Clinical trial NCT01121159: Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orbital Floor Fracture
Medial Orbital Wall Fracture
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2010-05-12
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: shape and volume assessing software
timeFrame: up to 3 days after surgery
Secondary outcomes:
measure: shape and volume assessing software
timeFrame: up to 3 days after surgery
measure: Clinical tests to assess vision
timeFrame: up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery
measure: Rate of complications
timeFrame: up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Ulm
country: Germany
facility: Bundeswehrkrankenhaus Ulm
city: Singapore
country: Singapore
facility: National University Hospital
city: Madrid
country: Spain
facility: Hospital de 12 Octubre
Study officials:
affiliation: Medizinische Hachschule Hannover
name: Niels Gellrich, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.