NCT04633031

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. 1.Profile before bracing therapy
  2. 2.Profile after initiation of bracing therapy
  3. 3.Profile immediately after termination of bracing therapy
  4. 4.Profile more than 3 months after termination of brace

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
7.5 years until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
Last Updated

March 2, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

October 16, 2012

Last Update Submit

March 1, 2021

Conditions

Idiopathic Scoliosis

Keywords

bracingsagittal balance

Outcome Measures

Primary Outcomes (1)

  • Delordosing effect of TLSO brace

    3 years

Secondary Outcomes (1)

  • Difference between Boston and Cheneau brace concerning delordosing effect

    3 years

Study Arms (2)

Group 1

Cheneau brace

Device: Cheneau

Group 2

Boston brace

Device: Boston

Interventions

BostonDEVICE
Group 2
CheneauDEVICE
Group 1

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • late onset idiopathic scoliosis
  • non-operative indication

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Pellenberg

Pellenberg, 3212, Belgium

Location

Study Officials

  • Pierre Moens, Dr

    UZ Leuven

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2012

First Posted

November 17, 2020

Study Start

October 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

March 2, 2021

Record last verified: 2021-03

Locations

BE(1)