A Cohort Study for Clinical Evaluation of OmniMax MMF System

NCT03075865 | Completed FDA Device

• 1 other identifier: 1116
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 3

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.

Conditions

Mandibular Fractures

Keywords

intermaxillary fixation; maxillo-mandibular fixation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time for Implantation of OmniMax MMF

  Operative

• Tissue necrosis and mucosal overgrowth

  6 weeks

Other Outcomes (2)

• Patient Satisfaction

  6 weeks

• Gloves Perforation and Accidental Puncture

  Operative

Study Arms (1)

OmniMax MMF

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.

Device: OmniMax MMF system

Interventions

OmniMax MMF system DEVICE

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.

Also known as: OmniMax

OmniMax MMF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults involved in trauma events resulting in uncomplicated mandibular fractures and needing intermaxillary fixation for fracture repair and fracture healing.

You may qualify if:

• Males or females
• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Zimmer Biomet: lead
• University of Iowa: collaborator
• Medical University of South Carolina: collaborator
• University of California, Davis: collaborator

Study Sites (3)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

College of Dental Medicine

Charleston, South Carolina, 29425, United States

Location

Related Publications (22)

• 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.

  PMID: 21035935 BACKGROUND

• Ansari K, Hamlar D, Ho V, Hilger P, Cote 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.

  PMID: 21768561 BACKGROUND

• 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.

  PMID: 22190780 BACKGROUND

• 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.

  PMID: 22110819 BACKGROUND

• 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.

  PMID: 19164992 BACKGROUND

• 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.

  PMID: 18423287 BACKGROUND

• 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. doi: 10.1016/j.joms.2006.06.311.

  PMID: 17884516 BACKGROUND

• 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. doi: 10.1016/j.joms.2007.04.022.

  PMID: 17719392 BACKGROUND

• 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. doi: 10.1016/j.ijom.2003.10.014.

  PMID: 15183406 BACKGROUND

• Ayoub AF, Rowson J. Comparative assessment of two methods used for interdental immobilization. J Craniomaxillofac Surg. 2003 Jun;31(3):159-61. doi: 10.1016/s1010-5182(03)00022-2.

  PMID: 12818601 BACKGROUND

• Vartanian AJ, Alvi A. Bone-screw mandible fixation: an intraoperative alternative to arch bars. Otolaryngol Head Neck Surg. 2000 Dec;123(6):718-21. doi: 10.1067/mhn.2000.111286.

  PMID: 11112964 BACKGROUND

• Valentino J, Marentette LJ. Supplemental maxillomandibular fixation with miniplate osteosynthesis. Otolaryngol Head Neck Surg. 1995 Feb;112(2):215-20. doi: 10.1016/S0194-59989570239-3.

  PMID: 7838541 BACKGROUND

• 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.

  PMID: 21216063 BACKGROUND

• 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.

  PMID: 22654363 BACKGROUND

• 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.

  PMID: 21470746 BACKGROUND

• 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.

  PMID: 22099624 BACKGROUND

• 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.

  PMID: 24036784 BACKGROUND

• 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.

  PMID: 25488313 BACKGROUND

• 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.

  PMID: 24642133 BACKGROUND

• 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.

  PMID: 24075236 BACKGROUND

• Meursinge Reynders R, Ladu L, Ronchi L, Di Girolamo N, de Lange J, Roberts N, Pluddemann 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.

  PMID: 25875916 BACKGROUND

• 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.

  PMID: 19304032 BACKGROUND

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Officials

• Brian M Hatcher, PhD

  Zimmer Biomet CMF & Thoracic

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 9, 2017
• Study Start: June 28, 2017
• Primary Completion: January 10, 2019
• Study Completion: June 28, 2019
• Last Updated: July 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)