Scoliosis
Conditions
Keywords
Scoliosis, spinal disease, pediatrics, Adolescents, Universal Spinal Instrumentation System, Moss Miami Spinal Instrumentation System, Orthopedic Surgery
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 systems for the treatment of adolescent idiopathic scoliosis.
Interventions
PROCEDUREMoss Miami Spine Instrumentation System
PROCEDUREUniversal Spine Instrumentation System
Sponsors
Canadian Institutes of Health Research (CIHR)
Synthes Canada
DePuy-Acromed, Inc.
Johnson & Johnson
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Quality of life at two years post-surgery, as measured by the self-report Quality of Life Profile for Spinal Disorders | — |
Secondary
| Measure | Time frame |
|---|---|
| Deformity, based on clinical exam and spinal radiographs | — |
| Clinicians' ratings of clinical photographs | — |
| Physical function | — |
| Surgeons' global satisfaction with the instrumentation system | — |
| Complications of treatment (infection, loss of fixation, neurologic damage, and non-union) | — |
| Surgical outcomes, as measured by blood transfusions, duration of surgery,and length of hospitalization | — |
Countries
Canada
Outcome results
None listed