Orbital Floor FractureOrbita 3NCT01121159
Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants
An observational study of Orbital Floor Fracture and Medial Orbital Wall Fracture, run by AO Clinical Investigation and Publishing Documentation at 6 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orbital Floor Fracture, Medial Orbital Wall Fracture
- What is being tested?
- orbital fracture repair
- Type of treatment
- Surgery or procedure
- How many people
- 185 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Jun 2010to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with fractures of the orbital floor and/or medial orbital wall in one of the study centers
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Injury of the globe
- Neurological diseases with influence on eye motility or sight
- Legal incompetence
- Active malignancy
- Life-threatening condition
- Alcohol and drug abuse
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Germany3 sites
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Bundeswehrkrankenhaus Ulm
Ulm, 89081
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
About this study
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
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.
- Being tested
- orbital fracture repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orbital fracture repairProcedure or surgery
All patients will receive orbital fracture repair with one of the 4 specified implants
| Study group | Role | What they receive |
|---|---|---|
| Preoperatively preformed orbital plates | Reconstruction with MatrixMIDFACE Preformed Orbital Plate (Synthes) or Custom-made orbital implant Receives: Procedure: orbital fracture repair | |
| Non-preformed orbital plates | Reconstruction with Orbital Floor Mesh Plate or SynPOR Titanium Reinforced Fan Sheet (both Synthes) Receives: Procedure: orbital fracture repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 days after surgery
Secondary outcomes (3)
shape and volume assessing software
6 specific points and regions in the orbit will be compared between the reconstructed and the non-affected orbit
Measured: up to 3 days after surgery
Clinical tests to assess vision
Globe position, visual acuity, bulbus motility and diplopia will be assessed with clinical tests
Measured: 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
Measured: up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Orbital Floor FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niels Gellrich, Prof, Principal investigator, Medizinische Hachschule Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121159
- Sponsor's protocol ID
- Orbita3
- Acronym
- Orbita 3
- Status last verified
- Aug 2020
- First submitted
- 7 May 2010
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27519662Zimmerer 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.
PubMed 29530645
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01121159
- Acronym / sponsor ID
- Orbita 3 / Orbita3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperatively preformed orbital plates | – | Procedure: orbital fracture repairReconstruction with MatrixMIDFACE Preformed Orbital Plate (Synthes) or Custom-made orbital implant |
| Non-preformed orbital plates | – | Procedure: orbital fracture repairReconstruction with Orbital Floor Mesh Plate or SynPOR Titanium Reinforced Fan Sheet (both Synthes) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with fractures of the orbital floor and/or medial orbital wall in one of the study centers
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| orbital fracture repairAll patients will receive orbital fracture repair with one of the 4 specified implants | Procedure or surgery | Non-preformed orbital plates, Preoperatively preformed orbital plates |
Primary outcome
shape and volume assessing software
Time frame: up to 3 days after surgery
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.
3 secondary outcomes
shape and volume assessing software
Time frame: up to 3 days after surgery
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
Rate of complications
Time frame: up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Results publication: PubMed 27519662Zimmerer 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.
- Results publication: PubMed 29530645Zimmerer 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 resultsLink provided by the sponsor.
- Link to published resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels Gellrich, Prof principal investigator
Medizinische Hachschule Hannover
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orbital Floor Fracture and Medial Orbital Wall Fracture, run by AO Clinical Investigation and Publishing Documentation at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, United States, Singapore, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shape and volume assessing software (time frame: up to 3 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01121159, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.