Casting Vs Bracing for Idiopathic Early-Onset Scoliosis
Status: Active_not_recruiting
Location: See all (26) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 3
Healthy Volunteers: f
View:
⁃ Patient Inclusion
• Diagnosis of idiopathic early-onset scoliosis
• Child standing independently but not older than 3 years of age
• 20≤ Cobb angle ≤70° (largest structural curvature)
• Rib-vertebral angle difference (RVAD) greater than 20 degrees or Rib Phase II
• Parental consent to participate
⁃ Parent Inclusion
• Parent or guardian of the minor subject
• Consent to participate
• Able to complete surveys
Locations
United States
Arkansas
Arkansas Children's Hospital
Little Rock
Colorado
Children's Hospital Colorado
Aurora
Delaware
Nemours/Alfred I. duPont Hospital for Children
Wilmington
Georgia
Children's Healthcare of Atlanta
Atlanta
Iowa
University of Iowa
Iowa City
Illinois
Lurie Children's Hospital of Chicago
Chicago
Shriners Hospitals for Children - Chicago
Chicago
Massachusetts
Children's Hospital of Boston
Boston
Maryland
Johns Hopkins
Baltimore
Michigan
University of Michigan
Ann Arbor
Minnesota
Gillette Children's Specialty Healthcare
Saint Paul
Missouri
Children's Mercy Kansas City
Kansas City
St. Louis Children's Hospital/Washington University
St. Louis
North Carolina
University of North Carolina Chapel Hill
Chapel Hill
Duke University Medical Center
Durham
New York
Golisano Children's Hospital/University of Rochester
Rochester
Oregon
Doernbecher Children's Hospital / OHSU
Portland
Shriners Hospitals for Children - Portland
Portland
Pennsylvania
Children's Hospital of Pennsylvania
Philadelphia
Shriners Hospitals for Children - Philadelphia
Philadelphia
Tennessee
Vanderbilt University Medical Center
Nashville
Texas
Texas Children's Hospital
Houston
Virginia
University of Virginia
Charlottesville
Washington
Seattle Children's Hospital
Seattle
Other Locations
Italy
Italian Scientific Spine Institute (ISICO)
Milano
New Zealand
Starship Child Health
Auckland
Time Frame
Start Date: 2021-02-09
Completion Date: 2026-01-30
Participants
Target number of participants: 71
Treatments
Active_comparator: Casting
Subjects will be treated with serial casting
Active_comparator: Bracing
Subjects will be treated with full-time orthotics (braces)
Authors
Matthew Halsey, Benjamin Roye, Sumeet Garg, Purnendu Gupta, John Thometz, Richard Schwend, Scott Luhmann, Mark Abel, Joshua Holt, Daniel Bouton, John Anderson, Ozgur Dede, Robert Lark, Tenner Guillaume, James Sanders, Nicholas Fletcher, Stuart L Weinstein, Laurel Blakemore, Ryan Fitzgerald, Nigel Price, Susan Nelson, Tyler Christman, Frank Gerow, Matthew Oetgen, Suken Shah, Mark Erickson, John Sarwark, Michal Szczodry, Geoffrey Haft, David Bumpass, Stephen Mendelson, Joshua Pahys, Joseph Khoury, Kim Hammerberg, Derek Kelly, Robert Fitch, Scott Yang, Michael Vitale, Joseph Perra, Cheryl Lawing, Dennis Devito, Patrick Bosch, Steven Koop, Gregory Mencio, John Grayhack, Klane White, Stephanie Ihnow, Keith Bachmann, Jeffrey Martus, Michelle Welborn, Benny Dahl, Darrell Hanson, Paul Rubery, Elizabeth Hubbard, Anuj Singla, Graham Shea, Sabrina Donzelli, Fabio Zaina, Hee-Kit Wong, Ron El-Hawary, Kenneth Cheung, Firoz Miyanji, Haemish Crawford, Kenny Kwan, Ahmet Alanay, Stefano Negrini, Jason Cheung
Related Therapeutic Areas
Sponsors
Collaborators: Pediatric Spine Study Group, Orthopedic Research and Education Foundation
Leads: University of Iowa