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

September 20, 2007 updated by: Hospital Cruz Roja Mexicana

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

  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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Mexico
    • Federal District
      • Mexico City, Federal District, Mexico, 11510
        • Recruiting
        • Hospital Cruz Roja Mexicana, Delegacion Distrito Federal
        • Principal Investigator:
          • Jorge D Tejada-Hoyos, Resident
        • Sub-Investigator:
          • Carlos Torres-Castro, Resident
        • Sub-Investigator:
          • Eduardo A Caballero-Quirarte, MD Adscrit
        • Sub-Investigator:
          • Marcos R Muciño-Maldonado, MD Adscrit
        • Sub-Investigator:
          • Boris Ortuño-Numbela, MD Adscrit
        • Sub-Investigator:
          • Jesus E Rodriguez-Olguin, MD Adscrit
        • Sub-Investigator:
          • Jose L Rosas-Cadena, MD Adscrit
        • Sub-Investigator:
          • Jose Villaroel, MD Adscrit
        • Sub-Investigator:
          • Humberto L Vives-Aceves, MD Adscit
        • Sub-Investigator:
          • Alejandro Bello-González, TyO Chief

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Defined Population
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
1
Pediatric patients under 16 years old with long bones fractures
Procedure: clinical evaluation
analyze the x ray from each patient and evaluate the treatment y development of bone healing.
Other Names:
  • AO classification
Procedure: observational study
evaluate the walk patron, bone healing and range of motion at 1,3,6,12 months
Other Names:
  • AO clasification

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Cruz Roja Mexicana

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jorge D Tejada-Hoyos, M.D., orthopaedic resident

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2007

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRM-2008-TYO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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