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

• shape and volume assessing software [ Time Frame: up to 3 days after surgery ] [ Designated as safety issue: No ]
  6 specific points and regions in the orbit will be compared between the reconstructed and the non-affected orbit
• 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 ] [ Designated as safety issue: No ]
  Globe position, visual acuity, bulbus motility and diplopia will be assessed with clinical tests
• Rate of complications [ Time Frame: up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery ] [ Designated as safety issue: No ]
  Complications will be documented at every follow-up

• shape and volume assessing software [ Time Frame: up to 3 days post-op ] [ Designated as safety issue: No ]
  6 specific points and regions in the orbit will be compared between the reconstructed and the non-affected orbit
• Clinical tests to assess vision [ Time Frame: pre-op, up to 3 days post-op, 1 week post-op, 4 weeks post-op, 12 weeks post-op ] [ Designated as safety issue: No ]
  Globe position, visual acuity, bulbus motility and diplopia will be assessed with clinical tests
• Rate of complications [ Time Frame: up to 3 days post-op, 1 week post-op, 4 weeks post-op, 12 weeks post-op ] [ Designated as safety issue: No ]
  Complications will be documented at every follow-up

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.

patients with fractures of the orbital floor and/or medial orbital wall in one of the study centers

• Orbital Floor Fracture
• Medial Orbital Wall Fracture

• Preoperatively preformed orbital plates
  Reconstruction with MatrixMIDFACE Preformed Orbital Plate (Synthes) or Custom-made orbital implant
  Intervention: Procedure: orbital fracture repair
• Non-preformed orbital plates
  Reconstruction with Orbital Floor Mesh Plate or SynPOR Titanium Reinforced Fan Sheet (both Synthes)
  Intervention: Procedure: orbital fracture repair

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