Mandibular Fractures
Conditions
Brief summary
The purpose of this trial is to compare operating room time between conventional treatment techniques \[without Virtual surgical Planning (VSP)\] versus treatment with use of Virtual surgical Planning (VSP) in patients that undergo mandibular reconstruction via open reduction internal fixation (ORIF).
Interventions
DEVICEControl group without use of VSP
The control group will include patients that undergo mandibular reconstruction via open reduction internal fixation (intraoral or extraoral approach) in standard fashion (without virtual surgical planning assistance and occlusal splint)
DEVICETreatment Group with use of VSP
The treatment group corresponds to patients undergoing mandibular reconstruction via open reduction internal fixation (intraoral or extraoral approach) utilizing virtual surgical planning via 3D Systems, bite registration and fabrication of occlusal splint via intraoral digital scanner, and mandibular hardware
Sponsors
Stryker Instruments
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient consent * Complex mandible fracture (at least two fractures) that require ORIF of at least one fracture. This will exclude condylar fractures
Exclusion criteria
* Patient refusal to participate in study * Infected mandible fracture * Closed reduction treatment of mandible fracture * Fractures older than 2-3 weeks at the time of treatment * Other concomitant mid-facial bone fractures (ie, zygomaticomaxillary complex (ZMC), Lefort fractures) * Other etiologies than trauma of the mandibular fracture or pathologic fracture secondary to benign or malignant pathology that may require resection * Pregnant patients will NOT be excluded from the study * Co-morbidities (auto-immune disease, osteoporosis, titanium or metal allergy, uncontrolled diabetes (A1c greater than 8)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Time Taken to Complete an Open Reduction Internal Fixation (ORIF) | from start of ORIF to end of ORIF (about 2-3 hours) | The time taken to complete an Open Reduction Internal Fixation (ORIF) \[referred to as the plating time\] was defined as beginning after dissection was complete and fractures were initially reduced, and ending after all fracture sites were fixated with the final screw placed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Fractures That Are Not Well Aligned | 1 week after ORIF | — |
| Number of Participants With Infections | 1 week after ORIF | — |
| Type of Archbars Used in ORIF | from start of ORIF to end of ORIF (about 2-3 hours) | Archbars are used for fixating jaws during the treatment of mandible fractures. Archbars are anchored onto both jaws (that is, onto the maxillar/upper jaw, and onto the mandibular/lower jaw); therefore, each participant receives 2 arch bars, one for each jaw. Data are reported categorically as the type of arch bar received for a jaw. |
| Number of Participants Whose Occlusal Splint Fit Appropriately | from start of ORIF to end of ORIF (about 2-3 hours) | — |
| Number of Participants With Malocclusion | 1 week after ORIF | — |
| Number of Participants Who Required Intraoperative Surgical Revisions | from start of ORIF to end of ORIF (about 2-3 hours) | — |
| Distance of Maximal Interincisal Opening | 6 weeks after ORIF | Maximal interincisal opening is the maximum distance a person can open their mouth between their upper and lower incisors measured in millimeters. |
| Number of Participants With Hardware Failure | from baseline to 6 weeks after ORIF | Number of Participants with hardware failure as defined as plate fracture or screw loosening |
| Type of Surgical Approach to the Fracture Site | from start of ORIF to end of ORIF (about 2-3 hours) | The type of surgical approach to the fracture site is reported categorically as either extraoral or intraoral. This is counted based on each fracture approached surgically (a participant may have more than 1 approach if they had more than 1 fracture site). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Control group without use of VSP: The control group will include patients that undergo mandibular reconstruction via open reduction internal fixation (intraoral or extraoral approach) in standard fashion (without virtual surgical planning assistance and occlusal splint) | 9 |
| Treatment Group Treatment Group with use of VSP: The treatment group corresponds to patients undergoing mandibular reconstruction via open reduction internal fixation (intraoral or extraoral approach) utilizing virtual surgical planning via 3D Systems, bite registration and fabrication of occlusal splint via intraoral digital scanner, and mandibular hardware | 7 |
| Total | 16 |
Baseline characteristics
| Characteristic | Treatment Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 26.7 years STANDARD_DEVIATION 8.5 | 30.75 years STANDARD_DEVIATION 10.83 | 33.9 years STANDARD_DEVIATION 12.3 |
| Mandible Fracture Severity as Assessed by the Mandible Injury Severity Score | 18.3 score on a scale STANDARD_DEVIATION 8 | 16.8 score on a scale STANDARD_DEVIATION 8.8 | 15.7 score on a scale STANDARD_DEVIATION 9.4 |
| Number of Mandible Fractures | 2.13 fractures STANDARD_DEVIATION 0.38 | 2.24 fractures STANDARD_DEVIATION 0.45 | 2.33 fractures STANDARD_DEVIATION 0.5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 7 participants | 16 participants | 9 participants |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 13 |
| other Total, other adverse events | 2 / 15 | 0 / 13 |
| serious Total, serious adverse events | 1 / 15 | 1 / 13 |
Outcome results
Primary
The Time Taken to Complete an Open Reduction Internal Fixation (ORIF)
The time taken to complete an Open Reduction Internal Fixation (ORIF) \[referred to as the plating time\] was defined as beginning after dissection was complete and fractures were initially reduced, and ending after all fracture sites were fixated with the final screw placed.
Time frame: from start of ORIF to end of ORIF (about 2-3 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | The Time Taken to Complete an Open Reduction Internal Fixation (ORIF) | 54.6 minutes | Standard Deviation 28.9 |
| Treatment Group | The Time Taken to Complete an Open Reduction Internal Fixation (ORIF) | 34 minutes | Standard Deviation 12.5 |
Secondary
Distance of Maximal Interincisal Opening
Maximal interincisal opening is the maximum distance a person can open their mouth between their upper and lower incisors measured in millimeters.
Time frame: 6 weeks after ORIF
Population: Data were not collected for 4 participants in the control group. Data were not collected for 3 participants in the treatment group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Distance of Maximal Interincisal Opening | 34.6 millimeters | Standard Deviation 8.16 |
| Treatment Group | Distance of Maximal Interincisal Opening | 31.8 millimeters | Standard Deviation 6.83 |
Secondary
Number of Participants Who Required Intraoperative Surgical Revisions
Time frame: from start of ORIF to end of ORIF (about 2-3 hours)
Population: Data were not collected for 9 participants in the control group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Number of Participants Who Required Intraoperative Surgical Revisions | 0 Participants |
Secondary
Number of Participants Whose Occlusal Splint Fit Appropriately
Time frame: from start of ORIF to end of ORIF (about 2-3 hours)
Population: Data were not collected for 9 participants in the control group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants Whose Occlusal Splint Fit Appropriately | 7 Participants |
Secondary
Number of Participants With Fractures That Are Not Well Aligned
Time frame: 3 weeks after ORIF
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants With Fractures That Are Not Well Aligned | 0 Participants |
| Treatment Group | Number of Participants With Fractures That Are Not Well Aligned | 0 Participants |
Secondary
Number of Participants With Fractures That Are Not Well Aligned
Time frame: 1 week after ORIF
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants With Fractures That Are Not Well Aligned | 0 Participants |
| Treatment Group | Number of Participants With Fractures That Are Not Well Aligned | 0 Participants |
Secondary
Number of Participants With Fractures That Are Not Well Aligned
Time frame: 6 weeks after ORIF
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants With Fractures That Are Not Well Aligned | 0 Participants |
| Treatment Group | Number of Participants With Fractures That Are Not Well Aligned | 0 Participants |
Secondary
Number of Participants With Hardware Failure
Number of Participants with hardware failure as defined as plate fracture or screw loosening
Time frame: from baseline to 6 weeks after ORIF
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants With Hardware Failure | 0 Participants |
| Treatment Group | Number of Participants With Hardware Failure | 0 Participants |
Secondary
Number of Participants With Infections
Time frame: 3 weeks after ORIF
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants With Infections | 0 Participants |
| Treatment Group | Number of Participants With Infections | 0 Participants |
Secondary
Number of Participants With Infections
Time frame: 1 week after ORIF
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants With Infections | 1 Participants |
| Treatment Group | Number of Participants With Infections | 1 Participants |
Secondary
Number of Participants With Infections
Time frame: 6 weeks after ORIF
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants With Infections | 0 Participants |
| Treatment Group | Number of Participants With Infections | 0 Participants |
Secondary
Number of Participants With Malocclusion
Time frame: 3 weeks after ORIF
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants With Malocclusion | 1 Participants |
| Treatment Group | Number of Participants With Malocclusion | 0 Participants |
Secondary
Number of Participants With Malocclusion
Time frame: 1 week after ORIF
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants With Malocclusion | 0 Participants |
| Treatment Group | Number of Participants With Malocclusion | 0 Participants |
Secondary
Number of Participants With Malocclusion
Time frame: 6 weeks after ORIF
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants With Malocclusion | 2 Participants |
| Treatment Group | Number of Participants With Malocclusion | 0 Participants |
Secondary
Type of Archbars Used in ORIF
Archbars are used for fixating jaws during the treatment of mandible fractures. Archbars are anchored onto both jaws (that is, onto the maxillar/upper jaw, and onto the mandibular/lower jaw); therefore, each participant receives 2 arch bars, one for each jaw. Data are reported categorically as the type of arch bar received for a jaw.
Time frame: from start of ORIF to end of ORIF (about 2-3 hours)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Type of Archbars Used in ORIF | Erich | 10 archbars |
| Control Group | Type of Archbars Used in ORIF | Ivy Loops | 0 archbars |
| Control Group | Type of Archbars Used in ORIF | Synthes MatrixWAVE | 4 archbars |
| Control Group | Type of Archbars Used in ORIF | Stryker SMARTLock Hybrid | 0 archbars |
| Control Group | Type of Archbars Used in ORIF | Biomet Omnimax | 2 archbars |
| Control Group | Type of Archbars Used in ORIF | None | 2 archbars |
| Treatment Group | Type of Archbars Used in ORIF | Stryker SMARTLock Hybrid | 2 archbars |
| Treatment Group | Type of Archbars Used in ORIF | None | 0 archbars |
| Treatment Group | Type of Archbars Used in ORIF | Biomet Omnimax | 0 archbars |
| Treatment Group | Type of Archbars Used in ORIF | Synthes MatrixWAVE | 1 archbars |
| Treatment Group | Type of Archbars Used in ORIF | Ivy Loops | 2 archbars |
| Treatment Group | Type of Archbars Used in ORIF | Erich | 9 archbars |
Secondary
Type of Surgical Approach to the Fracture Site
The type of surgical approach to the fracture site is reported categorically as either extraoral or intraoral. This is counted based on each fracture approached surgically (a participant may have more than 1 approach if they had more than 1 fracture site).
Time frame: from start of ORIF to end of ORIF (about 2-3 hours)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Type of Surgical Approach to the Fracture Site | Intraoral | 7 specified approaches |
| Control Group | Type of Surgical Approach to the Fracture Site | Extraoral | 7 specified approaches |
| Treatment Group | Type of Surgical Approach to the Fracture Site | Intraoral | 5 specified approaches |
| Treatment Group | Type of Surgical Approach to the Fracture Site | Extraoral | 7 specified approaches |