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Completed

NCT Number: NCT02299362

The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome Study

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.

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Key information

Conditions

Early Onset Scoliosis Congenital Spinal Deformities Infantile Idiopathic Scoliosis Neuromuscular Spinal Deformity Syndromic Spinal Deformity Thoracic Insufficiency Syndrome

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

British Columbia Children's Hospital, Vancouver, British Columbia, Canada

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About this study

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:

  • How do clinical parameters (e.g. height, weight, pulmonary function, incidence of complications) differ between:
  • Age groups
  • Etiologic groups
  • Treatment types including operative and non-operative methods
  • Patients who receive definitive spinal fusion versus those who do not
  • How do radiographic parameters (e.g. curve size, spinal height, thoracic dimensions, sagittal profile, pelvic parameters, spinal balance) differ between:
  • Age groups
  • Etiologic groups
  • Treatment types including operative and non-operative methods
  • Patients who receive definitive spinal fusion versus those who do not
  • How does health-related quality of life (HRQOL), using the EOSQ-24 outcomes tool, differ between:
  • Age groups
  • Etiologic groups
  • Treatment types including operative and non-operative methods
  • Patients who receive definitive spinal fusion versus those who do not
  • What demographic, clinical, radiographic, and surgical factors contribute to the incidence of complications?
  • For patients with a particular diagnosis, age and/or treatment type, what are the clinical, radiographic and HRQOL changes before and after treatment?
  • 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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Clinical and Radiographic

    Time frame: 18 years

    Evaluation of long-term clinical measures such as: BMI, Pulmonary functionality, incidence of complications; and radiographic outcomes (e.g. coronal spinal curvature, sagittal profile, spinal and thoracic growth, coronal and sagittal alignment.

Secondary outcomes

  1. Patient based outcomes

    Time frame: 18 years

    Evaluation of the effect of treatment on patients and families by use of serial early-onset scoliosis questionnaire (EOSQ-24) scores during treatment. EOSQ covers the following domains: Child's Health Related Quality of Life (16 items), Family Impact (2 items) and Satisfaction (2 items).

Sponsors and collaborators

Lead sponsor

Growing Spine Study Group

Other

Collaborators

  • Growing Spine Foundation

Registry information

Acronym: GSSG

Important dates

Study start
2008
Primary completion
2020
Study completion
2020
First posted
Nov 24, 2014
Registry last updated
Feb 6, 2020

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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