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Celia
07-03-2007, 09:00 AM
Hey Gang,

In the event that you missed the most recent update which is readily available to anyone searching for it on the internet, here is a list of hospitals participating in the BRAIST study where a select group of children are randomized to watchful waiting and hence *not* receiving any form of treatment whatsoever for their scoliosis. Personally I have very strong views on this study and believe it's negligent and a reckless disregard for human life!


http://clinicaltrials.gov/ct/show/NCT00448448;jsessionid=B23787EF94630B0004F452F6C4C 27A19?order=16



Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)

This study is currently recruiting patients.
Verified by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) May 2007

Sponsors and Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Iowa
Canadian Institutes of Health Research (CIHR)
Shriners Hospitals for Children
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT00448448

Purpose:

The purpose of this project is to establish the effectiveness of thoracolumbosacral orthoses (TLSOs) in the treatment of adolescent idiopathic scoliosis (AIS), using a multi-center, prospective, randomized, controlled design.

Primary Aim:

1. To compare the risk of curve progression to surgical threshold (≥ 50 degrees) in subjects randomized to a TLSO to those randomized to watchful waiting.


Total Enrollment: 500 Study start: February 2007; Expected completion: August 2010

Eligibility:

Ages Eligible for Study: 10 Years - 15 Years, Genders Eligible for Study: Both CriteriaInclusion Criteria:

Diagnosis of adolescent idiopathic scoliosis (AIS)
Age 10-15 years inclusive
Skeletally immature (Risser grade 0, 1 or 2)
Pre-menarchal or post-menarchal by less than or equal to one year
Primary Cobb angle between 25 and 40 degrees inclusive
Curve apex caudal to T7
Physical and mental ability to adhere to bracing protocol
No history of previous surgical or orthotic treatment for AIS
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 illnesses possibly responsible for the curvature
A history of previous surgical or orthotic treatment
Inability to read and understand English, French or Spanish

Location and Contact Information:

Please refer to this study by ClinicalTrials.gov identifier NCT00448448
Stuart L. Weinstein, MD 319-356-1872 stuart-weinstein@uiowa.edu
Lori Dolan, PhD 319-356-1075 lori-dolan@uiowa.edu

United States, California
Children's Hospital Central California, Madera, California, 93638, United States; Recruiting
Matthew F. Halsey, MD 559-353-5941
Alicia Haro 559-353-5942
Matthew F. Halsey, MD, Principal Investigator


Rady Childrens Hospital, San Diego, California, 92123, United States; Recruiting
Peter O. Newton, MD 858-966-6789
Jeff Pawelek 858-576-1700
Peter O. Newton, MD, Principal Investigator


United States, Delaware
Alfred I. duPont Hospital for Children and Nemours Children's Clinic, Wilmington, Delaware, 19899, United States; Recruiting
Suken A. Shah, MD 302-651-5904
Aaron Littleton 302-651-5906
Suken A. Shah, MD, Principal Investigator


United States, Georgia
Children's Healthcare of Atlanta, Atlanta, Georgia, 30342-4755, United States; Recruiting
Michael L. Schmitz, MD 404-255-1933
Elena Morales 404-785-7504
Michael L. Schmitz, MD, Principal Investigator


United States, Illinois
Children's Memorial Hospital, Chicago, Illinois, 60614, United States; Recruiting
John J. Grayhack, MD 773-327-1270
Jill Meyers
John J. Grayhack, MD, Principal Investigator


United States, Iowa
University of Iowa Children's Hospital, Iowa City, Iowa, 52242, United States; Recruiting
Stuart L. Weinstein, MD 319-356-1872
Lori Dolan, PhD 319-356-1075
Stuart L. Weinstein, MD, Principal Investigator


United States, Massachusetts
Children's Hospital Boston, Boston, Massachusetts, 02115, United States; Not yet recruiting
John B. Emans, MD 617-355-7132
Ryan Hirschfeld 617-355-2748
John B. Emans, MD, Principal Investigator


United States, Missouri
St. Louis Children's Hospital, St. Louis, Missouri, 63110, United States; Recruiting
Matthew B. Dobbs, MD 314-454-4814
Melissa Kirchhofer 314-454-4113
Matthew B. Dobbs, MD, Principal Investigator


Mercy Children's Hospital, Kansas City, Missouri, 64108, United States; Not yet recruiting
Rick Schwend, MD
Valorie Thomas, APRN 816-234-3693 Ext. 6902 vthomas@cmh.edu
Rick Schwend, MD, Principal Investigator


Shriners Hospitals for Children - St. Louis, St. Louis, Missouri, 63131, United States; Recruiting
Matthew Dobbs, MD 314-454-2045
Laura Meyer 314-454-4113 meyerl@wudosis.wustl.edu
Matthew Dobbs, MD, Principal Investigator


United States, New Mexico
Carrie Tingley Hospital, Albuquerque, New Mexico, 87102-1715, United States; Recruiting
Patrick Bosch, MD 505-572-5271
Brittany Eastlund 505-272-9656
Patrick Bosch, MD, Principal Investigator


United States, New York
Hospital for Joint Diseases, New York, New York, 10003, United States; Not yet recruiting
David S. Feldman, MD 212-533-5310
David S. Feldman, MD, Principal Investigator


United States, Ohio
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 45229, United States; Not yet recruiting
Charles T. Mehlman, DO, MPH 513-636-4785
Charles T. Mehlman, DO, MPH, Principal Investigator


United States, Pennsylvania
Shriners Hospitals For Children - Erie, Erie, Pennsylvania, 16505, United States; Not yet recruiting
Jim Sanders, MD 814-875-8728
Sharon McConnell, MS 814-875-8776 smcconnell@shrinenet.org
Jim Sanders, MD, Principal Investigator


United States, Texas
Shriners Hospitals for Children - Houston, Houston, Texas, 77030, United States; Not yet recruiting
Richard Haynes, MD 713-793-3775
Barbara Lacy 713-793-3975 blacy@shrinenet.org
Richard Haynes, MD, Principal Investigator


United States, Utah
Shriners Hospitals for Children - Intermountain (Salt Lake City), Salt Lake City, Utah, 84103, United States; Not yet recruiting
Jacques d'Astous, MD 801-536-3600
Susan Geyer 801-536-3561 sgeyer@shrinenet.org
Jacques d'Astous, MD, Principal Investigator


United States, Virginia
University of Viginia Health System, Charlottesville, Virginia, 22908-0232, United States; Recruiting
Mark F. Abel, MD 434-982-4215
Karen Johnson 434-924-5938
Mark F. Abel, MD, Principal Investigator


United States, Washington
Children's Hospital & Regional Medical Center, Seattle, Washington, 98105, United States; Recruiting
Kit M. Song, MD 206-987-2000
Kristie Bjornson 206-987-2066
Kit M. Song, MD, Principal Investigator


Canada, British Columbia
BC Children's Hospital, Vancouver, British Columbia, V6H 3V4, Canada; Recruiting
Chris Reilly, MD 604-875-3711
Bronwyn Slobogean 604-875-2359
Chris Reilly, MD, Principal Investigator


Canada, Ontario
Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada; Recruiting
James G. Wright, MD 416-813-6433
Gina Maniatis 416-813-7654 Ext. 2959
James G. Wright, MD, Principal Investigator


Canada, Quebec
Shriner's Hospital for Children, Montreal, Quebec, Canada; Not yet recruiting
Jean Ouellet, MD 514-412-4464
Dee Anne Naylor 514-934-1934
Jean Ouellet, MD, Principal Investigator

Study chairs or principal investigators
Stuart L. Weinstein, MD, Principal Investigator, University of Iowa
Lori A. Dolan, PhD, Study Director, University of Iowa More Information
BrAIST Education Module
Study ID Numbers: NIH/NIAMS 1RO1ARO52113
Last Updated: June 6, 2007
Record first received: March 14, 2007
ClinicalTrials.gov Identifier: NCT00448448
Health Authority: United States: Federal Government; Canada: Canadian Institutes of Health Research
ClinicalTrials.gov processed this record on July 02, 2007