Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis
NCT ID: NCT00273598
Last Updated: 2017-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
126 participants
INTERVENTIONAL
1997-09-30
2002-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
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Moss Miami Spine Instrumentation System
Universal Spine Instrumentation System
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of idiopathic scoliosis requiring posterior instrumentation and fusion(including those also requiring anterior release with or without anterior instrumentation) who could receive either the USS or the Moss Miami system
* Patients with scoliosis and an incidental finding of conus \< L1-2 disc level, provided they have no symptoms or signs
* Patients with scoliosis and an incidental finding of a small syrinx (provided the syrinx is non-progressive and does not require neurosurgical treatment)
* Patients with non-progressive spondylolysis
Exclusion Criteria
* Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia requiring Arnold Chiari decompression
* Primary muscle diseases, such as muscular dystrophy
* Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, or spina bifida, etc.)
* Primary abnormalities of bones(e.g. osteogenesis imperfecta)
* Congenital scoliosis
8 Years
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Synthes Canada
INDUSTRY
DePuy-Acromed, Inc.
INDUSTRY
Johnson & Johnson
INDUSTRY
The Hospital for Sick Children
OTHER
Responsible Party
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James Wright
Surgeon-in-Chief & Chief of Perioperative Services
Principal Investigators
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James G Wright, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children, Toronto Canada
Locations
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The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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References
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Wright JG, Donaldson S, Howard A, Stephens D, Alman B, Hedden D. Are surgeons' preferences for instrumentation related to patient outcomes? A randomized clinical trial of two implants for idiopathic scoliosis. J Bone Joint Surg Am. 2007 Dec;89(12):2684-93. doi: 10.2106/JBJS.F.00720.
Other Identifiers
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0019970040
Identifier Type: -
Identifier Source: org_study_id