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NCT01121159 · ClinicalTrials.gov registry record
Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants
A clinical trial of Orbital Floor Fracture and Medial Orbital Wall Fracture, sponsored by AO Clinical Investigation and Publishing Documentation.
- Completed
- Registry status
- 185
- Enrollment target
- 6
- Study locations
NCT01121159: Completed study of Orbital Floor Fracture and Medial Orbital Wall Fracture, sponsored by AO Clinical Investigation and Publishing Documentation.
NCT01121159 is a study of Orbital Floor Fracture and Medial Orbital Wall Fracture that has completed, run by AO Clinical Investigation and Publishing Documentation. The registered enrollment target is 185 participants. The trial reports 6 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01121159, a study of Orbital Floor Fracture and Medial Orbital Wall Fracture, has completed, sponsored by AO Clinical Investigation and Publishing Documentation.
- COMPLETED
- Registry status
- 185 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE orbital fracture repair
Study Locations (6)
Other
- Universitätsklinikum Freiburg - Freiburg im Breisgau
- Bundeswehrkrankenhaus Ulm - Ulm
- National University Hospital - Singapore
- Hospital de 12 Octubre - Madrid
Texas
- University of Texas Health Science Center at San Antonio - San Antonio
Lower Saxony
- Medizinische Hochschule Hannover - Hanover
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2010-06 |
| Est. Completion | 2014-10 |
What the finished NCT01121159 record still lists
NCT01121159 is an observational study that tracks outcomes without assigning an intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap.
The record links to 2 conditions, with Orbital Floor Fracture appearing as the primary indexed condition, and to 1 intervention - of which orbital fracture repair is the first listed.
NCT01121159 lists 6 locations in 3 states (Other, Texas, Lower Saxony).
Frequently Asked Questions
What is clinical trial NCT01121159 about?
NCT01121159 is a clinical study titled "Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants". 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.
What is the current status of trial NCT01121159?
This trial is currently completed. The enrollment target is 185 participants. The study started on 2010-06. Estimated completion is 2014-10.
What conditions does trial NCT01121159 study?
This clinical trial studies the following conditions: Orbital Floor Fracture, Medial Orbital Wall Fracture.
What interventions are being tested in trial NCT01121159?
The interventions under investigation include: orbital fracture repair (PROCEDURE).
Who is sponsoring clinical trial NCT01121159?
This trial is sponsored by AO Clinical Investigation and Publishing Documentation, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01121159 being conducted?
This trial has 6 study locations across Texas, Lower Saxony. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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