Accuracy of Navigation in Placement of Sacroiliac Screw

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00955565

Enrollment

150

Registered

2009-08-10

Start date

2008-06-30

Completion date

2010-01-31

Last updated

2010-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fracture

Brief 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.

Interventions

PROCEDURENavigated

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.

PROCEDUREConventional

Subjects receive standard fluoroscopic placement of the sacroiliac screw.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Radiologically confirmed sacroiliac dislocation or sacroiliac fracture * Sacroiliac arthritis * Age 18 years and more * Written informed consent by patient or his/her legal representative

Exclusion criteria

* Poor life expectancy (\<3months) * Fracture of pathologic origin * History of substance abuse (recreational drugs, alcohol)within 12 months prior to screening * Prisoner * Currently involved in another study that precludes or complicates participation * Disease or condition that would preclude accurate evaluation (e.g., significant psychiatric disease)

Design outcomes

Primary

Measure	Time frame
Proportion of misplaced sacroiliac screws as evaluated by postop CT-scanning.	2 days

Secondary

Measure	Time frame
Fluoroscopic time, complications and surgery duration.	2 days

Countries

Germany, United Arab Emirates, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026