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Accuracy of Navigation in Placement of Sacroiliac Screw

Primary Purpose

Hip Fracture

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Navigated
Conventional
Sponsored by
AO Clinical Investigation and Publishing Documentation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Virginia Health System
  • Charité Berlin, Campus Virchow Klinikum
  • Medizinische Hochschule Hannover
  • Universitätsklinikum des Saarlandes
  • Klinikum rechts der Isar der TU München
  • Universitätsklinikum Münster
  • Katharinenhospital
  • Universität Ulm
  • Rashid Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Navigated

Conventional

Arm Description

Outcomes

Primary Outcome Measures

Proportion of misplaced sacroiliac screws as evaluated by postop CT-scanning.

Secondary Outcome Measures

Fluoroscopic time, complications and surgery duration.

Full Information

First Posted
July 17, 2009
Last Updated
January 6, 2010
Sponsor
AO Clinical Investigation and Publishing Documentation
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1. Study Identification

Unique Protocol Identification Number
NCT00955565
Brief Title
Accuracy of Navigation in Placement of Sacroiliac Screw
Official Title
Accuracy of Navigation in Placement of Sacroiliac Screw. Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AO Clinical Investigation and Publishing Documentation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Navigated
Arm Type
Experimental
Arm Title
Conventional
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Navigated
Other Intervention Name(s)
BrainLab Vector Vision®Trauma Navigation Software
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional
Intervention Description
Subjects receive standard fluoroscopic placement of the sacroiliac screw.
Primary Outcome Measure Information:
Title
Proportion of misplaced sacroiliac screws as evaluated by postop CT-scanning.
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Fluoroscopic time, complications and surgery duration.
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beate P. Hanson, MD
Organizational Affiliation
AO Clinical Investigation and Documentation, Davos, Switzerland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ulrich C. Stöckle, Prof. MD
Organizational Affiliation
Klinikum rechts der Isar der TU München
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908-0159
Country
United States
Facility Name
Charité Berlin, Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Klinikum rechts der Isar der TU München
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Katharinenhospital
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany
Facility Name
Universität Ulm
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
Rashid Hospital
City
Dubai
Country
United Arab Emirates

12. IPD Sharing Statement

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Accuracy of Navigation in Placement of Sacroiliac Screw

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