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

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 this use.

Will I have to stop taking my current medications?

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

Is intracranial pressure (ICP) monitoring safe for humans?

Intracranial pressure (ICP) monitoring is generally safe, with a low complication rate of 8.3% in a study involving children. Most complications were minor, such as hardware failure and cerebrospinal fluid leakage, and there were no cases of permanent harm or death. ^{1 2 3 4 5}

How does the treatment using an intracranial pressure monitor differ from other treatments for femoral neck fracture?

The use of an intracranial pressure (ICP) monitor for femoral neck fracture is unique because it involves monitoring pressure inside the skull, which is typically used for brain-related conditions. This approach is novel for femoral neck fractures, as it focuses on assessing and managing pressure changes that are not directly related to the fracture itself. ^{2 4 6 7 8}

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

Absence of a consenting parent/guardian or parent/guardian unwilling to consent to participation

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. United States pubmed.ncbi.nlm.nih.gov

Intracranial pressure versus cerebral perfusion pressure as a marker of outcomes in severe head injury: a prospective evaluation. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Intracranial pressure monitoring. [2004]

3. United States pubmed.ncbi.nlm.nih.gov

The value of intracranial pressure monitoring in acute hemispheric stroke. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Monitoring and interpretation of intracranial pressure. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Complications following intracranial pressure monitoring in children: a 6-year single-center experience. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Intracranial pressure monitoring and management of intracranial hypertension. [2014]

7. Austria pubmed.ncbi.nlm.nih.gov

Telemetric Intracranial Pressure: A Snapshot Does not Give the Full Story. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

The historic evolution of intracranial pressure and cerebrospinal fluid pulse pressure concepts: Two centuries of challenges. [2022]