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

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

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.

Study Overview

• Status: Completed
• Conditions: Orbital Floor Fracture; Medial Orbital Wall Fracture
• Intervention / Treatment: Procedure: orbital fracture repair

• Study Type: Observational
• Enrollment (Actual): 185

Contacts and Locations

Study Locations

• Germany
  • Freiburg, Germany, 79106
    • Universitätsklinikum Freiburg
  • Ulm, Germany, 89081
    • Bundeswehrkrankenhaus Ulm
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Medizinische Hochschule Hannover
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital
• Spain
  • Madrid, Spain, 28041
    • Hospital de 12 Octubre
• United States
  • Texas
    • San Antonio, Texas, United States, 78229-3900
      • University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preoperatively preformed orbital plates; Reconstruction with MatrixMIDFACE Preformed Orbital Plate (Synthes) or Custom-made orbital implant	Procedure: orbital fracture repair; All patients will receive orbital fracture repair with one of the 4 specified implants
Non-preformed orbital plates; Reconstruction with Orbital Floor Mesh Plate or SynPOR Titanium Reinforced Fan Sheet (both Synthes)	Procedure: orbital fracture repair; All patients will receive orbital fracture repair with one of the 4 specified implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation
• Investigators: Principal Investigator: Niels Gellrich, Prof, Medizinische Hachschule Hannover

Publications and helpful links

General Publications

• 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, Basic J, Dittmann J, Rasse M, Gellrich NC. A prospective multicenter study to compare the precision of posttraumatic internal orbital reconstruction with standard preformed and individualized orbital implants. J Craniomaxillofac Surg. 2016 Sep;44(9):1485-97. doi: 10.1016/j.jcms.2016.07.014. Epub 2016 Jul 21.
• Zimmerer RM, Gellrich NC, von Bulow 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, Basic J, Metzger M, Rasse M, Dittman J, Rometsch E, Espinoza K, Hesse R, Cornelius CP. Is there more to the clinical outcome in posttraumatic reconstruction of the inferior and medial orbital walls than accuracy of implant placement and implant surface contouring? A prospective multicenter study to identify predictors of clinical outcome. J Craniomaxillofac Surg. 2018 Apr;46(4):578-587. doi: 10.1016/j.jcms.2018.01.007. Epub 2018 Feb 1.

Helpful Links

• Link to published results
• Link to published results

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: May 7, 2010
• First Submitted That Met QC Criteria: May 10, 2010
• First Posted (ESTIMATE): May 12, 2010

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: Orbita3