Expired Study
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Baltimore, Maryland 21287


Purpose:

Prospective randomized controlled trial comparing use of single leg spica with double leg spica casts in the treatment of pediatric femur fractures in children ages 2 through 6 years old.


Study summary:

Introduction - double-leg spica casting is the treatment of choice at many centers for the treatment of diaphyseal femur fractures in children 2 to 6 years old. - Investigators hypothesize that these patients can be effectively treated with single-leg spica casting and that such treatment will result in easier care and better patient function during treatment. Methods - Prospective randomized controlled study of patients between 2 and 6 years old with diaphyseal femur fractures - patients randomly assigned to either immediate single or double-leg spica casting groups after consent was obtained - Radiographs serially evaluated for maintenance of reduction with respect to length, varus/valgus angulation and procurvatum/recurvatum angulation - After casts removal, the Activity Scale for Kids (Performance Version) questionnaire and a custom written survey were given to parents evaluating ease of care and function of children during treatment.


Criteria:

Inclusion Criteria: - diaphyseal femur fracture - age between 2 and 6 years old Exclusion Criteria: - underlying bone disorder - neuromuscular disease


Study is Available At:


Original ID:

NA_00005452


NCT ID:

NCT01293916


Secondary ID:


Study Acronym:


Brief Title:

Spica Casting in Pediatric Femur Fractures: Study of Single Leg Versus Double Leg Spica Casts


Official Title:

Spica Casting in Pediatric Femur Fractures: A Prospective Randomized Controlled Study of Single Leg vs Double Leg Spica Casts


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

2 Years


Maximum Age:

6 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Johns Hopkins University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

52


Enrollment Type:

Actual


Overall Contact Information

Official Name:Dirk Leu, MD
Study Director
Johns Hopkins University

Study Dates

Start Date:June 2006
Completion Date:January 2009
Completion Type:Actual
Primary Completion Date:January 2009
Primary Completion Type:Actual
Verification Date:February 2019
Last Changed Date:February 1, 2019
First Received Date:February 10, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Acceptable fracture healing
Time Frame:8 weeks
Safety Issues:False
Description:evaluation of shortening, angulation, and rotation radiographically at time of fracture healing

Study Interventions

Intervention Type:Other
Name:Spica casting
Description:single versus double leg spica casting
Arm Name:Double leg spica cast

Study Arms

Study Arm Type:Active Comparator
Arm Name:Double leg spica cast
Description:The current accepted treatment is the double leg spica cast in the treatment of pediatric diaphyseal femur fractures.
Study Arm Type:Experimental
Arm Name:Single leg spica casts
Description:The study group is the single leg spica cast group

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Johns Hopkins University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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