Orbital FracturesNCT01432964
Use of a Low Profile Titanium Mesh in Orbital Reconstruction
An observational study of Orbital Fractures, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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 are severe complications causing enophthalmos, diplopia and visual acuity disturbance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orbital Fractures
- What is being tested?
- Orbital revision surgery
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2008to Oct 2010
- 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: Patient with facial fractures, treated at the Department of Oral and Maxillofacial Surgery, University Hospital Bern, Bern, Switzerland.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Oral and Maxillofacial Surgery, Bern University Hospital
Bern, 3010 Bern
About this study
Official title: Low Profile Titanium Mesh in the Use of Orbital Reconstruction
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 are severe complications causing enophthalmos, diplopia and visual acuity disturbance. To prevent such complications, immediate repair of orbital injuries with the restoration of normal anatomy is indicated in orbital floor fractures. With the help of biodegradable implants small and medium-sized defects are easily managed (Büchel 2005, Lieger 2010). In extensive fractures however, only calvarian bone and titanium mesh considered to provide a sufficient support of the orbital content.
Calvarial bone can be difficult to mould and to adapt to the form and size of the orbital lesion. In addition, donor site morbidity cannot be disregarded. Orbital reconstruction mesh on the other hand is always available and easier to apply. There are however important requirements for these meshes, such as biocompatibility, excellent stability, optimal adaptability and patient comfort. Recently, the company Medartis developed a titanium mesh featuring a low profile. In order to regain normal function, normal anatomy has to be re-established. It therefore seemed reasonable to assess an implant, which would facilitate orbital reconstruction without disturbing normal anatomy by its size, profile height or properties.
The purpose of this study was to assess the use and accuracy of the low profile titanium mesh for primary internal orbital reconstruction.
Read the 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 multitude of both autogenous and alloplastic materials have been used for orbital reconstruction, including methylmethacrylate, Teflon, silicone, Supramid, Marlex, Silastic, gelatin film, bioactive glas, bone and cartilage (Haug 1999). The use of alloplastic materials has been tempered by complications such as infection, displacement and extrusion, fistula and cyst formation. During the past two decades, autogenous bone grafts have become increasingly popular for orbital reconstruction. Unfortunately, problems with bone grafts can occur and include unpredictable rates of bone resorption and the risk of subsequent dystopia or delayed enophthalmos, donor site complication, time consumption with harvesting and variable graft thickness and irregularities along with difficulty in graft contouring (Park 2001). These problems have revived interest in alloplastic alternatives, particularly in titanium and its alloys (Park 2001). Titanium shows a low infection rate, related in part to its excellent biocompatibility, which manifests as osseointegration. This circumstance is thought to lessen the rate of infection.
During the past decade, different studies have examined a titanium meshes for orbital repair. Plates used in these studies demonstrate a minimum profile height of 0.25mm.
Objective
Assess the use and accuracy of the low profile titanium mesh for primary internal orbital reconstruction
Methods
Clinical assessment prior to operation by a maxillofacial surgeon with regards to bone and soft tissue lesions as well as concomitant injuries. An ophthalmologist then assessed eye lesions and quantified eye mobility (in mm), bulb positioning (Hertel's exophthalmometry, in mm) as well as the field of binocular vision (Goldmann perimetry, in % of the total).
Preoperative 1mm CT-scans were obtained to analyse size and location of the defect as well as extend of muscle entrapment. The fractures were classified according to the scores introduced by Jaquiery(Jaquiery 2007).
Follow up by at 2, 6 and 12 weeks after the operation (assessments see above), including postoperative CT-scan within 12 weeks. Volume analysis of CT comparing the two orbits (OsiriX Medical Image Software (Version 3.7.1, www.osirix-viewer.com).
- Conditions
- Orbital Fractures
- Being tested
- Orbital revision surgery
- Keywords
- Orbital Fractures, Fracture Fixation, Blow-out Fractures, Surgical Mesh, Titanium, Computer-assisted Image Processing
- Medical subject headings
- Orbital Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orbital revision surgeryProcedure or surgery
Surgical revisions were performed under general anaesthesia. The orbital floor was routinely exposed via a transconjunctival incision. In patients with involvement of the medial wall, a combined transconjunctival-transcaruncular approach was used. Herniated or incarcerated tissue was then complete repositioned. Stable borders around the bony defect in the orbital floor were exposed. The aluminium template was pre-bend and controlled in situ. Type and size of mesh were chosen and adjustments performed, as needed. Following the bending of the titanium mesh according to the template, it was inserted and fixed with 1.5mm screws. Alternatively the mesh could be preformed, using a sterilized skull model to shape and contour it to a normal orbit. Finally the eye bulb mobility was controlled using fine forceps (forced duction test) and the wound closed (Vicryl 5/0 rapid; optional).
| Study group | Role | What they receive |
|---|---|---|
| 1 | 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. Receives: Procedure: Orbital revision surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological Volume analysis of bony orbits (difference in cm3)
Measured: postoperative, within 12 weeks after operation
Secondary outcomes (3)
Eye motility (in mm)
Measured: at 12 weeks after the operation
En/Exophthalmos (Hertel Test) (in mm)
Measured: at 12 weeks after the operation
Diplopia (in %)
Measured: at 12 weeks after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startDec 2008
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Orbital FracturesStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- International Bone Research Association
- Investigators
- Olivier Lieger, MD, DMD, Principal investigator, Department of Oral and Maxillofacial Surgery, University Hospital Bern, SwitzerlandTateyuki Iizuka, MD, DDS, PhD, Study director, Department of Oral and Maxillofacial Surgery, University Hospital Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432964
- Sponsor's protocol ID
- 011/09
- Other IDs
- 0709-0050
- Status last verified
- Sep 2011
- First submitted
- 12 Sep 2011
- Last updated
- 13 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ellis E 3rd, el-Attar A, Moos KF. An analysis of 2,067 cases of zygomatico-orbital fracture. J Oral Maxillofac Surg. 1985 Jun;43(6):417-28. doi: 10.1016/s0278-2391(85)80049-5.
PubMed 3858478Buchel P, Rahal A, Seto I, Iizuka T. Reconstruction of orbital floor fracture with polyglactin 910/polydioxanon patch (ethisorb): a retrospective study. J Oral Maxillofac Surg. 2005 May;63(5):646-50. doi: 10.1016/j.joms.2004.11.013.
PubMed 15883939Lieger O, Schaller B, Zix J, Kellner F, Iizuka T. Repair of orbital floor fractures using bioresorbable poly-L/DL-lactide plates. Arch Facial Plast Surg. 2010 Nov-Dec;12(6):399-404. doi: 10.1001/archfacial.2010.91.
PubMed 21079117Haug RH, Nuveen E, Bredbenner T. An evaluation of the support provided by common internal orbital reconstruction materials. J Oral Maxillofac Surg. 1999 May;57(5):564-70. doi: 10.1016/s0278-2391(99)90076-9.
PubMed 10319830Park HS, Kim YK, Yoon CH. Various applications of titanium mesh screen implant to orbital wall fractures. J Craniofac Surg. 2001 Nov;12(6):555-60. doi: 10.1097/00001665-200111000-00010.
PubMed 11711822Jaquiery C, Aeppli C, Cornelius P, Palmowsky A, Kunz C, Hammer B. Reconstruction of orbital wall defects: critical review of 72 patients. Int J Oral Maxillofac Surg. 2007 Mar;36(3):193-9. doi: 10.1016/j.ijom.2006.11.002. Epub 2007 Jan 22.
PubMed 17241771
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Profile Titanium Mesh in the Use of Orbital Reconstruction
- ClinicalTrials.gov ID
- NCT01432964
- Acronym / sponsor ID
- 011/09
- Conditions
- Orbital Fractures
- Keywords
- Orbital Fractures, Fracture Fixation, Blow-out Fractures, Surgical Mesh, Titanium, Computer-assisted Image Processing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- International Bone Research Association
- Study start
- Dec 2008
- Study completion
- Oct 2010 (actual)
- First posted
- 13 Sep 2011 (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.
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 are severe complications causing enophthalmos, diplopia and visual acuity disturbance. To prevent such complications, immediate repair of orbital injuries with the restoration of normal anatomy is indicated in orbital floor fractures. With the help of biodegradable implants small and medium-sized defects are easily managed (Büchel 2005, Lieger 2010). In extensive fractures however, only calvarian bone and titanium mesh considered to provide a sufficient support of the orbital content.
Calvarial bone can be difficult to mould and to adapt to the form and size of the orbital lesion. In addition, donor site morbidity cannot be disregarded. Orbital reconstruction mesh on the other hand is always available and easier to apply. There are however important requirements for these meshes, such as biocompatibility, excellent stability, optimal adaptability and patient comfort. Recently, the company Medartis developed a titanium mesh featuring a low profile. In order to regain normal function, normal anatomy has to be re-established. It therefore seemed reasonable to assess an implant, which would facilitate orbital reconstruction without disturbing normal anatomy by its size, profile height or properties.
The purpose of this study was to assess the use and accuracy of the low profile titanium mesh for primary internal orbital reconstruction.
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 multitude of both autogenous and alloplastic materials have been used for orbital reconstruction, including methylmethacrylate, Teflon, silicone, Supramid, Marlex, Silastic, gelatin film, bioactive glas, bone and cartilage (Haug 1999). The use of alloplastic materials has been tempered by complications such as infection, displacement and extrusion, fistula and cyst formation. During the past two decades, autogenous bone grafts have become increasingly popular for orbital reconstruction. Unfortunately, problems with bone grafts can occur and include unpredictable rates of bone resorption and the risk of subsequent dystopia or delayed enophthalmos, donor site complication, time consumption with harvesting and variable graft thickness and irregularities along with difficulty in graft contouring (Park 2001). These problems have revived interest in alloplastic alternatives, particularly in titanium and its alloys (Park 2001). Titanium shows a low infection rate, related in part to its excellent biocompatibility, which manifests as osseointegration. This circumstance is thought to lessen the rate of infection.
During the past decade, different studies have examined a titanium meshes for orbital repair. Plates used in these studies demonstrate a minimum profile height of 0.25mm.
Objective
Assess the use and accuracy of the low profile titanium mesh for primary internal orbital reconstruction
Methods
Clinical assessment prior to operation by a maxillofacial surgeon with regards to bone and soft tissue lesions as well as concomitant injuries. An ophthalmologist then assessed eye lesions and quantified eye mobility (in mm), bulb positioning (Hertel's exophthalmometry, in mm) as well as the field of binocular vision (Goldmann perimetry, in % of the total).
Preoperative 1mm CT-scans were obtained to analyse size and location of the defect as well as extend of muscle entrapment. The fractures were classified according to the scores introduced by Jaquiery(Jaquiery 2007).
Follow up by at 2, 6 and 12 weeks after the operation (assessments see above), including postoperative CT-scan within 12 weeks. Volume analysis of CT comparing the two orbits (OsiriX Medical Image Software (Version 3.7.1, www.osirix-viewer.com).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Orbital revision surgeryAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with facial fractures, treated at the Department of Oral and Maxillofacial Surgery, University Hospital Bern, Bern, Switzerland.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 revision surgerySurgical revisions were performed under general anaesthesia. The orbital floor was routinely exposed via a transconjunctival incision. In patients with involvement of the medial wall, a combined transconjunctival-transcaruncular approach was used. Herniated or incarcerated tissue was then complete repositioned. Stable borders around the bony defect in the orbital floor were exposed. The aluminium template was pre-bend and controlled in situ. Type and size of mesh were chosen and adjustments performed, as needed. Following the bending of the titanium mesh according to the template, it was inserted and fixed with 1.5mm screws. Alternatively the mesh could be preformed, using a sterilized skull model to shape and contour it to a normal orbit. Finally the eye bulb mobility was controlled using fine forceps (forced duction test) and the wound closed (Vicryl 5/0 rapid; optional). | Procedure or surgery | 1 |
Primary outcome
Radiological Volume analysis of bony orbits (difference in cm3)
Time frame: postoperative, within 12 weeks after operation
3 secondary outcomes
Eye motility (in mm)
Time frame: at 12 weeks after the operation
En/Exophthalmos (Hertel Test) (in mm)
Time frame: at 12 weeks after the operation
Diplopia (in %)
Time frame: at 12 weeks after the operation
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 Sep 2011.
- Background: PubMed 3858478Ellis E 3rd, el-Attar A, Moos KF. An analysis of 2,067 cases of zygomatico-orbital fracture. J Oral Maxillofac Surg. 1985 Jun;43(6):417-28. doi: 10.1016/s0278-2391(85)80049-5.
- Background: PubMed 15883939Buchel P, Rahal A, Seto I, Iizuka T. Reconstruction of orbital floor fracture with polyglactin 910/polydioxanon patch (ethisorb): a retrospective study. J Oral Maxillofac Surg. 2005 May;63(5):646-50. doi: 10.1016/j.joms.2004.11.013.
- Background: PubMed 21079117Lieger O, Schaller B, Zix J, Kellner F, Iizuka T. Repair of orbital floor fractures using bioresorbable poly-L/DL-lactide plates. Arch Facial Plast Surg. 2010 Nov-Dec;12(6):399-404. doi: 10.1001/archfacial.2010.91.
- Background: PubMed 10319830Haug RH, Nuveen E, Bredbenner T. An evaluation of the support provided by common internal orbital reconstruction materials. J Oral Maxillofac Surg. 1999 May;57(5):564-70. doi: 10.1016/s0278-2391(99)90076-9.
- Background: PubMed 11711822Park HS, Kim YK, Yoon CH. Various applications of titanium mesh screen implant to orbital wall fractures. J Craniofac Surg. 2001 Nov;12(6):555-60. doi: 10.1097/00001665-200111000-00010.
- Background: PubMed 17241771Jaquiery C, Aeppli C, Cornelius P, Palmowsky A, Kunz C, Hammer B. Reconstruction of orbital wall defects: critical review of 72 patients. Int J Oral Maxillofac Surg. 2007 Mar;36(3):193-9. doi: 10.1016/j.ijom.2006.11.002. Epub 2007 Jan 22.
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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.
Olivier Lieger, MD, DMD principal investigator
Department of Oral and Maxillofacial Surgery, University Hospital Bern, Switzerland
Tateyuki Iizuka, MD, DDS, PhD study director
Department of Oral and Maxillofacial Surgery, University Hospital Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orbital Fractures, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 inclusion and 3 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 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Radiological Volume analysis of bony orbits (difference in cm3) (time frame: postoperative, within 12 weeks after operation). 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 NCT01432964, which also lists 6 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 Sep 2011.