Clinical trial NCT02791776: Impact of the Choice of the Distal Vertebral in the Surgery of the Thoracic Adolescent Idiopathic Scoliosis
Official title: Impact of the Choice of the Distal Vertebral When Posterior Instrumentation in the Surgery of the Thoracic Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis
Keywords: scoliosis
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 157
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
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.
timeFrame: Comparaison beetween before the chirurgical intervention and 5 years later
Secondary outcomes:
measure: Evaluate the impact of this correction on the quality of life of patients with self-administered questionnaire (SAQ Parent, patient SAQ)
timeFrame: Comparaison beetween before the chirurgical intervention and 5 years later
measure: To evaluate the incidence and predictors of complications.
timeFrame: Comparaison beetween before the chirurgical intervention and 5 years later
measure: To evaluate the influence of the correction of the deformity
timeFrame: Comparaison beetween before the chirurgical intervention and 5 years later
Other outcomes:
Locations:
city: Berck
country: France
facility: Institut François Calot/Centre Hélio-Marin
city: Bordeaux
country: France
facility: Groupe hospitalier Pellegrin
city: Lyon
country: France
facility: HFME
city: Marseille
country: France
facility: Hôpital de la Timone Enfants
city: Marseille
country: France
facility: CHU Hôpital Nord
city: Nantes
country: France
facility: Chirurgie infantile, Hôpital mère-enfant pédiatrie, CHU Nantes
city: Nice
country: France
facility: Fondation LENVAL, Hôpitaux Pédiatriques de Nice CHU-LENVAL
city: Paris
country: France
facility: Hôpital Saint-Joseph
city: Paris
country: France
facility: APHP - Hôpital Necker-Enfants-Malades
city: Paris
country: France
facility: AP-HP Hôpital Robert Debré
city: Rouen
country: France
facility: Clinique Chirurgicale Infantile, Hôpital Charles Nicolle, CHU de Rouen
city: Saint-Pierre
country: France
facility: Groupe Hospitalier Sud Réunion Terre Rouge Boissy
city: Toulouse
country: France
facility: CHU Hôpital des Enfants
city: Tours
country: France
facility: CHU de Tours Hôpital Clocheville
city: Trélazé
country: France
facility: Centre du rachis, Maison de Spécialistes de Trélazé, sur le site du Village Santé Angers Loire
city: Beirut
country: Lebanon
facility: Hotel Dieu De France Hospital Youssef Souda
Study officials:
affiliation: Fondation LENVAL, Hôpitaux Pédiatriques de Nice CHU-LENVAL
name: Jean-Luc CLEMENT, MD
role: PRINCIPAL_INVESTIGATOR
References: