3D Printed Models for Mandibular Fracture Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3D Printed Model.
- Who it may be relevant to
- Registry conditions: Mandible Fracture, Maxillofacial Trauma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Determining the Ease of Utilizing 3D Printed Models to Aide in Isolated Mandibular Fracture Repair
Overview
The investigators will test the hypothesis that patients randomized to the intervention (3D printing with pre-bent plate) arm have less operative room time and less time for the critical part of the procedure than patients in the control arm (no 3D printing, current standards of care). Personalized medicine and care for fracture treatment.
Detailed description
The goal of treatment is to re-establish the patient's preinjury dental occlusion and facial harmony. Fractures that are nondisplaced and exhibit no occlusal changes may be amenable to nonsurgical management, but most mandible fractures will require stabilization for satisfactory healing and to restore pretraumatic maxillomandibular orientation. Various treatment strategies have been described and vary widely depending on the fracture location and surgeon's preference. The patient's demographics, comorbidities, dentition, and fracture characterization will all influence the choice of fixation by the treating surgeon.
There are very few randomized control trials that show outcomes when 3D printing is used for intervention planning and performing a procedure. These data are essential to establish value of 3D printing as a clinical service. There is also anecdotal evidence that a 3D printed model of a mandible fracture can be useful for pre-operative planning because the oral and maxillofacial surgeon can better assess the geometry of the bone lesions and can pre-bend fixation plates before the procedure. This hypothetically decreases the amount of time in the operating room.
The investigators propose a parallel design randomized control trial to study the value of 3D printing for preoperative planning in patients with a fracture of the mandible who require open reduction, internal fixation. The study will be split into two arms: 1) Patients that will have a 3D model generated for the surgical procedure 2) The control group who will follow normal standards of care as outlined above and won't have the additional 3D model created pre-operatively.
Interventions
- Device 3D Printed Model
3D Printed Model generated pre-operatively of the patients mandible.
Primary outcome measures
- Total time in the OR [Time frame: Total procedural time]
- Subjective outcome to surgeon [Time frame: Up to 2 days post-procedure]
Eligibility criteria
Inclusion criteria
Patient ≥ 18 years of age
- Patients who have received either a cone beam or conventional CT
- Admitted through University of Cincinnati Hospital and Medical Center emergency department
- All isolated mandible fractures referred to University of Cincinnati Hospital Oral \& maxillofacial surgery clinic
- Surgical team members from the division of plastic and otolaryngology
Exclusion criteria
- Patient < 18 years of age
- Patients who have neither cone beam nor conventional CT
- Patients requiring a repeat procedure
- Unexpected exposure of hardware
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- University of Cincinnati Medical Center — Cincinnati
- UC Health Holmes Hospital — Cincinnati
Publications
- Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24. PMID 18582931
- de Vries EN, Ramrattan MA, Smorenburg SM, Gouma DJ, Boermeester MA. The incidence and nature of in-hospital adverse events: a systematic review. Qual Saf Health Care. 2008 Jun;17(3):216-23. doi: 10.1136/qshc.2007.023622. PMID 18519629
- Visser A, Geboers B, Gouma DJ, Goslings JC, Ubbink DT. Predictors of surgical complications: A systematic review. Surgery. 2015 Jul;158(1):58-65. doi: 10.1016/j.surg.2015.01.012. Epub 2015 Feb 27. PMID 25731783
- Cheng H, Clymer JW, Po-Han Chen B, Sadeghirad B, Ferko NC, Cameron CG, Hinoul P. Prolonged operative duration is associated with complications: a systematic review and meta-analysis. J Surg Res. 2018 Sep;229:134-144. doi: 10.1016/j.jss.2018.03.022. Epub 2018 Apr 24. PMID 29936980
- Adi M, Ogden GR, Chisholm DM. An analysis of mandibular fractures in Dundee, Scotland (1977 to 1985). Br J Oral Maxillofac Surg. 1990 Jun;28(3):194-9. doi: 10.1016/0266-4356(90)90088-3. PMID 2135661
- Telfer MR, Jones GM, Shepherd JP. Trends in the aetiology of maxillofacial fractures in the United Kingdom (1977-1987). Br J Oral Maxillofac Surg. 1991 Aug;29(4):250-5. doi: 10.1016/0266-4356(91)90192-8. PMID 1911673
- Chrcanovic BR, Abreu MH, Freire-Maia B, Souza LN. 1,454 mandibular fractures: a 3-year study in a hospital in Belo Horizonte, Brazil. J Craniomaxillofac Surg. 2012 Feb;40(2):116-23. doi: 10.1016/j.jcms.2011.03.012. Epub 2011 Mar 31. PMID 21458284
- Pickrell BB, Serebrakian AT, Maricevich RS. Mandible Fractures. Semin Plast Surg. 2017 May;31(2):100-107. doi: 10.1055/s-0037-1601374. PMID 28496390
Identifiers
NCT: NCT05733221 · 2022-0794