Clinical Trial: A Multicenter RCT to Investigate the Treatment of Double (Bilateral) Mandibular Fractures
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Multicenter Randomized Controlled Clinical Investigation to Investigate the Treatment of Double (Bilateral) Mandibular Fractures
Brief 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.
Detailed Summary: Prospective data will be collected in 314 patients suffering from bilateral (double) mandibular fracture randomly treated either with non-rigid fixation on both fracture sides or a combination of rigid fixation on one side and non-rigid fixation on the other side. This is a study where patients will be treated per randomization to one of the two established treatments and followed for further clinical examination post-operatively at 6 weeks and 3 months after the intervention.
Sponsor: AO Clinical Investigation and Documentation
Current Primary Outcome: Number of anticipated procedure- or condition-related Adverse Events [ Time Frame: 6 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Degree of displacement of the fracture [ Time Frame: Pre-operatively (Day -1) ]
- Location of the tooth with respect to the line of fracture [ Time Frame: Pre-operatively (Day -1) ]
- Mechanism of production of the fracture: [ Time Frame: Pre-operatively (Day -1) ]
- Time in days between the occurrence of the injury and the surgery [ Time Frame: Intraoperatively (Day 0) ]
- Length of the surgery [ Time Frame: Intraoperatively (Day 0) ]Time in minutes from the first incision to skin closure
- Length of the hospital stay [ Time Frame: Intraoperatively (Day 0) ]Time in days between the admission and the discharge of the (acute) hospital
- Characteristics of the hardware [ Time Frame: Intraoperatively (Day 0) ]Characteristics of the hardware/device used to reduce the fracture concerning its shape, thickness and number or screws
- Use of antibiotics [ Time Frame: Intraoperatively (Day 0) ]Administration of antibiotics during surgery
- Difficulty of application of the hardware [ Time Frame: Intraoperatively (Day 0) ]Surgeon's own assessment of difficulty of application of the hardware from very easy to very difficult
- Dysfunction of the mandible [ Time Frame: 6 weeks, 3 months ]Helkimo Index
Original Secondary Outcome: Same as current
Information By: AO Clinical Investigation and Documentation
Dates:
Date Received: December 4, 2014
Date Started: April 2015
Date Completion: July 2018
Last Updated: March 9, 2017
Last Verified: March 2017
