Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)

Adolescent Idiopathic Scoliosis Clinical Trial

— BrAIST  

Official title:

Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00448448
• Other study ID #: 200108052
• Secondary ID: R01AR052113
• Status: Terminated
• Phase: N/A
• Start date: February 2007
• Est. completion date: September 2013

Study information

• Verified date: November 2019
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 383
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Device:
• Brace
Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months.

Other:
• Observation
Clinical, radiographic, and self-report follow-up every 6 months.

Locations

Country	Name	City	State
Canada	Shriner's Hospital for Children	Montreal	Quebec
Canada	Hospital for Sick Children	Toronto	Ontario
Canada	BC Children's Hospital	Vancouver	British Columbia
United States	Carrie Tingley Hospital	Albuquerque	New Mexico
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Children's Hospital Boston	Boston	Massachusetts
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Shriner's Hospital for Children	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	University of Iowa Children's Hospital	Iowa City	Iowa
United States	Children's Mercy Hospitals and Clinics.	Kansas City	Missouri
United States	Shriners Hospitals for Children - Lexington	Lexington	Kentucky
United States	Children's Hospital Central California	Madera	California
United States	Shriners Hospitals for Children - Minneapolis	Minneapolis	Minnesota
United States	Hospital for Special Surgery	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Rochester Medical Center	Rochester	New York
United States	Shriners Hospital of Northern California	Sacramento	California
United States	Shriners Hospitals for Children - St. Louis	Saint Louis	Missouri
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Shriners Hospitals for Children - Salt Lake City	Salt Lake City	Utah
United States	Rady Childrens Hospital	San Diego	California
United States	Children's Hospital and Regional Medical Center	Seattle	Washington
United States	Alfred I. duPont Hospital for Children and Nemours Children's Clinic	Wilmington	Delaware

Sponsors (6)

Lead Sponsor	Collaborator
Stuart Weinstein	Canadian Institutes of Health Research (CIHR), Children's Mercy Hospital Kansas City, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Shriners Hospitals for Children, University of Rochester

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (5)

Dolan LA, Weinstein SL, Abel MF et al. 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 Deformity

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. — View 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.00000000000012 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skeletal Maturity With a Cobb Angle of <50 Degrees (Successful Outcome)		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.