NCT02299362

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,602 (actual)
• Sponsor: Growing Spine Study Group · Academic / Other
• Sex: All
• Age: 1 Day – 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Timeline

• Start date: 2008-10-01
• Primary completion: 2020-02-04
• Completion: 2020-02-04
• First posted: 2014-11-24
• Last updated: 2020-02-06

Locations

27 sites across 7 countries: United States, Canada, Egypt, Ghana, Spain, Turkey (Türkiye), United Kingdom