Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants

Completed

Conditions studied: Orbital Floor Fracture, Medial Orbital Wall Fracture

In brief

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.

Key facts

Study ID

NCT01121159

Run by

AO Clinical Investigation and Publishing Documentation

People needed

185

Starts

2010-06-01

Expected to finish

2014-10-01

Last updated by the study team

2020-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• Medizinische Hochschule Hannover — Hanover, Lower Saxony, Germany
• Universitätsklinikum Freiburg — Freiburg im Breisgau, Germany
• Bundeswehrkrankenhaus Ulm — Ulm, Germany
• National University Hospital — Singapore, Singapore
• Hospital de 12 Octubre — Madrid, Spain

Full record on ClinicalTrials.gov

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