Pediatric Facial Fracture Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Children's Hospital of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Joseph E. Losee, Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00759486
First received: September 24, 2008
Last updated: July 29, 2013
Last verified: July 2013
  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
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
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:

  1. 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).
  2. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 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
ClinicalTrials.gov Identifier: NCT00759486     History of Changes
Other Study ID Numbers: 0509046
Study First Received: September 24, 2008
Last Updated: July 29, 2013
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 August 28, 2014