Pediatric Facial Fracture Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Children's Hospital of Pittsburgh.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Children's Hospital of Pittsburgh
Information provided by:
Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00759486
First received: September 24, 2008
Last updated: October 1, 2008
Last verified: September 2008
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Purpose
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.
| Condition |
|---|
|
Craniofacial Fracture |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Pediatric Facial Fracture Growth and Development Study |
Resource links provided by NLM:
Further study details as provided by Children's Hospital of Pittsburgh:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | October 2005 |
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.
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
All races ages ranging from birth to 18 years who have sustained a craniofacial fracture.
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759486
Contacts
| Contact: Joseph E Losee, MD | 412-692-7949 | joseph.losee@chp.edu |
| Contact: Jennifer Szczepaniak, BS | 412-692-6203 | jennifer.szczepaniak@chp.edu |
Locations
| United States, Pennsylvania | |
| Children's Hospitla of Pittsburgh of UPMC | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Joseph E Losee, md 412-692-7949 joseph.losee@chp.edu | |
| Contact: Jennifer Szczepaniak, BS 412-692-6203 jennifer.szczepaniak@chp.edu | |
Sponsors and Collaborators
Children's Hospital of Pittsburgh
Investigators
| Principal Investigator: | Joseph E Losee, MD | Children's Hospital of Pittsburgh of UPMC |
More Information
No publications provided
| Responsible Party: | Joseph E. Losee, MD, Children's Hospital of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00759486 History of Changes |
| Other Study ID Numbers: | 0509046 |
| Study First Received: | September 24, 2008 |
| Last Updated: | October 1, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital of Pittsburgh:
|
craniofacial fracture Subjects who are in the active phase of craniofacial skeletal growth, and have sustained a craniofacial fracture |
Additional relevant MeSH terms:
|
Fractures, Bone Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013