Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants (Orbita 3)
This study is currently recruiting participants.
Verified September 2012 by AO Clinical Investigation and Documentation
Sponsor:
AO Clinical Investigation and Documentation
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01121159
First received: May 7, 2010
Last updated: September 20, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Orbital Floor Fracture Medial Orbital Wall Fracture |
Procedure: orbital fracture repair |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by AO Clinical Investigation and Documentation:
Primary Outcome Measures:
- shape and volume assessing software [ Time Frame: up to 3 days after surgery ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- shape and volume assessing software [ Time Frame: up to 3 days after surgery ] [ Designated as safety issue: No ]6 specific points and regions in the orbit will be compared between the reconstructed and the non-affected orbit
- Clinical tests to assess vision [ Time Frame: up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery ] [ Designated as safety issue: No ]Globe position, visual acuity, bulbus motility and diplopia will be assessed with clinical tests
- Rate of complications [ Time Frame: up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery ] [ Designated as safety issue: No ]Complications will be documented at every follow-up
| Estimated Enrollment: | 170 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2013 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Preoperatively preformed orbital plates
Reconstruction with MatrixMIDFACE Preformed Orbital Plate (Synthes) or Custom-made orbital implant
|
Procedure: orbital fracture repair
All patients will receive orbital fracture repair with one of the 4 specified implants
|
|
Non-preformed orbital plates
Reconstruction with Orbital Floor Mesh Plate or SynPOR Titanium Reinforced Fan Sheet (both Synthes)
|
Procedure: orbital fracture repair
All patients will receive orbital fracture repair with one of the 4 specified implants
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
patients with fractures of the orbital floor and/or medial orbital wall in one of the study centers
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121159
Contacts
| Contact: Markus Zeppetzauer, MSc | 0041 44 200 24 45 | markus.zeppetzauer@aofoundation.org |
Locations
| United States, Texas | |
| University of Texas Health Science Center at San Antonio | Recruiting |
| San Antonio, Texas, United States, 78229-3900 | |
| Contact: Edward Ellis III, Prof. 210-567-3470 ELLISE3@UTHSCSA.EDU | |
| Principal Investigator: Edward Ellis III, Prof. | |
| Germany | |
| Medizinische Hochschule Hannover | Recruiting |
| Hannover, Niedersachsen, Germany, 30625 | |
| Contact: Nils-Claudius Gellrich, Professor 49 511 532 4748 Gellrich.Nils-Claudius@MH-Hannover.de | |
| Principal Investigator: Nils-Claudius Gellrich, Professor | |
| Universitätsklinikum Freiburg | Recruiting |
| Freiburg, Germany, 79106 | |
| Contact: Rainer Schmelzeisen, Prof. +49 761 270 47 01 rainer.schmelzeisen@uniklinik-freiburg.de | |
| Principal Investigator: Rainer Schmelzeisen, Prof. | |
| Bundeswehrkrankenhaus Ulm | Recruiting |
| Ulm, Germany, 89081 | |
| Contact: Alexander Schramm, Prof. +4973117101701 alexander.schramm@extern.uni-ulm.de | |
| Principal Investigator: Alexander Schramm, Prof. | |
| Singapore | |
| National University Hospital | Recruiting |
| Singapore, Singapore, 119074 | |
| Contact: Lim Thiam Chye, Prof. +65 6772 4240 thiam_chye_lim@nuhs.edu.sg | |
| Principal Investigator: Lim Thiam Chye, Prof. | |
| Spain | |
| Hospital de 12 Octubre | Recruiting |
| Madrid, Spain, 28041 | |
| Contact: Aniceto G Sanchez, Prof. Dr. +34 91 400 82 57 gsaniceto@meytel.net | |
| Principal Investigator: Aniceto G Sanchez, Prof. | |
Sponsors and Collaborators
AO Clinical Investigation and Documentation
More Information
No publications provided
| Responsible Party: | AO Clinical Investigation and Documentation |
| ClinicalTrials.gov Identifier: | NCT01121159 History of Changes |
| Other Study ID Numbers: | Orbita 3 |
| Study First Received: | May 7, 2010 |
| Last Updated: | September 20, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Fractures, Bone Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013