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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01121159
Other study ID # Orbita3
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03011047 - Efficacy of Endoscopic Transantral Surgical Approach in the Repair of Orbital Blow-Out Fractures N/A
Recruiting NCT06369129 - Accuracy& Orbital Volume Using Patient Specific Titanium Implant Vs Zirconia for Orbital Floor Reconstruction N/A