Pediatric Femur Research Project

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Missouri-Columbia
Children's Mercy Hospital-Kansas City, MO
Information provided by (Responsible Party):
J. Eric Gordon, Washington University
ClinicalTrials.gov Identifier:
NCT00943332
First received: July 17, 2009
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

Current treatment protocol for pediatric femoral shaft fractures is immediate spica casting for patients 6 years and younger and for patients over 6 years and older is percutaneous or open placement of titanium elastic intramedullary nails. The investigators would like to evaluate the current treatment protocol by comparing those patients 6 years and younger treated with closed reduction and spica casting to those 6 years and younger treated with percutaneous pinned with titanium elastic intramedullary nails or submuscular plating. The investigators will be comparing their post-operative functional level, pain management, impact on family and complications through chart and x-ray reviews. The goal is to improve patient care pre and post-operatively for those who have sustained a femoral shaft fracture 6 years old and younger and increase the knowledge of those residents/physicians who care for this patient population.


Condition Intervention
Femur Fracture
Procedure: femur fracture repair

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pediatric Femur Research Project

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Impact on family [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • post-operative functional level [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • pain management [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • complications [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 145
Study Start Date: June 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
spica casting Procedure: femur fracture repair
all participants will have undergone surgical intervention to repair a femur fracture, the investigators will simply be collecting data after the procedure; participants will not be consented until after the procedure
intramedullary nailing Procedure: femur fracture repair
all participants will have undergone surgical intervention to repair a femur fracture, the investigators will simply be collecting data after the procedure; participants will not be consented until after the procedure
submuscualr plating Procedure: femur fracture repair
all participants will have undergone surgical intervention to repair a femur fracture, the investigators will simply be collecting data after the procedure; participants will not be consented until after the procedure

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients will have undergone of the following interventions for the treatment of the femur fracture: spica casting, nancy nailing, or submuscular plating, by a participating physician in the trial. All of these treatments are considered standard of care for this pediatric population.

Criteria

Inclusion Criteria:

  • Child diagnosed with femur fracture between the ages of 2-6 years old
  • Patient will undergo surgical intervention for a femur fracture (e.g., submuscular plating, Nancy nailing, casting )

Exclusion Criteria:

  • Parent refusal to participate for any reason
  • Children with neuromuscular disorders having a Gross Motor Function Classification greater than 3
  • Pathologic 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: NCT00943332

Locations
United States, Missouri
Children's Hospital - University Missouri
Columbia, Missouri, United States, 65201
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
St. Louis Childrens Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
University of Missouri-Columbia
Children's Mercy Hospital-Kansas City, MO
Investigators
Principal Investigator: J. Eric Gordon, MD Washington Univeristy
  More Information

No publications provided

Responsible Party: J. Eric Gordon, Director of Clinical Services, Pediatric Orthopedic Surgery, Washington University
ClinicalTrials.gov Identifier: NCT00943332     History of Changes
Other Study ID Numbers: 09-0819
Study First Received: July 17, 2009
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Orthopedic Procedures
Fracture Fixation, Internal
Fracture Fixation, External
femur fracture
pediatrics

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 20, 2014