Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448448
Status:
TERMINATED
Last Update Posted:
2019-11-22
First Post:
2007-03-14
Brief Title:
Bracing in Adolescent Idiopathic Scoliosis Trial BrAIST
Sponsor:
Stuart Weinstein
Organization:
University of Iowa
Study Overview
Official Title:
Bracing in Adolescent Idiopathic Scoliosis Trial BrAIST
Status:
TERMINATED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Stopped for efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BrAIST
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 1randomly 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 surgeons 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
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 1randomly 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 surgeons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AR052113 | NIH | None | httpsreporternihgovquickSearchR01AR052113 |