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Impact of the Choice of the Distal Vertebral in the Surgery of the Thoracic Adolescent Idiopathic Scoliosis (VD-SIA)

Primary Purpose

Scoliosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Scoliosis
Sponsored by
Fondation Lenval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Scoliosis focused on measuring scoliosis

Eligibility Criteria

10 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut François Calot/Centre Hélio-Marin
  • Groupe hospitalier Pellegrin
  • HFME
  • Hôpital de la Timone Enfants
  • CHU Hôpital Nord
  • Chirurgie infantile, Hôpital mère-enfant pédiatrie, CHU Nantes
  • Fondation LENVAL, Hôpitaux Pédiatriques de Nice CHU-LENVAL
  • Hôpital Saint-Joseph
  • APHP - Hôpital Necker-Enfants-Malades
  • AP-HP Hôpital Robert Debré
  • Clinique Chirurgicale Infantile, Hôpital Charles Nicolle, CHU de Rouen
  • Groupe Hospitalier Sud Réunion Terre Rouge Boissy
  • CHU Hôpital des Enfants
  • CHU de Tours Hôpital Clocheville
  • Centre du rachis, Maison de Spécialistes de Trélazé, sur le site du Village Santé Angers Loire
  • Hotel Dieu De France Hospital Youssef Souda

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Scoliosis

Arm Description

self-administered questionnaire (SRS 30) to assess the state of health and disability of patients. collection of patient's radiographic and clinical parameters

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
To evaluate the incidence and predictors of complications.
Incidence and predictors of complications factors
To evaluate the influence of the correction of the deformity
% Reduction in primary and secondary curvatures

Full Information

First Posted
June 1, 2016
Last Updated
July 27, 2018
Sponsor
Fondation Lenval
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1. Study Identification

Unique Protocol Identification Number
NCT02791776
Brief Title
Impact of the Choice of the Distal Vertebral in the Surgery of the Thoracic Adolescent Idiopathic Scoliosis
Acronym
VD-SIA
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 11, 2014 (Actual)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
December 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
Keywords
scoliosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scoliosis
Arm Type
Other
Arm Description
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
Intervention Name(s)
Scoliosis
Intervention Description
self-administered questionnaire (SRS 30) to assess the state of health and disability of patients. Collection of patient's radiographic and clinical parameters
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Comparaison beetween before the chirurgical intervention and 5 years later
Secondary Outcome Measure Information:
Title
Evaluate the impact of this correction on the quality of life of patients with self-administered questionnaire (SAQ Parent, patient SAQ)
Description
SRS 30 questionnaires scores.
Time Frame
Comparaison beetween before the chirurgical intervention and 5 years later
Title
To evaluate the incidence and predictors of complications.
Description
Incidence and predictors of complications factors
Time Frame
Comparaison beetween before the chirurgical intervention and 5 years later
Title
To evaluate the influence of the correction of the deformity
Description
% Reduction in primary and secondary curvatures
Time Frame
Comparaison beetween before the chirurgical intervention and 5 years later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc CLEMENT, MD
Organizational Affiliation
Fondation LENVAL, Hôpitaux Pédiatriques de Nice CHU-LENVAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut François Calot/Centre Hélio-Marin
City
Berck
ZIP/Postal Code
62600
Country
France
Facility Name
Groupe hospitalier Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
HFME
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
Hôpital de la Timone Enfants
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHU Hôpital Nord
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
Chirurgie infantile, Hôpital mère-enfant pédiatrie, CHU Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Fondation LENVAL, Hôpitaux Pédiatriques de Nice CHU-LENVAL
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Hôpital Saint-Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
APHP - Hôpital Necker-Enfants-Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
AP-HP Hôpital Robert Debré
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Clinique Chirurgicale Infantile, Hôpital Charles Nicolle, CHU de Rouen
City
Rouen
Country
France
Facility Name
Groupe Hospitalier Sud Réunion Terre Rouge Boissy
City
Saint-Pierre
Country
France
Facility Name
CHU Hôpital des Enfants
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHU de Tours Hôpital Clocheville
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Centre du rachis, Maison de Spécialistes de Trélazé, sur le site du Village Santé Angers Loire
City
Trélazé
ZIP/Postal Code
49800
Country
France
Facility Name
Hotel Dieu De France Hospital Youssef Souda
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

Plan to Share IPD
No

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

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