Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis

The Hospital for Sick Children126 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

126

Conditions

Scoliosis

Interventions

Moss Miami Spine Instrumentation SystemPROCEDURE

Universal Spine Instrumentation SystemPROCEDURE

Eligibility

Sex: ALLMin age: 8 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

- Quality of life at two years post-surgery, as measured by the self-report Quality of Life Profile for Spinal Disorders

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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