Adolescent Idiopathic Scoliosis
Conditions
Keywords
adolescent idiopathic scoliosis, orthotics, bracing, partially randomized preference design
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.
Interventions
DEVICEBrace
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.
OTHERObservation
Clinical, radiographic, and self-report follow-up every 6 months.
Sponsors
Stuart L. Weinstein, MD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Canadian Institutes of Health Research (CIHR)
Shriners Hospitals for Children
Children's Mercy Hospital Kansas City
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor(s) are blinded to the treatment assignment.
Eligibility
Sex/Gender
ALL
Age
10 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. |
Countries
Canada, United States
Contacts
PRINCIPAL_INVESTIGATORStuart L. Weinstein, MD
University of Iowa
STUDY_DIRECTORLori A. Dolan, PhD
University of Iowa
Participant flow
Recruitment details
Subjects were recruited from 25 centers in the US and Canada (see list of participating centers). The first subject was enrolled in April 2007 and the last in February 2011.
Participants by arm
| Arm | Count |
|---|---|
| Brace 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.
Brace: Brace (TLSO) prescribed for at least 18 hours per day. Wear time measured using a temperature monitor. Orthotic evaluations are conducted every 6 months and as necessary to maintain brace fit and function. | 146 |
| Observation Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. | 96 |
| Total | 242 |
Baseline characteristics
| Characteristic | Brace | Total | Observation |
|---|---|---|---|
| Age, Continuous | 12.7 years STANDARD_DEVIATION 1 | 12.7 years STANDARD_DEVIATION 1.1 | 12.7 years STANDARD_DEVIATION 1.2 |
| Cobb angle | 30.5 angle in degrees STANDARD_DEVIATION 5.8 | 30.4 angle in degrees STANDARD_DEVIATION 6 | 30.3 angle in degrees STANDARD_DEVIATION 6.5 |
| Curve type using SRS classification Double Major | 37 participants | 69 participants | 32 participants |
| Curve type using SRS classification Double Thoracic | 15 participants | 22 participants | 7 participants |
| Curve type using SRS classification Lumbar | 5 participants | 9 participants | 4 participants |
| Curve type using SRS classification Thoracic | 38 participants | 59 participants | 21 participants |
| Curve type using SRS classification Thoracic/Thoracolumbar | 20 participants | 33 participants | 13 participants |
| Curve type using SRS classification Thoracolumbar | 19 participants | 32 participants | 13 participants |
| Curve type using SRS classification Triple | 12 participants | 18 participants | 6 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 12 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 22 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 14 Participants | 3 Participants |
| Race (NIH/OMB) White | 116 Participants | 189 Participants | 73 Participants |
| Risser grade 0 | 82 participants | 142 participants | 60 participants |
| Risser grade 1 | 45 participants | 64 participants | 19 participants |
| Risser grade 2 | 15 participants | 27 participants | 12 participants |
| Risser grade 3 | 2 participants | 5 participants | 3 participants |
| Risser grade 4 | 1 participants | 1 participants | 0 participants |
| Risser grade 5 | 1 participants | 1 participants | 0 participants |
| Risser grade MISSING | 0 participants | 2 participants | 2 participants |
| Sex: Female, Male Female | 135 Participants | 221 Participants | 86 Participants |
| Sex: Female, Male Male | 11 Participants | 21 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| other Total, other adverse events | 71 / 146 | 36 / 96 |
| serious Total, serious adverse events | 1 / 146 | 0 / 96 |
Outcome results
Primary
Skeletal Maturity With a Cobb Angle of <50 Degrees (Successful Outcome)
Time frame: 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.
Population: The primary analysis included all patients who had completed the trial by January 2013, including 116 patients from the randomized arm and 126 from the preference arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brace | Skeletal Maturity With a Cobb Angle of <50 Degrees (Successful Outcome) | 72 percentage of patient successes |
| Observation | Skeletal Maturity With a Cobb Angle of <50 Degrees (Successful Outcome) | 48 percentage of patient successes |
p-value: <0.026795% CI: [1.08, 3.46]Regression, Logistic