FracturesAO-PCNCT00533130
Evaluation of the AO Pediatric Classification for Long Bones Fractures Like a Guide for Treatment and Prognosis
An observational study of Fractures and Children, run by Hospital Cruz Roja Mexicana at 1 site in Mexico.
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? Read more about this study
- Who is it for?
- Ages Up to 16 yearsHealthy volunteers can take part
- What is being tested?
- clinical evaluation and observational study
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2007to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Pathologic fractures.
- Fractures not included en the AO pediatric classification for long bones.
- Diseases that modifying the bone healing: Diabetes mellitus, osteogenesis imperfect, etc.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Cruz Roja Mexicana, Delegacion Distrito Federal
Mexico City, Federal District, 11510
Jorge D Tejada-Hoyos, Resident
Carlos Torres-Castro, Resident
About this study
Official title: Phase 2/3 Eficacy Study of the AO Pediatric Classification in Treatment and Prognosis of Long Bones Fractures
- 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?
Read the 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
- Being tested
- clinical evaluation, observational study
- Keywords
- AO, Pediatric, Classification, Long Bones, fractures, bones
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical evaluationProcedure or surgery
Also called AO classification
analyze the x ray from each patient and evaluate the treatment y development of bone healing.
observational studyProcedure or surgery
Also called AO clasification
evaluate the walk patron, bone healing and range of motion at 1,3,6,12 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Pediatric patients under 16 years old with long bones fractures Receives: Procedure: clinical evaluation; Procedure: observational study |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startAug 2007
- Study completionJul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Cruz Roja Mexicana
- Sponsor type
- University, hospital or other
- Investigators
- Jorge D Tejada-Hoyos, M.D., Principal investigator, orthopaedic resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533130
- Sponsor's protocol ID
- CRM-2008-TYO
- Acronym
- AO-PC
- Status last verified
- Sep 2007
- First submitted
- 20 Sep 2007
- Last updated
- 21 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2/3 Eficacy Study of the AO Pediatric Classification in Treatment and Prognosis of Long Bones Fractures
- ClinicalTrials.gov ID
- NCT00533130
- Acronym / sponsor ID
- AO-PC / CRM-2008-TYO
- Keywords
- AO, Pediatric, Classification, Long Bones, fractures, bones
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Cruz Roja MexicanaUniversity, hospital or other
- Study start
- Aug 2007
- Study completion
- Jul 2008 (estimated)
- First posted
- 21 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: clinical evaluation, Procedure: observational studyPediatric patients under 16 years old with long bones fractures |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Less than 16 years old.
- Open physis.
- Long bone fractures.
- X ray AP \& lateral comparatives.
- Informed consent for parents or tutor.
Key exclusion criteria (3 listed)
- Pathologic fractures.
- Fractures not included en the AO pediatric classification for long bones.
- Diseases that modifying the bone healing: Diabetes mellitus, osteogenesis imperfect, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical evaluationAlso: AO classificationanalyze the x ray from each patient and evaluate the treatment y development of bone healing. | Procedure or surgery | 1 |
| observational studyAlso: AO clasificationevaluate the walk patron, bone healing and range of motion at 1,3,6,12 months | Procedure or surgery | 1 |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge D Tejada-Hoyos, M.D. principal investigator
orthopaedic resident
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures and Children, run by Hospital Cruz Roja Mexicana at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge D Tejada-Hoyos, M.D. (+52 55 53951111 ext. 137, jorgetejada_us@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2007.