Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
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

Tracking Information
First Submitted Date  ICMJE January 4, 2006
First Posted Date  ICMJE January 9, 2006
Last Update Posted Date October 12, 2017
Study Start Date  ICMJE September 1997
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2006)
- Quality of life at two years post-surgery, as measured by the self-report Quality of Life Profile for Spinal Disorders
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00273598 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2006)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2006)
  • - 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis
Official Title  ICMJE Comparing the Moss Miami and Universal Spinal Instrumentation Systems for the Treatment of Adolescent Idiopathic Scoliosis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Scoliosis
Intervention  ICMJE
  • Procedure: Moss Miami Spine Instrumentation System
  • Procedure: Universal Spine Instrumentation System
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: January 4, 2006)
126
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00273598
Other Study ID Numbers  ICMJE 0019970040
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James Wright, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • Synthes Canada
  • DePuy-Acromed, Inc.
  • Johnson & Johnson
Investigators  ICMJE
Principal Investigator: James G Wright, MD The Hospital for Sick Children, Toronto Canada
PRS Account The Hospital for Sick Children
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP