Clinical trial NCT02820012: Scoliosis Surgery - ST2R (Simultaneous Translation on Two Rods)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis
Keywords: Scoliosis
ST2R
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 164
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment radiographically of the dimensional scoliosis correction in the coronal plan
timeFrame: 60 months after chirurgical intervention
Secondary outcomes:
measure: Assessment of scoliosis in preoperative
timeFrame: baseline
measure: Assessment radiographically of the dimensional scoliosis correction in the coronal plan
timeFrame: 5 minutes after the end of the chirurgical intervention
measure: Assessment radiographically of the dimensional scoliosis correction in the sagittal plan
timeFrame: 5 minutes after the end of the chirurgical intervention
measure: Assessment radiographically of the dimensional scoliosis correction in the axial plan
timeFrame: 5 minutes after the end of the chirurgical intervention
measure: Assessment of the postoperative complications
timeFrame: 60 month after the chirurgical intervention
measure: Assessment of the intra operative complications
timeFrame: 5 minutes after the end of the chirurgical intervention
measure: Assessment of the patient's quality of life
timeFrame: 60 month after the chirurgical intervention
measure: Assessment radiographically of the dimensional scoliosis correction in the sagittal plan
timeFrame: 60 months after chirurgical intervention
measure: Assessment radiographically of the dimensional scoliosis correction in the axial plan
timeFrame: 60 months after chirurgical intervention
Other outcomes:
Locations:
city: Besançon
country: France
facility: Hôpital Jean Minjoz, CHU Besançon
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
city: Lyon
country: France
facility: Centre Orthopédique Santy
city: Nantes
country: France
facility: Hôpital mère-enfant pédiatrie, CHU Nantes
city: Nice
country: France
facility: Hôpitaux Pédiatriques CHU-LENVAL
Study officials:
affiliation: Fondation Lenval
name: Frederico Solla, MD
role: PRINCIPAL_INVESTIGATOR
References: