Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis

Study Overview
=================
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.

Official Title
-----------------
Comparing the Moss Miami and Universal Spinal Instrumentation Systems for the Treatment of Adolescent Idiopathic Scoliosis

Conditions
-----------------
Scoliosis

Intervention / Treatment
-----------------
* Procedure: Moss Miami Spine Instrumentation System
* Procedure: Universal Spine Instrumentation System


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Moss Miami Spine Instrumentation System|nan|
|Procedure: Universal Spine Instrumentation System|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Quality of life at two years post-surgery, as measured by the self-report Quality of Life Profile for Spinal Disorders |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function |  |  | 
| Deformity, based on clinical exam and spinal radiographs |  |  | 
| Clinicians' ratings of clinical photographs |  |  | 
| Surgical outcomes, as measured by blood transfusions, duration of surgery,and length of hospitalization |  |  | 
| Surgeons' global satisfaction with the instrumentation system |  |  | 
| Complications of treatment (infection, loss of fixation, neurologic damage, and non-union) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scoliosis, spinal disease, pediatrics, Adolescents, Universal Spinal Instrumentation System, Moss Miami Spinal Instrumentation System, Orthopedic Surgery