Pediatric Facial Fracture Study
This study is currently recruiting participants.
Verified July 2013 by Children's Hospital of Pittsburgh
Information provided by (Responsible Party):
Joseph E. Losee, Children's Hospital of Pittsburgh
First received: September 24, 2008
Last updated: July 29, 2013
Last verified: July 2013
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.
||Time Perspective: Prospective
||Pediatric Facial Fracture Growth and Development Study
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:
| Study Start Date:
| Estimated Primary Completion Date:
||October 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||up to 18 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
All races ages ranging from birth to 18 years who have sustained a craniofacial fracture.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759486
Children's Hospital of Pittsburgh
||Joseph E Losee, MD
||Children's Hospital of Pittsburgh of UPMC
No publications provided
||Joseph E. Losee, Ross H. Musgrave Professor of Pediatric Plastic Surgery Executive Vice-Chair and Program Director Department of Plastic Surgery University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 24, 2008
||July 29, 2013
||United States: Institutional Review Board
Keywords provided by Children's Hospital of Pittsburgh:
Subjects who are in the active phase of craniofacial skeletal growth, and have sustained a craniofacial fracture
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 16, 2014
Wounds and Injuries