Measures

1. Delordosing effect of TLSO brace [3 years]

Secondary Outcome Measures

1. Difference between Boston and Cheneau brace concerning delordosing effect [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• late onset idiopathic scoliosis

• non-operative indication

Exclusion Criteria:

• early onset idiopathic scoliosis

• neuromuscular scoliosis

• congenital scoliosis

• associated spondylolisthesis

• operative indication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Pellenberg	Pellenberg		Belgium	3212

Sponsors and Collaborators

• Universitaire Ziekenhuizen Leuven

Investigators

• Principal Investigator: Pierre Moens, Dr, UZ Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT04633031
• Other Study ID Numbers: Sxxxxx
• First Posted: Nov 17, 2020
• Last Update Posted: Mar 2, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by Universitaire Ziekenhuizen Leuven: bracing; sagittal balance
• Additional relevant MeSH terms: Scoliosis

Study Results

No Results Posted as of Mar 2, 2021