Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis
Phase 2
Completed
- Conditions
- Scoliosis
- Registration Number
- NCT00273598
- Lead Sponsor
- The Hospital for Sick Children
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method - Quality of life at two years post-surgery, as measured by the self-report Quality of Life Profile for Spinal Disorders
- Secondary Outcome Measures
Name Time Method Physical function Deformity, based on clinical exam and spinal radiographs Clinicians' ratings of clinical photographs Surgeons' global satisfaction with the instrumentation system Surgical outcomes, as measured by blood transfusions, duration of surgery,and length of hospitalization Complications of treatment (infection, loss of fixation, neurologic damage, and non-union)
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What biomechanical mechanisms underlie spinal correction differences between Moss Miami and Universal Spinal systems in adolescent idiopathic scoliosis?
How does Moss Miami instrumentation compare to Universal Spinal in achieving Cobb angle correction and long-term functional outcomes for AIS patients?
Which patient-specific biomarkers correlate with improved cosmetic results using either Moss Miami or Universal Spinal systems in adolescent scoliosis surgery?
What are the complication rates and management strategies for pedicle screw-related adverse events in NCT00273598 instrumentation systems?
Are there alternative spinal instrumentation systems or surgical approaches for AIS that demonstrate superior correction or reduced revision rates compared to Moss Miami/Universal Spinal?
Trial Locations
- Locations (1)
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
The Hospital for Sick Children🇨🇦Toronto, Ontario, Canada