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Pediatric Facial Fracture Study

This study is currently recruiting participants.
Verified October 2017 by Joseph Losee, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT00759486
First Posted: September 25, 2008
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Joseph Losee, University of Pittsburgh
  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: Observational Model: Other
Time Perspective: Prospective
Official Title: Pediatric Facial Fracture Growth and Development Study

Resource links provided by NLM:


Further study details as provided by Joseph Losee, University 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 ]

Estimated Enrollment: 1000
Study Start Date: October 2005
Estimated Primary Completion Date: October 2020 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
University of Pittsburgh
Investigators
Principal Investigator: Joseph E Losee, MD Children's Hospital of Pittsburgh of UPMC
  More Information

Responsible Party: Joseph Losee, Ross H. Musgrave Professor of Pediatric Plastic Surgery Executive Vice-Chair and Program Director Department of Plastic Surgery University of Pittsburgh Medical Center, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00759486     History of Changes
Other Study ID Numbers: 0509046
First Submitted: September 24, 2008
First Posted: September 25, 2008
Last Update Posted: October 18, 2017
Last Verified: October 2017

Keywords provided by Joseph Losee, University 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