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Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis

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.
ClinicalTrials.gov Identifier: NCT00273598
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : October 12, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Scoliosis Procedure: Moss Miami Spine Instrumentation System Procedure: Universal Spine Instrumentation System Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
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
Study Start Date : September 1997
Study Completion Date : September 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. - Quality of life at two years post-surgery, as measured by the self-report Quality of Life Profile for Spinal Disorders

Secondary Outcome Measures :
  1. Physical function
  2. Deformity, based on clinical exam and spinal radiographs
  3. Clinicians' ratings of clinical photographs
  4. Surgical outcomes, as measured by blood transfusions, duration of surgery,and length of hospitalization
  5. Surgeons' global satisfaction with the instrumentation system
  6. Complications of treatment (infection, loss of fixation, neurologic damage, and non-union)

Eligibility Criteria

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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
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 Posted: January 9, 2006    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017

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

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