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Intraoperative Monitoring of Femoral Head Perfusion

NCT04110639 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-08-05

No results posted yet for this study

Summary

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.

Conditions

  • Femoral Neck Fractures

Interventions

DEVICE

Intracranial pressure (ICP) monitor

The investigators' hypothesis is that by utilizing an intracranial pressure (ICP) monitor to detect the presence or absence of waveforms in the femoral head, investigators could reliably assess the perfusion levels within the femoral head and possibly reduce the incidence of osteonecrosis.

OTHER

Standard of Care

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

Sponsors & Collaborators

  • Geogia Trauma Foundation

    collaborator UNKNOWN

  • Children's Healthcare of Atlanta

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2023-10-31
Completion
2025-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04110639 on ClinicalTrials.gov