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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperatively preformed orbital plates | Reconstruction with MatrixMIDFACE Preformed Orbital Plate (Synthes) or Custom-made orbital implant |
| |
| Non-preformed orbital plates | Reconstruction with Orbital Floor Mesh Plate or SynPOR Titanium Reinforced Fan Sheet (both Synthes) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| orbital fracture repair | Procedure | All patients will receive orbital fracture repair with one of the 4 specified implants |
|
| Measure | Description | Time Frame |
|---|---|---|
| shape and volume assessing software | 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. | up to 3 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| shape and volume assessing software | 6 specific points and regions in the orbit will be compared between the reconstructed and the non-affected orbit | up to 3 days after surgery |
| Clinical tests to assess vision |
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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:
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:
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patients with fractures of the orbital floor and/or medial orbital wall in one of the study centers
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| Name | Affiliation | Role |
|---|---|---|
| Niels Gellrich, Prof | Medizinische Hachschule Hannover | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-3900 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27519662 | Result | Zimmerer RM, Ellis E 3rd, Aniceto GS, Schramm A, Wagner ME, Grant MP, Cornelius CP, Strong EB, Rana M, Chye LT, Calle AR, Wilde F, Perez D, Tavassol F, Bittermann G, Mahoney NR, Alamillos MR, Basic J, Dittmann J, Rasse M, Gellrich NC. A prospective multicenter study to compare the precision of posttraumatic internal orbital reconstruction with standard preformed and individualized orbital implants. J Craniomaxillofac Surg. 2016 Sep;44(9):1485-97. doi: 10.1016/j.jcms.2016.07.014. Epub 2016 Jul 21. | |
| 29530645 |
| Label | URL |
|---|---|
| Link to published results | View source |
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Globe position, visual acuity, bulbus motility and diplopia will be assessed with clinical tests
| up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery |
| Rate of complications | Complications will be documented at every follow-up | up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery |
| Medizinische Hochschule Hannover |
| Hanover |
| Lower Saxony |
| 30625 |
| Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Bundeswehrkrankenhaus Ulm | Ulm | 89081 | Germany |
| National University Hospital | Singapore | 119074 | Singapore |
| Hospital de 12 Octubre | Madrid | 28041 | Spain |
| Result |
| Zimmerer RM, Gellrich NC, von Bulow S, Strong EB, Ellis E 3rd, Wagner MEH, Sanchez Aniceto G, Schramm A, Grant MP, Thiam Chye L, Rivero Calle A, Wilde F, Perez D, Bittermann G, Mahoney NR, Redondo Alamillos M, Basic J, Metzger M, Rasse M, Dittman J, Rometsch E, Espinoza K, Hesse R, Cornelius CP. Is there more to the clinical outcome in posttraumatic reconstruction of the inferior and medial orbital walls than accuracy of implant placement and implant surface contouring? A prospective multicenter study to identify predictors of clinical outcome. J Craniomaxillofac Surg. 2018 Apr;46(4):578-587. doi: 10.1016/j.jcms.2018.01.007. Epub 2018 Feb 1. |
| Link to published results | View source |