Use of a Low Profile Titanium Mesh in Orbital Reconstruction

NCT01432964 | Completed

• 2 other identifiers: 011/090709-0050
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Orbital Fractures

Keywords

Orbital Fractures; Fracture Fixation; Blow-out Fractures; Surgical Mesh; Titanium; Computer-assisted Image Processing

Outcome Measures

Primary Outcomes (1)

• Radiological Volume analysis of bony orbits (difference in cm3)

  postoperative, within 12 weeks after operation

Secondary Outcomes (3)

• Eye motility (in mm)

  at 12 weeks after the operation

• En/Exophthalmos (Hertel Test) (in mm)

  at 12 weeks after the operation

• Diplopia (in %)

  at 12 weeks after the operation

Study Arms (1)

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.

Procedure: Orbital revision surgery

Interventions

Orbital revision surgery PROCEDURE

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).

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with facial fractures, treated at the Department of Oral and Maxillofacial Surgery, University Hospital Bern, Bern, Switzerland.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• International Bone Research Association: collaborator

Study Sites (1)

Department of Oral and Maxillofacial Surgery, Bern University Hospital

Bern, 3010 Bern, Switzerland

Location

Related Publications (6)

• 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.

  PMID: 3858478 BACKGROUND

• Buchel 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.

  PMID: 15883939 BACKGROUND

• Lieger 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.

  PMID: 21079117 BACKGROUND

• Haug 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.

  PMID: 10319830 BACKGROUND

• Park 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.

  PMID: 11711822 BACKGROUND

• Jaquiery 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.

  PMID: 17241771 BACKGROUND

MeSH Terms

Conditions

Orbital Fractures

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Officials

• Olivier Lieger, MD, DMD

  Department of Oral and Maxillofacial Surgery, University Hospital Bern, Switzerland

  PRINCIPAL INVESTIGATOR

• Tateyuki Iizuka, MD, DDS, PhD

  Department of Oral and Maxillofacial Surgery, University Hospital Bern, Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2011
• First Posted: September 13, 2011
• Study Start: December 1, 2008
• Study Completion: October 1, 2010
• Last Updated: September 13, 2011

Record last verified: 2011-09

Locations

CH (1)