Clinical Trials
This page outlines the Division's involvement in a number of active clinical trials, including:
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In progress
Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)
SickKids Principal Investigator: Dr. James G. Wright
Funding: NIH, Children's Miracle Network, Shriners Hospitals for Children, CIHR
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.
The results of this trial were e-published in The New England Journal of Medicine on October 17, 2013. Please see http://www.nejm.org/doi/full/10.1056/NEJMoa1307337 for the full text.
Principal Investigators:
Dr. Lori A. Dolan (University of Iowa)
Dr. Stuart Weinstein (University of Iowa)
Dr. Jim Wright (HSC)
Project Director: Dr. Lori A. Dolan
Collaborators at The Hospital for Sick Children:
Dr. Ben Alman
Dr. Andrew Howard
Additional Publications:
1. 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.
For more information about the study results please visit http://clinicaltrials.gov/ct2/show/results/NCT00448448.
Functional Outcomes Following Orthopaedic Surgery based on Gait Laboratory Analysis versus Observational Analysis: A Randomized Controlled Trial
SickKids Principal Investigator: Dr. Unni Narayanan
Funding: CIHR
A randomized, multi-centre trial to evaluate the effectiveness of gait analysis for decision making and its impact on functional outcomes following multi-level orthopaedic surgery for children with ambulatory cerebral palsy
For additional information please visit:
http://www.clinicaltrials.gov/ct2/show/NCT00419432?term=unni+narayanan&rank=1
Simple Bone Cysts in Kids (SBoCK)
SickKids Principal Investigator: Dr. James G. Wright
Funding: CIHR
Simple bone cysts (SBCs) are cysts filled with fluid that occur most frequently in the long bones of children. There are many ways to treat SBCs but it is unclear if one is better than another. This trial follows the prior SBC study comparing the effectiveness of curettage with puncture alone and followed by injection with a bone substitute, two common surgical procedures for the treatment of SBCs.
For additional information please visit:
http://clinicaltrials.gov/ct2/show/NCT02193841?term=simple+bone+cysts+in+kids&rank=1
http://www.sickkids.ca/research/SBoCK/
A Double-Blind, RCT Comparing Botox and Placebo in the Treatment of Idiopathic Clubfoot
SickKids Principal Investigator: Dr. James G. Wright
To determine the effectiveness of Botox in treating patients with idiopathic clubfoot by comparing outcomes of subjects treated with manipulation and casting plus Botox to those treated with manipulation and casting plus placebo.
For additional information please visit: http://clinicaltrials.gov/ct2/show/study/NCT00152347?term=botox+placebo+clubfoot&rank=1
Retro versus Trans Articular Drilling for Juvenile Osteochondritis Dissecans of the Knee: A Multicenter, Randomized Controlled Study
SickKids Principal Investigator: Dr. Lucas Murnaghan
Comparing post-operative patient functioning associated with the two surgical techniques commonly used to treat stable OCD lesions that do not show healing from non-surgical treatment.
For additional information please visit:
http://clinicaltrials.gov/ct2/show/record/NCT01754298?term=Murnaghan&rank=1
Completed
A Comparison of Casting and External Fixation for Paediatric Femoral Shaft Fractures
SickKids Principal Investigator: Dr. James G. Wright
Treatments for femoral fractures in children vary and have been investigated only in case series. This multi-centre randomized trial compares malunion rates after external fixation and after early application of a hip spica cast for paediatric femoral shaft fractures.
SickKids Principal Investigator: Dr. James G. Wright
Although many techniques for the surgical treatment of scoliosis have been described, few trials compare implant systems and the relationship between surgeons' preferences for implants and patient outcomes is unknown. The purpose of this study was to compare the quality of life and curve correction associated with use of the Moss Miami system and the Universal Spine System for spinal fusion in patients with adolescent idiopathic scoliosis.
Funding: Canadian Institutes Health Research (CIHR) Industrial Partnership with DePuy AcroMed-Johnson and Johnson Medical Products and Synthes, Canada.
SickKids Principal Investigator: Dr. James G. Wright
Funding: Pediatric Orthopaedic Society of North America (POSNA), Salter Chair in Surgical Research, and Shriners Hospitals for Children
Simple bone cysts are common benign lesions in growing children that predispose them to fracture and are sometimes painful. The purpose of this trial was to compare rates of healing of simple bone cysts treated with intralesional injections of bone marrow with rates of healing of those treated with methylprednisolone acetate.