Accuracy of Navigation in Placement of Sacroiliac Screw

Phase 4

Completed

• Conditions: Hip Fracture
• Interventions: Procedure: Navigated; Procedure: Conventional

• Registration Number: NCT00955565
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-07-17
• Study First Submitted QC: 2009-08-07
• Study First Posted: 2009-08-10
• Status Verified: 2010-01
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2010-01-06
• Last Update Posted: 2010-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Navigated	Navigated	-
Conventional	Conventional	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Fluoroscopic time, complications and surgery duration.	2 days

Trial Locations

Locations (9)

Rashid Hospital; 🇦🇪 Dubai, United Arab Emirates

Katharinenhospital; 🇩🇪 Stuttgart, Germany

Charité Berlin, Campus Virchow Klinikum; 🇩🇪 Berlin, Germany

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States

Universitätsklinikum des Saarlandes; 🇩🇪 Homburg, Germany

Klinikum rechts der Isar der TU München; 🇩🇪 München, Germany

Universität Ulm; 🇩🇪 Ulm, Germany

Universitätsklinikum Münster; 🇩🇪 Münster, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany