Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:7/15/2018
Start Date:June 2010
End Date:October 2014

Use our guide to learn which trials are right for you!

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

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.


Inclusion Criteria:

1. Patients ≥ 18 years

2. Fracture (not older than 14 days) of the medial orbital wall and/or the orbital floor

3. 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

4. At least partial sight in both eyes before the accident

5. Willingness and ability to participate in the study follow-up according to the
protocol

6. Ability to understand and read local language at elementary level

7. Signed informed consent

Exclusion Criteria:

1. Bilateral orbital fracture

2. Fractures of the orbital roof

3. Comminuted zygoma fracture

4. More than one piece fracture of the intraorbital bone lateral to the inferior orbital
fissure

5. Previous dislocated orbital fractures on either side

6. Vision or diplopia not assessable

7. Injury of the globe

8. Neurological diseases with influence on eye motility or sight

9. Legal incompetence

10. Active malignancy

11. Life-threatening condition

12. Alcohol and drug abuse
We found this trial at
2
sites
Hannover, Niedersachsen 30625
?
mi
from
Hannover,
Click here to add this to my saved trials
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials