Status:
COMPLETED
Use of a Low Profile Titanium Mesh in Orbital Reconstruction
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
International Bone Research Association
Conditions:
Orbital Fractures
Eligibility:
All Genders
18+ years
Brief Summary
In craniofacial trauma, the involvement of orbital structures is noted in up to 40% of cases (Ellis 1985). Post-traumatic orbital deformities caused by incorrect reconstruction of orbital dimensions a...
Detailed Description
Background Extensive bone loss after orbital trauma requires reconstruction to preserve ocular function and aesthetics. The optimal material for orbital reconstruction remains controversial. Today a ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- adult patients (\>18 years)
- presenting a unilateral orbital blow-out or blow-in fracture of ≥ 2.0cm2, causing an actual or expected functional or aesthetical deficit
- has to be operated within two weeks of trauma
- Exclusion Criteria
- individuals who did not have any vision on the affected side
- individuals, who, according to ophthalmologists, should not have a surgical treatment
- patients who were unable to adequately understand written or oral information in German or French
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01432964
Start Date
December 1 2008
End Date
October 1 2010
Last Update
September 13 2011
Active Locations (1)
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1
Department of Oral and Maxillofacial Surgery, Bern University Hospital
Bern, Switzerland, 3010 Bern