A Study on the Use of a Brace Following Low Back Surgery | NCT00620399

Studies
A Study on the Use of a Brace Following Low Back Surgery

NCT00620399

Sponsor

Sunnybrook Health Sciences Centre

Status

Completed

Last Update Posted

Apr 20, 2020Actual

Enrollment

Not provided

Phase

Phase 3

Conditions

Lumbar Fusion

Interventions

lumbar corset

Countries

United States

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

Apr 2020

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

May 1996

Primary Completion Date

Jun 2003Actual

Completion Date

Jun 2003Actual

First Submitted Date

Feb 11, 2008

First Submission Date that Met QC Criteria

Feb 20, 2008

First Posted Date

Feb 21, 2008Estimated

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

Apr 16, 2020

Last Update Posted Date

Apr 20, 2020Actual

Name	Class
Medtronic Sofamor Danek	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study evaluated the hypothesis that bracing following lumbar spinal fusion surgery improves functional outcome following surgery

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 3

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	brace	Other: lumbar corset
2	Placebo Comparator	no brace	Other: lumbar corset

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lumbar corset	Other		1 2

Measure	Description	Time Frame
functional outcome scores		2 years following surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-80
Undergoing posterior lumbar fusion surgery for degenerative conditions

Exclusion Criteria:

Unable to complete questionnaires due to language or cognitive barrier
Declined study participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals of Cleveland		Cleveland	Ohio	44106	United States