Mandibular FracturesOmniMaxNCT03075865
A Cohort Study for Clinical Evaluation of OmniMax MMF System
An observational study of Mandibular Fractures, run by Zimmer Biomet at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- OmniMax MMF system
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 39 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Jun 2017to 28 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults involved in trauma events resulting in uncomplicated mandibular fractures and needing intermaxillary fixation for fracture repair and fracture healing.
Who may be able to join
- 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).
Who cannot join
- 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).
Show all 11Show fewer
- 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).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
College of Dental Medicine
Charleston, South Carolina, 29425
University of Iowa
Iowa City, Iowa, 52242
University of California Davis Medical Center
Sacramento, California, 95817
About this study
Official title: The OmniMax MMF System: A Cohort Study for Clinical Evaluation
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.
Read the 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.
- Conditions
- Mandibular Fractures
- Being tested
- OmniMax MMF system
- Keywords
- intermaxillary fixation, maxillo-mandibular fixation
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmniMax MMF systemDevice
Also called OmniMax
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: OmniMax MMF system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (2)
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.
Measured: Operative
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start28 Jun 2017
- Primary completion10 Jan 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Mandibular FracturesStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Iowa, Medical University of South Carolina, University of California, Davis
- Responsible party
- Sponsor
- Investigators
- Brian M Hatcher, PhD, Study director, Zimmer Biomet CMF & Thoracic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075865
- Sponsor's protocol ID
- 1116
- Acronym
- OmniMax
- Status last verified
- Jul 2021
- First submitted
- 3 Mar 2017
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 21035935Ansari 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.
PubMed 21768561Sahoo 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.
PubMed 22190780Cornelius 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.
PubMed 22110819Roccia 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.
PubMed 19164992Bagheri 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.
PubMed 18423287Gaujac 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.
PubMed 17884516Coletti 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.
PubMed 17719392Fabbroni 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.
PubMed 15183406Ayoub 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.
PubMed 12818601Vartanian 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.
PubMed 11112964Valentino 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.
PubMed 7838541Hashemi 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.
PubMed 21216063Nandini 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.
PubMed 22654363Rai 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.
PubMed 21470746
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The OmniMax MMF System: A Cohort Study for Clinical Evaluation
- ClinicalTrials.gov ID
- NCT03075865
- Acronym / sponsor ID
- OmniMax / 1116
- Conditions
- Mandibular Fractures
- Keywords
- intermaxillary fixation, maxillo-mandibular fixation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- University of Iowa, Medical University of South Carolina, University of California, Davis
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OmniMax MMF | – | Device: OmniMax MMF systemPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults involved in trauma events resulting in uncomplicated mandibular fractures and needing intermaxillary fixation for fracture repair and fracture healing.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmniMax MMF systemAlso: OmniMaxOmniMax 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. | Device | OmniMax MMF |
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
2 secondary outcomes
Time for Implantation of OmniMax MMF
Time frame: Operative
Tissue necrosis and mucosal overgrowth
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Background: PubMed 21035935Engelstad 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.
- Background: PubMed 21768561Ansari 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.
- Background: PubMed 22190780Sahoo 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.
- Background: PubMed 22110819Cornelius 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.
- Background: PubMed 19164992Roccia 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.
- Background: PubMed 18423287Bagheri 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.
- Background: PubMed 17884516Gaujac 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.
- Background: PubMed 17719392Coletti 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.
- Background: PubMed 15183406Fabbroni 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.
- Background: PubMed 12818601Ayoub 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.
- Background: PubMed 11112964Vartanian 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.
- Background: PubMed 7838541Valentino 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian M Hatcher, PhD study director
Zimmer Biomet CMF & Thoracic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mandibular Fractures, run by Zimmer Biomet at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root Damage (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03075865, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.