The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome Study
Condition: Early Onset Scoliosis; Congenital Spinal Deformities; Infantile Idiopathic Scoliosis; Neuromuscular Spinal Deformity; Syndromic Spinal Deformity; Thoracic Insufficiency Syndrome
MeSH terms: Scoliosis; Congenital Abnormalities
Study type: Observational [Patient Registry]

Summary: 
      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.
    

Detailed 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

        4. What demographic, clinical, radiographic, and surgical factors contribute to the
           incidence of complications?

        5. For patients with a particular diagnosis, age and/or treatment type, what are the
           clinical, radiographic and HRQOL changes before and after treatment?

        6. 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).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients receiving treatment at participating study sites who are eligible and agree to
        participate in the study.
      
Keywords: Early Onset Scoliosis; EOS; Pulmonary function; Infantile Idiopathic Scoliosis; MCGR; Magnetically controlled growing rods; Growing rods; Growth friendly spine surgery; Cast