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The purpose of this study is to compare the precision of computer-assisted navigation for hip screw implantation to conventional fixation without navigation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navigated | Experimental |
| |
| Conventional | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navigated | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of misplaced sacroiliac screws as evaluated by postop CT-scanning. | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Fluoroscopic time, complications and surgery duration. | 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beate P. Hanson, MD | AO Clinical Investigation and Documentation, Davos, Switzerland | Study Director |
| Ulrich C. Stöckle, Prof. MD | Klinikum rechts der Isar der TU München | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Health System | Charlottesville | Virginia | 22908-0159 | United States | ||
| Charité Berlin, Campus Virchow Klinikum |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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|
|
| Conventional | Procedure | Subjects receive standard fluoroscopic placement of the sacroiliac screw. |
|
| Berlin |
| 13353 |
| Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitätsklinikum des Saarlandes | Homburg | 66421 | Germany |
| Klinikum rechts der Isar der TU München | München | 81675 | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Katharinenhospital | Stuttgart | 70174 | Germany |
| Universität Ulm | Ulm | 89075 | Germany |
| Rashid Hospital | Dubai | United Arab Emirates |
| D007869 |
| Leg Injuries |