Comparing Two Instrumentation Systems for the Treatment o... | NCT00273598

Studies
Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis

NCT00273598

Sponsor

The Hospital for Sick Children

Status

Completed

Last Update Posted

Oct 12, 2017Actual

Enrollment

126

Phase

Phase 2

Conditions

Scoliosis

Interventions

Moss Miami Spine Instrumentation System
Universal Spine Instrumentation System

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1997

Primary Completion Date

Not provided

Completion Date

Sep 2002Actual

First Submitted Date

Jan 4, 2006

First Submission Date that Met QC Criteria

Jan 4, 2006

First Posted Date

Jan 9, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2017

Last Update Posted Date

Oct 12, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

James Wright, Surgeon-in-Chief & Chief of Perioperative Services, The Hospital for Sick ChildrenPrincipal Investigator

Lead Sponsor

The Hospital for Sick ChildrenOTHER

Collaborators

Name	Class
Canadian Institutes of Health Research (CIHR)	OTHER_GOV
Synthes Canada	INDUSTRY
DePuy-Acromed, Inc.	INDUSTRY
Johnson & Johnson

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

126

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
- Quality of life at two years post-surgery, as measured by the self-report Quality of Life Profile for Spinal Disorders

Secondary Outcomes

Measure	Description	Time Frame
Physical function
Deformity, based on clinical exam and spinal radiographs
Clinicians' ratings of clinical photographs

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James G Wright, MD	The Hospital for Sick Children, Toronto Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Hospital for Sick Children		Toronto	Ontario	M5G 1X8	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18056501	Background	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.

ID	Term
D012600	Scoliosis
D013122	Spinal Diseases

ID	Term
D013121	Spinal Curvatures
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Name	Type	Description	Arm Group Labels	Other Names
Moss Miami Spine Instrumentation System	Procedure
Universal Spine Instrumentation System	Procedure