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Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)

2014-07-23 21:29:57 | BioPortfolio

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 be randomly assigned to wear a thoracolumbosacral orthoses brace or not wear a brace. 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. Monitors placed in the brace will be used to determine the actual wear time by each participant.

Study Design

Allocation: Randomized, Control: Active Control, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Conditions

Adolescent Idiopathic Scoliosis

Intervention

Brace, Watchful waiting

Location

Children's Hospital Central California
Madera
California
United States
93638

Status

Recruiting

Source

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:29:57-0400

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Medical and Biotech [MESH] Definitions

Clinical management approach wherein immediate therapy is not provided but there is a period of observation during which periodic tests monitor patient and the progression of the illness. (Driffield T, Smith PC Med Decis Making. 2007 Mar-Apr;27(2):178-88)

The different methods of scheduling patient visits, appointment systems, individual or group appointments, waiting times, waiting lists for hospitals, walk-in clinics, etc.

Any observable response or action of an adolescent.

An adolescent who is receiving long-term in-patient services or who resides in an institutional setting.

Adolescent hospitalized for short term care.

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