Impact of the Choice of the Distal Vertebral in the Surgery of the Thoracic Adolescent Idiopathic Scoliosis

NCT ID: NCT02791776

Last Updated: 2018-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-11
• Study Completion Date: 2014-12-31

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.

Conditions

Scoliosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Scoliosis

self-administered questionnaire (SRS 30) to assess the state of health and disability of patients.

collection of patient's radiographic and clinical parameters

Group Type: OTHER

Scoliosis

Intervention Type: OTHER

self-administered questionnaire (SRS 30) to assess the state of health and disability of patients.

Collection of patient's radiographic and clinical parameters

Interventions

Scoliosis

self-administered questionnaire (SRS 30) to assess the state of health and disability of patients.

Collection of patient's radiographic and clinical parameters

Intervention Type: OTHER

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Lenval

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Luc CLEMENT, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation LENVAL, Hôpitaux Pédiatriques de Nice CHU-LENVAL

Locations

Institut François Calot/Centre Hélio-Marin

Berck, , France

Groupe hospitalier Pellegrin

Bordeaux, , France

HFME

Lyon, , France

Hôpital de la Timone Enfants

Marseille, , France

CHU Hôpital Nord

Marseille, , France

Chirurgie infantile, Hôpital mère-enfant pédiatrie, CHU Nantes

Nantes, , France

Fondation LENVAL, Hôpitaux Pédiatriques de Nice CHU-LENVAL

Nice, , France

Hôpital Saint-Joseph

Paris, , France

APHP - Hôpital Necker-Enfants-Malades

Paris, , France

AP-HP Hôpital Robert Debré

Paris, , France

Clinique Chirurgicale Infantile, Hôpital Charles Nicolle, CHU de Rouen

Rouen, , France

Groupe Hospitalier Sud Réunion Terre Rouge Boissy

Saint-Pierre, , France

CHU Hôpital des Enfants

Toulouse, , France

CHU de Tours Hôpital Clocheville

Tours, , France

Centre du rachis, Maison de Spécialistes de Trélazé, sur le site du Village Santé Angers Loire

Trélazé, , France

Hotel Dieu De France Hospital Youssef Souda

Beirut, , Lebanon

Countries

France; Lebanon

Other Identifiers

14-HPNCL-04

Identifier Type: -

Identifier Source: org_study_id