Clinical Trial: A Cohort Study for Clinical Evaluation of OmniMax MMF System

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: The OmniMax MMF System: A Cohort Study for Clinical Evaluation

Brief 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.

Detailed Summary: 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.
Sponsor: Zimmer Biomet

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Zimmer Biomet

Dates:
Date Received: March 3, 2017
Date Started: May 1, 2017
Date Completion: December 31, 2017
Last Updated: March 3, 2017
Last Verified: February 2017