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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by AO Clinical Investigation and Documentation
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01121159
First received: May 7, 2010
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Orbital Floor Fracture
Medial Orbital Wall Fracture
Procedure: orbital fracture repair

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • shape and volume assessing software [ Time Frame: up to 3 days after surgery ] [ Designated as safety issue: No ]
    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:
  • 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


Estimated Enrollment: 170
Study Start Date: June 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121159

Contacts
Contact: Markus Zeppetzauer, MSc 0041 44 200 24 45 markus.zeppetzauer@aofoundation.org

Locations
United States, Texas
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229-3900
Contact: Edward Ellis III, Prof.    210-567-3470    ELLISE3@UTHSCSA.EDU   
Principal Investigator: Edward Ellis III, Prof.         
Germany
Medizinische Hochschule Hannover Recruiting
Hannover, Niedersachsen, Germany, 30625
Contact: Nils-Claudius Gellrich, Professor    49 511 532 4748    Gellrich.Nils-Claudius@MH-Hannover.de   
Principal Investigator: Nils-Claudius Gellrich, Professor         
Universitätsklinikum Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Rainer Schmelzeisen, Prof.    +49 761 270 47 01    rainer.schmelzeisen@uniklinik-freiburg.de   
Principal Investigator: Rainer Schmelzeisen, Prof.         
Bundeswehrkrankenhaus Ulm Recruiting
Ulm, Germany, 89081
Contact: Alexander Schramm, Prof.    +4973117101701    alexander.schramm@extern.uni-ulm.de   
Principal Investigator: Alexander Schramm, Prof.         
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Lim Thiam Chye, Prof.    +65 6772 4240    thiam_chye_lim@nuhs.edu.sg   
Principal Investigator: Lim Thiam Chye, Prof.         
Spain
Hospital de 12 Octubre Recruiting
Madrid, Spain, 28041
Contact: Aniceto G Sanchez, Prof. Dr.    +34 91 400 82 57    gsaniceto@meytel.net   
Principal Investigator: Aniceto G Sanchez, Prof.         
Sponsors and Collaborators
AO Clinical Investigation and Documentation
  More Information

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT01121159     History of Changes
Other Study ID Numbers: Orbita 3
Study First Received: May 7, 2010
Last Updated: March 18, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014