ScoliosisMASINCT01087034
Bracing During Infantile Scoliosis: Airways Study
An observational study of Scoliosis, run by Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau at 2 sites in France.
Trial summary
Idiopathic juvenile thoracic scoliosis is a tridimensional deformation of the spine which may impact on the intrathoracic organs. Bracing is one of the oldest treatments of spinal deformities. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- Acoustic reflection method evaluation, EOS™ and Non invasive respiratory muscle assessment
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 15 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2010to Jun 2011
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with evolutive juvenile thoracic scoliosis requiring either a Milwaukee or a Cheneaux brace
Who may be able to join
- children with evolutive juvenile thoracic scoliosis
- with a Cobb angle ≥ 30°
- requiring either a Milwaukee or a Cheneaux brace
- in a stable respiratory state
Who cannot join
- history of spine surgery
Trial locations and contacts
2 sites in 1 country.
France2 sites
Armand Trousseau University Hospital
Paris, 75012
Ecole Nationale Supérieure des Arts et Metiers
Paris, 75013
About this study
Official title: Bracing During Infantile Scoliosis: Airways Study by Acoustic Method, EOS™ Acquisition and Noninvasive Respiratory Muscles Assessment
Idiopathic juvenile thoracic scoliosis is a tridimensional deformation of the spine which may impact on the intrathoracic organs. Bracing is one of the oldest treatments of spinal deformities. It relies on the indirect manipulation of spinal curvatures in order to prevent curve progression, which may affect respiratory function.
The acoustic reflection method is based on the analysis of the reflection of a single transient planar wave giving the longitudinal cross-sectional area profile of the examined cavity. It is noninvasive and harmless.
Read more
The EOS™ device allows a double incidence, full body, and low-dose X-ray acquisition with thoracic 3D reconstruction.
The aim of the study is to evaluate the impact of bracing on the upper airways patency (by means of the acoustic method), on the breathing pattern (noninvasive respiratory muscles assessment), and on the thoracic penetration index (by means of the EOS™)
- Conditions
- Scoliosis
- Being tested
- Acoustic reflection method evaluation, EOS™, Non invasive respiratory muscle assessment
- Keywords
- Infantile scoliosis, bracing, acoustic reflection method, EOS™, noninvasive, upper airways, thoracic penetration index, Idiopathic juvenile evolutive thoracic scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic reflection method evaluationDevice
Evaluation of airways by acoustic relection method, with and without the bracing device
EOS™Radiation
Scoliosis and thoracic penetration index evaluation by EOS™ acquisition, with and without the bracing device
Non invasive respiratory muscle assessmentOther
Non invasive respiratory muscles assessment, with and without the bracing device.
| Study group | Role | What they receive |
|---|---|---|
| Milwaukee brace | Children with an infantile scoliosis requiring Milwaukee bracing Receives: Device: Acoustic reflection method evaluation; Radiation: EOS™; Other: Non invasive respiratory muscle assessment | |
| Cheneaux brace | Children with an infantile scoliosis requiring Cheaneaux bracing Receives: Device: Acoustic reflection method evaluation; Radiation: EOS™; Other: Non invasive respiratory muscle assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of bracing on airways
The aim of the study is to evaluate the impact of bracing on the upper airways patency (by means of the acoustic method), on the breathing pattern (noninvasive respiratory muscles assessment), and on the thoracic penetration index (by means of the EOS™ system)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole Nationale Supérieure des Arts et Metiers
- Responsible party
- Principal investigator, Dr Nicolas LEBOULANGER, Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
- Investigators
- Nicolas LEBOULANGER, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisBrigitte FAUROUX, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087034
- Sponsor's protocol ID
- MA-SInf
- Acronym
- MASI
- Status last verified
- Jun 2012
- First submitted
- 12 Mar 2010
- Last updated
- 12 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Donnelly LF, Bisset GS 3rd. Airway compression in children with abnormal thoracic configuration. Radiology. 1998 Feb;206(2):323-6. doi: 10.1148/radiology.206.2.9457181.
PubMed 9457181Dubousset J, Charpak G, Skalli W, de Guise J, Kalifa G, Wicart P. [Skeletal and spinal imaging with EOS system]. Arch Pediatr. 2008 Jun;15(5):665-6. doi: 10.1016/S0929-693X(08)71868-2. No abstract available. French.
PubMed 18582707Heary RF, Bono CM, Kumar S. Bracing for scoliosis. Neurosurgery. 2008 Sep;63(3 Suppl):125-30. doi: 10.1227/01.NEU.0000320387.93907.97.
PubMed 18812914Jones RS, Kennedy JD, Hasham F, Owen R, Taylor JF. Mechanical inefficiency of the thoracic cage in scoliosis. Thorax. 1981 Jun;36(6):456-61. doi: 10.1136/thx.36.6.456.
PubMed 7314016Margonato V, Fronte F, Rainero G, Merati G, Veicsteinas A. Effects of short term cast wearing on respiratory and cardiac responses to submaximal and maximal exercise in adolescents with idiopathic scoliosis. Eura Medicophys. 2005 Jun;41(2):135-40.
PubMed 16200029
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bracing During Infantile Scoliosis: Airways Study by Acoustic Method, EOS™ Acquisition and Noninvasive Respiratory Muscles Assessment
- ClinicalTrials.gov ID
- NCT01087034
- Acronym / sponsor ID
- MASI / MA-SInf
- Conditions
- Scoliosis
- Keywords
- Infantile scoliosis, bracing, acoustic reflection method, EOS™, noninvasive, upper airways, thoracic penetration index, Idiopathic juvenile evolutive thoracic scoliosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Club d'Anesthésie-Réanimation Pédiatrique Armand TrousseauUniversity, hospital or other
- Collaborators
- Ecole Nationale Supérieure des Arts et Metiers
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Mar 2010 (estimated)
- 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.
Idiopathic juvenile thoracic scoliosis is a tridimensional deformation of the spine which may impact on the intrathoracic organs. Bracing is one of the oldest treatments of spinal deformities. It relies on the indirect manipulation of spinal curvatures in order to prevent curve progression, which may affect respiratory function.
The acoustic reflection method is based on the analysis of the reflection of a single transient planar wave giving the longitudinal cross-sectional area profile of the examined cavity. It is noninvasive and harmless.
The EOS™ device allows a double incidence, full body, and low-dose X-ray acquisition with thoracic 3D reconstruction.
The aim of the study is to evaluate the impact of bracing on the upper airways patency (by means of the acoustic method), on the breathing pattern (noninvasive respiratory muscles assessment), and on the thoracic penetration index (by means of the EOS™)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milwaukee brace | – | Device: Acoustic reflection method evaluation, Radiation: EOS™, Other: Non invasive respiratory muscle assessmentChildren with an infantile scoliosis requiring Milwaukee bracing |
| Cheneaux brace | – | Device: Acoustic reflection method evaluation, Radiation: EOS™, Other: Non invasive respiratory muscle assessmentChildren with an infantile scoliosis requiring Cheaneaux bracing |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with evolutive juvenile thoracic scoliosis requiring either a Milwaukee or a Cheneaux brace
Key inclusion criteria (4 listed)
- children with evolutive juvenile thoracic scoliosis
- with a Cobb angle ≥ 30°
- requiring either a Milwaukee or a Cheneaux brace
- in a stable respiratory state
Key exclusion criteria (1 listed)
- history of spine surgery
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 |
|---|---|---|
| Acoustic reflection method evaluationEvaluation of airways by acoustic relection method, with and without the bracing device | Device | Cheneaux brace, Milwaukee brace |
| EOS™Scoliosis and thoracic penetration index evaluation by EOS™ acquisition, with and without the bracing device | Radiation | Cheneaux brace, Milwaukee brace |
| Non invasive respiratory muscle assessmentNon invasive respiratory muscles assessment, with and without the bracing device. | Other | Cheneaux brace, Milwaukee brace |
Primary outcome
Impact of bracing on airways
Time frame: 6 months
The aim of the study is to evaluate the impact of bracing on the upper airways patency (by means of the acoustic method), on the breathing pattern (noninvasive respiratory muscles assessment), and on the thoracic penetration index (by means of the EOS™ system)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2012.
- Background: PubMed 9457181Donnelly LF, Bisset GS 3rd. Airway compression in children with abnormal thoracic configuration. Radiology. 1998 Feb;206(2):323-6. doi: 10.1148/radiology.206.2.9457181.
- Background: PubMed 18582707Dubousset J, Charpak G, Skalli W, de Guise J, Kalifa G, Wicart P. [Skeletal and spinal imaging with EOS system]. Arch Pediatr. 2008 Jun;15(5):665-6. doi: 10.1016/S0929-693X(08)71868-2. No abstract available. French.
- Background: PubMed 18812914Heary RF, Bono CM, Kumar S. Bracing for scoliosis. Neurosurgery. 2008 Sep;63(3 Suppl):125-30. doi: 10.1227/01.NEU.0000320387.93907.97.
- Background: PubMed 7314016Jones RS, Kennedy JD, Hasham F, Owen R, Taylor JF. Mechanical inefficiency of the thoracic cage in scoliosis. Thorax. 1981 Jun;36(6):456-61. doi: 10.1136/thx.36.6.456.
- Background: PubMed 16200029Margonato V, Fronte F, Rainero G, Merati G, Veicsteinas A. Effects of short term cast wearing on respiratory and cardiac responses to submaximal and maximal exercise in adolescents with idiopathic scoliosis. Eura Medicophys. 2005 Jun;41(2):135-40.
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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.
Nicolas LEBOULANGER, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Brigitte FAUROUX, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis, run by Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau at 2 sites in France.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Impact of bracing on airways (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01087034, which also lists 5 linked publications.
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 12 Jun 2012.