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Completed

NCT Number: NCT00955565

Accuracy of Navigation in Placement of Sacroiliac Screw

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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Key information

Conditions

Hip Fracture Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Charité Berlin, Campus Virchow Klinikum, Berlin, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Navigated

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.

Other names: BrainLab Vector Vision®Trauma Navigation Software

Conventional

Procedure

Subjects receive standard fluoroscopic placement of the sacroiliac screw.

Primary outcomes

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

    Time frame: 2 days

Secondary outcomes

  1. Fluoroscopic time, complications and surgery duration.

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 10, 2009
Registry last updated
Jan 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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