Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants

Orbital Floor Fracture Clinical Trial

— Orbita 3  

Official title:

A Prospective Multicenter Study to Compare the Accuracy of Posttraumatic Orbital Reconstruction of the Medial Orbital Wall and/or the Orbital Floor With Preoperatively Preformed Versus Non-preformed Orbital Plates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121159
• Other study ID #: Orbita3
• Status: Completed
• Start date: June 2010
• Est. completion date: October 2014

Study information

• Verified date: August 2020
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: October 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Medial Orbital Wall Fracture
• Orbital Floor Fracture

Intervention

Procedure:
• orbital fracture repair
All patients will receive orbital fracture repair with one of the 4 specified implants

Locations

Country	Name	City	State
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen
Germany	Bundeswehrkrankenhaus Ulm	Ulm
Singapore	National University Hospital	Singapore
Spain	Hospital de 12 Octubre	Madrid
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation

Countries where clinical trial is conducted

United States,  Germany,  Singapore,  Spain, 

References & Publications (2)

Zimmerer RM, Ellis E 3rd, Aniceto GS, Schramm A, Wagner ME, Grant MP, Cornelius CP, Strong EB, Rana M, Chye LT, Calle AR, Wilde F, Perez D, Tavassol F, Bittermann G, Mahoney NR, Alamillos MR, Bašic J, Dittmann J, Rasse M, Gellrich NC. A prospective multic — View Citation

Zimmerer RM, Gellrich NC, von Bülow S, Strong EB, Ellis E 3rd, Wagner MEH, Sanchez Aniceto G, Schramm A, Grant MP, Thiam Chye L, Rivero Calle A, Wilde F, Perez D, Bittermann G, Mahoney NR, Redondo Alamillos M, Bašic J, Metzger M, Rasse M, Dittman J, Romet — View Citation

Outcome

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

External Links

•   Link to published results
•   Link to published results