Adolescent Idiopathic ScoliosisBrAISTNCT00448448
Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)
A study testing Brace and Observation in people with Adolescent Idiopathic Scoliosis, run by Stuart L. Weinstein, MD at 25 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Brace and Observation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 383 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Feb 2007to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States22 sites
Carrie Tingley Hospital
Albuquerque, New Mexico, 87102-1715
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342-4755
Children's Hospital Boston
Boston, Massachusetts, 02115
University of Virginia Health System
Charlottesville, Virginia, 22908-0232
Shriner's Hospital for Children
Chicago, Illinois, 60707
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
University of Iowa Children's Hospital
Iowa City, Iowa, 52242
Children's Mercy Hospitals and Clinics.
Kansas City, Missouri, 64108
Shriners Hospitals for Children - Lexington
Lexington, Kentucky, 40502
Children's Hospital Central California
Madera, California, 93638
Shriners Hospitals for Children - Minneapolis
Minneapolis, Minnesota, 55414
Hospital for Special Surgery
New York, New York, 10021
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Rochester Medical Center
Rochester, New York, 14642
Shriners Hospital of Northern California
Sacramento, California, 95817
Shriners Hospitals for Children - Salt Lake City
Salt Lake City, Utah, 84103
Rady Childrens Hospital
San Diego, California, 92123
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105
St. Louis Children's Hospital
St Louis, Missouri, 63110
Shriners Hospitals for Children - St. Louis
St Louis, Missouri, 63131
Alfred I. duPont Hospital for Children and Nemours Children's Clinic
Wilmington, Delaware, 19899
Canada3 sites
Shriner's Hospital for Children
Montreal, Quebec
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4
About this study
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.
Read the 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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Brace, Observation
- Keywords
- adolescent idiopathic scoliosis, orthotics, bracing, partially randomized preference design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BraceDevice
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.
ObservationOther
Clinical, radiographic, and self-report follow-up every 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Brace |
| Observation | Active comparator | Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Maturity With a Cobb Angle of <50 Degrees (Successful Outcome)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: Stopped for efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stuart L. Weinstein, MD
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor-investigator, Stuart L. Weinstein, MD, University of Iowa
- Investigators
- Stuart L. Weinstein, MD, Principal investigator, University of IowaLori A. Dolan, PhD, Study director, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448448
- Sponsor's protocol ID
- 200108052
- Other IDs
- R01AR052113
- Acronym
- BrAIST
- Status last verified
- Feb 2026
- First submitted
- 14 Mar 2007
- Last updated
- 2 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 24026162Amaral 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.
PubMed 41337495Sullivan 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.
PubMed 32488764Troy 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.
PubMed 30446865Schwieger 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.
PubMed 26555827Dolan 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.
PubMed 32205704Dolan 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.
PubMed 37994691Weinstein 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.
PubMed 24047455Schwieger 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.
PubMed 26886460Taylor 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.
PubMed 41379077Dolan 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.
PubMed 31731999
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)
- ClinicalTrials.gov ID
- NCT00448448
- Acronym / sponsor ID
- BrAIST / 200108052
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- adolescent idiopathic scoliosis, orthotics, bracing, partially randomized preference design
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped for efficacy
- Enrolment
- 383 participants (actual)
- Lead sponsor
- Stuart L. Weinstein, MDUniversity, hospital or other
- Collaborators
- 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 start
- Feb 2007
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 Mar 2007 (estimated)
- Results
- Posted 23 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brace | Active comparator | Device: BraceThis 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 | Other: ObservationObservation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
- History of previous surgical or orthotic treatment for AIS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BraceBrace (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. | Device | Brace |
| ObservationClinical, radiographic, and self-report follow-up every 6 months. | Other | Observation |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24026162Weinstein 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.
- Background: PubMed 41337495Amaral 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.
- Background: PubMed 32488764Sullivan 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.
- Background: PubMed 30446865Troy 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.
- Results publication: PubMed 26555827Schwieger 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.
- Results publication: PubMed 32205704Dolan 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.
- Results publication: PubMed 37994691Dolan 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.
- Results publication: PubMed 24047455Weinstein 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.
- Results publication: PubMed 26886460Schwieger 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.
- Results publication: PubMed 41379077Taylor 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.
- Results publication: PubMed 31731999Dolan 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.
- 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.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart L. Weinstein, MD principal investigator
University of Iowa
Lori A. Dolan, PhD study director
University of Iowa
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brace and Observation in people with Adolescent Idiopathic Scoliosis, run by Stuart L. Weinstein, MD at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00448448, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.