Casting vs Bracing for Idiopathic Early-Onset Scoliosis
Status: Recruiting
Location: See all (38) 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: No
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
Recruiting
Little Rock
Colorado
Children's Hospital Colorado
Recruiting
Aurora
Delaware
Nemours/Alfred I. duPont Hospital for Children
Recruiting
Wilmington
Georgia
Children's Healthcare of Atlanta
Recruiting
Atlanta
Iowa
University of Iowa
Recruiting
Iowa City
Illinois
Lurie Children's Hospital of Chicago
Recruiting
Chicago
Shriners Hospitals for Children - Chicago
Recruiting
Chicago
Indiana
Riley's Hospital for Children at IU Healthcare
Recruiting
Indianapolis
Massachusetts
Children's Hospital of Boston
Recruiting
Boston
Maryland
Johns Hopkins
Recruiting
Baltimore
Michigan
University of Michigan
Recruiting
Ann Arbor
Minnesota
Gillette Children's Specialty Healthcare
Recruiting
Saint Paul
Missouri
Children's Mercy Kansas City
Recruiting
Kansas City
St. Louis Children's Hospital/Washington University
Recruiting
Saint Louis
North Carolina
University of North Carolina Chapel Hill
Recruiting
Chapel Hill
Duke University Medical Center
Active, not recruiting
Durham
New York
Morgan Stanley Children's Hospital
Recruiting
New York
Golisano Children's Hospital/University of Rochester
Recruiting
Rochester
Oregon
Doernbecher Children's Hospital / OHSU
Recruiting
Portland
Shriners Hospitals for Children - Portland
Recruiting
Portland
Pennsylvania
Children's Hospital of Pennsylvania
Recruiting
Philadelphia
Shriners Hospitals for Children - Philadelphia
Recruiting
Philadelphia
Children's Hospital of Pittsburgh
Recruiting
Pittsburgh
Tennessee
Campbell Clinic/Le Bonheur Children's Hospital
Recruiting
Germantown
Vanderbilt University Medical Center
Recruiting
Nashville
Texas
Texas Children's Hospital
Recruiting
Houston
Virginia
University of Virginia
Recruiting
Charlottesville
Washington
Seattle Children's Hospital
Recruiting
Seattle
Wisconsin
Children's Hospital of Wisconsin
Recruiting
Milwaukee
Other Locations
Canada
IWK Health Centre
Not yet recruiting
Halifax
CHU Sainte-Justine
Recruiting
Montréal
British Columbia Children's Hospital
Recruiting
Vancouver
Hong Kong Special Administrative Region
University of Hong Kong
Recruiting
Hong Kong
Italy
Italian Scientific Spine Institute (ISICO)
Recruiting
Milano
New Zealand
Starship Child Health
Recruiting
Auckland
Singapore
National University Hospital
Recruiting
Singapore
Turkey
Acibadem Maslak Hospital
Not yet recruiting
Istanbul
United Kingdom
Royal Orthopaedic Hospital
Recruiting
Birmingham
Contact Information
Primary
Lori A Dolan, PhD
lori-dolan@uiowa.edu
319-356-1075
Time Frame
Start Date: February 9, 2021
Estimated Completion Date: September 30, 2023
Participants
Target number of participants: 440
Treatments
Active Comparator: Casting
Subjects will be treated with serial casting
Active Comparator: Bracing
Subjects will be treated with full-time orthotics (braces)
Authors
Brian Kelly, Benjamin Roye, Sumeet Garg, Purnendu Gupta, John Thometz, Richard Schwend, Patrick Cahill, Daniel Miller, Scott Luhmann, Mark Abel, Joshua Holt, Daniel Bouton, John Anderson, Ozgur Dede, Robert Lark, Tenner Guillaume, Nicholas Fletcher, Stuart L Weinstein, Laurel Blakemore, Paul Sponseller, Ryan Fitzgerald, Nigel Price, Anuj Singla, Susan Nelson, Richard McCarthy, Tyler Christman, Christopher Reilly, Frank Gerow, Joshua Murphy, 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, Ying Li, Patrick Bosch, Steven Koop, Gregory Mencio, John Grayhack, Klane White, Stephanie Ihnow, Keith Bachmann, Jeffrey Martus, James Sanders, Michael Schmidt, Michelle Welborn, Benny Dahl, Darrell Hanson, Elizabeth Hubbard, Paul Rubery, Adrian Gardner, Timothy Ward, Yilgor Caglor, Loek-Lim Lau, Kenneth Cheung, Brian Smith, Hee Kit Wong, Loek Lim Lau, Graham Shea, Walter Truong, Hee-Kit Wong, Kenny Kwan, Jason Cheung, Matthew Halsey, Lori A Dolan, Xue-Cheng Liu, Eduardo Beauchamp, Ron El-Hawary, Sabrina Donzelli, Haemish Crawford, Ahmet Alanay, Stefano Negrini, Fabio Zaina, Amir Samdani, Stefan Parent, Timothy Hresko, Firoz Miyanji
Related Therapeutic Areas
Sponsors
Leads: University of Iowa
Collaborators: Orthopedic Research and Education Foundation, Pediatric Spine Study Group