A Cohort Study for Clinical Evaluation of OmniMax MMF System

Completed

Conditions studied: Mandibular Fractures

In brief

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.

Key facts

Study ID

NCT03075865

Run by

Zimmer Biomet

People needed

39

Starts

2017-06-28

Expected to finish

2019-06-28

Last updated by the study team

2021-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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).

Where it is running

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

Full record on ClinicalTrials.gov

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