Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis

The Hospital for Sick Children

Status and phase

Completed

Phase 2

Conditions

Scoliosis

Treatments

Procedure: Moss Miami Spine Instrumentation System

Procedure: Universal Spine Instrumentation System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00273598

0019970040

Details and patient eligibility

About

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.

Sex

All

Ages

8 to 18 years old

Volunteers

No Healthy Volunteers

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