Reconstruction Techniques for Orbital Fractures
(OFx Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the best treatment for orbital blow-out fractures, which affect the bones around the eye. Researchers compare three approaches: nonsurgical treatment, early surgical reconstruction, and delayed surgical reconstruction. They aim to determine which method promotes better healing over six months. The trial seeks participants with a dislocated fracture in specific areas around the eye, confirmed by a CT scan. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important research.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that many people with orbital fractures heal well without surgery. One study found that most patients recovered without long-term double vision or other issues. For those considering surgery, options include waiting before surgery or undergoing it soon after the injury. These surgeries aim to restore the area around the eye to its normal position. Studies indicate that these procedures are generally safe and effective, helping to repair fractures and improve eye alignment. Overall, both nonsurgical and surgical treatments for orbital fractures are well-tolerated.12345
Why are researchers excited about this trial?
Researchers are excited about the treatments for orbital fractures in this trial because they explore different timings for reconstructive surgery, which could significantly impact recovery outcomes. Unlike the standard approach, which often involves immediate or early surgery, this trial investigates the benefits of "delayed" reconstruction. This could offer insights into whether waiting longer before surgical intervention provides better healing or reduces complications. By comparing nonsurgical management, early reconstruction, and delayed reconstruction, the study aims to identify the most effective strategy for treating dislocated fractures of the orbital wall, potentially reshaping current treatment protocols.
What evidence suggests that this trial's treatments could be effective for orbital blow-out fractures?
Research has shown that many people with orbital fractures can heal well without surgery. One study found that a large number of patients with fractures in the orbital floor or medial wall recovered on their own without ongoing double vision. In this trial, participants may receive nonsurgical management.
For those undergoing surgery, the trial includes options for primary "early" reconstruction and primary "delayed" reconstruction. Early repair of these fractures has shown good results, with studies indicating that fixing the fractures early often leads to better recovery, reducing problems like double vision and a sunken eye appearance. For surgeries done later, research highlights that with careful planning, surgery can effectively correct deformities. Each treatment approach in this trial has demonstrated positive results, depending on the specific needs and timing of the treatment.12678Who Is on the Research Team?
Eppo B. Wolvius, Prof.
Principal Investigator
Department of Oral & Maxillofacial Surgery, Erasmus MC, Rotterdam
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive surgical or nonsurgical treatment for orbital fractures as per standard of care
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nonsurgical
- Primary "delayed" reconstruction
- Primary "early" reconstruction
- Secondary reconstruction
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients with dislocated fracture of the inferior and/or medial orbital wall
Find a Clinic Near You
Who Is Running the Clinical Trial?
AO Innovation Translation Center
Lead Sponsor
AO Clinical Investigation and Publishing Documentation
Lead Sponsor
Citations
Surgical versus non-surgical management of orbital fractures
The primary objectives of this observational cohort study are (1) to document current treatment practices for and (2) to assess the outcomes of ...
A nonsurgical approach with repeated orthoptic evaluation ...
This study showed that a high percentage of patients with orbital floor and/or medial wall fracture recovered spontaneously without lasting diplopia or ...
Isolated Orbital Fracture—Treatment and Outcomes in a ...
Results: We included 246 patients in the study cohort, of which 96 (39%) were treated surgically and 150 (61%) nonsurgically. Median time from injury to surgery ...
Isolated Orbital Fracture – Treatment and Outcomes in a ...
We included 246 patients in the study cohort, of which 96 (39%) were treated surgically and 150 (61%) non-surgically. Median time from injury to surgery was 11 ...
Long-term clinical outcomes of isolated orbital floor fracture ...
At 6 months, nine patients (40.9%) in the Ti mesh group had experienced postoperative diplopia compared to six patients (30.0%) in the PP group ...
Management of orbital fractures: challenges and solutions
Data accrued in the past 10 years have shown that the repair of orbital fractures with calvarium is safe and has an acceptable reduction of enophthalmos and ...
Some Sports-Related Orbital Fractures in Children Can Be ...
This study shows that nearly 25% of children who sustain an orbital fracture from sports may require surgical intervention.
Functional outcome after non-surgical management of ...
Patients without EOM entrapment improved with an average of 7 weeks of conservative management. Conclusions This study supports urgent surgical ...
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