A Cohort Study for Clinical Evaluation of OmniMax MMF System

Mandibular Fractures Clinical Trial

— OmniMax  

Official title:

The OmniMax MMF System: A Cohort Study for Clinical Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075865
• Other study ID #: 1116
• Status: Completed
• Start date: June 28, 2017
• Est. completion date: June 28, 2019

Study information

• Verified date: July 2021
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 28, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Mandibular Fractures

Intervention

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.

Locations

Country	Name	City	State
United States	College of Dental Medicine	Charleston	South Carolina
United States	University of Iowa	Iowa City	Iowa
United States	University of California Davis Medical Center	Sacramento	California

Sponsors (4)

Lead Sponsor	Collaborator
Zimmer Biomet	Medical University of South Carolina, University of California, Davis, University of Iowa

Country where clinical trial is conducted

United States, 

References & Publications (22)

Ansari K, Hamlar D, Ho V, Hilger P, Côté D, Aziz T. A comparison of anterior vs posterior isolated mandible fractures treated with intermaxillary fixation screws. Arch Facial Plast Surg. 2011 Jul-Aug;13(4):266-70. doi: 10.1001/archfacial.2011.46. — View Citation

Ayoub AF, Rowson J. Comparative assessment of two methods used for interdental immobilization. J Craniomaxillofac Surg. 2003 Jun;31(3):159-61. — View Citation

Bagheri SC, Dimassi M, Shahriari A, Khan HA, Jo C, Steed MB. Facial trauma coverage among level-1 trauma centers of the United States. J Oral Maxillofac Surg. 2008 May;66(5):963-7. doi: 10.1016/j.joms.2008.01.020. — View Citation

Chao AH, Hulsen J. Bone-supported arch bars are associated with comparable outcomes to Erich arch bars in the treatment of mandibular fractures with intermaxillary fixation. J Oral Maxillofac Surg. 2015 Feb;73(2):306-13. doi: 10.1016/j.joms.2014.08.025. Epub 2014 Aug 27. — View Citation

Coletti DP, Salama A, Caccamese JF Jr. Application of intermaxillary fixation screws in maxillofacial trauma. J Oral Maxillofac Surg. 2007 Sep;65(9):1746-50. — View Citation

Cornelius CP, Ehrenfeld M. The Use of MMF Screws: Surgical Technique, Indications, Contraindications, and Common Problems in Review of the Literature. Craniomaxillofac Trauma Reconstr. 2010 Jun;3(2):55-80. doi: 10.1055/s-0030-1254376. — View Citation

Engelstad ME, Kelly P. Embrasure wires for intraoperative maxillomandibular fixation are rapid and effective. J Oral Maxillofac Surg. 2011 Jan;69(1):120-4. doi: 10.1016/j.joms.2010.06.209. Epub 2010 Oct 29. — View Citation

Fabbroni G, Aabed S, Mizen K, Starr DG. Transalveolar screws and the incidence of dental damage: a prospective study. Int J Oral Maxillofac Surg. 2004 Jul;33(5):442-6. — View Citation

Gaujac C, Ceccheti MM, Yonezaki F, Garcia IR Jr, Peres MP. Comparative analysis of 2 techniques of double-gloving protection during arch bar placement for intermaxillary fixation. J Oral Maxillofac Surg. 2007 Oct;65(10):1922-5. — View Citation

Hashemi HM, Parhiz A. Complications using intermaxillary fixation screws. J Oral Maxillofac Surg. 2011 May;69(5):1411-4. doi: 10.1016/j.joms.2010.05.070. Epub 2011 Jan 8. — View Citation

Ingole PD, Garg A, Shenoi SR, Badjate SJ, Budhraja N. Comparison of intermaxillary fixation screw versus eyelet interdental wiring for intermaxillary fixation in minimally displaced mandibular fracture: a randomized clinical study. J Oral Maxillofac Surg. 2014 May;72(5):958.e1-7. doi: 10.1016/j.joms.2014.01.005. Epub 2014 Jan 18. — View Citation

Laurentjoye M, Majoufre-Lefebvre C, Siberchicot F, Ricard AS. Result of maxillomandibular fixation using intraoral cortical bone screws for condylar fractures of the mandible. J Oral Maxillofac Surg. 2009 Apr;67(4):767-70. doi: 10.1016/j.joms.2008.06.055. — View Citation

Meursinge Reynders R, Ladu L, Ronchi L, Di Girolamo N, de Lange J, Roberts N, Plüddemann A. Insertion torque recordings for the diagnosis of contact between orthodontic mini-implants and dental roots: protocol for a systematic review. Syst Rev. 2015 Apr 2;4:39. doi: 10.1186/s13643-015-0014-6. — View Citation

Nandini GD, Balakrishna R, Rao J. Self Tapping Screws v/s Erich Arch Bar for Inter Maxillary Fixation: A Comparative Clinical Study in the Treatment of Mandibular Fractures. J Maxillofac Oral Surg. 2011 Jun;10(2):127-31. doi: 10.1007/s12663-011-0191-3. Epub 2011 Apr 20. — View Citation

Park KN, Oh SM, Lee CY, Kim JY, Yang BE. Design and application of hybrid maxillomandibular fixation for facial bone fractures. J Craniofac Surg. 2013;24(5):1801-5. doi: 10.1097/SCS.0b013e3182a21163. — View Citation

Rai A, Datarkar A, Borle RM. Are maxillomandibular fixation screws a better option than Erich arch bars in achieving maxillomandibular fixation? A randomized clinical study. J Oral Maxillofac Surg. 2011 Dec;69(12):3015-8. doi: 10.1016/j.joms.2010.12.015. Epub 2011 Apr 5. — View Citation

Roccia F, Rossi P, Gallesio C, Boffano P. Self-tapping and self-drilling screws for intermaxillary fixation in management of mandibular fractures. J Craniofac Surg. 2009 Jan;20(1):68-70. doi: 10.1097/SCS.0b013e318190df2f. — View Citation

Sahoo NK, Mohan R. IMF Screw: An Ideal Intermaxillary Fixation Device During Open Reduction of Mandibular Fracture. J Maxillofac Oral Surg. 2010 Jun;9(2):170-2. doi: 10.1007/s12663-010-0049-0. Epub 2010 Sep 22. — View Citation

Schulte-Geers M, Kater W, Seeberger R. Root trauma and tooth loss through the application of pre-drilled transgingival fixation screws. J Craniomaxillofac Surg. 2012 Oct;40(7):e214-7. doi: 10.1016/j.jcms.2011.10.022. Epub 2011 Nov 17. — View Citation

Valentino J, Marentette LJ. Supplemental maxillomandibular fixation with miniplate osteosynthesis. Otolaryngol Head Neck Surg. 1995 Feb;112(2):215-20. — View Citation

Vartanian AJ, Alvi A. Bone-screw mandible fixation: an intraoperative alternative to arch bars. Otolaryngol Head Neck Surg. 2000 Dec;123(6):718-21. — View Citation

West GH, Griggs JA, Chandran R, Precheur HV, Buchanan W, Caloss R. Treatment outcomes with the use of maxillomandibular fixation screws in the management of mandible fractures. J Oral Maxillofac Surg. 2014 Jan;72(1):112-20. doi: 10.1016/j.joms.2013.08.001. Epub 2013 Sep 25. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Satisfaction	Less screws for fixation and design of the device to protect the soft tissue is expected to increase the level of patient satisfaction and patient compliance with both, the oral hygiene and the length of fixation period.	6 weeks
Other	Gloves Perforation and Accidental Puncture	Design of OmniMax MMF system is expected to reduce the risk for accidental glove perforation and/or wire puncture during implantation of the device.	Operative
Primary	Root Damage	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	6 weeks
Secondary	Time for Implantation of OmniMax MMF	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.	Operative
Secondary	Tissue necrosis and mucosal overgrowth	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.	6 weeks