Idiopathic ScoliosisNCT04633031
The Effect of Bracing on Sagittal Balance in Scoliosis
An observational study of Idiopathic Scoliosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- Boston and Cheneau
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Female and male subjects who underwent bracing therapy for an idiopathic scoliosis
Who may be able to join
- late onset idiopathic scoliosis
- non-operative indication
Who cannot join
- early onset idiopathic scoliosis
- neuromuscular scoliosis
- congenital scoliosis
- associated spondylolisthesis
- operative indication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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:
- Profile before bracing therapy
- Profile after initiation of bracing therapy
- Profile immediately after termination of bracing therapy
- 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.
- Conditions
- Idiopathic Scoliosis
- Being tested
- Boston, Cheneau
- Keywords
- bracing, sagittal balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BostonDevice
CheneauDevice
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Cheneau brace Receives: Device: Cheneau | |
| Group 2 | Boston brace Receives: Device: Boston |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delordosing effect of TLSO brace
Measured: 3 years
Secondary outcomes (1)
Difference between Boston and Cheneau brace concerning delordosing effect
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study startOct 2012 (estimated)
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Why it stopped: never approved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Moens, Dr, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633031
- Sponsor's protocol ID
- Sxxxxx
- Status last verified
- Mar 2021
- First submitted
- 16 Oct 2012
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bracing on Sagittal Balance in Scoliosis, Are we Doing the Right Thing?
- ClinicalTrials.gov ID
- NCT04633031
- Acronym / sponsor ID
- Sxxxxx
- Conditions
- Idiopathic Scoliosis
- Keywords
- bracing, sagittal balance
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: never approved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Oct 2012 (estimated)
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Profile before bracing therapy
- Profile after initiation of bracing therapy
- Profile immediately after termination of bracing therapy
- 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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: CheneauCheneau brace |
| Group 2 | – | Device: BostonBoston brace |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Female and male subjects who underwent bracing therapy for an idiopathic scoliosis
Key inclusion criteria (2 listed)
- late onset idiopathic scoliosis
- non-operative indication
Key exclusion criteria (5 listed)
- early onset idiopathic scoliosis
- neuromuscular scoliosis
- congenital scoliosis
- associated spondylolisthesis
- operative indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boston | Device | Group 2 |
| Cheneau | Device | Group 1 |
Primary outcome
Delordosing effect of TLSO brace
Time frame: 3 years
1 secondary outcome
Difference between Boston and Cheneau brace concerning delordosing effect
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Moens, Dr principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Scoliosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delordosing effect of TLSO brace (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.