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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in France

Lebanon1 site
  • Hotel Dieu De France Hospital Youssef Souda

    Beirut

Other trials in Lebanon

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 groups in NCT02791776
Study groupRoleWhat they receive
ScoliosisOtherself-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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted7 Jun 2016 (estimated)
  2. Study start11 Nov 2014
  3. Primary completion31 Dec 2014
  4. Study completion31 Dec 2014

Resources

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)
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

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.

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