A Cohort Study for Clinical Evaluation of OmniMax MMF System (OmniMax)

July 16, 2021 updated by: Zimmer Biomet

The OmniMax MMF System: A Cohort Study for Clinical Evaluation

OmniMax MMF system was designed as a device with faster application/removal time, less mucosal tissue overgrowth over the plates and screws, better tolerance for placement over prolong periods of time, better patient hygiene and a lower risk for further treatments secondary to root damage from the insertion of the screws, compared to the standard of care for maxillo-mandibular fixation and other hybrid systems. This clinical trial intends to highlight the clinical benefits of the OmniMax MMF system applied to patients undergoing repair of uncomplicated mandibular fracture(s) for whom OmniMax MMF system is used as a single mean for maxillo-mandibular fixation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to highlight and evaluate the clinical benefits of OmniMax MMF system applied to patients undergoing repair of uncomplicated mandibular fracture(s). A total of 50 subjects involved in trauma events resulting in uncomplicated mandibular fracture(s) will be enrolled at up to 5 sites from 3 surgical subspecialties: maxillofacial surgery, ENT, and plastic surgery. Subjects considered for participation will receive OmniMax MMF system for maxillo-mandibular fixation for a period of 4 to 8 weeks. Incidence of root damage associated with screw insertion, time for implantation and removal of the device, oral hygiene during the maxillomandibular fixation period, mucosal overgrowth, gingival necrosis, post-operative pain, stability of the occlusion, fracture healing, patient overall satisfaction/compliance with length of treatment, incidence of glove perforation and accidental puncture, will be evaluated in all participants who remain in IMF post-operatively. Adverse Events associated with the use of OmniMax MMF system will also be collected.

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • College of Dental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults involved in trauma events resulting in uncomplicated mandibular fractures and needing intermaxillary fixation for fracture repair and fracture healing.

Description

Inclusion Criteria:

  • Males or females
  • 18 years of age or older
  • Able and willing to sign ICF and medical photography consent
  • Undergoing a surgical procedure to repair uncomplicated mandibular fracture(s) requiring open reduction internal fixation (ORIF) or closed maxillo-mandibular fixation (MMF)
  • Fracture repair done within 10 days after facial trauma
  • Use of OmniMax MMF system as a single mean for IMF (maxillary plate and mandibular plates together with no other device combined, such as Erich bars or IMF screws).

Exclusion Criteria:

  • General contraindications unfavorable for the use of MMF (psychological disorders, seizures disorders, airway compromise, immune-compromised patients, etc).
  • History of radiation therapy to the head or neck region.
  • Limited blood supply to the area of device application.
  • Insufficient quantity or quality of bone.
  • History of foreign body sensitivity.
  • History of previous use of bisphosphonates (i.e. alendronate, pamidronate, neridronate, olpadronate, ibandronate, risendronate, zolendronate).
  • Clinically active or latent infection.
  • Patients with less than 20 teeth.
  • Deciduous dentition.
  • Patients for whom the use of OmniMax MMF system would not be appropriate in judgment of the surgeon (i.e., excessive overjet or deep overbite).
  • Mandibular fracture pattern that could prevent the use of OmniMax MMF system for adequate reduction and stabilization (i.e., comminuted fractures, dental alveolar fractures).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OmniMax MMF
Patients involved in trauma events will receive intermaxillary fixation with OmniMax MMF system for temporary stabilization of mandibular fracture(s) to maintain proper occlusion during surgery and allow for postoperative fracture healing.
Device: OmniMax MMF system
OmniMax MMF system consists of arch bars and screws that work together to achieve temporary fixation of the maxilla and mandible to provide indirect or passive stabilization of fractures and maintenance of occlusion in the oral and maxillofacial region. The arch bars have hooks designed to accommodate either wires or elastic bands for temporary maxillomandibular fixation (MMF) either intraoperative or postoperative.
Other Names:
  • OmniMax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Root Damage
Time Frame: 6 weeks
Dental root damage can be caused from insertion of the screws at time of implantation. Some of these events may require further medical or surgical treatment
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time for Implantation of OmniMax MMF
Time Frame: Operative
The OmniMax MMF system, with a better segmentalized design and extended screw slots, allows for fixation of this device using less quantity of screws for fixation (compared to other hybrid systems). This system may impact the efficiency of the medical care by significantly reducing the operative time.
Operative
Tissue necrosis and mucosal overgrowth
Time Frame: 6 weeks
The reduced number of screws needed to fixate a full OmniMax MMF system (8 versus up to 14 in other bone-borne systems) is expected to improve the post-operative gingival tissue health, avoiding soft tissue irritation, overgrowth, compression and necrosis of the gingival area.
6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: 6 weeks
Less screws for fixation and design of the device to protect the soft tissue is expected to increase the level of patient satisfaction and patient compliance with both, the oral hygiene and the length of fixation period.
6 weeks
Gloves Perforation and Accidental Puncture
Time Frame: Operative
Design of OmniMax MMF system is expected to reduce the risk for accidental glove perforation and/or wire puncture during implantation of the device.
Operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Collaborators

Medical University of South Carolina
University of Iowa
University of California, Davis

Investigators

  • Study Director: Brian M Hatcher, PhD, Zimmer Biomet CMF & Thoracic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2017

Primary Completion (Actual)

January 10, 2019

Study Completion (Actual)

June 28, 2019

Study Registration Dates

First Submitted

March 3, 2017

First Submitted That Met QC Criteria

March 3, 2017

First Posted (Actual)

March 9, 2017

Study Record Updates

Last Update Posted (Actual)

July 19, 2021

Last Update Submitted That Met QC Criteria

July 16, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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