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Bracing vs. Casting for Femur Fractures

N/A

Waitlist Available

Research Sponsored by Children's Hospital Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients ages 0-5 years with an isolated diaphyseal femur fracture

Patients ages 0-5 years with an isolated diaphyseal femur fracture.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this will be reviewed and counted for up to 1 year.

Awards & highlights

Study Summary

This trial will compare the benefits of two treatments for broken femurs in young children.

Who is the study for?

This trial is for children aged 0-5 years with a specific type of thigh bone break (isolated diaphyseal femur fracture). Their parents must be at least 18 and able to complete surveys. Children over 5, those with multiple injuries or other medical conditions that could affect bone healing, and parents under 18 are not eligible.Check my eligibility

What is being tested?

The study compares two treatments for young children's thigh bone fractures: the traditional hip spica cast versus a functional brace. It aims to assess which method is better in terms of patient outcomes and cost-effectiveness through a multi-center randomized controlled trial.See study design

What are the potential side effects?

While the information provided does not specify side effects, generally, casting may cause skin irritation or discomfort; bracing might lead to similar issues but allows more movement which can impact healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child is 5 years or younger with a thigh bone fracture not involving the joint.

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My child is 5 or younger with a thigh bone fracture not involving the joint.

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I am a parent over 18 and can understand and complete a survey.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this will be reviewed and counted for up to 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this will be reviewed and counted for up to 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and this will be reviewed and counted for up to 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in Leg Length

Changes in union/rate of malunion

Economic costs (operating room cost)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Spica Cast GroupExperimental Treatment1 Intervention

If subject is randomized into the hip spica cast group, subject will proceed to the operating room and be given general anesthesia to administer the spica cast. Cast will be used for up to 8 weeks, until adequate callous formation is confirmed.

Group II: Functional Bracing GroupExperimental Treatment1 Intervention

In a presented abstract, the functional brace group has been to shown equivalent outcomes to the hip spica cast. Subject will be administered the functional brace without going to the operating room to be put under full anesthesia. Most cases will not require any sedation in this group (in some cases, light sedation may be needed). Brace will be used for up to 8 weeks post-administration, until adequate callous formation is confirmed.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor

232 Previous Clinical Trials

5,076,648 Total Patients Enrolled

Pediatric Orthopaedic Society of North AmericaOTHER

6 Previous Clinical Trials

1,243 Total Patients Enrolled

Media Library

Functional Brace Clinical Trial Eligibility Overview. Trial Name: NCT03948139 — N/A

Femur Fractures Clinical Trial 2023: Functional Brace Highlights & Side Effects. Trial Name: NCT03948139 — N/A

Functional Brace 2023 Treatment Timeline for Medical Study. Trial Name: NCT03948139 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are participating in this research?

"Indeed, clinicaltrials.gov affirms that this medical experiment is presently recruiting participants; it was posted on October 16th 2018 and last updated June 16th 2022. Additionally, the study requires 150 patients from 2 different sites to be enrolled."

Answered by AI

Is it possible to become a participant in this clinical research?

"To gain admittance to this clinical trial, prospective participants need to have suffered bone fractures and be aged between 0-5. The researchers are aiming for a sample size of 150 individuals."

Answered by AI

Are participants aged 30 and above eligible to join this trial?

"The enrollment qualifications for this clinical trial mandate that participants must be aged between 0 and 5. Additionally, there are 66 medical studies involving minors under the age of 18 as well as 295 trials focusing on patients over 65 years old."

Answered by AI

Are there opportunities to join this medical experiment at present?

"Affirmative. The clinical trial database shows that this medical study is presently accepting volunteers. Posting began on October 16th 2018, and the information was last updated June 16th 2022. 150 patients are needed from 2 sites for the trial to be successful."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Femur Fracture: Functional Bracing vs. Hip Spica Cast

Lindsay Andras 2018. "Femur Fracture: Functional Bracing vs. Hip Spica Cast". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03948139.