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NCT00533130 Clinical Trial

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

Children Clinical Trial

— AO-PC  

Official title:
Phase 2/3 Eficacy Study of the AO Pediatric Classification in Treatment and Prognosis of Long Bones Fractures

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00533130
Other study ID # CRM-2008-TYO
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received September 20, 2007
Last updated September 20, 2007
Start date August 2007
Est. completion date July 2008

Study information
Verified date September 2007
Source Hospital Cruz Roja Mexicana
Contact Jorge D Tejada-Hoyos, M.D.
Phone +52 55 53951111
Email jorgetejada_us@yahoo.com
Is FDA regulated No
Health authority Mexico: Ministry of Health
Study type Observational

Clinical Trial Summary

1. Is the AO Pediatric classification for long bones fractures reproductible?

2. Is the AO Pediatric Classification for long bones fractures a treatment guide?

3. The AO pediatric Classification for long bones fractures could be a prognosis factor?

Description:

PROPOUSE:

1. To determinate the efectivity of the AO pediatric classification for long bones fractures.

2. To evaluate the functionality of the AO pediatric classification for long bones fractures.

3. To analyze if the AO pediatric classification for long bones fractures is a prognosis factor

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date July 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 16 Years
Eligibility 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.

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Procedure:
• clinical evaluation
analyze the x ray from each patient and evaluate the treatment y development of bone healing.
• observational study
evaluate the walk patron, bone healing and range of motion at 1,3,6,12 months

Locations
Country Name City State
Mexico Hospital Cruz Roja Mexicana, Delegacion Distrito Federal Mexico City Federal District

Sponsors (1)
Lead Sponsor Collaborator
Hospital Cruz Roja Mexicana

Country where clinical trial is conducted

Mexico, 

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