Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants (Orbita 3)

AO Clinical Investigation and Publishing Documentation

Status: Completed

Conditions: Orbital Floor Fracture; Medial Orbital Wall Fracture

Treatments: Procedure: orbital fracture repair

Study type: Observational

Funder types: Other

Identifiers

NCT01121159

Orbita3

Details and patient eligibility

About

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.

Enrollment: 185 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients ≥ 18 years

2. Fracture (not older than 14 days) of the medial orbital wall and/or the orbital floor

3. 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

4. At least partial sight in both eyes before the accident

5. Willingness and ability to participate in the study follow-up according to the protocol

6. Ability to understand and read local language at elementary level

7. Signed informed consent

Exclusion criteria

1. Bilateral orbital fracture
2. Fractures of the orbital roof
3. Comminuted zygoma fracture
4. More than one piece fracture of the intraorbital bone lateral to the inferior orbital fissure
5. Previous dislocated orbital fractures on either side
6. Vision or diplopia not assessable
7. Injury of the globe
8. Neurological diseases with influence on eye motility or sight
9. Legal incompetence
10. Active malignancy
11. Life-threatening condition
12. Alcohol and drug abuse

Trial design

185 participants in 2 patient groups

Preoperatively preformed orbital plates

Description:

Reconstruction with MatrixMIDFACE Preformed Orbital Plate (Synthes) or Custom-made orbital implant

Treatment:

Procedure: orbital fracture repair

Non-preformed orbital plates

Description:

Reconstruction with Orbital Floor Mesh Plate or SynPOR Titanium Reinforced Fan Sheet (both Synthes)

Treatment:

Procedure: orbital fracture repair