NCT04110639

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
1.9 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

August 5, 2021

Status Verified

July 1, 2021

Enrollment Period

2.1 years

First QC Date

September 15, 2019

Last Update Submit

August 3, 2021

Conditions

Femoral Neck Fractures

Outcome Measures

Primary Outcomes (1)

  • Intraoperative Femoral Head Perfusion Monitoring

    Establish an intra-operative technique to monitor femoral head blood flow in patients with femoral neck fractures.

    During surgery

Secondary Outcomes (1)

  • Reduce Osteonecrosis

    Post-op: One Year after surgery

Study Arms (2)

Validation Group

ACTIVE COMPARATOR

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

Study Group

EXPERIMENTAL

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

Interventions

Intracranial pressure (ICP) monitorDEVICE

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.

Study Group
Standard of CareOTHER

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

Validation Group

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

Location

Related Publications (8)

  • Dedrick DK, Mackenzie JR, Burney RE. Complications of femoral neck fracture in young adults. J Trauma. 1986 Oct;26(10):932-7. doi: 10.1097/00005373-198610000-00013.

    PMID: 3773004BACKGROUND

  • Maurer SG, Wright KE, Kummer FJ, Zuckerman JD, Koval KJ. Two or three screws for fixation of femoral neck fractures? Am J Orthop (Belle Mead NJ). 2003 Sep;32(9):438-42.

    PMID: 14560825BACKGROUND

  • Min BW, Kim SJ. Avascular necrosis of the femoral head after osteosynthesis of femoral neck fracture. Orthopedics. 2011 May 18;34(5):349. doi: 10.3928/01477447-20110317-13.

    PMID: 21598895BACKGROUND

  • Wang C, Xu GJ, Han Z, Jiang X, Zhang CB, Dong Q, Ma JX, Ma XL. Correlation Between Residual Displacement and Osteonecrosis of the Femoral Head Following Cannulated Screw Fixation of Femoral Neck Fractures. Medicine (Baltimore). 2015 Nov;94(47):e2139. doi: 10.1097/MD.0000000000002139.

    PMID: 26632739BACKGROUND

  • Stromqvist B, Brismar J, Hansson LI, Palmer J. Technetium-99m-methylenediphosphonate scintimetry after femoral neck fracture. A three-year follow-up study. Clin Orthop Relat Res. 1984 Jan-Feb;(182):177-89.

    PMID: 6229381BACKGROUND

  • Speer KP, Spritzer CE, Harrelson JM, Nunley JA. Magnetic resonance imaging of the femoral head after acute intracapsular fracture of the femoral neck. J Bone Joint Surg Am. 1990 Jan;72(1):98-103.

    PMID: 2295679BACKGROUND

  • Schrader T, Jones CR, Kaufman AM, Herzog MM. Intraoperative Monitoring of Epiphyseal Perfusion in Slipped Capital Femoral Epiphysis. J Bone Joint Surg Am. 2016 Jun 15;98(12):1030-40. doi: 10.2106/JBJS.15.01002.

    PMID: 27307364BACKGROUND

  • Keating, John. Rockwood and Green Chapter 49 - Femoral Neck Fractures p.2031-2070. Wolters Kluwer Health 2015. Philadelphia, PA.

    BACKGROUND

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Monitoring, PhysiologicStandard of Care

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2019

First Posted

October 1, 2019

Study Start

September 1, 2021

Primary Completion

October 1, 2023

Study Completion

October 1, 2025

Last Updated

August 5, 2021

Record last verified: 2021-07

Locations

US(1)