ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 9 for:    11468499 [PUBMED-IDS]

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 : Not yet recruiting
First Posted : November 6, 2017
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.


Condition or disease Intervention/treatment Phase
Scoliosis Device: ASTS Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
Experimental: ASTS device
Implantation of device ASTS (for ACTIVE TREATMENT SCOLIOSIS SYSTEM ) in children between 4 and 10
Device: ASTS
Implantation of a motorized spinal distraction rod




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. Post-surgical pain [ Time Frame: 3 months, after the implantation ]
    Self-assessment of pain using a visual analog scale

  2. Post-surgical pain [ Time Frame: months after the implantation ]
    Self-assessment of pain using a visual analog scale

  3. Post-surgical pain [ Time Frame: 9 months after the implantation ]
    Self-assessment of pain using a visual analog scale

  4. Post-surgical pain [ Time Frame: 1 year after the implantation ]
    Self-assessment of pain using a visual analog scale

  5. Survey to evaluate the quality of life [ Time Frame: Day 0 ]
    Assess quality of life in the questionnaire PedsQL

  6. Survey to evaluate the quality of life [ Time Frame: 6 months after the implantation ]
    Assess quality of life in the questionnaire PedsQL

  7. Survey to evaluate the quality of life [ Time Frame: 1 year after the implantation ]
    Assess quality of life in the questionnaire PedsQL

  8. 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,

  9. wound closure without tension, [ Time Frame: Day 0 ]
    Number of participant with closure of the wound without tension,

  10. good positioning of the radiographic implant. [ Time Frame: Day 0 ]
    Number participant with good positioning of the radiographic implant.

  11. Number of medical visits [ Time Frame: 1 year ]
    Measure of the number of medical visit in the year after implant

  12. Determine the number of iterative extensions made during follow-up [ Time Frame: 1 year ]
    Number of iterative extensions of 1 year.

  13. 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,

  14. correction of deformation immediately after the operation, [ Time Frame: 3 months after implantation ]
    Number of participant with correction of deformation immediately after the operation,

  15. Loss correction at 1 year [ Time Frame: 6 months after implantation ]
    Loss correction at 1 year

  16. Loss correction at 1 year [ Time Frame: 9 month after implantation ]
    Loss correction at 1 year

  17. Loss correction at 1 year [ Time Frame: 1 year after implantation ]
    Loss correction at 1 year

  18. Increase the distance T1-S1 at 1 year [ Time Frame: 1 year ]
    Increase the distance T1-S1 at 1 year (in mm)

  19. 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)

  20. 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)

  21. 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)

  22. 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)

  23. Nature of complications [ Time Frame: 1 years ]
    describe the nature of complication

  24. Nature of complications [ Time Frame: 2 years ]
    describe the nature of complication

  25. Nature of complications [ Time Frame: 3 years ]
    describe the nature of complication

  26. Nature of complications [ Time Frame: 5 years ]
    describe the nature of complication



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:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03330158


Contacts
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

Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Franck Accadbled, MD PhD University Hospital, Toulouse

Publications:

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03330158     History of Changes
Other Study ID Numbers: RC31/15/7851
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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