Mandibular FracturesNCT04283981
Comparison of Operating Room Time Length With the Use of Virtual Surgical Planning Versus Conventional Treatment of Mandible Fractures
A study testing Treatment Group with use of VSP in people with Mandibular Fractures, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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). 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?
- Treatment Group with use of VSP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2021to 10 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patient consent
- Complex mandible fracture (at least two fractures) that require ORIF of at least one fracture. This will exclude condylar fractures
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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).
- Conditions
- Mandibular Fractures
- Being tested
- Control group without use of VSP, Treatment Group with use of VSP
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group without use of VSPDevice
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)
Treatment Group with use of VSPDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Not described Receives: Device: Control group without use of VSP |
| Treatment Group | Experimental | Not described Receives: Device: Treatment Group with use of VSP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from start of ORIF to end of ORIF (about 2-3 hours)
Secondary outcomes (15)
Number of Participants With Malocclusion
Measured: 1 week after ORIF
Number of Participants With Malocclusion
Measured: 3 weeks after ORIF
Number of Participants With Malocclusion
Measured: 6 weeks after ORIF
Number of Participants With Fractures That Are Not Well Aligned
Measured: 1 week after ORIF
Number of Participants With Fractures That Are Not Well Aligned
Measured: 3 weeks after ORIF
Number of Participants With Fractures That Are Not Well Aligned
Measured: 6 weeks after ORIF
Number of Participants With Infections
Measured: 1 week after ORIF
Number of Participants With Infections
Measured: 3 weeks after ORIF
Number of Participants With Infections
Measured: 6 weeks after ORIF
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.
Measured: from start of ORIF to end of ORIF (about 2-3 hours)
Number of Participants Whose Occlusal Splint Fit Appropriately
Measured: from start of ORIF to end of ORIF (about 2-3 hours)
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).
Measured: from start of ORIF to end of ORIF (about 2-3 hours)
Number of Participants Who Required Intraoperative Surgical Revisions
Measured: from start of ORIF to end of ORIF (about 2-3 hours)
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.
Measured: 6 weeks after ORIF
Number of Participants With Hardware Failure
Number of Participants with hardware failure as defined as plate fracture or screw loosening
Measured: from baseline to 6 weeks after ORIF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start24 Jan 2021
- Primary completion31 Oct 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mandibular FracturesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Instruments
- Responsible party
- Principal investigator, Simon Young, The University of Texas Health Science Center, Houston
- Investigators
- Timothy Woernley, DDS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283981
- Sponsor's protocol ID
- HSC-DB-19-1074
- Status last verified
- May 2024
- First submitted
- 19 Feb 2020
- Last updated
- 20 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Operating Room Time Length With the Use of Virtual Surgical Planning Versus Conventional Treatment of Mandible Fractures
- ClinicalTrials.gov ID
- NCT04283981
- Acronym / sponsor ID
- HSC-DB-19-1074
- Conditions
- Mandibular Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Stryker Instruments
- Study start
- 24 Jan 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 25 Feb 2020 (actual)
- Results
- Posted 20 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Device: Control group without use of VSP |
| Treatment Group | Experimental | Device: Treatment Group with use of VSP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient consent
- Complex mandible fracture (at least two fractures) that require ORIF of at least one fracture. This will exclude condylar fractures
Key exclusion criteria (8 listed)
- 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)
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 |
|---|---|---|
| Control group without use of VSPThe 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) | Device | Control Group |
| Treatment Group with use of VSPThe 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 | Device | Treatment Group |
Primary outcome
The Time Taken to Complete an Open Reduction Internal Fixation (ORIF)
Time frame: 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.
15 secondary outcomes
Number of Participants With Malocclusion
Time frame: 1 week after ORIF
Number of Participants With Malocclusion
Time frame: 3 weeks after ORIF
Number of Participants With Malocclusion
Time frame: 6 weeks after ORIF
Number of Participants With Fractures That Are Not Well Aligned
Time frame: 1 week after ORIF
Number of Participants With Fractures That Are Not Well Aligned
Time frame: 3 weeks after ORIF
Number of Participants With Fractures That Are Not Well Aligned
Time frame: 6 weeks after ORIF
Number of Participants With Infections
Time frame: 1 week after ORIF
Number of Participants With Infections
Time frame: 3 weeks after ORIF
Number of Participants With Infections
Time frame: 6 weeks after ORIF
Type of Archbars Used in ORIF
Time frame: from start of ORIF to end of ORIF (about 2-3 hours)
Number of Participants Whose Occlusal Splint Fit Appropriately
Time frame: from start of ORIF to end of ORIF (about 2-3 hours)
Type of Surgical Approach to the Fracture Site
Time frame: from start of ORIF to end of ORIF (about 2-3 hours)
Number of Participants Who Required Intraoperative Surgical Revisions
Time frame: from start of ORIF to end of ORIF (about 2-3 hours)
Distance of Maximal Interincisal Opening
Time frame: 6 weeks after ORIF
Number of Participants With Hardware Failure
Time frame: from baseline to 6 weeks after ORIF
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Timothy Woernley, DDS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Group with use of VSP in people with Mandibular Fractures, run by The University of Texas Health Science Center, Houston at 1 site 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 2 inclusion and 8 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 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 20 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Time Taken to Complete an Open Reduction Internal Fixation (ORIF) (time frame: from start of ORIF to end of ORIF (about 2-3 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2024.