ScoliosisVD-SIANCT02791776
Impact of the Choice of the Distal Vertebral in the Surgery of the Thoracic Adolescent Idiopathic Scoliosis
A study testing Scoliosis in people with Scoliosis, run by Fondation Lenval at 16 sites in 2 countries.
Trial summary
The problem of choosing the supporting vertebra was the subject of several studies. They do not suggest as regards the techniques that are not currently used or with insufficient setback. Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- Scoliosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 11 Nov 2014to 31 Dec 2014
- Phase
- Interventional
- 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 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Thoracic idiopathic scoliosis (Lenke 1 or 2) of the child in puberty and adolescent surgery for posterior spinal fusion with instrumentation with a minimum decline of 5 years.
- Thoracic scoliosis Lenke 1 or 2.
- Affiliates or beneficiaries of a social security scheme
- Initial medical examination.
Who cannot join
- Scoliosis adult scoliosis and whose age at the time of the transaction is less than 10 years.
- Double major scoliosis (Lenke 3 or 4)
- Scoliosis thoracolumbar or lumbar (Lenke 5 or 6).
- Non-idiopathic scoliosis.
- Opposition by the patient or legal guardian with the use of pre- and postoperative data
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
France15 sites
Institut François Calot/Centre Hélio-Marin
Berck, 62600
Groupe hospitalier Pellegrin
Bordeaux, 33000
HFME
Lyon, 69000
Hôpital de la Timone Enfants
Marseille, 13385
CHU Hôpital Nord
Marseille, 13915
Chirurgie infantile, Hôpital mère-enfant pédiatrie, CHU Nantes
Nantes, 44093
Fondation LENVAL, Hôpitaux Pédiatriques de Nice CHU-LENVAL
Nice, 06200
Hôpital Saint-Joseph
Paris, 75014
APHP - Hôpital Necker-Enfants-Malades
Paris, 75015
AP-HP Hôpital Robert Debré
Paris, 75019
Clinique Chirurgicale Infantile, Hôpital Charles Nicolle, CHU de Rouen
Rouen
Groupe Hospitalier Sud Réunion Terre Rouge Boissy
Saint-Pierre
CHU Hôpital des Enfants
Toulouse, 31059
CHU de Tours Hôpital Clocheville
Tours, 37000
Centre du rachis, Maison de Spécialistes de Trélazé, sur le site du Village Santé Angers Loire
Trélazé, 49800
About this study
Official title: Impact of the Choice of the Distal Vertebral When Posterior Instrumentation in the Surgery of the Thoracic Adolescent Idiopathic Scoliosis
The problem of choosing the supporting vertebra was the subject of several studies. They do not suggest as regards the techniques that are not currently used or with insufficient setback.
The need to have a sufficient number of files with a minimum decline of 5 years for proposing a multicenter study that will be conducted within the framework of the Scoliosis Research Group (SRG) and will result in a roundtable at the next congress GES in March 2015. the GES gathers most of the teams that support this pathology.
Read the detailed description
Idiopathic scoliosis is a deformity in three planes of space the child's spine and scalable teenager with growth. In adults is causing severe deformities of respiratory failure responsible and disabling back pain. Scoliosis is most often idiopathic without cause found that the genetic origin is being identified. It is detected by the school doctor, the doctor or pediatrician. The management is based primarily on monitoring small angle discoveries scoliosis and the orthopedic treatment of progressive scoliosis by the specialized services of pediatric orthopedics or rehabilitation as recommended by the HAS (February 2008). Surgical treatment is reserved for the orthopedic treatment failures or advanced scoliosis discovered too late.
The goal of surgery is to reduce as much as possible distortion in the three planes of space and avoid the progression of the deformity in adulthood. Its principle is to correct the deformity using instrumentation and maintain over time this correction with a bone graft. This is commonly called spinal fusion with instrumentation. The instrumentation includes all of the vertebral anchors connected to rods.
Indications are asked in each case most often in adolescence and sometimes in younger children and rarely in adulthood. The procedure performed in adolescence allows to benefit from a flexible spine still allowing good reduction of the deformation, a lesser neurological risk and good consolidation of the bony fusion guarantees a stable income in the long term.
Among all types of curves, thoracic scoliosis pose the problem of choosing the bends to be instrumented. This choice is an essential element for the initial correction and become the long-term. It is the result of a compromise between a long instrumentation that orchestrates all of the deformation to the detriment of the mobility of the lumbar spine and a shorter instrumentation that preserves mobility at the expense perhaps of a smaller reduction. These short instrumentations called selective thoracic instrumentation, the choice of the support or lower vertebra vertebra of instrumentation is an unsolved problem and is the subject of this work.
The immediate results of the posterior vertebral arthrodesis are assessed by the correction of the deformity in three planes of space: measuring the angle of the curvature in the coronal plane, analyzing the return of a physiological kyphosis in sagittal plane and correction of the vertebral rotation in the horizontal plane. The results for medium and long term are assessed by analyzing the maintenance of correction of the deformity and the evolution of the above spine and above underlying arthrodesis. This is appreciated by the coronal and sagittal balance, changing the supporting vertebra and the first non-instrumented vertebra and evolution spine underlying uninstrumented.
The problem of choosing the supporting vertebra was the subject of several studies. They do not suggest as regards the techniques that are not currently used or with insufficient setback.
The need to have a sufficient number of files with a minimum decline of 5 years for proposing a multicenter study that will be conducted within the framework of the Scoliosis Research Group (SRG) and will result in a roundtable at the next congress GES in March 2015. the GES gathers most of the teams that support this pathology.
- Conditions
- Scoliosis
- Being tested
- Scoliosis
- Keywords
- scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScoliosisOther
self-administered questionnaire (SRS 30) to assess the state of health and disability of patients.
Collection of patient's radiographic and clinical parameters
| Study group | Role | What they receive |
|---|---|---|
| Scoliosis | Other | self-administered questionnaire (SRS 30) to assess the state of health and disability of patients.
collection of patient's radiographic and clinical parameters Receives: Other: Scoliosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze at least up of 5 years, the development of the first non-instrumented vertebra and spine underlying depending on the choice of the supporting vertebra thoracic idiopathic scoliosis adolescents who underwent selective thoracic instrumentation.
The results should be assessed using the position of the distal vertebra of the instrumentation with respect to the neutral vertebra. The distal vertebra will be identified VN if it matches the neutral vertebra, VN-1, VN-2 ... if it is located above the VN and VN + 1, TN + 2 ... to a vertebra situated below the vertebra neutral.
Measured: Comparaison beetween before the chirurgical intervention and 5 years later
Secondary outcomes (3)
Evaluate the impact of this correction on the quality of life of patients with self-administered questionnaire (SAQ Parent, patient SAQ)
SRS 30 questionnaires scores.
Measured: Comparaison beetween before the chirurgical intervention and 5 years later
To evaluate the incidence and predictors of complications.
Incidence and predictors of complications factors
Measured: Comparaison beetween before the chirurgical intervention and 5 years later
To evaluate the influence of the correction of the deformity
% Reduction in primary and secondary curvatures
Measured: Comparaison beetween before the chirurgical intervention and 5 years later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study start11 Nov 2014
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc CLEMENT, MD, Principal investigator, Fondation LENVAL, Hôpitaux Pédiatriques de Nice CHU-LENVAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791776
- Sponsor's protocol ID
- 14-HPNCL-04
- Acronym
- VD-SIA
- Status last verified
- Jun 2018
- First submitted
- 1 Jun 2016
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Choice of the Distal Vertebral When Posterior Instrumentation in the Surgery of the Thoracic Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT02791776
- Acronym / sponsor ID
- VD-SIA / 14-HPNCL-04
- Conditions
- Scoliosis
- Keywords
- scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 11 Nov 2014 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 7 Jun 2016 (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.
The problem of choosing the supporting vertebra was the subject of several studies. They do not suggest as regards the techniques that are not currently used or with insufficient setback.
The need to have a sufficient number of files with a minimum decline of 5 years for proposing a multicenter study that will be conducted within the framework of the Scoliosis Research Group (SRG) and will result in a roundtable at the next congress GES in March 2015. the GES gathers most of the teams that support this pathology.
Detailed description
Idiopathic scoliosis is a deformity in three planes of space the child's spine and scalable teenager with growth. In adults is causing severe deformities of respiratory failure responsible and disabling back pain. Scoliosis is most often idiopathic without cause found that the genetic origin is being identified. It is detected by the school doctor, the doctor or pediatrician. The management is based primarily on monitoring small angle discoveries scoliosis and the orthopedic treatment of progressive scoliosis by the specialized services of pediatric orthopedics or rehabilitation as recommended by the HAS (February 2008). Surgical treatment is reserved for the orthopedic treatment failures or advanced scoliosis discovered too late.
The goal of surgery is to reduce as much as possible distortion in the three planes of space and avoid the progression of the deformity in adulthood. Its principle is to correct the deformity using instrumentation and maintain over time this correction with a bone graft. This is commonly called spinal fusion with instrumentation. The instrumentation includes all of the vertebral anchors connected to rods.
Indications are asked in each case most often in adolescence and sometimes in younger children and rarely in adulthood. The procedure performed in adolescence allows to benefit from a flexible spine still allowing good reduction of the deformation, a lesser neurological risk and good consolidation of the bony fusion guarantees a stable income in the long term.
Among all types of curves, thoracic scoliosis pose the problem of choosing the bends to be instrumented. This choice is an essential element for the initial correction and become the long-term. It is the result of a compromise between a long instrumentation that orchestrates all of the deformation to the detriment of the mobility of the lumbar spine and a shorter instrumentation that preserves mobility at the expense perhaps of a smaller reduction. These short instrumentations called selective thoracic instrumentation, the choice of the support or lower vertebra vertebra of instrumentation is an unsolved problem and is the subject of this work.
The immediate results of the posterior vertebral arthrodesis are assessed by the correction of the deformity in three planes of space: measuring the angle of the curvature in the coronal plane, analyzing the return of a physiological kyphosis in sagittal plane and correction of the vertebral rotation in the horizontal plane. The results for medium and long term are assessed by analyzing the maintenance of correction of the deformity and the evolution of the above spine and above underlying arthrodesis. This is appreciated by the coronal and sagittal balance, changing the supporting vertebra and the first non-instrumented vertebra and evolution spine underlying uninstrumented.
The problem of choosing the supporting vertebra was the subject of several studies. They do not suggest as regards the techniques that are not currently used or with insufficient setback.
The need to have a sufficient number of files with a minimum decline of 5 years for proposing a multicenter study that will be conducted within the framework of the Scoliosis Research Group (SRG) and will result in a roundtable at the next congress GES in March 2015. the GES gathers most of the teams that support this pathology.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scoliosis | Other | Other: Scoliosisself-administered questionnaire (SRS 30) to assess the state of health and disability of patients. collection of patient's radiographic and clinical parameters |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Thoracic idiopathic scoliosis (Lenke 1 or 2) of the child in puberty and adolescent surgery for posterior spinal fusion with instrumentation with a minimum decline of 5 years.
- Thoracic scoliosis Lenke 1 or 2.
- Affiliates or beneficiaries of a social security scheme
- Initial medical examination.
Key exclusion criteria (5 listed)
- Scoliosis adult scoliosis and whose age at the time of the transaction is less than 10 years.
- Double major scoliosis (Lenke 3 or 4)
- Scoliosis thoracolumbar or lumbar (Lenke 5 or 6).
- Non-idiopathic scoliosis.
- Opposition by the patient or legal guardian with the use of pre- and postoperative data
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 |
|---|---|---|
| Scoliosisself-administered questionnaire (SRS 30) to assess the state of health and disability of patients. Collection of patient's radiographic and clinical parameters | Other | Scoliosis |
Primary outcome
Analyze at least up of 5 years, the development of the first non-instrumented vertebra and spine underlying depending on the choice of the supporting vertebra thoracic idiopathic scoliosis adolescents who underwent selective thoracic instrumentation.
Time frame: Comparaison beetween before the chirurgical intervention and 5 years later
The results should be assessed using the position of the distal vertebra of the instrumentation with respect to the neutral vertebra. The distal vertebra will be identified VN if it matches the neutral vertebra, VN-1, VN-2 ... if it is located above the VN and VN + 1, TN + 2 ... to a vertebra situated below the vertebra neutral.
3 secondary outcomes
Evaluate the impact of this correction on the quality of life of patients with self-administered questionnaire (SAQ Parent, patient SAQ)
Time frame: Comparaison beetween before the chirurgical intervention and 5 years later
To evaluate the incidence and predictors of complications.
Time frame: Comparaison beetween before the chirurgical intervention and 5 years later
To evaluate the influence of the correction of the deformity
Time frame: Comparaison beetween before the chirurgical intervention and 5 years later
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 30 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Scoliosis
Active, not recruiting
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Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
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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.
Jean-Luc CLEMENT, MD principal investigator
Fondation LENVAL, Hôpitaux Pédiatriques de Nice CHU-LENVAL
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scoliosis in people with Scoliosis, run by Fondation Lenval at 16 sites in 2 countries.
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 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: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France, Lebanon. 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?
Analyze at least up of 5 years, the development of the first non-instrumented vertebra and spine underlying depending on the choice of the supporting vertebra thoracic idiopathic scoliosis adolescents who underwent selective thoracic instrumentation. (time frame: Comparaison beetween before the chirurgical intervention and 5 years later). 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 30 Jul 2018.