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Device

Intraoperative Monitoring for Femoral Neck Fracture

N/A
Waitlist Available
Research Sponsored by Children's Healthcare of Atlanta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 1 to 18 years
Diagnosis of acute femoral neck fracture
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-op: one year after surgery
Awards & highlights

Study Summary

This trial will use a device to see how well blood flows to the femoral head after surgery for a femoral neck fracture. The device is FDA approved, but not for this use.

Who is the study for?
This trial is for children and teenagers aged 1 to 18 with a recent femoral neck fracture. They must have a parent or guardian who can consent to their participation. It's not open to those without consent, at risk of being lost to follow-up, or with hip fractures that aren't femoral neck fractures or are treated with arthroplasty.Check my eligibility
What is being tested?
The study is testing the use of an Intracranial Pressure (ICP) monitor, which isn't usually used for this purpose, during surgery to fix femoral neck fractures. The goal is to record blood flow in the femoral head and compare it with standard care.See study design
What are the potential side effects?
Since the ICP monitor is FDA approved but not typically used for monitoring blood flow in the femur, potential side effects may include discomfort at the sensor site and risks associated with typical surgical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 1 and 18 years old.
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I have been diagnosed with a broken hip bone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-op: one year after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-op: one year after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intraoperative Femoral Head Perfusion Monitoring
Secondary outcome measures
Reduce Osteonecrosis

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Study GroupExperimental Treatment1 Intervention
A study group of 20 patients with displaced femoral neck fracture patients (Garden 2-4) treated with open or closed reduction and internal fixation
Group II: Validation GroupActive Control1 Intervention
A validation group of 10 patients with minimally displaced femoral neck fractures (Garden 1) which will be pinned in situ without manipulation

Find a Location

Who is running the clinical trial?

Children's Healthcare of AtlantaLead Sponsor
165 Previous Clinical Trials
105,100 Total Patients Enrolled
Geogia Trauma FoundationUNKNOWN

Media Library

Intracranial pressure (ICP) monitor (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04110639 — N/A
Femoral Neck Fracture Research Study Groups: Validation Group, Study Group
Femoral Neck Fracture Clinical Trial 2023: Intracranial pressure (ICP) monitor Highlights & Side Effects. Trial Name: NCT04110639 — N/A
Intracranial pressure (ICP) monitor (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04110639 — N/A

Frequently Asked Questions

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

Are there any vacancies open for enrollment in this clinical trial?

"Data from clinicaltrials.gov suggests that this medical trial is not currently recruiting participants. It was initially posted on September 1st 2021 and last modified on August 3rd 2021. Despite no longer accepting candidates, 28 other trials are taking applicants at the moment."

Answered by AI

Am I eligible to enroll in this experiment?

"This trial is welcoming 30 individuals who have suffered from femoral neck fractures between the ages of one and eighteen. Both male and female patients are eligible to participate, provided they meet the defined age criteria."

Answered by AI

Are individuals under the age of 65 permitted to participate in this medical investigation?

"To participate in this trial, individuals must be between 1 year old and 18. There are 1 clinical trials for people within the specified age range and 27 others for patients over 65 years of age."

Answered by AI
Recent research and studies
~9 spots leftby Mar 2025