ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02820012
Recruitment Status : Active, not recruiting
First Posted : June 30, 2016
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Scoliosis Other: Scoliosis Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 Start Date : May 2013
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
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.

Other: Scoliosis
Questionnaires, radiography




Primary Outcome Measures :
  1. Assessment radiographically of the dimensional scoliosis correction in the coronal plan [ Time Frame: 60 months after chirurgical intervention ]
    Cobb angle measurements of curvatures


Secondary Outcome Measures :
  1. Assessment of scoliosis in preoperative [ Time Frame: baseline ]
    Cobb angles measurements of curvatures

  2. Assessment radiographically of the dimensional scoliosis correction in the coronal plan [ Time Frame: 5 minutes after the end of the chirurgical intervention ]
    Cobb angle measurements of curvatures

  3. Assessment radiographically of the dimensional scoliosis correction in the sagittal plan [ Time Frame: 5 minutes after the end of the chirurgical intervention ]
    angle of thoracic kyphosis vertebrae between T4 and T12

  4. Assessment radiographically of the dimensional scoliosis correction in the axial plan [ Time Frame: 5 minutes after the end of the chirurgical intervention ]
    measure of the vertebral rotation of the apical vertebra of the main curvature

  5. Assessment of the postoperative complications [ Time Frame: 60 month after the chirurgical intervention ]
    number of each postoperative complication

  6. Assessment of the intra operative complications [ Time Frame: 5 minutes after the end of the chirurgical intervention ]
    number of each intra operative complication

  7. Assessment of the patient's quality of life [ Time Frame: 60 month after the chirurgical intervention ]
    result to a self-administered questionnaire (SRS22)

  8. Assessment radiographically of the dimensional scoliosis correction in the sagittal plan [ Time Frame: 60 months after chirurgical intervention ]
    angle of thoracic kyphosis vertebrae between T4 and T12

  9. Assessment radiographically of the dimensional scoliosis correction in the axial plan [ Time Frame: 60 months after chirurgical intervention ]
    measure of the vertebral rotation of the apical vertebra of the main curvature



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02820012


Locations
France
Hôpital Jean Minjoz, CHU Besançon
Besançon, France, 25030
Hôpital Femme Mère Enfant
Bron, France, 69500
Centre Orthopédique Santy
Lyon, France, 69008
Hôpital mère-enfant pédiatrie, CHU Nantes
Nantes, France, 44093
Hôpitaux Pédiatriques CHU-LENVAL
Nice, France, 06200
Sponsors and Collaborators
Fondation Lenval
Investigators
Principal Investigator: Jean-Luc CLEMENT, MD Fondation Lenval

Responsible Party: Fondation Lenval
ClinicalTrials.gov Identifier: NCT02820012     History of Changes
Other Study ID Numbers: 14-HPNCL-01
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fondation Lenval:
Scoliosis
ST2R

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases