Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants

Study Overview
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Brief Summary
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Accuracy of posttraumatic orbital reconstruction of the medial orbital wall and/or floor is better with preoperatively preformed orbital implants than with non-preformed orbital implants.

Official Title
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A Prospective Multicenter Study to Compare the Accuracy of Posttraumatic Orbital Reconstruction of the Medial Orbital Wall and/or the Orbital Floor With Preoperatively Preformed Versus Non-preformed Orbital Plates

Conditions
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Orbital Floor Fracture, Medial Orbital Wall Fracture

Intervention / Treatment
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* Procedure: orbital fracture repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years Fracture (not older than 14 days) of the medial orbital wall and/or the orbital floor Scheduled for reconstruction surgery with one of the following implants: MatrixMIDFACE Preformed Orbital Plate Custom-made orbital implant Orbital Floor Mesh Plate SynPOR Titanium Reinforced Fan Sheet At least partial sight in both eyes before the accident Willingness and ability to participate in the study follow-up according to the protocol Ability to understand and read local language at elementary level Signed informed consent Exclusion Criteria: Bilateral orbital fracture Fractures of the orbital roof Comminuted zygoma fracture More than one piece fracture of the intraorbital bone lateral to the inferior orbital fissure Previous dislocated orbital fractures on either side Vision or diplopia not assessable Injury of the globe Neurological diseases with influence on eye motility or sight Legal incompetence Active malignancy Life-threatening condition Alcohol and drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preoperatively preformed orbital plates<br>Reconstruction with MatrixMIDFACE Preformed Orbital Plate (Synthes) or Custom-made orbital implant | Procedure: orbital fracture repair<br>* All patients will receive orbital fracture repair with one of the 4 specified implants<br>|
| Non-preformed orbital plates<br>Reconstruction with Orbital Floor Mesh Plate or SynPOR Titanium Reinforced Fan Sheet (both Synthes) | Procedure: orbital fracture repair<br>* All patients will receive orbital fracture repair with one of the 4 specified implants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| shape and volume assessing software | A post-op CT or CBCT scan will be analyzed with specially developed software that can compare shape and volume of the reconstruced orbit to the uninjured orbit. | up to 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| shape and volume assessing software | 6 specific points and regions in the orbit will be compared between the reconstructed and the non-affected orbit | up to 3 days after surgery | 
| Clinical tests to assess vision | Globe position, visual acuity, bulbus motility and diplopia will be assessed with clinical tests | up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery | 
| Rate of complications | Complications will be documented at every follow-up | up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery |