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NCT02341443 · ClinicalTrials.gov registry record · NA
A Multicenter RCT to Investigate the Treatment of Double (Bilateral) Mandibular Fractures
A NA study, sponsored by AO Clinical Investigation and Publishing Documentation.
- Completed
- Registry status
- NA
- Development phase
- 314
- Enrollment target
NCT02341443 is a NA study that has completed, run by AO Clinical Investigation and Publishing Documentation. The registered enrollment target is 314 participants.
The verdict
NCT02341443, a NA study, has completed, sponsored by AO Clinical Investigation and Publishing Documentation.
- COMPLETED
- Registry status
- NA
- Development phase
- 314 participants
- Enrollment target
Study Summary
Mandibular fractures represent approximately 50% of the total facial fractures and are commonly (more than half) presented in more than one location. A few simple fractures can be treated using a conservative approach. More often, however, mandibular fractures require stabilization using open reduction and internal fixation. Simple mandibular fractures can be treated using non-rigid fixation techniques that rely on the load-sharing principle, by which stabilization is accomplished with both fixation devices and bone surfaces. On the other hand, more complex fractures with continuity defects or comminuted need to be handle using rigid fixation where the device assumes all the forces (load-bearing principle). These approaches are well established, whereas the level of evidence for the treatment of bilateral double mandibular fractures (DMF) is still scarce. In fact, which surgical treatment, or combination of treatments, leads to the best outcome and the lowest rate of complications in bilateral DMFs is an open question. The purpose of this study is to assess the complication rate in patients suffering from bilateral DMF treated either using non-rigid fixation on both fracture sides or a combination of rigid fixation on one side and non-rigid fixation on the other side.
Interventions
- PROCEDURE Implants
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2015-04 |
| Est. Completion | 2019-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02341443
The ClinicalTrials.gov registry entry for NCT02341443 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 314 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AO Clinical Investigation and Publishing Documentation, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Implants is the first listed.
NCT02341443 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02341443 about?
NCT02341443 is a clinical study titled "A Multicenter RCT to Investigate the Treatment of Double (Bilateral) Mandibular Fractures". Mandibular fractures represent approximately 50% of the total facial fractures and are commonly (more than half) presented in more than one location. A few simple fractures can be treated using a conservative approach. More often, however, mandibular fractures require stabilization using open reduct...
What is the current status of trial NCT02341443?
This trial is currently completed. It is a NA study. The enrollment target is 314 participants. The study started on 2015-04. Estimated completion is 2019-05.
What interventions are being tested in trial NCT02341443?
The interventions under investigation include: Implants (PROCEDURE).
Who is sponsoring clinical trial NCT02341443?
This trial is sponsored by AO Clinical Investigation and Publishing Documentation, which has 18 total clinical trials registered on ClinicalTrials.gov.
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