Accuracy of Navigation in Placement of Sacroiliac Screw

Hip Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955565
• Other study ID #: Sacroliac screw-08
• Status: Completed
• Phase: Phase 4
• First received: July 17, 2009
• Last updated: January 6, 2010
• Start date: June 2008
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: AO Clinical Investigation and Documentation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionUnited States: Institutional Review BoardUnited Arab Emirates: General Authority for Health Services for Abu Dhabi
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Fracture
• Hip Fractures

Intervention

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.
• Conventional
Subjects receive standard fluoroscopic placement of the sacroiliac screw.

Locations

Country	Name	City	State
Germany	Charité Berlin, Campus Virchow Klinikum	Berlin
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum des Saarlandes	Homburg
Germany	Klinikum rechts der Isar der TU München	München
Germany	Universitätsklinikum Münster	Münster
Germany	Katharinenhospital	Stuttgart
Germany	Universität Ulm	Ulm
United Arab Emirates	Rashid Hospital	Dubai
United States	University of Virginia Health System	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Documentation

Countries where clinical trial is conducted

United States,  Germany,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of misplaced sacroiliac screws as evaluated by postop CT-scanning.		2 days	No
Secondary	Fluoroscopic time, complications and surgery duration.		2 days	No