Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants

Completed

• Conditions: Orbital Floor Fracture; Medial Orbital Wall Fracture
• Interventions: Procedure: orbital fracture repair

• Registration Number: NCT01121159
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-07
• Study First Submitted QC: 2010-05-10
• Study First Posted: 2010-05-12
• Study Start: 2010-06
• Primary Completion: 2014-06
• Study Completion: 2014-10
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
shape and volume assessing software	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.

Secondary Outcome Measures

Name	Time	Method
shape and volume assessing software	up to 3 days after surgery	6 specific points and regions in the orbit will be compared between the reconstructed and the non-affected orbit
Rate of complications	up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery	Complications will be documented at every follow-up
Clinical tests to assess vision	up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery	Globe position, visual acuity, bulbus motility and diplopia will be assessed with clinical tests

Trial Locations

Locations (6)

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Hospital de 12 Octubre; 🇪🇸 Madrid, Spain

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Niedersachsen, Germany

Bundeswehrkrankenhaus Ulm; 🇩🇪 Ulm, Germany

National University Hospital; 🇸🇬 Singapore, Singapore