Accuracy of Navigation in Placement of Sacroiliac Screw

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hip Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Navigated

Group Type EXPERIMENTAL

Navigated

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

Conventional

Intervention Type PROCEDURE

Subjects receive standard fluoroscopic placement of the sacroiliac screw.

Interventions

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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.

Intervention Type PROCEDURE

Conventional

Subjects receive standard fluoroscopic placement of the sacroiliac screw.

Intervention Type PROCEDURE

Other Intervention Names

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BrainLab Vector Vision®Trauma Navigation Software

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No