Scoliosis Surgery - ST2R (Simultaneous Translation on Two Rods)
- Conditions
- Scoliosis
- Interventions
- Other: Scoliosis
- Registration Number
- NCT02820012
- Lead Sponsor
- Fondation Lenval
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 164
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Scoliosis 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.
- Primary Outcome Measures
Name Time Method Assessment radiographically of the dimensional scoliosis correction in the coronal plan 60 months after chirurgical intervention Cobb angle measurements of curvatures
- Secondary Outcome Measures
Name Time Method Assessment radiographically of the dimensional scoliosis correction in the sagittal plan 60 months after chirurgical intervention angle of thoracic kyphosis vertebrae between T4 and T12
Assessment of the patient's quality of life 60 month after the chirurgical intervention result to a self-administered questionnaire (SRS22)
Assessment of scoliosis in preoperative baseline Cobb angles measurements of curvatures
Assessment of the postoperative complications 60 month after the chirurgical intervention number of each postoperative complication
Assessment radiographically of the dimensional scoliosis correction in the coronal plan 5 minutes after the end of the chirurgical intervention Cobb angle measurements of curvatures
Assessment radiographically of the dimensional scoliosis correction in the axial plan 60 months after chirurgical intervention measure of the vertebral rotation of the apical vertebra of the main curvature
Assessment of the intra operative complications 5 minutes after the end of the chirurgical intervention number of each intra operative complication
Trial Locations
- Locations (5)
Hôpital mère-enfant pédiatrie, CHU Nantes
🇫🇷Nantes, France
Hôpital Jean Minjoz, CHU Besançon
🇫🇷Besançon, France
Hôpital Femme Mère Enfant
🇫🇷Bron, France
Centre Orthopédique Santy
🇫🇷Lyon, France
Hôpitaux Pédiatriques CHU-LENVAL
🇫🇷Nice, France