Evaluation of the AO Pediatric Classification for Long Bo... | NCT00533130

Studies
Evaluation of the AO Pediatric Classification for Long Bones Fractures Like a Guide for Treatment and Prognosis

NCT00533130

Sponsor

Hospital Cruz Roja Mexicana

Status

Unknown status

Last Update Posted

Sep 21, 2007Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Fractures
Children

Interventions

clinical evaluation
observational study

Countries

Mexico

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

Sep 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Not provided

Completion Date

Jul 2008Estimated

First Submitted Date

Sep 20, 2007

First Submission Date that Met QC Criteria

Sep 20, 2007

First Posted Date

Sep 21, 2007Estimated

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

Sep 20, 2007

Last Update Posted Date

Sep 21, 2007Estimated

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

Is the AO Pediatric classification for long bones fractures reproductible?
Is the AO Pediatric Classification for long bones fractures a treatment guide?
The AO pediatric Classification for long bones fractures could be a prognosis factor?

Detailed Description

PROPOUSE:

To determinate the efectivity of the AO pediatric classification for long bones fractures.
To evaluate the functionality of the AO pediatric classification for long bones fractures.
To analyze if the AO pediatric classification for long bones fractures is a prognosis factor

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Pediatric patients under 16 years old with long bones fractures	Procedure: clinical evaluation Procedure: observational study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
clinical evaluation	Procedure	analyze the x ray from each patient and evaluate the treatment y development of bone healing.	1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients:

Less than 16 years old.
Open physis.
Long bone fractures.
X ray AP & lateral comparatives.
Informed consent for parents or tutor.
Don´t let the treatment during the time of study.

Exclusion Criteria:

Pathologic fractures.
Fractures not included en the AO pediatric classification for long bones.
Diseases that modifying the bone healing: Diabetes mellitus, osteogenesis imperfect, etc.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jorge D Tejada-Hoyos, M.D.	Contact	+52 55 53951111	137	jorgetejada_us@yahoo.com
Myriam L Hernandez-Rojas, M.D.	Contact	+52 55 55868456		myrianhernandez@hotmail.com

Overall Officials

Name	Affiliation	Role
Jorge D Tejada-Hoyos, M.D.	orthopaedic resident	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Cruz Roja Mexicana, Delegacion Distrito Federal	Recruiting	Mexico City	Federal District	11510	Mexico

ID	Term
D050723	Fractures, Bone

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided