Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00273598
First received: January 4, 2006
Last updated: December 2, 2013
Last verified: December 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical function [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Complications of treatment (infection, loss of fixation, neurologic damage, and non-union) [ Designated as safety issue: Yes ]

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: January 4, 2006
Last Updated: December 2, 2013
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

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

ClinicalTrials.gov processed this record on April 30, 2015