ClinicalTrials.gg
Enrolling by invitationNCT04110639Updated Aug 5, 2021

Intraoperative Monitoring of Femoral Head Perfusion

An interventional study of Intracranial pressure (ICP) monitor and Standard of Care in Femoral Neck Fractures, sponsored by Children's Healthcare of Atlanta. Enrolling by invitation at 1 site in United States. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2021-08-05.

Sponsored by Children's Healthcare of Atlanta · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years 1 month ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
1 Year to 18 Years
Sex
All
01

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.

Read the detailed description

Hip fractures are a common entity in the realm of orthopedic trauma care and make up about 20% of the average workload of a trauma center. The lifetime risk of sustaining a hip fracture is significant; in women the range is 40-50% and among men it is 13-22%. Among all hip fractures, intracapsular femoral neck fractures (FNF) account for approximately 50% and are a significant undertaking for both the patient and treating physician. As the average age of the general population increases, the incidence of FNF in the worldwide population is likewise expected to rise (1.66 million observed in 1990 and 6.26 million projected 2050) with profound societal and economic impact.1

Operative indications and the methodology of surgical intervention in cases of femoral neck fractures are well established. Generally speaking, treatment options can be divided in two groups: reduction with internal fixation or arthroplasty. This treatment decision depends on patient factors and fracture characteristics. Within the realm of internal fixation, advances in the quality of modern implants have yielded largely good surgical outcomes. However, internal fixation of femoral neck fractures is not without complications. Osteonecrosis of the femoral head (ONFH) and nonunion are the major causes of morbidity and economic burden.2 The rate of ONFH in a recent meta-analysis was 0-22% (mean 6.9%) with a trend towards higher rates in women, patients less than 60 years of age, and those treated with cannulated screw fixation.1,3,4 Identifying measures to minimize the risk of osteonecrosis and nonunion would be beneficial to patient outcomes. Prior studies have noted correlations between residual displacement of the femoral head or varus malreduction with fixation failure (13-fold increase).1,5 In both cases, it is suspected that failure to restore normal anatomy of the femoral head and neck compromises the biomechanical alignment of the hip, and most importantly, its blood flow.

To date, there has not been a well-described intra-operative method to assess femoral head perfusion in adults, or to correlate these finding with late complications such as osteonecrosis. The diagnosis of osteonecrosis is typically made late in the patient's post-operative course when it becomes apparent on radiographs. Some investigators have studied the utility of select imaging studies at predicting femoral head perfusion and found single photon-emission computerized tomography (CT) to be accurate, but not easily available in all centers.6 MRI is felt to be superior to radiographs for early detection, but still not reliable in the first few weeks after injury.7 While the use of post-operative MRI and CT to elucidate femoral head perfusion has been investigated, neither can provide a real-time, intra-operative, measure of blood flow to the femoral head. If a real-time perfusion assessment tool was available, surgeons could determine the necessity for, and adequacy of, intraoperative reduction. Lack of perfusion could alter a surgeon's operative plan and might prompt an attempt at improving the reduction or a change in surgical management.

The purpose of this prospective study is to establish an intra-operative technique to monitor femoral head blood flow in patients with femoral neck fractures. 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 outcomes will be osteonecrosis and fracture union. The implications of this study may lead to changes in post-operative management, the intra-operative surgical plan if little to no epiphyseal perfusion is present and potentially new treatments for FNF patients to avoid the dreaded complication of osteonecrosis.

The intracranial pressure monitor will be utilized during the standard operative fixation of displaced and non-displaced FNF patients. This will allow a real-time assessment of femoral head perfusion pressure following reduction and fixation of these fractures. Correlations will be made to patients' blood pressure, demographic data, and injury characteristics. The monitor uses a sterile transducer that contains a pressure-monitoring catheter. This produces an artifact free, high fidelity waveform tracing without the need for a "fluid-filled" system. In the proposed application, the monitor would quantify perfusion pressure in the femoral head rather than cerebral tissue pressure. Following the investigators' protocol, the ICP monitor will be inserted through the cannulated screw used for fracture fixation and then removed after the measurement has been recorded.

Dr. Tim Schrader, the principal investigator, currently utilizes this ICP monitor as standard of care for all patients being treated for unstable slipped capital femoral epiphysis, a pediatric condition of the hip that similarly has an associated risk of osteonecrosis. He has demonstrated that the presence of femoral head perfusion as detected by a waveform on intra-osseous placed ICP monitor has been associated with the absence of osteonecrosis post-operatively.8

02

Conditions studied

  • Femoral Neck Fractures
03

In context

Femoral Neck Fractures

207 studies on the registry are indexed under Femoral Neck Fractures; 40 are open to participants now.

This study's planned enrollment of 30 is below the median of 100 across 142 interventional studies indexed under Femoral Neck Fractures.

Browse Femoral Neck Fractures studies →

Lead sponsor

Children's Healthcare of Atlanta is the lead sponsor of 97 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceIntracranial 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.

  • OtherStandard of Care

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

06

What researchers measure

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.

    Time frame: During surgery

Secondary outcomes

  1. Reduce Osteonecrosis

    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.

    Time frame: Post-op: One Year after surgery

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 3773004 ↗
  • 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. PubMed 14560825 ↗
  • 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. PubMed 21598895 ↗
  • 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. PubMed 26632739 ↗
  • 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. PubMed 6229381 ↗
  • 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. PubMed 2295679 ↗
  • 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. PubMed 27307364 ↗
  • Keating, John. Rockwood and Green Chapter 49 - Femoral Neck Fractures p.2031-2070. Wolters Kluwer Health 2015. Philadelphia, PA.
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2021; primary completion for Oct 2023, 25 months later.

Of 63 non-industry interventional studies with no phase under Femoral Neck Fractures, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 62. This study's planned 25 months is below that.

Counting every sponsor, half of 69 studies reached it within 46 months; a quarter within 25 and three quarters within 68.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2019
First posted
Oct 1, 2019
StartEst.
Sep 2021
Primary completionEst.
Oct 2023
CompletionEst.
Oct 2025
Last update
Aug 5, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04110639
Lead sponsor
Children's Healthcare of Atlanta
Collaborators
Geogia Trauma Foundation
Responsible party
TIm Schrader, MD (Principal Investigator, Children's Healthcare of Atlanta) — Principal investigator
First posted
Oct 1, 2019
Start date
Sep 2021 (estimated)
Primary completion
Oct 2023 (estimated)
Completion
Oct 2025 (estimated)
Last update
Aug 5, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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