Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)

Stuart L. Weinstein, MD

Status: Terminated

Conditions: Adolescent Idiopathic Scoliosis

Treatments: Device: Brace; Other: Observation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00448448

R01AR052113 (U.S. NIH Grant/Contract)

200108052

Details and patient eligibility

About

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.

Full 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.

Enrollment: 383 patients

Sex: All

Ages: 10 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

383 participants in 2 patient groups

Brace

Active Comparator group

Description:

This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function.

Treatment:

Device: Brace

Observation

Active Comparator group

Description:

Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.

Treatment:

Other: Observation