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Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child (ASTS)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330158
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE July 11, 2016
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date November 9, 2020
Actual Study Start Date  ICMJE February 5, 2019
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2018)
  • Ability to Implant the device [ Time Frame: Day 0: the day of the implantation ]
    The surgeon will have to say if the implantation of the device has been done or not
  • Change of the position of the implant [ Time Frame: 1 years after the implantation ]
    1 year after the implantation of the device, radiographs will be realised to ensure that the implant is still well positioning
  • Change of the position of the implant [ Time Frame: 2 years after the implantation ]
    2 years after the implantation of the device, radiographs will be realised to ensure that the implant is still weel positioning
  • Change of the position of the implant [ Time Frame: 3 years after the implantation ]
    3 years after the implantation of the device, radiographs will be realised to ensure that the implant is still weel positioning
  • Change of the implant's length [ Time Frame: 3 months, 6 months, 9 months, 1 year, 2 years and 3 years after the implantation ]
    The elongation of the implant will be measured in mm on the digital radiography
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
  • Ability to Implant the device [ Time Frame: Day 0: the day of the implantation ]
    The surgeon will have to say if the implantation of the device has been done or not
  • Change of the position of the implant [ Time Frame: 1 years after the implantation ]
    1 year after the implantation of the device, radiographs will be realised to ensure that the implant is still weel positioning
  • Change of the position of the implant [ Time Frame: 2 years after the implantation ]
    2 years after the implantation of the device, radiographs will be realised to ensure that the implant is still weel positioning
  • Change of the position of the implant [ Time Frame: 3 years after the implantation ]
    3 years after the implantation of the device, radiographs will be realised to ensure that the implant is still weel positioning
  • Change of the implant's length [ Time Frame: 3 months, 6 months, 9 months, 1 year, 2 years and 3 years after the implantation ]
    The elongation of the implant will be measured in mm on the digital radiography
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2018)
  • Post-surgical pain [ Time Frame: 3 months, after the implantation ]
    Self-assessment of pain using a visual analog scale
  • Post-surgical pain [ Time Frame: months after the implantation ]
    Self-assessment of pain using a visual analog scale
  • Post-surgical pain [ Time Frame: 9 months after the implantation ]
    Self-assessment of pain using a visual analog scale
  • Post-surgical pain [ Time Frame: 1 year after the implantation ]
    Self-assessment of pain using a visual analog scale
  • Survey to evaluate the quality of life [ Time Frame: Day 0 ]
    Assess quality of life in the questionnaire PedsQL
  • Survey to evaluate the quality of life [ Time Frame: 6 months after the implantation ]
    Assess quality of life in the questionnaire PedsQL
  • Survey to evaluate the quality of life [ Time Frame: 1 year after the implantation ]
    Assess quality of life in the questionnaire PedsQL
  • to ease for the surgeon to implant the device, [ Time Frame: Day 0 ]
    Number of participant with ease for the surgeon to implant the device,
  • wound closure without tension, [ Time Frame: Day 0 ]
    Number of participant with closure of the wound without tension,
  • good positioning of the radiographic implant. [ Time Frame: Day 0 ]
    Number participant with good positioning of the radiographic implant.
  • Number of medical visits [ Time Frame: 1 year ]
    Measure of the number of medical visit in the year after implant
  • Determine the number of iterative extensions made during follow-up [ Time Frame: 1 year ]
    Number of iterative extensions of 1 year.
  • correction of deformation immediately after the operation, [ Time Frame: 3 months, 6 months, 9 month and 1 year ]
    Number of participant with correction of deformation immediately after the operation,
  • correction of deformation immediately after the operation, [ Time Frame: 3 months after implantation ]
    Number of participant with correction of deformation immediately after the operation,
  • Loss correction at 1 year [ Time Frame: 6 months after implantation ]
    Loss correction at 1 year
  • Loss correction at 1 year [ Time Frame: 9 month after implantation ]
    Loss correction at 1 year
  • Loss correction at 1 year [ Time Frame: 1 year after implantation ]
    Loss correction at 1 year
  • Increase the distance T1-S1 at 1 year [ Time Frame: 1 year ]
    Increase the distance T1-S1 at 1 year (in mm)
  • Effective Elongation measured on radiographs of specification of the device (in mm) [ Time Frame: 3 months after implantation ]
    Effective Elongation measured on radiographs of specification of the device (in mm)
  • Effective Elongation measured on radiographs of specification of the device [ Time Frame: 6 months after implantation ]
    Effective Elongation measured on radiographs of specification of the device (in mm)
  • Effective Elongation measured on radiographs of specification of the device [ Time Frame: 9 month after implantation ]
    Effective Elongation measured on radiographs of specification of the device (in mm)
  • Effective Elongation measured on radiographs of specification of the device [ Time Frame: 1 year after implantation ]
    Effective Elongation measured on radiographs of specification of the device (in mm)
  • Nature of complications [ Time Frame: 1 years ]
    describe the nature of complication
  • Nature of complications [ Time Frame: 2 years ]
    describe the nature of complication
  • Nature of complications [ Time Frame: 3 years ]
    describe the nature of complication
  • Nature of complications [ Time Frame: 5 years ]
    describe the nature of complication
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
  • Post-surgical pain [ Time Frame: 3 months, after the implantation ]
    Self-assessment of pain using a visual analog scale
  • Post-surgical pain [ Time Frame: months after the implantation ]
    Self-assessment of pain using a visual analog scale
  • Post-surgical pain [ Time Frame: 9 months after the implantation ]
    Self-assessment of pain using a visual analog scale
  • Post-surgical pain [ Time Frame: 1 year after the implantation ]
    Self-assessment of pain using a visual analog scale
  • Quality of life [ Time Frame: Day 0 ]
    Assess quality of life in the questionnaire PedsQL
  • Quality of life [ Time Frame: 6 months after the implantation ]
    Assess quality of life in the questionnaire PedsQL
  • Quality of life [ Time Frame: 1 year after the implantation ]
    Assess quality of life in the questionnaire PedsQL
  • to ease for the surgeon to implant the device, [ Time Frame: Day 0 ]
    Number of participant with ease for the surgeon to implant the device,
  • wound closure without tension, [ Time Frame: Day 0 ]
    Number of participant with closure of the wound without tension,
  • good positioning of the radiographic implant. [ Time Frame: Day 0 ]
    Number participant with good positioning of the radiographic implant.
  • Number of medical visits [ Time Frame: 1 year ]
    Measure of the number of medical visit in the year after implant
  • Determine the number of iterative extensions made during follow-up [ Time Frame: 1 year ]
    Number of iterative extensions of 1 year.
  • correction of deformation immediately after the operation, [ Time Frame: 3 months, 6 months, 9 month and 1 year ]
    Number of participant with correction of deformation immediately after the operation,
  • correction of deformation immediately after the operation, [ Time Frame: 3 months after implantation ]
    Number of participant with correction of deformation immediately after the operation,
  • Loss correction at 1 year [ Time Frame: 6 months after implantation ]
    Loss correction at 1 year
  • Loss correction at 1 year [ Time Frame: 9 month after implantation ]
    Loss correction at 1 year
  • Loss correction at 1 year [ Time Frame: 1 year after implantation ]
    Loss correction at 1 year
  • Increase the distance T1-S1 at 1 year [ Time Frame: 1 year ]
    Increase the distance T1-S1 at 1 year (in mm)
  • Effective Elongation measured on radiographs of specification of the device (in mm) [ Time Frame: 3 months after implantation ]
    Effective Elongation measured on radiographs of specification of the device (in mm)
  • Effective Elongation measured on radiographs of specification of the device (in mm) [ Time Frame: 6 months after implantation ]
    Effective Elongation measured on radiographs of specification of the device (in mm)
  • Effective Elongation measured on radiographs of specification of the device (in mm) [ Time Frame: 9 month after implantation ]
    Effective Elongation measured on radiographs of specification of the device (in mm)
  • Effective Elongation measured on radiographs of specification of the device (in mm) [ Time Frame: 1 year after implantation ]
    Effective Elongation measured on radiographs of specification of the device (in mm)
  • Nature of complications [ Time Frame: 1 years ]
    descrive the nature of complication
  • Nature of complications [ Time Frame: 2 years ]
    descrive the nature of complication
  • Nature of complications [ Time Frame: 3 years ]
    descrive the nature of complication
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child
Official Title  ICMJE Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child
Brief Summary

The purpose of this biomedical research is to evaluate the feasibility of the treatment with the new spinal distraction device ASTS in patients aged 4 to 10 years with severe early onset scoliosis.

The hypothesis of this project is that the new fully implantable motorized spinal distraction device may provide a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.

The ASTS (for Active Scoliosis Treatment System) growing rod is a new fully implantable motorized spinal distraction device which can ensure a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.

Detailed Description

Despite a better understanding and technical progress, the evolutionary early scoliosis remains a therapeutic challenge. The definition includes idiopathic scoliosis beginning before the age of 3 years, congenital scoliosis, neuromuscular and syndromic. Spinal deformity is often progressive and may compromise cardiorespiratory function.

The goal of treatment is to prevent further avoiding spinal fusion in a subject in growth. Surgery is indicated in case of failure or cons-indication of conservative treatment (corset or plaster). The principle is to position the posterior rods subcutaneous or in muscle attached to two ends of the deformation.

Intraoperative distraction allows correction of the deformity. A new distraction is performed every 6 months until skeletal maturity.

Considerable complication rates are reported (58%), mainly implant infections and disassembly, because of the need for multiple reoperations. Motorized implants can potentially avoid repeated interventions limiting complications.

Thus, the central hypothesis of this project is a new fully implantable motorized spinal distraction device may provide a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Scoliosis
Intervention  ICMJE Device: ASTS
Implantation of a motorized spinal distraction rod
Study Arms  ICMJE Experimental: ASTS device
Implantation of device ASTS (for ACTIVE TREATMENT SCOLIOSIS SYSTEM ) in children between 4 and 10
Intervention: Device: ASTS
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2017)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2025
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient 4 to 10 years
  • Patient weight between 15kg at 50kg
  • Introducing severe scoliosis (Cobb angle> 40 °) with early onset
  • Failed or cons-indication of conservative treatment (cast or brace)
  • Agreement of parents or legal guardian (written agreement) and the patient (at least an oral agreement).

Exclusion Criteria:

  • Contraindication to surgery
  • Age less than 4 years or above 10 years
  • Weight less 15kg and above 50 kg
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Franck Accadbled, MD, PhD 33 5 34 55 85 25 accadbled.f@chu-toulouse.fr
Contact: Jérôme Sales de Gauzy, MD, Ph D 33 5 34 55 85 23 salesdegauzy.j@chu-toulouse.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03330158
Other Study ID Numbers  ICMJE RC31/15/7851
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Franck Accadbled, MD PhD University Hospital, Toulouse
PRS Account University Hospital, Toulouse
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP