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
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