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Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants | Clinical Trials | Clareo Health

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Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants

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

NCT01121159•AO Clinical Investigation and Publishing Documentation

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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
+2 more criteria

Locations (6)

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

Key Dates

Start Date

June 1, 2010

Primary Completion Date

June 1, 2014

Completion Date

October 1, 2014

Last Updated

August 13, 2020

Enrollment

185

ACTUAL participants

Conditions

Orbital Floor FractureMedial Orbital Wall Fracture

Interventions

orbital fracture repair

PROCEDURE

Accuracy& Orbital Volume Using Patient Specific Titanium Implant Vs Zirconia for Orbital Floor Reconstruction

NCT06369129

Blow-Out FracturesOrbital Fractures+2 more

View study

ENROLLING_BY_INVITATION

Multi-Institutional IMPACT Validation

NCT06850857

Facial InjuriesMandible Fracture+7 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 13, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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