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NCT Number: NCT02820012

Scoliosis Surgery - ST2R (Simultaneous Translation on Two Rods)

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.

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Key information

Conditions

Scoliosis Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

6 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Jean Minjoz, CHU Besançon, Besançon, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scoliosis

Other

Questionnaires, radiography

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fondation Lenval

Other

Registry information

Official study title

Multicenter Study on the Contribution of Surgical Treatment by ST2R Technique (Simultaneous Translation on Two Rods) in Scoliosis of the Children and Adolescents

Acronym: ST2R

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Jun 30, 2016
Registry last updated
May 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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