Craniofacial FractureNCT00759486
Pediatric Facial Fracture Study
An observational study of Craniofacial Fracture, run by University of Pittsburgh at 1 site in United States.
Trial summary
The goal of this study is to establish a prospective, long-term, comprehensive growth and development study of the pediatric craniofacial skeleton following fracture, whose recruitment is ongoing. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Craniofacial Fracture
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jan 2018
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All races ages ranging from birth to 18 years who have sustained a craniofacial fracture.
Who may be able to join
- Criteria for inclusion in the research study will be any pediatric patient, birth to 18 years, who are in the active phase of craniofacial skeletal growth, and have sustained a craniofacial fracture.
- The racial, gender and ethnic characteristics of the proposed subject population reflects the demographics of the University of Pittsburgh and the surrounding area and/or the patient population of the University of Pittsburgh Medical Center.
- The investigators shall attempt to recruit subjects in respective proportion to these demographics. No exclusion criteria shall be based on race, ethnicity, gender or HIV status.
Who cannot join
- Criteria for exclusion in the research study will be any pediatric patient, birth to 18 years, who are not in the active phase of craniofacial skeletal growth, and have not sustained a craniofacial fracture.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospitla of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Pediatric Facial Fracture Growth and Development Study
The goal of this study is to establish a prospective, long-term, comprehensive growth and development study of the pediatric craniofacial skeleton following fracture, whose recruitment is ongoing.
Read the detailed description
This is a prospective, long-term, comprehensive growth and development study of the pediatric craniofacial skeleton following fracture.
This study will encompass two specific aims:
- To compare the growth and development of the pediatric craniofacial skeleton after fracture to publish standardized means of dentofacial growth in the Bolton-Brush Growth Study. Patients will be matched according to age, gender, and ethnicity. The status of dental eruption will be recorded as well as the vertical and anteroposterior classification of occlusion. The effect of trauma on the eruption and vitality of permanent teeth will be recorded. We will further assess the popularly held theories of craniofacial growth and effects of injury to various facial growth sites (i.e. mandibular condyles, nasal septum).
- Attempt to evaluate the effects of various treatment modalities of facial fracture on skeletal growth and development (i.e. open reduction and internal fixation versus closed reduction and external fixation), (open reduction and internal fixation with metallic vs. absorbable fixation). We will evaluate the effect of metallic internal fixation on subsequent craniofacial skeletal growth and development, as well as the routine needed for its removal.
- Conditions
- Craniofacial Fracture
- Keywords
- craniofacial fracture, Subjects who are in the active phase of craniofacial skeletal growth, and have sustained a craniofacial fracture
What is being measured
The primary outcome is the main question the study is designed to answer.
This protocol represents a descriptive and prospective, long-term, comprehensive growth and development study of the pediatric craniofacial skeleton following fracture
Measured: until subjects reach 18 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startOct 2005
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniofacial FractureStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Losee, University of Pittsburgh
- Investigators
- Joseph E Losee, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759486
- Sponsor's protocol ID
- 0509046
- Status last verified
- Oct 2018
- First submitted
- 24 Sep 2008
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Facial Fracture Growth and Development Study
- ClinicalTrials.gov ID
- NCT00759486
- Acronym / sponsor ID
- 0509046
- Conditions
- Craniofacial Fracture
- Keywords
- craniofacial fracture, Subjects who are in the active phase of craniofacial skeletal growth, and have sustained a craniofacial fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Oct 2005 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 25 Sep 2008 (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.
The goal of this study is to establish a prospective, long-term, comprehensive growth and development study of the pediatric craniofacial skeleton following fracture, whose recruitment is ongoing.
Detailed description
This is a prospective, long-term, comprehensive growth and development study of the pediatric craniofacial skeleton following fracture.
This study will encompass two specific aims:
- To compare the growth and development of the pediatric craniofacial skeleton after fracture to publish standardized means of dentofacial growth in the Bolton-Brush Growth Study. Patients will be matched according to age, gender, and ethnicity. The status of dental eruption will be recorded as well as the vertical and anteroposterior classification of occlusion. The effect of trauma on the eruption and vitality of permanent teeth will be recorded. We will further assess the popularly held theories of craniofacial growth and effects of injury to various facial growth sites (i.e. mandibular condyles, nasal septum).
- Attempt to evaluate the effects of various treatment modalities of facial fracture on skeletal growth and development (i.e. open reduction and internal fixation versus closed reduction and external fixation), (open reduction and internal fixation with metallic vs. absorbable fixation). We will evaluate the effect of metallic internal fixation on subsequent craniofacial skeletal growth and development, as well as the routine needed for its removal.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All races ages ranging from birth to 18 years who have sustained a craniofacial fracture.
Key inclusion criteria (3 listed)
- Criteria for inclusion in the research study will be any pediatric patient, birth to 18 years, who are in the active phase of craniofacial skeletal growth, and have sustained a craniofacial fracture.
- The racial, gender and ethnic characteristics of the proposed subject population reflects the demographics of the University of Pittsburgh and the surrounding area and/or the patient population of the University of Pittsburgh Medical Center.
- The investigators shall attempt to recruit subjects in respective proportion to these demographics. No exclusion criteria shall be based on race, ethnicity, gender or HIV status.
Key exclusion criteria (1 listed)
- Criteria for exclusion in the research study will be any pediatric patient, birth to 18 years, who are not in the active phase of craniofacial skeletal growth, and have not sustained a craniofacial fracture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
This protocol represents a descriptive and prospective, long-term, comprehensive growth and development study of the pediatric craniofacial skeleton following fracture
Time frame: until subjects reach 18 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
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.
Joseph E Losee, MD principal investigator
University of Pittsburgh
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 Craniofacial Fracture, run by University of Pittsburgh at 1 site in United States.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 23 Oct 2018. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This protocol represents a descriptive and prospective, long-term, comprehensive growth and development study of the pediatric craniofacial skeleton following fracture (time frame: until subjects reach 18 years of age). It is what the study was designed to measure, not a finding.
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 23 Oct 2018; AzTrials last refreshed its copy on 29 Oct 2026.