30 Participants Needed

Intraoperative Monitoring for Femoral Neck Fracture

Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Children's Healthcare of Atlanta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.12345

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.24678

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.

Eligibility Criteria

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.
See 1 more

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
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
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 Clinic Near You

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+

References

Intracranial pressure versus cerebral perfusion pressure as a marker of outcomes in severe head injury: a prospective evaluation. [2014]
Intracranial pressure monitoring. [2004]
The value of intracranial pressure monitoring in acute hemispheric stroke. [2022]
Monitoring and interpretation of intracranial pressure. [2022]
Complications following intracranial pressure monitoring in children: a 6-year single-center experience. [2019]
Intracranial pressure monitoring and management of intracranial hypertension. [2014]
Telemetric Intracranial Pressure: A Snapshot Does not Give the Full Story. [2021]
The historic evolution of intracranial pressure and cerebrospinal fluid pulse pressure concepts: Two centuries of challenges. [2022]
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