Completed

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

What is being tested

Spica casting

Other

Who is being recruted

Femoral Fractures+1

+ Leg Injuries

+ Wounds and Injuries

From 2 to 6 Years

+4 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: June 2006

See protocol details

Summary

Principal SponsorJohns Hopkins University

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2006

Actual date on which the first participant was enrolled.

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.

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

NCT01293916

Principal SponsorJohns Hopkins University

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

52 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 2 to 6 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Femoral FracturesLeg InjuriesWounds and InjuriesFractures, Bone

Criteria

2 inclusion criteria required to participate

diaphyseal femur fracture

age between 2 and 6 years old

2 exclusion criteria prevent from participating

underlying bone disorder

neuromuscular disease

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

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

Group II

Experimental

The study group is the single leg spica cast group

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Johns Hopkins Hospital

Baltimore, United StatesOpen Johns Hopkins Hospital in Google Maps

CompletedOne Study Center