Pediatric Femur Research Project

NCT ID: NCT00943332

Last Updated: 2019-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2018-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Femur Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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spica casting

femur fracture repair

Intervention Type PROCEDURE

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

femur fracture repair

Intervention Type PROCEDURE

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

femur fracture repair

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role collaborator

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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J. Eric Gordon, MD

Role: PRINCIPAL_INVESTIGATOR

Washington Univeristy

Locations

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Children's Hospital - University Missouri

Columbia, Missouri, United States

Site Status

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

St. Louis Childrens Hospital

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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09-0819-201105030

Identifier Type: -

Identifier Source: org_study_id

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