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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01293916
Enrollment
52
Registered
2011-02-11
Start date
2006-06-30
Completion date
2009-01-31
Last updated
2019-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femur Fracture

Keywords

pediatric, femur, femoral, fracture, spica, cast, diaphyseal, single, double, patient age 2 to 6 years old

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.

Interventions

OTHERSpica casting

single versus double leg spica casting

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* underlying bone disorder * neuromuscular disease

Design outcomes

Primary

MeasureTime frameDescription
Acceptable fracture healing8 weeksevaluation of shortening, angulation, and rotation radiographically at time of fracture healing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026