Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04985461 |
| Other study ID # |
ENT-002 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 30, 2017 |
| Est. completion date |
March 12, 2020 |
Study information
| Verified date |
July 2021 |
| Source |
Altru Health System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Patients sustaining fractures of the upper (maxilla) and/or lower (mandible) jaw may be
candidates for the minimally invasive technology evaluated in this study. Patients will be
offered standard care including steel jaw wires or the polymer-based "zip tie"-like devices
to be studied. Written consent with a full explanation of traditional "jaw wiring" techniques
versus this experimental approach will be obtained from the patient. As mandible and maxilla
fractures are typically treated under general anesthesia in the operating room, the devices
will be applied to the patient's dentition while under general anesthetic. An exception to
this will be minimally displaced or easily reduced fractures that can be treated by applying
these devices in clinic under topical or local anesthetic. (Of note, wire-based techniques
have been used for decades in a clinic-based application for such minimally or easily-reduced
fractures.) The devices will allow stabilizing forces to the dental occlusion, achieving a
similar function to temporary steel wire techniques ("arch bars"). This will allow the
surgeon/principal investigator to treat the fractures with standard techniques such as
applying titanium plates applied to the bone with titanium screws (known as "open reduction
with internal fixation") or with sustained immobilization for 1-6 weeks (known as "closed
reduction"). Note the devices are approved for 3 weeks duration. If treatment requires more
than 3 weeks of immobilization, the devices will be removed and new devices re-applied. The
experimental devices will be used solely as a replacement for wire-based techniques to
achieve an immobile, stable jaw. If for any reason the required forces needed for jaw
fracture stabilization are deemed inadequate with the experimental devices, standard steel
wire techniques will be employed.
Description:
Background: Mandible fractures are the second most common facial fractures behind nasal
fractures. Like other fractures in the body, immobilization of the fractured segments is
required for healing. For various fractures, immobilization can be achieved through casts,
surgically-implanted hardware (plates, rods, screws), and other methods. Jaw fractures
(mandible and maxilla) benefit from their unique connection to dentition. As the teeth are
rigidly connected to the mandible and maxilla, jaw fractures can be immobilized by
immobilizing the teeth in anatomic orientation. Placing the teeth in anatomic orientation
(known as "dental occlusion") ensures that the cusps and the facets of the teeth fit
appropriately as the fracture heals. The process of achieving this positioning is referred to
as maxillo-mandibular fixation. The current leading technology to achieve maxillo-mandibular
fixation (MMF) is "jaw wiring," commonly referred to as "arch bars" by facial trauma
surgeons. Arch bars have been a standard of care for decades and almost invariably require
application under general anesthetic for patient tolerance. Alternative variations of jaw
wiring include Ivy loops, Ernst ligatures, and screw fixation approaches - all of which have
achieved minimal adoption because of significant drawbacks. Wire-based MMF techniques
commonly use 24 gauge stainless steel wires. The alternative wiring techniques (i.e., Ivy
loops, Ernst ligatures) offer speed of application, but still require considerable
manipulation by the surgeon in an operating room to apply them to the patient. The screw
fixation techniques pose risks to tooth roots and to the gingiva (gums) and have also shown
very limited clinician adoption.
All of these techniques, including the more widely adopted arch bars, induce considerable
trauma to the gums and mucosa of the patient, causing considerable pain. Also, as these
techniques are applied in the operating room under general anesthesia, the techniques incur
considerable cost due to the time-consuming nature of these techniques. Further, the metal
wires used in these techniques can be rigid and pointed, placing the surgical team at risk
for sharps injuries.
Thus, there is a need for improved devices, systems and methods for achieving
maxillo-mandibular fixation in a manner that can minimize patient discomfort, avoid the
intensive labor and financial demands of such approaches, and provide a safer application for
the surgical team.
This observational clinical trial aims to assess the 1) efficacy of treating mandible/maxilla
fractures, 2) efficiency of application, 3) tissue trauma characteristics of a novel new
cable tie-like device system used to replace wire-based techniques of maxillo-mandibular
fixation, 4) the potential for these devices to be successfully applied in a clinic setting,
5) the post-treatment course for patients treated with prolonged stabilization (typically 1-6
weeks of maxillo-mandibular fixation), 6) patient's experience while wearing dental occlusion
ties, and 7) the surgeon's experience with and impression of these new devices.
Study Design:
This study is a prospective, non-controlled clinical trial designed to obtain initial
clinical data to further establish:
1. the clinical indications for the technology
2. appropriate sites of application for the technology (operating room and/or clinical
setting)
3. clinician and patient experience during application and treatment with the devices, and
4. initial outcomes data.
Objective data such as operating room times, fracture patterns, and length of treatment will
be recorded on three study forms (1. Treatment application data collection form, 2. Patient
data collection form, and 3. Post-treatment data collection form). These forms also solicit
subjective, unprompted data that can assist in collecting insights from the patients and the
study surgeons that may not otherwise have been anticipated. Prior experiments including
bench testing, cadaver testing, and a small feasibility trial have been completed in
anticipation of this study.
Human subject participation:
Human subjects will be recruited through already existing referral patterns for patient care.
Patients sustaining mandible or maxilla fractures and seeking care at Altru Health System may
participate.
Inclusion criteria include: patients sustaining any form of mandible or maxilla fracture.
Exclusion criteria include:
1. patients with inadequate dentition (ie an edentulous patient),
2. patients under 12 years of age,
3. patients with comminuted mandible and/or maxilla fractures requiring advanced trauma
techniques,
4. patients unable to consent due to intoxication, mental illness, or unconscious state,
and
5. patients who are pregnant.
Data collection:
Data will be collected from the treating surgeon using the Treatment Application Data
Collection Form and the Post-treatment Data Collection Form. Data will be collected from the
patient using the Patient Data Collection Form. These three forms are intended to be a
concise way to obtain specific data and sentiments about the patient's and surgeon's
experience with the device/system. Additional data such as CT scan information will be
obtained from the patient's medical record.
The output of this study will be a prospective case series manuscript describing the use of
minimally invasive maxillo-mandibular fixation ties. As such, standard clinical data such as
CT reports, clinical histories, and operating room times will be assessed and described in
the future manuscript. This data will be stored in the standard clinical electronic medical
record (EPIC). The patient's electronic medical records will be accessed subsequently for
data compilation, but when this data is obtained any PHI will be immediately de-identified
and linked to a patient-specific letter code (for example, patient A). The de-coding list
will be kept as a hard copy stored in a physically locked cabinet in the principal
investigator's office. Any paper ("hard copy") data will have the patient's name and other
identifiable data replaced with this unique letter-specific identifier. All hard copy data
will be shredded at the end of the study. All pictures will be electronically stored in the
patient's electronic medical record, through standard electronic medical record and operating
room processes. Photographs, CT images, and other electronic files (ie an MRI image) for
future manuscript and presentation publication will be stored on a single password-protected
USB "thumb" drive in the locked cabinet. Any pictures used in future manuscripts or
presentations or posters will show patient dentition but a minimal view of the patient's face
- for example approximately the lower one third of the face. This could include the upper
aspects of the chin and of the nostrils of the nose, but no other anatomic features beyond
these anatomic landmarks. Patients will have consented to this level of photography prior to
any involvement in the study.
