Scoliosis Surgery - ST2R (Simultaneous Translation on Two Rods)

Scoliosis Clinical Trial

— ST2R  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820012
• Other study ID #: 14-HPNCL-01
• Status: Completed
• Phase: N/A
• Start date: May 1, 2013
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: Fondation Lenval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: December 31, 2021
• Est. primary completion date: July 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis

Intervention

Other:
• Scoliosis
Questionnaires, radiography

Locations

Country	Name	City	State
France	Hôpital Jean Minjoz, CHU Besançon	Besançon
France	Hôpital Femme Mère Enfant	Bron
France	Centre Orthopédique Santy	Lyon
France	Hôpital mère-enfant pédiatrie, CHU Nantes	Nantes
France	Hôpitaux Pédiatriques CHU-LENVAL	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Lenval

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment radiographically of the dimensional scoliosis correction in the coronal plan	Cobb angle measurements of curvatures	60 months after chirurgical intervention
Secondary	Assessment of scoliosis in preoperative	Cobb angles measurements of curvatures	baseline
Secondary	Assessment radiographically of the dimensional scoliosis correction in the coronal plan	Cobb angle measurements of curvatures	5 minutes after the end of the chirurgical intervention
Secondary	Assessment radiographically of the dimensional scoliosis correction in the sagittal plan	angle of thoracic kyphosis vertebrae between T4 and T12	5 minutes after the end of the chirurgical intervention
Secondary	Assessment radiographically of the dimensional scoliosis correction in the axial plan	measure of the vertebral rotation of the apical vertebra of the main curvature	5 minutes after the end of the chirurgical intervention
Secondary	Assessment of the postoperative complications	number of each postoperative complication	60 month after the chirurgical intervention
Secondary	Assessment of the intra operative complications	number of each intra operative complication	5 minutes after the end of the chirurgical intervention
Secondary	Assessment of the patient's quality of life	result to a self-administered questionnaire (SRS22)	60 month after the chirurgical intervention
Secondary	Assessment radiographically of the dimensional scoliosis correction in the sagittal plan	angle of thoracic kyphosis vertebrae between T4 and T12	60 months after chirurgical intervention
Secondary	Assessment radiographically of the dimensional scoliosis correction in the axial plan	measure of the vertebral rotation of the apical vertebra of the main curvature	60 months after chirurgical intervention