Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis

This study has been completed.

Sponsors and Collaborators:	The Hospital for Sick Children Canadian Institutes of Health Research (CIHR) Synthes Canada DePuy-Acromed, Inc. Johnson & Johnson
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00273598

Purpose

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.

Condition	Intervention	Phase
Scoliosis	Procedure: Moss Miami Spine Instrumentation System Procedure: Universal Spine Instrumentation System	Phase II

MedlinePlus related topics: Scoliosis Spinal Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Comparing the Moss Miami and Universal Spinal Instrumentation Systems for the Treatment of Adolescent Idiopathic Scoliosis

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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)

Estimated Enrollment:	126
Study Start Date:	September 1997
Estimated Study Completion Date:	September 2002

Eligibility

Ages Eligible for Study:	8 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273598

Locations

Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8

Sponsors and Collaborators

The Hospital for Sick Children

Canadian Institutes of Health Research (CIHR)

Synthes Canada

DePuy-Acromed, Inc.

Johnson & Johnson

Investigators

Principal Investigator:

James G Wright, MD

The Hospital for Sick Children, Toronto Canada

More Information

Study ID Numbers:	0019970040
Study First Received:	January 4, 2006
Last Updated:	October 10, 2006
ClinicalTrials.gov Identifier:	NCT00273598
Health Authority:	Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:

Scoliosis
spinal disease
pediatrics
Adolescents

Universal Spinal Instrumentation System
Moss Miami Spinal Instrumentation System
Orthopedic Surgery

Study placed in the following topic categories:

Spinal Diseases
Scoliosis
Musculoskeletal Diseases
Bone Diseases

Additional relevant MeSH terms:

Spinal Curvatures

ClinicalTrials.gov processed this record on January 16, 2009