Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants
Orbita 3
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
1 other identifier
observational
185
4 countries
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2010
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2010
CompletedFirst Posted
Study publicly available on registry
May 12, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedAugust 13, 2020
August 1, 2020
4 years
May 7, 2010
August 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
shape and volume assessing software
up to 3 days after surgery
Clinical tests to assess vision
up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery
Rate of complications
up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery
Study Arms (2)
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)
Interventions
All patients will receive orbital fracture repair with one of the 4 specified implants
Eligibility Criteria
patients with fractures of the orbital floor and/or medial orbital wall in one of the study centers
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900, United States
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
Related Publications (2)
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.
PMID: 27519662RESULTZimmerer 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.
PMID: 29530645RESULT
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Niels Gellrich, Prof
Medizinische Hachschule Hannover
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2010
First Posted
May 12, 2010
Study Start
June 1, 2010
Primary Completion
June 1, 2014
Study Completion
October 1, 2014
Last Updated
August 13, 2020
Record last verified: 2020-08