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Femoral Neck FracturesNCT04110639

Intraoperative Monitoring of Femoral Head Perfusion

A study testing Intracranial pressure (ICP) monitor in people with Femoral Neck Fractures, run by Children's Healthcare of Atlanta at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 1 year to 18 years
Conditions the study is for
Femoral Neck Fractures
What is being tested?
Intracranial pressure (ICP) monitor
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Sep 2021to Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30342

Other trials in United States

About this study

Official title: Intraoperative Monitoring of Femoral Head Perfusion in Femoral Neck Fractures

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

Being tested
Intracranial pressure (ICP) monitor, Standard of Care
Medical subject headings
Femoral Neck Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Standard of CareOther

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

Study groups in NCT04110639
Study groupRoleWhat they receive
Validation GroupActive comparatorA validation group of 10 patients with minimally displaced femoral neck fractures (Garden 1) which will be pinned in situ without manipulation
Receives: Other: Standard of Care
Study GroupExperimentalA study group of 20 patients with displaced femoral neck fracture patients (Garden 2-4) treated with open or closed reduction and internal fixation
Receives: Device: Intracranial pressure (ICP) monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intraoperative Femoral Head Perfusion Monitoring

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

    Measured: During surgery

Secondary outcomes (1)
  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.

    Measured: Post-op: One Year after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2019
  2. Study startSep 2021 (estimated)
  3. Primary completionOct 2023 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04110639
Sponsor's protocol ID
17-148
Status last verified
Jul 2021
First submitted
15 Sep 2019
Last updated
5 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

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.

Questions about this trial

What is this clinical trial studying?

A study testing Intracranial pressure (ICP) monitor in people with Femoral Neck Fractures, run by Children's Healthcare of Atlanta at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraoperative Femoral Head Perfusion Monitoring (time frame: During surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04110639, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.

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