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(352) 733-0111

PSSG

  • Status
    Accepting Candidates
  • Age
    1 Day - 18 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

The purpose of this study is to examine the treatment, both surgical and non-surgical, of patients with any form of early onset scoliosis. Such treatment may include the use of growth friendly devices that are surgically or magnetically lengthened; or the use of serial body casting or bracing, or observation. Outcomes examined will be what can be seen physically on the patient and on x-ray, as well as parent perception of how the treatment effects their child with the use of a health-related quality of life (HRQOL) questionnaire.

Description

This multi-center study will evaluate the long-term clinical and radiographic outcomes of Early Onset Scoliosis (EOS) and other Early Onset Spinal and Chest Wall Deformities in a large population of patients.

The study will attempt to answer the following clinical questions:

  1. How do clinical parameters (e.g. height, weight, pulmonary function, incidence of complications) differ between:

    1. Age groups

    2. Etiologic groups

    3. Treatment types including operative and non-operative methods

    4. Patients who receive definitive spinal fusion versus those who do not

  2. How do radiographic parameters (e.g. curve size, spinal height, thoracic dimensions, sagittal profile, pelvic parameters, spinal balance) differ between:

    1. Age groups

    2. Etiologic groups

    3. Treatment types including operative and non-operative methods

    4. Patients who receive definitive spinal fusion versus those who do not

  3. How does health-related quality of life (HRQOL), using the EOSQ-24 outcomes tool, differ

Between:

  1. Age groups

  2. Etiologic groups

  3. Treatment types including operative and non-operative methods

  4. Patients who receive definitive spinal fusion versus those who do not

  5. What demographic, clinical, radiographic, and surgical factors contribute to the incidence of complications?

  6. For patients with a particular diagnosis, age and/or treatment type, what are the clinical, radiographic and HRQOL changes before and after treatment?

  7. What are the mechanisms that cause rod breakage in growing rod constructs? (This study question is a collaborative research study with the U.S. Food and Drug Administration).

Details

Full study title Pediatric Spine Registry
Protocol number OCR18323
ClinicalTrials.gov ID NCT02299362

Eligibility

Inclusion Criteria:

  • Patients of any age and any diagnosis who undergo a growth-friendly surgical procedure, including but not limited to growing rods, VEPTR, Shilla, hybrid constructs, spinal tethering and staples

  • Patients of any age and any diagnosis who undergo casting

  • Patients of any diagnosis 10 years of age and younger who undergo spinal fusion of the thoracic and/or lumbar spine

  • Patients of any diagnosis under 6 years of age with scoliosis curves of the thoracic and/or lumbar spine measuring > 25 degrees. Observed and braced patients included

Exclusion Criteria:

  • Cervical spine anomalies alone will not be included

  • Patient/family is unwilling to participate in the study

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

    Stephanie Ihnow
  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.