Accuracy of Navigation in Placement of Sacroiliac Screw
The purpose of this study is to compare the precision of computer-assisted navigation for hip screw implantation to conventional fixation without navigation.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Accuracy of Navigation in Placement of Sacroiliac Screw. Multicenter Randomized Controlled Trial|
- Proportion of misplaced sacroiliac screws as evaluated by postop CT-scanning. [ Time Frame: 2 days ] [ Designated as safety issue: No ]
- Fluoroscopic time, complications and surgery duration. [ Time Frame: 2 days ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Subjects receive receive computer assisted placement of the sacroiliac screws. The computer assisted placement will be performed by using the BrainLab Vector Vision®Trauma Navigation Software. Two approaches will be used, the 2D navigation and 3D navigation.
Other Name: BrainLab Vector Vision®Trauma Navigation Software
|Active Comparator: Conventional||
Subjects receive standard fluoroscopic placement of the sacroiliac screw.
Standard treatment for sacroiliac dislocations and sacroiliac fractures is placement of two screws through the iliosacral joint into the sacral ala or the body of the S1 vertebra. Correct positioning is technically demanding. Screw displacement may reduce the strength of fixation and lead to neurological complications.
Secondary objectives of the study are to compare the fluoroscopy time, complications and surgery duration between the treatments.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955565
|United States, Virginia|
|University of Virginia Health System|
|Charlottesville, Virginia, United States, 22908-0159|
|Charité Berlin, Campus Virchow Klinikum|
|Berlin, Germany, 13353|
|Medizinische Hochschule Hannover|
|Hannover, Germany, 30625|
|Universitätsklinikum des Saarlandes|
|Homburg, Germany, 66421|
|Klinikum rechts der Isar der TU München|
|München, Germany, 81675|
|Münster, Germany, 48149|
|Stuttgart, Germany, 70174|
|Ulm, Germany, 89075|
|United Arab Emirates|
|Dubai, United Arab Emirates|
|Study Director:||Beate P. Hanson, MD||AO Clinical Investigation and Documentation, Davos, Switzerland|
|Principal Investigator:||Ulrich C. Stöckle, Prof. MD||Klinikum rechts der Isar der TU München|