CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
OmniMax MMF systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03075865
NCT03075865N/ACompleted
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The OmniMax MMF System: A Cohort Study for Clinical Evaluation

Zimmer Biomet·observational·Posted Mar 9, 2017·Updated Jul 19, 2021

In Brief

An observational study evaluating OmniMax MMF system for Mandibular Fractures. Completed, enrolled 39 participants across 3 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMandibular Fractures
CountriesUnited States
CollaboratorsUniversity of Iowa, Medical University of South Carolina, University of California, Davis

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 9, 2017
Enrollment StartJun 28, 2017
Primary CompletionJan 10, 2019
Study CompletionJun 28, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.3 years ago

Interventions

OmniMax MMF systemdevice

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.