Accuracy of Navigation in Placement of Sacroiliac Screw

January 6, 2010 updated by: AO Clinical Investigation and Publishing Documentation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Charité Berlin, Campus Virchow Klinikum
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Homburg, Germany, 66421
        • Universitätsklinikum des Saarlandes
      • München, Germany, 81675
        • Klinikum Rechts der Isar der TU München
      • Münster, Germany, 48149
        • Universitätsklinikum Münster
      • Stuttgart, Germany, 70174
        • Katharinenhospital
      • Ulm, Germany, 89075
        • Universitat Ulm
  • United Arab Emirates
      • Dubai, United Arab Emirates
        • Rashid hospital
  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908-0159
        • University Of Virginia Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional
Procedure: Conventional
Subjects receive standard fluoroscopic placement of the sacroiliac screw.
Experimental: Navigated
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.
Other Names:
  • BrainLab Vector Vision®Trauma Navigation Software

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Fluoroscopic time, complications and surgery duration.
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AO Clinical Investigation and Publishing Documentation

Investigators

  • Principal Investigator: Ulrich C. Stöckle, Prof. MD, Klinikum Rechts der Isar der TU München

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

July 17, 2009

First Submitted That Met QC Criteria

August 7, 2009

First Posted (Estimate)

August 10, 2009

Study Record Updates

Last Update Posted (Estimate)

January 7, 2010

Last Update Submitted That Met QC Criteria

January 6, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sacroliac screw-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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