The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome Study
- Conditions
- Infantile Idiopathic ScoliosisNeuromuscular Spinal DeformityCongenital Spinal DeformitiesEarly Onset ScoliosisSyndromic Spinal DeformityThoracic Insufficiency Syndrome
- Registration Number
- NCT02299362
- Lead Sponsor
- Growing Spine Study Group
- Brief 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2602
- 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
- Cervical spine anomalies alone will not be included
- Patient/family is unwilling to participate in the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical and Radiographic 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 Outcome Measures
Name Time Method Patient based outcomes 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).
Trial Locations
- Locations (27)
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Texas Scottish Rite Hospital for Children
🇺🇸Dallas, Texas, United States
Rady Children's Hospital
🇺🇸San Diego, California, United States
Indiana University Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
Nemours/Alfred I. Dupont Hospital for Children
🇺🇸Wilmington, Delaware, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Hospital Sainte-Justine
🇨🇦Montreal, Quebec, Canada
FOCOS Orthopaedic Hospital
🇬ðŸ‡Accra, Pantang West, Ghana
Cairo University
🇪🇬Giza, Egypt
C.S. Mott Childrens Hospital
🇺🇸Ann Arbor, Michigan, United States
British Columbia Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
University of Rochester
🇺🇸Rochester, New York, United States
Hacettepe University
🇹🇷Ankara, Turkey
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Children's Mercy Kansas City
🇺🇸Kansas City, Missouri, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
Hospitales Unversitarios Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Unversitario La Paz
🇪🇸Madrid, Spain
Royal Orthopaedic Hospital
🇬🇧Birmingham, United Kingdom