Status:
COMPLETED
Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Synthes Canada
Conditions:
Scoliosis
Eligibility:
All Genders
8-18 years
Phase:
PHASE2
Brief Summary
Idiopathic scoliosis affects 2-5% of adolescents. This study will compare the quality of life, functional outcome, cosmetic result, and the correction of spinal deformity of two instrumentation system...
Eligibility Criteria
Inclusion
- Age 8-18 years
- 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
- Spinal cord abnormalities with any neurologic symptoms or signs
- 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
Key Trial Info
Start Date :
September 1 1997
Trial Type :
INTERVENTIONAL
End Date :
September 1 2002
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00273598
Start Date
September 1 1997
End Date
September 1 2002
Last Update
October 12 2017
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8