A Cohort Study for Clinical Evaluation of OmniMax MMF System

Completed

• Conditions: Mandibular Fractures
• Interventions: Device: OmniMax MMF system

• Registration Number: NCT03075865
• Lead Sponsor: Zimmer Biomet

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 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 Timeline

• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-09
• Study Start: 2017-06-28
• Primary Completion: 2019-01-10
• Study Completion: 2019-06-28
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-16
• Last Update Posted: 2021-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OmniMax MMF	OmniMax MMF system	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.

Primary Outcome Measures

Name	Time	Method
Root Damage	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

Secondary Outcome Measures

Name	Time	Method
Time for Implantation of OmniMax MMF	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	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.

Trial Locations

Locations (3)

College of Dental Medicine; 🇺🇸 Charleston, South Carolina, United States

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States