NCT01544933

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
Last Updated

March 6, 2012

Status Verified

August 1, 2011

Enrollment Period

6 months

First QC Date

February 22, 2012

Last Update Submit

March 5, 2012

Conditions

Keywords

spinal fracturesThoracic vertebraespinal canalkyphosis

Outcome Measures

Primary Outcomes (1)

  • residual kyphosis

    measurement of residual kyphosis by x-ray

    3 years

Secondary Outcomes (1)

  • vertebral canal narrowing

    3 years

Study Arms (2)

burst fractures in vertebrae with true ribs

between T1 and T10

burst fractures in vertebrae with floating ribs

between T11 and T12

Eligibility Criteria

Age17 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • burst fractures in thoracic spine

You may not qualify if:

  • fractures that were not burst fractures in thoracic spine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rodrigo Tisot

Passo Fundo, Rio Grande do Sul, 99010-121, Brazil

Location

MeSH Terms

Conditions

Spinal FracturesKyphosis

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and InjuriesFractures, BoneSpinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Rodrigo A Tisot, Dr

    Hospital Ortopedico de Passo Fundo

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 22, 2012

First Posted

March 6, 2012

Study Start

February 1, 2011

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

March 6, 2012

Record last verified: 2011-08

Locations