Clinical trial NCT04500041: Casting Vs Bracing for Idiopathic Early-Onset Scoliosis
Official title: Casting Vs Bracing for Idiopathic Early-Onset Scoliosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Scoliosis Idiopathic
Early-Onset Scoliosis Deformity of Spine
Keywords: Cast
Brace
Spinal Orthosis
Spinal Orthotic
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Orthopedic Research and Education Foundation
name: Pediatric Spine Study Group
First posted: 2020-08-05
Enrollment: 71
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment (casting or bracing) via randomized assignment OR based on family preference
Primary purpose: TREATMENT

Brief summary: Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis

Detailed description: This study uses a multicenter, prospective hybrid research design, which will combine two methods of treatment assignment (randomized and parent preference) and an embedded internal pilot study for sample size re-estimation. Patients will be treated either with serial casts or a full-time brace and followed until curve resolution, failure or palliation (neither resolution nor failure after 2 years of treatment). Results of this study will provide clinicians and families with evidence to support informed treatment decisions.

Eligibility criteria: Will enroll both patients with scoliosis and 1 of their parents/guardians

Inclusion Criteria:

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

Exclusion Criteria:

Patient Exclusion

* Previous operative or non-operative treatment for idiopathic early-onset scoliosis
* Not independently walking by 18 months of age or other signs/symptoms indicative of developmental delay

Primary outcomes:
measure: Curve Response
timeFrame: on or before 24 months of treatment
Secondary outcomes:
measure: Patient Health-related Quality of Life (HRQOL)
timeFrame: on or before 24 months of treatment
Other outcomes:
measure: Parent and Family Functioning
timeFrame: on or before 24 months of treatment
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Wilmington
country: United States
facility: Nemours/Alfred I. duPont Hospital for Children
state: Delaware
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Shriners Hospitals for Children - Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Children's Hospital of Boston
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Paul
country: United States
facility: Gillette Children's Specialty Healthcare
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
city: St. Louis
country: United States
facility: St. Louis Children's Hospital/Washington University
state: Missouri
city: Rochester
country: United States
facility: Golisano Children's Hospital/University of Rochester
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Doernbecher Children's Hospital / OHSU
state: Oregon
city: Portland
country: United States
facility: Shriners Hospitals for Children - Portland
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Shriners Hospitals for Children - Philadelphia
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Milano
country: Italy
facility: Italian Scientific Spine Institute (ISICO)
city: Auckland
country: New Zealand
facility: Starship Child Health
Study officials:
affiliation: University of Iowa
name: Stuart L Weinstein, MD
role: PRINCIPAL_INVESTIGATOR
References: