Impact of the Choice of the Distal Vertebral in the Surgery of the Thoracic Adolescent Idiopathic Scoliosis
VD-SIA
1 other identifier
interventional
157
2 countries
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2014
Shorter than P25 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2014
CompletedFirst Submitted
Initial submission to the registry
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
June 7, 2016
CompletedJuly 30, 2018
June 1, 2018
2 months
June 1, 2016
July 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
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)
Comparaison beetween before the chirurgical intervention and 5 years later
To evaluate the incidence and predictors of complications.
Comparaison beetween before the chirurgical intervention and 5 years later
To evaluate the influence of the correction of the deformity
Comparaison beetween before the chirurgical intervention and 5 years later
Study Arms (1)
Scoliosis
OTHERself-administered questionnaire (SRS 30) to assess the state of health and disability of patients. collection of patient's radiographic and clinical parameters
Interventions
self-administered questionnaire (SRS 30) to assess the state of health and disability of patients. Collection of patient's radiographic and clinical parameters
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fondation Lenvallead
Study Sites (16)
Institut François Calot/Centre Hélio-Marin
Berck, 62600, France
Groupe hospitalier Pellegrin
Bordeaux, 33000, France
HFME
Lyon, 69000, France
Hôpital de la Timone Enfants
Marseille, 13385, France
CHU Hôpital Nord
Marseille, 13915, France
Chirurgie infantile, Hôpital mère-enfant pédiatrie, CHU Nantes
Nantes, 44093, France
Fondation LENVAL, Hôpitaux Pédiatriques de Nice CHU-LENVAL
Nice, 06200, France
Hôpital Saint-Joseph
Paris, 75014, France
APHP - Hôpital Necker-Enfants-Malades
Paris, 75015, France
AP-HP Hôpital Robert Debré
Paris, 75019, 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, 31059, France
CHU de Tours Hôpital Clocheville
Tours, 37000, France
Centre du rachis, Maison de Spécialistes de Trélazé, sur le site du Village Santé Angers Loire
Trélazé, 49800, France
Hotel Dieu De France Hospital Youssef Souda
Beirut, Lebanon
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Luc CLEMENT, MD
Fondation LENVAL, Hôpitaux Pédiatriques de Nice CHU-LENVAL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2016
First Posted
June 7, 2016
Study Start
November 11, 2014
Primary Completion
December 31, 2014
Study Completion
December 31, 2014
Last Updated
July 30, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share