Overview

This trial is active, not recruiting.

Condition scoliosis
Treatment scoliosis
Sponsor Fondation Lenval
Start date May 2013
End date November 2020
Trial size 164 participants
Trial identifier NCT02820012, 14-HPNCL-01

Summary

Although practiced for many years, surgical correction of scoliosis is relatively subject published for idiopathic scoliosis and a few published for other types of scoliosis.

This study involves a creation of an observatory of patients undergoing scoliosis by ST2R reduction technique (Simultaneous Translation on Two Rods) associated with the PASS ® system.

The main objective is to analyze the three-dimensional correction of the deformity after intervention and its maintenance over time depending on the etiology of scoliosis.

This research is conducted in pediatric surgery services specialized in this technique.

Correcting radiographic parameters is directly related to the surgical procedure. The quality of life of patients is indirectly affected by the surgery. Secondary objectives are to analyze the surgical technique and to evaluate its impact on the quality of life of patients.

This study will firstly to have a better understanding in:

- Scoliosis of the children and adolescents and their surgical treatment;

- The impact of the surgical procedure by the ST2R technique on the three-dimensional correction, and the patient's quality of life; and secondly, better management of patients requiring surgery for scoliosis as well as a public health impact.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Other)
Preoperative data: demographics, clinical diagnosis and etiology, relevant prior medical treatment, x-rays, and patient questionnaire will be completed in the database. The self-questionnaire (SAQ parents, patients, SR22) provided will assess the state of health and disability of patients. After surgery: the clinical questionnaire will be completed by the investigator to collect the parameters of the operation and the patient's clinical data Immediate Postoperative visit: J1 to S1: radiological and clinical examinations . Visit Month 1 to M3, M 12, M 24 , M 36 , M 60 : During these visits, clinical and radiological examinations will be realized.
scoliosis
Questionnaires, radiography

Primary Outcomes

Measure
Assessment radiographically of the dimensional scoliosis correction in the coronal plan
time frame: 60 months after chirurgical intervention

Secondary Outcomes

Measure
Assessment of scoliosis in preoperative
time frame: baseline
Assessment radiographically of the dimensional scoliosis correction in the coronal plan
time frame: 5 minutes after the end of the chirurgical intervention
Assessment radiographically of the dimensional scoliosis correction in the sagittal plan
time frame: 5 minutes after the end of the chirurgical intervention
Assessment radiographically of the dimensional scoliosis correction in the axial plan
time frame: 5 minutes after the end of the chirurgical intervention
Assessment of the postoperative complications
time frame: 60 month after the chirurgical intervention
Assessment of the intra operative complications
time frame: 5 minutes after the end of the chirurgical intervention
Assessment of the patient's quality of life
time frame: 60 month after the chirurgical intervention
Assessment radiographically of the dimensional scoliosis correction in the sagittal plan
time frame: 60 months after chirurgical intervention
Assessment radiographically of the dimensional scoliosis correction in the axial plan
time frame: 60 months after chirurgical intervention

Eligibility Criteria

Male or female participants from 6 years up to 20 years old.

Inclusion Criteria: - Scoliosis of the children and adolescents requiring surgical treatment by the technical ST2R - Non-opposition form signed by the patient in a state to consent - Non-opposition form signed by at least one of the legal representatives - Children affiliated to the Social Security system Exclusion Criteria: - All cases that do not require surgical treatment by the technical ST2R - Malformation or vertebral fractures - All patients not willing to comply with instructions postoperative - Opposition by the patient or legal guardian with the use of pre- and postoperative data - Not affiliated to the Social Security system

Additional Information

Official title Multicenter Study on the Contribution of Surgical Treatment by ST2R Technique (Simultaneous Translation on Two Rods) in Scoliosis of the Children and Adolescents
Principal investigator Jean-Luc CLEMENT, MD
Description The correction of the deformity in three planes of space is the main goal of surgical treatment of children's scoliosis and adolescents. The techniques provide a satisfactory correction of the deformity in the coronal plane but remain insufficient in the sagittal plane and in particular for the correction of thoracic hypokyphosis. Dr. Clarke and his team have shown that ST2R reduction technique (Simultaneous Translation on Two Rods) associated with the PASS ® system gave a good correction of the thoracic hypokyphosis of idiopathic scoliosis. The results of his single-center studies have shown that ST2R technique allowed to restore normal thoracic kyphosis with an average gain of 23 ° in patients preoperatively hypokyphosis, higher than the gains made by other techniques (rotation of the shaft, close off Gradually, in situ bending), while providing a frontal correction 70%, similar to results reported by other techniques. The results of this technique for non idiopathic scoliosis are still to be analyzed. The creation of an observatory of children's and adolescents scoliosis (idiopathic, neuromuscular, etc ...) operated by the technique of reduction by simultaneous translation on two rods with the same instrumentation will: - Firstly, to confirm or refute the first published results idiopathic scoliosis - And secondly to analyze the results of the same technique on all other scoliosis. The impact of the intervention on the quality of life of patients is an essential element that will be evaluated.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Fondation Lenval.