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Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00273598
First Posted: January 9, 2006
Last Update Posted: December 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Canadian Institutes of Health Research (CIHR)
Synthes Canada
DePuy-Acromed, Inc.
Johnson & Johnson
Information provided by (Responsible Party):
James Wright, The Hospital for Sick Children
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Comparing the Moss Miami and Universal Spinal Instrumentation Systems for the Treatment of Adolescent Idiopathic Scoliosis

Resource links provided by NLM:


Further study details as provided by James Wright, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: James Wright, Surgeon-in-Chief & Chief of Perioperative Services, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00273598     History of Changes
Other Study ID Numbers: 0019970040
First Submitted: January 4, 2006
First Posted: January 9, 2006
Last Update Posted: December 3, 2013
Last Verified: December 2013

Keywords provided by James Wright, The Hospital for Sick Children:
Scoliosis
spinal disease
pediatrics
Adolescents
Universal Spinal Instrumentation System
Moss Miami Spinal Instrumentation System
Orthopedic Surgery

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases


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