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Intraoperative Monitoring of Femoral Head Perfusion

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ClinicalTrials.gov Identifier: NCT04110639
Recruitment Status : Enrolling by invitation
First Posted : October 1, 2019
Last Update Posted : January 23, 2020
Sponsor:
Collaborator:
Geogia Trauma Foundation
Information provided by (Responsible Party):
TIm Schrader, MD, Children's Healthcare of Atlanta

Brief 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.

Condition or disease Intervention/treatment Phase
Femoral Neck Fractures Device: Intracranial pressure (ICP) monitor Other: Standard of Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Intraoperative Monitoring of Femoral Head Perfusion in Femoral Neck Fractures
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Validation Group
A validation group of 10 patients with minimally displaced femoral neck fractures (Garden 1) which will be pinned in situ without manipulation
Other: Standard of Care
10 patients with minimally displaced femoral neck fractures (Garden 1) which will be pinned in situ without manipulation

Experimental: Study Group
A study group of 20 patients with displaced femoral neck fracture patients (Garden 2-4) treated with open or closed reduction and internal fixation
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.




Primary Outcome Measures :
  1. Intraoperative Femoral Head Perfusion Monitoring [ Time Frame: During surgery ]
    Establish an intra-operative technique to monitor femoral head blood flow in patients with femoral neck fractures.


Secondary Outcome Measures :
  1. Reduce Osteonecrosis [ Time Frame: Post-op: One Year after surgery ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients
  • Ages 1 to 18 years
  • Acute femoral neck fracture
  • Consent to enrollment

Exclusion Criteria:

  • Hip fractures other than femoral neck fractures
  • Femoral neck fractures treated with arthroplasty
  • Absence of a consenting parent/guardian or parent/guardian unwilling to consent to participation
  • Loss to follow-up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110639


Locations
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United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Children's Healthcare of Atlanta
Geogia Trauma Foundation
Publications:
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Responsible Party: TIm Schrader, MD, Principal Investigator, Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT04110639    
Other Study ID Numbers: 17-148
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Femoral Neck Fractures
Fractures, Bone
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries