Scoliosis Surgery - ST2R (Simultaneous Translation on Two Rods)

NCT ID: NCT02820012

Last Updated: 2022-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-01
• Study Completion Date: 2021-12-31

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.

Conditions

Scoliosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Scoliosis

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.

Group Type: OTHER

Scoliosis

Intervention Type: OTHER

Questionnaires, radiography

Interventions

Scoliosis

Questionnaires, radiography

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Lenval

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederico Solla, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Lenval

Locations

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, , France

Countries

France

Other Identifiers

14-HPNCL-01

Identifier Type: -

Identifier Source: org_study_id