Intraoperative Monitoring for Femoral Neck Fracture
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?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Intraoperative monitoring of femoral head perfusion using an ICP monitor during standard operative fixation
Post-operative Monitoring
Participants are monitored for osteonecrosis and fracture union using post-operative imaging and clinical assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Intracranial pressure (ICP) monitor
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Healthcare of Atlanta
Lead Sponsor
Geogia Trauma Foundation
Collaborator