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.

Minimally Invasive Dental Occlusion Ties

Jaw Fractures

Jaw; Fracture, Upper Jaw

Mandibular Fractures

Maxilla Fracture

Jaw Fixation

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.

dental occlusion ties maxillo-mandibular fixation

Minimally Invasive Dental Occlusion Ties Clinical Trial

Patients will be assessed after treatment with a CT scan to assess if the fracture has been reduced or not (This is a binary variable as stated by the radiologist reading the study).

Patients will be evaluated in clinic for post-operative healing. Those discharged from clinic without a need for hardware removal or revision surgery will be considered healed. (This is a binary variable - healed vs not-healed.)

Chair of Otolaryngology, Principal Investigator

The number of dental occlusion ties applied will be recorded on the surgeon post-operative data collection form.

The operative time recorded in minutes from case start to case end.

Minimally Invasive Dental Occlusion Ties

About this trial

Study ID

Status

Type

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status