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Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis

Primary Purpose

Scoliosis

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Moss Miami Spine Instrumentation System
Universal Spine Instrumentation System
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis focused on measuring Scoliosis, spinal disease, pediatrics, Adolescents, Universal Spinal Instrumentation System, Moss Miami Spinal Instrumentation System, Orthopedic Surgery

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hospital for Sick Children

Outcomes

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)

Full Information

First Posted
January 4, 2006
Last Updated
October 11, 2017
Sponsor
The Hospital for Sick Children
Collaborators
Canadian Institutes of Health Research (CIHR), Synthes Canada, DePuy-Acromed, Inc., Johnson & Johnson
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1. Study Identification

Unique Protocol Identification Number
NCT00273598
Brief Title
Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis
Official Title
Comparing the Moss Miami and Universal Spinal Instrumentation Systems for the Treatment of Adolescent Idiopathic Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Canadian Institutes of Health Research (CIHR), Synthes Canada, DePuy-Acromed, Inc., Johnson & Johnson

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
Keywords
Scoliosis, spinal disease, pediatrics, Adolescents, Universal Spinal Instrumentation System, Moss Miami Spinal Instrumentation System, Orthopedic Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
126 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Moss Miami Spine Instrumentation System
Intervention Type
Procedure
Intervention Name(s)
Universal Spine Instrumentation System
Primary Outcome Measure Information:
Title
- Quality of life at two years post-surgery, as measured by the self-report Quality of Life Profile for Spinal Disorders
Secondary Outcome Measure Information:
Title
Physical function
Title
Deformity, based on clinical exam and spinal radiographs
Title
Clinicians' ratings of clinical photographs
Title
Surgical outcomes, as measured by blood transfusions, duration of surgery,and length of hospitalization
Title
Surgeons' global satisfaction with the instrumentation system
Title
Complications of treatment (infection, loss of fixation, neurologic damage, and non-union)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James G Wright, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18056501
Citation
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. doi: 10.2106/JBJS.F.00720.
Results Reference
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Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis

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