Intraoperative Monitoring for Femoral Neck Fracture

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Healthcare of Atlanta

Disqualifiers: Other hip fractures, Arthroplasty, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to track blood flow in the hip during surgery for certain hip fractures. An ICP monitor (intracranial pressure monitor, typically used for brain pressure) checks blood flow in the hip after fixing a fracture. The trial includes two groups: one with less severe fractures and another with more severe ones. Children who have experienced a sudden hip fracture and can obtain consent from a parent or guardian may qualify for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this ICP monitor is safe for intraoperative use?

Research has shown that monitoring intracranial pressure is generally safe, with a low complication risk of 8.3%. This means fewer than 9 out of 100 people might experience issues. The device used in this trial has FDA approval for other purposes, indicating it has undergone safety testing in various situations. However, its use for monitoring blood flow in the hip is new and remains under study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the intraoperative monitoring protocol for femoral neck fractures because it aims to enhance surgical precision and patient outcomes. Unlike traditional methods that rely solely on visual and tactile feedback, this approach uses an intracranial pressure (ICP) monitor to provide real-time data during surgery. This could potentially lead to more accurate fixation of fractures and reduce complications, offering a significant improvement over existing techniques. By refining how surgeons address femoral neck fractures, this trial could pave the way for more reliable recovery and better long-term results for patients.

What evidence suggests that using an ICP monitor is effective for monitoring blood flow in femoral neck fractures?

This trial will compare two groups to evaluate the effectiveness of using an intracranial pressure (ICP) monitor during surgery for femoral neck fractures. Research has shown that the ICP monitor can track blood flow to the top of the thigh bone during surgery, offering a less invasive and cost-effective method to assess blood supply to the bone. Previous studies found this technique promising for accurately monitoring blood flow, which is crucial for proper healing. Using this approach may prevent problems like osteonecrosis, where bone tissue dies due to insufficient blood supply. Although originally designed for other purposes, the ICP monitor's ability to track blood flow makes it a potentially useful tool for treating hip fractures. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 1 and 18 years old.

Consent to enrollment

I have been diagnosed with a broken hip bone.

Exclusion Criteria

I had surgery to replace my hip due to a fracture.

Risk of loss to follow-up

I have had a hip fracture that is not in the femoral neck.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Intraoperative monitoring of femoral head perfusion using an ICP monitor during standard operative fixation

During surgery

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for osteonecrosis and fracture union using post-operative imaging and clinical assessments

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intracranial pressure (ICP) monitor

Trial Overview 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.

How Is the Trial Designed?

Group I: Study Group Experimental Treatment 1 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 Group Active Control 1 Intervention

A validation group of 10 patients with minimally displaced femoral neck fractures (Garden 1) which will be pinned in situ without manipulation

Who Is Running the Clinical Trial?

Children's Healthcare of Atlanta

Lead Sponsor

Trials

172

Recruited

108,000+

Geogia Trauma Foundation

Collaborator

Trials

1

Recruited

30+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8568476/

Intraoperative monitoring of femoral head perfusion in adult ... Our study demonstrated the feasibility of a relatively low cost, minimally invasive, technique to quantify femoral head perfusion.

2. withpower.com withpower.com/trial/intraoperative-monitoring-for-femoral-neck-fracture-2baac

Intraoperative Monitoring for Femoral Neck Fracture An ICP monitor will be used to record blood flow/perfusion of the femoral head following fixation of femoral neck fractures. FDA approved device but not for ...

3. clinicaltrial.be clinicaltrial.be/en/details/177125?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Intraoperative Monitoring of Femoral Head Perfusion - Cli... The purpose of this prospective study is to establish an intra-operative technique to monitor femoral head blood flow in patients with femoral ...

4. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-023-03858-7

Methods to predict osteonecrosis of femoral head after femoral ... Femoral neck fracture (FNF) accounts for 53% of all proximal femoral fractures, either causing hip joint dysfunction in young patients or being ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2815841

Early vs Late Fixation of Extremity Fractures Among Adults ... The outcomes of extremity fracture fixation performed within 24 hours after TBI appear not to be worse than those of procedures performed 24 hours or later.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138304002001

Traumatic brain injury and stabilisation of long bone fractures ICP monitoring. From 70 to 80% of patients with severe TBI show an increase in intracranial pressure, which is of vascular origin in up to 70% and ...