Clinical trial NCT00273598: Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis
Official title: Comparing the Moss Miami and Universal Spinal Instrumentation Systems for the Treatment of Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Scoliosis
Keywords: Scoliosis
spinal disease
pediatrics
Adolescents
Universal Spinal Instrumentation System
Moss Miami Spinal Instrumentation System
Orthopedic Surgery
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Synthes Canada
name: DePuy-Acromed, Inc.
name: Johnson & Johnson
First posted: 2006-01-09
Enrollment: 126
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: - Quality of life at two years post-surgery, as measured by the self-report Quality of Life Profile for Spinal Disorders
Secondary outcomes:
measure: Physical function
measure: Deformity, based on clinical exam and spinal radiographs
measure: Clinicians' ratings of clinical photographs
measure: Surgical outcomes, as measured by blood transfusions, duration of surgery,and length of hospitalization
measure: Surgeons' global satisfaction with the instrumentation system
measure: Complications of treatment (infection, loss of fixation, neurologic damage, and non-union)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: James G Wright, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wright JG, Donaldson S, Howard A, Stephens D, Alman B, Hedden D. Are surgeons' preferences for instrumentation related to patient outcomes? A randomized clinical trial of two implants for idiopathic scoliosis. J Bone Joint Surg Am. 2007 Dec;89(12):2684-93. doi: 10.2106/JBJS.F.00720.