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

Completed

Conditions studied: Early Onset Scoliosis, Congenital Spinal Deformities, Infantile Idiopathic Scoliosis, Neuromuscular Spinal Deformity, Syndromic Spinal Deformity, Thoracic Insufficiency Syndrome

In brief

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.

Key facts

Study ID

NCT02299362

Run by

Growing Spine Study Group

People needed

2602

Starts

2008-10-01

Expected to finish

2020-02-04

Last updated by the study team

2020-02-06

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Rady Children's Hospital — San Diego, California, United States
• Nemours/Alfred I. Dupont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• Indiana University Riley Hospital for Children — Indianapolis, Indiana, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• C.S. Mott Childrens Hospital — Ann Arbor, Michigan, United States
• Children's Mercy Kansas City — Kansas City, Missouri, United States
• Washington University — St Louis, Missouri, United States
• Hospital for Special Surgery — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, 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
• Texas Children's Hospital — Houston, Texas, United States
• British Columbia Children's Hospital — Vancouver, British Columbia, Canada
• Hospital Sainte-Justine — Montreal, Quebec, Canada
• Cairo University — Giza, Egypt
• FOCOS Orthopaedic Hospital — Accra, Pantang West, Ghana
• Hospital Unversitario La Paz — Madrid, Spain
• Hospitales Unversitarios Virgen del Rocio — Seville, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.