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| Name | Class |
|---|---|
| Growing Spine Foundation | UNKNOWN |
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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.
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:
How do radiographic parameters (e.g. curve size, spinal height, thoracic dimensions, sagittal profile, pelvic parameters, spinal balance) differ between:
How does health-related quality of life (HRQOL), using the EOSQ-24 outcomes tool, differ between:
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).
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical and Radiographic | 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. | 18 years |
| Measure | Description | Time Frame |
|---|---|---|
| Patient based outcomes | 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). | 18 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving treatment at participating study sites who are eligible and agree to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Paul D Sponseller, MD, MBA | Johns Hopkins Bloomberg Children's Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States | ||
| Children's Hospital Los Angeles |
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| Label | URL |
|---|---|
| Growing Spine Foundation webpage | View source |
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Data stored in the GSSG database will also be shared with 24 sites that comprise the Children's Spine Study Group (CSSG). The collaboration between GSSG and CSSG is solely for research purposes.
Fully de-identified data from the GSSG database may be shared with key stakeholders including, but not limited to, medical device companies, professional societies, regulatory agencies, patients and surgeons to support endeavors that are aimed to improve the care of EOS patients. These data may be shared to support the following activities:
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| Los Angeles |
| California |
| 90027 |
| United States |
| Rady Children's Hospital | San Diego | California | 92123 | United States |
| Nemours/Alfred I. Dupont Hospital for Children | Wilmington | Delaware | 19899 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 10010 | United States |
| University of Florida | Gainesville | Florida | 32611 | United States |
| Indiana University Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Children's Hospital Boston | Boston | Massachusetts | 02115-5724 | United States |
| C.S. Mott Childrens Hospital | Ann Arbor | Michigan | 48109 | United States |
| Children's Mercy Kansas City | Kansas City | Missouri | 64108 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Texas Scottish Rite Hospital for Children | Dallas | Texas | 75219 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| British Columbia Children's Hospital | Vancouver | British Columbia | V6H 3V4 | Canada |
| Hospital Sainte-Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Cairo University | Giza | 12411 | Egypt |
| FOCOS Orthopaedic Hospital | Accra | Pantang West | Ghana |
| Hospital Unversitario La Paz | Madrid | 28029 | Spain |
| Hospitales Unversitarios Virgen del Rocio | Seville | 41013 | Spain |
| Hacettepe University | Ankara | 06450 | Turkey (Türkiye) |
| Royal Orthopaedic Hospital | Birmingham | B31 2AP | United Kingdom |