Clinical trial NCT00448448: Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)
Official title: Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: adolescent idiopathic scoliosis
orthotics
bracing
partially randomized preference design
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: Canadian Institutes of Health Research (CIHR)
name: Shriners Hospitals for Children
name: Children's Mercy Hospital Kansas City
name: University of Rochester
First posted: 2007-03-16
Enrollment: 383
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adolescent idiopathic scoliosis (AIS) is a structural curve of the spine with no clear underlying cause. Bracing is currently the standard of care for preventing curve progression and treating AIS. However, the effectiveness of bracing remains unclear. The purpose of this study is to compare the risk of curve progression in adolescents with AIS who wear a brace versus those who do not and to determine whether there are reliable factors that can predict the usefulness of bracing for a particular individual with AIS.

Detailed description: AIS is characterized by a lateral curvature of the spine greater than 10 degrees plus rotation of the spinal vertebrae. AIS is found in adolescents between the age of 10 and time of skeletal maturity. Progression of a spinal curve to 50 degrees suggests a high risk for continued curve progression throughout adulthood and usually indicates the need for spinal fusion surgery. Only about 10 percent of adolescents with AIS end up having curves that progress and require surgical intervention. While certain risk factors for curve progression have been identified, there is no reliable way of estimating the likelihood of needing surgery. Bracing is currently the standard of care for treating AIS. However, the effectiveness of bracing remains unclear, and it is unknown which adolescents in particular may benefit from bracing. Therefore, adolescents undergo bracing without knowing their likelihood of avoiding surgery. The purpose of this study is to compare the risk of curve progression in adolescents with AIS who wear a brace versus those who do not and to determine whether there are reliable factors that can predict the usefulness of bracing for a particular individual with AIS. The study will also evaluate the best dosing and duration schedule and how bracing affects quality of life, functioning, and psychosocial adjustment among participants.

Participation in this study will last until a participant reaches skeletal maturity or their spinal curve progresses to 50 degrees, after which usual care will continue. Participants will either be 1)randomly assigned to a treatment or 2) may decline randomization and choose their own treatment arm. Study visits will occur every 6 months at an orthopaedic surgeon's office and will include x-rays, a clinical exam, and questionnaires. Participants assigned to braces will be instructed to wear the brace at least 18 hours per day. Temperature monitors placed in the brace will be used to determine the actual wear time by each participant.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of AIS
* Skeletally immature (Risser grade 0, 1, or 2)
* Pre-menarchal or post-menarchal by no more than 1 year
* Primary Cobb angle between 20 and 40 degrees
* Curve apex caudal to T7 vertebrae
* Physical and mental ability to adhere to bracing protocol
* Ability to read and understand English, Spanish, or French
* Documented insurance coverage and/or personal willingness to pay for treatment

Exclusion Criteria:

* Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
* History of previous surgical or orthotic treatment for AIS

Primary outcomes:
measure: Skeletal Maturity With a Cobb Angle of <50 Degrees (Successful Outcome)
timeFrame: Skeletal maturity and the Cobb angle were measured at baseline and at each 6-month follow-up. Subjects were followed until they reached criteria for either success or failure. The average duration of follow-up was 23.67 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Madera
country: United States
facility: Children's Hospital Central California
state: California
city: Sacramento
country: United States
facility: Shriners Hospital of Northern California
state: California
city: San Diego
country: United States
facility: Rady Childrens Hospital
state: California
city: Wilmington
country: United States
facility: Alfred I. duPont Hospital for Children and Nemours Children's Clinic
state: Delaware
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Shriner's Hospital for Children
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Children's Hospital
state: Iowa
city: Lexington
country: United States
facility: Shriners Hospitals for Children - Lexington
state: Kentucky
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Minneapolis
country: United States
facility: Shriners Hospitals for Children - Minneapolis
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics.
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Shriners Hospitals for Children - St. Louis
state: Missouri
city: Albuquerque
country: United States
facility: Carrie Tingley Hospital
state: New Mexico
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Shriners Hospitals for Children - Salt Lake City
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Seattle
country: United States
facility: Children's Hospital and Regional Medical Center
state: Washington
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: Shriner's Hospital for Children
state: Quebec
Study officials:
affiliation: University of Iowa
name: Stuart L. Weinstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Lori A. Dolan, PhD
role: STUDY_DIRECTOR
References:
citation: Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Design of the Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST). Spine (Phila Pa 1976). 2013 Oct 1;38(21):1832-41. doi: 10.1097/01.brs.0000435048.23726.3e.
citation: Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. 2013 Oct 17;369(16):1512-21. doi: 10.1056/NEJMoa1307337. Epub 2013 Sep 19.
citation: Schwieger T, Campo S, Weinstein SL, Dolan LA, Ashida S, Steuber KR. Body Image and Quality of Life and Brace Wear Adherence in Females With Adolescent Idiopathic Scoliosis. J Pediatr Orthop. 2017 Dec;37(8):e519-e523. doi: 10.1097/BPO.0000000000000734.
citation: Schwieger T, Campo S, Weinstein SL, Dolan LA, Ashida S, Steuber KR. Body Image and Quality-of-Life in Untreated Versus Brace-Treated Females With Adolescent Idiopathic Scoliosis. Spine (Phila Pa 1976). 2016 Feb;41(4):311-9. doi: 10.1097/BRS.0000000000001210.
citation: Dolan LA, Weinstein SL, Abel MF, Bosch PP, Dobbs MB, Farber TO, Halsey MF, Hresko MT, Krengel WF, Mehlman CT, Sanders JO, Schwend RM, Shah SA, Verma K. Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST): Development and Validation of a Prognostic Model in Untreated Adolescent Idiopathic Scoliosis Using the Simplified Skeletal Maturity System. Spine Deform. 2019 Nov;7(6):890-898.e4. doi: 10.1016/j.jspd.2019.01.011.