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A Cohort Study for Clinical Evaluation of OmniMax MMF System

NCT03075865 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 39

Last updated 2021-07-19

No results posted yet for this study

Summary

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.

Conditions

  • Mandibular Fractures

Interventions

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.

Sponsors & Collaborators

  • University of Iowa

    collaborator OTHER

  • Medical University of South Carolina

    collaborator OTHER

  • University of California, Davis

    collaborator OTHER

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Brian M Hatcher, PhD · Zimmer Biomet CMF & Thoracic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-28
Primary Completion
2019-01-10
Completion
2019-06-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03075865 on ClinicalTrials.gov