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Clinical Trials/NCT00955565
NCT00955565
Completed
Phase 4

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

AO Clinical Investigation and Publishing Documentation9 sites in 3 countries150 target enrollmentJune 2008
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ConditionsHip Fracture

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Hip Fracture
Sponsor
AO Clinical Investigation and Publishing Documentation
Enrollment
150
Locations
9
Primary Endpoint
Proportion of misplaced sacroiliac screws as evaluated by postop CT-scanning.
Status
Completed
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2008
End Date
January 2010
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
AO Clinical Investigation and Publishing Documentation

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
  • •Currently involved in another study that precludes or complicates participation
  • •Disease or condition that would preclude accurate evaluation (e.g., significant psychiatric disease)

Outcomes

Primary Outcomes

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

Time Frame: 2 days

Secondary Outcomes

  • Fluoroscopic time, complications and surgery duration.(2 days)

Study Sites (9)

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