The Influence of the Ribs on the Gravity of Burst Thoraci... | NCT01544933

Studies
The Influence of the Ribs on the Gravity of Burst Thoracic Spine Fractures

NCT01544933

Sponsor

Universidade de Passo Fundo

Status

Completed

Last Update Posted

Mar 6, 2012Estimated

Enrollment

2Actual

Phase

Not provided

Conditions

Burst Thoracic Spine Fractures

Interventions

Not provided

Countries

Brazil

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

Aug 2011

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

Feb 2011

Primary Completion Date

Aug 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Feb 22, 2012

First Submission Date that Met QC Criteria

Mar 5, 2012

First Posted Date

Mar 6, 2012Estimated

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

Mar 5, 2012

Last Update Posted Date

Mar 6, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rodrigo Arnold Tisot, Principal investigator, Universidade de Passo FundoPrincipal Investigator

Lead Sponsor

Universidade de Passo FundoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to analyse the anatomic influence of the ribs related to the incidence and severity of burst spine fractures.

Detailed Description

To analyse the anatomic influence of the ribs related to the incidence and severity of burst spine fractures, with the measurements of kyphosis, vertebral collapse and vertebral canal narrowing

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
burst fractures in vertebrae with true ribs		between T1 and T10
burst fractures in vertebrae with floating ribs		between T11 and T12

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
residual kyphosis	measurement of residual kyphosis by x-ray	3 years

Secondary Outcomes

Measure	Description	Time Frame
vertebral canal narrowing	vertebral canal narrowing in CT	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

burst fractures in thoracic spine

Exclusion Criteria:

fractures that were not burst fractures in thoracic spine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

79 Years

Standard Ages

ChildAdultOlder Adult

Study Population

patients with burst fractures of the thoracic spine treated by the Hospital Ortopedico de Passo Fundo

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rodrigo A Tisot, Dr	Hospital Ortopedico de Passo Fundo	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rodrigo Tisot		Passo Fundo	Rio Grande do Sul	99010-121	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D016103	Spinal Fractures
D007738	Kyphosis

Ancestor Terms

ID	Term
D013124	Spinal Injuries
D019567	Back Injuries
D014947	Wounds and Injuries
D050723	Fractures, Bone

Browse Leaves

Not provided

Browse Branches

Not provided