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Scoliosis Surgery - ST2R (Simultaneous Translation on Two Rods) (ST2R)

Primary Purpose

Scoliosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Scoliosis
Sponsored by
Fondation Lenval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Scoliosis focused on measuring Scoliosis, ST2R

Eligibility Criteria

6 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Jean Minjoz, CHU Besançon
  • Hôpital Femme Mère Enfant
  • Centre Orthopédique Santy
  • Hôpital mère-enfant pédiatrie, CHU Nantes
  • Hôpitaux Pédiatriques CHU-LENVAL

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Scoliosis

Arm Description

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.

Outcomes

Primary Outcome Measures

Assessment radiographically of the dimensional scoliosis correction in the coronal plan
Cobb angle measurements of curvatures

Secondary Outcome Measures

Assessment of scoliosis in preoperative
Cobb angles measurements of curvatures
Assessment radiographically of the dimensional scoliosis correction in the coronal plan
Cobb angle measurements of curvatures
Assessment radiographically of the dimensional scoliosis correction in the sagittal plan
angle of thoracic kyphosis vertebrae between T4 and T12
Assessment radiographically of the dimensional scoliosis correction in the axial plan
measure of the vertebral rotation of the apical vertebra of the main curvature
Assessment of the postoperative complications
number of each postoperative complication
Assessment of the intra operative complications
number of each intra operative complication
Assessment of the patient's quality of life
result to a self-administered questionnaire (SRS22)
Assessment radiographically of the dimensional scoliosis correction in the sagittal plan
angle of thoracic kyphosis vertebrae between T4 and T12
Assessment radiographically of the dimensional scoliosis correction in the axial plan
measure of the vertebral rotation of the apical vertebra of the main curvature

Full Information

First Posted
May 31, 2016
Last Updated
May 13, 2022
Sponsor
Fondation Lenval
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1. Study Identification

Unique Protocol Identification Number
NCT02820012
Brief Title
Scoliosis Surgery - ST2R (Simultaneous Translation on Two Rods)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2013 (Actual)
Primary Completion Date
July 23, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
Keywords
Scoliosis, ST2R

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederico Solla, MD
Organizational Affiliation
Fondation Lenval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Jean Minjoz, CHU Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Hôpital Femme Mère Enfant
City
Bron
ZIP/Postal Code
69500
Country
France
Facility Name
Centre Orthopédique Santy
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Hôpital mère-enfant pédiatrie, CHU Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpitaux Pédiatriques CHU-LENVAL
City
Nice
ZIP/Postal Code
06200
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Scoliosis Surgery - ST2R (Simultaneous Translation on Two Rods)

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