The Effect of Bracing on Sagittal Balance in Scoliosis

The Effect of Bracing on Sagittal Balance in Scoliosis, Are we Doing the Right Thing?

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.

Study Overview

• Status: Withdrawn
• Conditions: Idiopathic Scoliosis
• Intervention / Treatment: Device: Cheneau; Device: Boston

• Study Type: Observational

Contacts and Locations

Study Locations

• Belgium
  • Pellenberg, Belgium, 3212
    • UZ Pellenberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• late onset idiopathic scoliosis
• non-operative indication

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Cheneau brace	Device: Cheneau
Group 2; Boston brace	Device: Boston

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Delordosing effect of TLSO brace	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference between Boston and Cheneau brace concerning delordosing effect	3 years

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Pierre Moens, Dr, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2012
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: October 16, 2012
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: bracing; sagittal balance
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: Sxxxxx