Accuracy of Navigation in Placement of Sacroiliac Screw
1 other identifier
interventional
150
3 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2008
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 17, 2009
CompletedFirst Posted
Study publicly available on registry
August 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedJanuary 7, 2010
January 1, 2010
1.6 years
July 17, 2009
January 6, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of misplaced sacroiliac screws as evaluated by postop CT-scanning.
2 days
Secondary Outcomes (1)
Fluoroscopic time, complications and surgery duration.
2 days
Study Arms (2)
Navigated
EXPERIMENTALConventional
ACTIVE COMPARATORInterventions
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.
Subjects receive standard fluoroscopic placement of the sacroiliac screw.
Eligibility Criteria
You may qualify if:
- Radiologically confirmed sacroiliac dislocation or sacroiliac fracture
- Sacroiliac arthritis
- Age 18 years and more
- Written informed consent by patient or his/her legal representative
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
University of Virginia Health System
Charlottesville, Virginia, 22908-0159, United States
Charité Berlin, Campus Virchow Klinikum
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 17, 2009
First Posted
August 10, 2009
Study Start
June 1, 2008
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
January 7, 2010
Record last verified: 2010-01