NCT00955565

Accuracy of Navigation in Placement of Sacroiliac Screw

Accuracy of Navigation in Placement of Sacroiliac Screw. Multicenter Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: AO Clinical Investigation and Publishing Documentation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the precision of computer-assisted navigation for hip screw implantation to conventional fixation without navigation.

Detailed description

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.

Conditions

• Hip Fracture

Interventions

Type	Name	Description
PROCEDURE	Navigated	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.
PROCEDURE	Conventional	Subjects receive standard fluoroscopic placement of the sacroiliac screw.

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2009-08-10
• Last updated: 2010-01-07

Locations

9 sites across 3 countries: United States, Germany, United Arab Emirates