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| ID | Type | Description | Link |
|---|---|---|---|
| R01AR052113 | U.S. NIH Grant/Contract | View source |
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Stopped for efficacy
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Shriners Hospitals for Children | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brace | Active Comparator | 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. |
|
| Observation | Active Comparator | Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brace | Device | 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. |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart L. Weinstein, MD | University of Iowa | Principal Investigator |
| Lori A. Dolan, PhD | University of Iowa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Central California | Madera | California | 93638 | United States | ||
| Shriners Hospital of Northern California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24026162 | Background | 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. | |
| 41337495 | Background | Amaral JZ, Kallur A, Dolan LA, Nguyen AQ, Schultz RJ, Martin BM, Coello P, Scioscia JP, Chhabra BN, Hanson DS, Gerow FT, Smith BG. Bracing Outcomes and Risk of Curve Progression in Adolescents with Idiopathic Scoliosis and Autism Spectrum Disorder. J Bone Joint Surg Am. 2026 Apr 1;108(7):499-506. doi: 10.2106/JBJS.25.00668. Epub 2025 Dec 3. |
| Label | URL |
|---|---|
| BrAIST-Calc is an online aid for patients with Adolescent Idiopathic Scoliosis who want to estimate their personal risk of scoliosis surgery with and without bracing treatment. | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Children's Mercy Hospital Kansas City | OTHER |
| University of Rochester | OTHER |
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The outcomes assessor(s) are blinded to the treatment assignment.
| Observation | Other | Clinical, radiographic, and self-report follow-up every 6 months. |
|
| Sacramento |
| California |
| 95817 |
| United States |
| Rady Childrens Hospital | San Diego | California | 92123 | United States |
| Alfred I. duPont Hospital for Children and Nemours Children's Clinic | Wilmington | Delaware | 19899 | United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30342-4755 | United States |
| Shriner's Hospital for Children | Chicago | Illinois | 60707 | United States |
| University of Iowa Children's Hospital | Iowa City | Iowa | 52242 | United States |
| Shriners Hospitals for Children - Lexington | Lexington | Kentucky | 40502 | United States |
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States |
| Shriners Hospitals for Children - Minneapolis | Minneapolis | Minnesota | 55414 | United States |
| Children's Mercy Hospitals and Clinics. | Kansas City | Missouri | 64108 | United States |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Shriners Hospitals for Children - St. Louis | St Louis | Missouri | 63131 | United States |
| Carrie Tingley Hospital | Albuquerque | New Mexico | 87102-1715 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Shriners Hospitals for Children - Salt Lake City | Salt Lake City | Utah | 84103 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908-0232 | United States |
| Children's Hospital and Regional Medical Center | Seattle | Washington | 98105 | United States |
| BC Children's Hospital | Vancouver | British Columbia | V6H 3V4 | Canada |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Shriner's Hospital for Children | Montreal | Quebec | Canada |
| 32488764 | Background | Sullivan TB, Bastrom TP, Bartley CE, Dolan LA, Weinstein SL, Newton PO. More severe thoracic idiopathic scoliosis is associated with a greater three-dimensional loss of thoracic kyphosis. Spine Deform. 2020 Dec;8(6):1205-1211. doi: 10.1007/s43390-020-00149-7. Epub 2020 Jun 2. |
| 30446865 | Background | Troy MJ, Miller PE, Price N, Talwalkar V, Zaina F, Donzelli S, Negrini S, Hresko MT. The "Risser+" grade: a new grading system to classify skeletal maturity in idiopathic scoliosis. Eur Spine J. 2019 Mar;28(3):559-566. doi: 10.1007/s00586-018-5821-8. Epub 2018 Nov 16. |
| 26555827 | Result | 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. |
| 32205704 | Result | Dolan LA, Donzelli S, Zaina F, Weinstein SL, Negrini S. Adolescent Idiopathic Scoliosis Bracing Success Is Influenced by Time in Brace: Comparative Effectiveness Analysis of BrAIST and ISICO Cohorts. Spine (Phila Pa 1976). 2020 Sep 1;45(17):1193-1199. doi: 10.1097/BRS.0000000000003506. |
| 37994691 | Result | Dolan LA, Weinstein SL, Dobbs MB, Flynn JMJ, Green DW, Halsey MF, Hresko MT, Krengel WF 3rd, Mehlman CT, Milbrandt TA, Newton PO, Price N, Sanders JO, Schmitz ML, Schwend RM, Shah SA, Song K, Talwalkar V. BrAIST-Calc: Prediction of Individualized Benefit From Bracing for Adolescent Idiopathic Scoliosis. Spine (Phila Pa 1976). 2024 Feb 1;49(3):147-156. doi: 10.1097/BRS.0000000000004879. Epub 2023 Nov 23. |
| 24047455 | Result | 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. |
| 26886460 | Result | 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. |
| 41379077 | Result | Taylor TN, Ratnasamy PP, Lee TM, Tuason D, Li DT, Cooperman DR, Dolan LA, Smith BG. The Proximal Humerus Ossification System Predicts Surgical Curve Progression in Unbraced Patients With Adolescent Idiopathic Scoliosis. J Pediatr Orthop. 2026 Apr 1;46(4):249-254. doi: 10.1097/BPO.0000000000003195. Epub 2025 Dec 11. |
| 31731999 | Result | 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. |
| FG001 | Observation | Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Observation: Clinical, radiographic, and self-report follow-up every 6 months. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Age, gender, race, height, Scoliosis Research Society curve classification, Cobb angle, Risser grade
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Observation | Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Risser grade | The Risser grade is a measure of the amount of ossification and eventual fusion of the iliac apophysis reflecting skeletal maturity. Grades range from 0 to 5, with higher grades indicating greater maturity. Patients who are classified as being Risser 0, 1 or 2 are regarded as having significant skeletal growth remaining and therefore as being at higher risk for scoliosis progression relative to those classified as Risser 3 or greater. Girls are generally considered skeletally mature at Risser 4 or greater; boys at Risser 5. | Number | participants |
| |||||||||||||||
| Cobb angle | The Cobb angle is the most frequently used measurement of the magnitude of the curvature of the spine, and is a function of the tilt of the vertebrae at the top and bottom of the spinal curvature. A Cobb angle of 10 degrees or greater in association with rotation of the vertebrae indicates the presence of scoliosis. | Mean | Standard Deviation | angle in degrees |
| ||||||||||||||
| Curve type using SRS classification | The Scoliosis Research Society has classified scoliosis according to the apex of the curvature(s). | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Skeletal Maturity With a Cobb Angle of <50 Degrees (Successful Outcome) | 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. | Posted | Number | percentage of patient successes | 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. |
|
|
|
|
Adverse event data were collected continuously while subjects were on protocol, which was an average of 23.67 months
Multiple events per participant were recorded
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function. 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. | 1 | 146 | 71 | 146 | ||
| EG001 | Observation | Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Observation: Clinical, radiographic, and self-report follow-up every 6 months. | 0 | 96 | 36 | 96 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety and Depression | Psychiatric disorders | SnoMed | Systematic Assessment | Subject was hospitalized for anxiety and depression |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SnoMed term not found | Reproductive system and breast disorders | SnoMed | Systematic Assessment | non-specific report of abnormal breast development |
|
| Arm Pain | Musculoskeletal and connective tissue disorders | SnoMed | Systematic Assessment |
| |
| Backache | Musculoskeletal and connective tissue disorders | SnoMed | Systematic Assessment |
| |
| Depression | Psychiatric disorders | SnoMed | Systematic Assessment |
| |
| Dislocation of patellofemoral joint | Musculoskeletal and connective tissue disorders | SnoMed | Systematic Assessment |
| |
| Eruption of skin | Skin and subcutaneous tissue disorders | SnoMed | Systematic Assessment | Rash |
|
| Foot pain | Musculoskeletal and connective tissue disorders | SnoMed | Systematic Assessment |
| |
| Fracture of great toe | Musculoskeletal and connective tissue disorders | SnoMed | Systematic Assessment |
| |
| Headaches | Nervous system disorders | SnoMed | Systematic Assessment |
| |
| Hip pain | Musculoskeletal and connective tissue disorders | SnoMed | Systematic Assessment |
| |
| Numbness of limb | Nervous system disorders | SnoMed | Systematic Assessment | Report of either or both arm and leg numbness and/or tingling |
|
| Numbness of saddle area | Nervous system disorders | SnoMed | Systematic Assessment | Report of numbness in hip area |
|
| Pain | Nervous system disorders | SnoMed | Systematic Assessment | Report of side pain |
|
| Shoulder pain | Nervous system disorders | SnoMed | Systematic Assessment |
| |
| Suicidal thoughts | Psychiatric disorders | SnoMed | Systematic Assessment | Subject with history of depression; event not related to protocol |
|
| Superficial bruising | Skin and subcutaneous tissue disorders | SnoMed | Systematic Assessment |
| |
| Superficial ulcer of skin | Skin and subcutaneous tissue disorders | SnoMed | Systematic Assessment |
| |
| Vaso vagal episode | Nervous system disorders | SnoMed | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | SnoMed | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | SnoMed | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | SnoMed | Systematic Assessment | Report of asthma exacerbation |
|
| Knee pain | Musculoskeletal and connective tissue disorders | SnoMed | Systematic Assessment |
| |
| Knee reflex abnormal | Nervous system disorders | SnoMed | Systematic Assessment | Report of asymmetrical patella reflexes |
|
| Neck pain | Musculoskeletal and connective tissue disorders | SnoMed | Systematic Assessment |
|
Study was terminated early due to efficacy. 119 subjects were still on protocol.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lori A. Dolan | University of Iowa Dept of Orthopaedics and Rehabilitation | 319-356-1075 | lori-dolan@uiowa.edu |
| ID | Term |
|---|---|
| D001915 | Braces |
| D019370 | Observation |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| MISSING |
|
| Thoracolumbar |
|
| Lumbar |
|
| Double Major |
|
| Double Thoracic |
|
| Thoracic/Thoracolumbar |
|
| Triple |
|