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

Primary Purpose

Femur Fracture

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spica casting
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femur Fracture focused on measuring pediatric, femur, femoral, fracture, spica, cast, diaphyseal, single, double, patient age 2 to 6 years old

Eligibility Criteria

2 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • diaphyseal femur fracture
  • age between 2 and 6 years old

Exclusion Criteria:

  • underlying bone disorder
  • neuromuscular disease

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Double leg spica cast

Single leg spica casts

Arm Description

The current accepted treatment is the double leg spica cast in the treatment of pediatric diaphyseal femur fractures.

The study group is the single leg spica cast group

Outcomes

Primary Outcome Measures

Acceptable fracture healing
evaluation of shortening, angulation, and rotation radiographically at time of fracture healing

Secondary Outcome Measures

Full Information

First Posted
February 10, 2011
Last Updated
February 1, 2019
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT01293916
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femur Fracture
Keywords
pediatric, femur, femoral, fracture, spica, cast, diaphyseal, single, double, patient age 2 to 6 years old

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Double leg spica cast
Arm Type
Active Comparator
Arm Description
The current accepted treatment is the double leg spica cast in the treatment of pediatric diaphyseal femur fractures.
Arm Title
Single leg spica casts
Arm Type
Experimental
Arm Description
The study group is the single leg spica cast group
Intervention Type
Other
Intervention Name(s)
Spica casting
Intervention Description
single versus double leg spica casting
Primary Outcome Measure Information:
Title
Acceptable fracture healing
Description
evaluation of shortening, angulation, and rotation radiographically at time of fracture healing
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: diaphyseal femur fracture age between 2 and 6 years old Exclusion Criteria: underlying bone disorder neuromuscular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Leu, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paul D Sponseller, MD MPH
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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