Accuracy of Navigation in Placement of Sacroiliac Screw

This study has been completed.
Sponsor:
Information provided by:
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00955565
First received: July 17, 2009
Last updated: January 6, 2010
Last verified: January 2010
  Purpose

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


Condition Intervention Phase
Hip Fracture
Procedure: Navigated
Procedure: Conventional
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Accuracy of Navigation in Placement of Sacroiliac Screw. Multicenter Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • Proportion of misplaced sacroiliac screws as evaluated by postop CT-scanning. [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fluoroscopic time, complications and surgery duration. [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: June 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: BrainLab Vector Vision®Trauma Navigation Software
Active Comparator: Conventional Procedure: Conventional
Subjects receive standard fluoroscopic placement of the sacroiliac screw.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955565

Locations
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908-0159
Germany
Charité Berlin, Campus Virchow Klinikum
Berlin, Germany, 13353
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Universitätsklinikum des Saarlandes
Homburg, Germany, 66421
Klinikum rechts der Isar der TU München
München, Germany, 81675
Universitätsklinikum Münster
Münster, Germany, 48149
Katharinenhospital
Stuttgart, Germany, 70174
Universität Ulm
Ulm, Germany, 89075
United Arab Emirates
Rashid Hospital
Dubai, United Arab Emirates
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
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
  More Information

No publications provided

Responsible Party: Ulrich C. Stöckle, Klinikum rechts der Isar der TU München
ClinicalTrials.gov Identifier: NCT00955565     History of Changes
Other Study ID Numbers: Sacroliac screw-08
Study First Received: July 17, 2009
Last Updated: January 6, 2010
Health Authority: Germany: Ethics Commission
United States: Institutional Review Board
United Arab Emirates: General Authority for Health Services for Abu Dhabi

Additional relevant MeSH terms:
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on April 15, 2014