Scoliosis Surgery - ST2R (Simultaneous Translation on Two Rods)

NCT02820012 | Completed

• 1 other identifier: 14-HPNCL-01
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 5

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.

Conditions

Scoliosis

Keywords

Scoliosis; ST2R

Outcome Measures

Primary Outcomes (1)

• Assessment radiographically of the dimensional scoliosis correction in the coronal plan

  Cobb angle measurements of curvatures

  60 months after chirurgical intervention

Secondary Outcomes (9)

• Assessment of scoliosis in preoperative

  baseline

• Assessment radiographically of the dimensional scoliosis correction in the coronal plan

  5 minutes after the end of the chirurgical intervention

• Assessment radiographically of the dimensional scoliosis correction in the sagittal plan

  5 minutes after the end of the chirurgical intervention

• Assessment radiographically of the dimensional scoliosis correction in the axial plan

  5 minutes after the end of the chirurgical intervention

• Assessment of the postoperative complications

  60 month after the chirurgical intervention

Study Arms (1)

Scoliosis

OTHER

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

Interventions

Scoliosis OTHER

Questionnaires, radiography

Scoliosis

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (5)

Hôpital Jean Minjoz, CHU Besançon

Besançon, 25030, France

Location

Hôpital Femme Mère Enfant

Bron, 69500, France

Location

Centre Orthopédique Santy

Lyon, 69008, France

Location

Hôpital mère-enfant pédiatrie, CHU Nantes

Nantes, 44093, France

Location

Hôpitaux Pédiatriques CHU-LENVAL

Nice, 06200, France

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Frederico Solla, MD

  Fondation Lenval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 30, 2016
• Study Start: May 1, 2013
• Primary Completion: July 23, 2021
• Study Completion: December 31, 2021
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)