The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome Study
GSSG
1 other identifier
observational
2,602
7 countries
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2008
Longer than P75 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 18, 2014
CompletedFirst Posted
Study publicly available on registry
November 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2020
CompletedFebruary 6, 2020
February 1, 2020
11.4 years
November 18, 2014
February 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Patient based outcomes
18 years
Eligibility Criteria
Patients receiving treatment at participating study sites who are eligible and agree to participate in the study.
You may qualify if:
- 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
You may not qualify if:
- Cervical spine anomalies alone will not be included
- Patient/family is unwilling to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Growing Spine Study Grouplead
- Growing Spine Foundationcollaborator
Study Sites (27)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Children's Hospital Los Angeles
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
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Paul D Sponseller, MD, MBA
Johns Hopkins Bloomberg Children's Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 18 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2014
First Posted
November 24, 2014
Study Start
October 1, 2008
Primary Completion
February 4, 2020
Study Completion
February 4, 2020
Last Updated
February 6, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share
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: 1. Filings for medical device clearance by the U.S. Food and Drug Administration (FDA) 2. Health care cost assessments 3. Future clinical research studies on EOS