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Accuracy of Navigation in Placement of Sacroiliac Screw

A

AO Clinical Investigation and Publishing Documentation

Status and phase

Completed
Phase 4

Conditions

Hip Fracture

Treatments

Procedure: Navigated
Procedure: Conventional

Study type

Interventional

Funder types

Other

Identifiers

NCT00955565
Sacroliac screw-08

Details and patient eligibility

About

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

Full 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.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

150 participants in 2 patient groups

Navigated
Experimental group
Treatment:
Procedure: Navigated
Conventional
Active Comparator group
Treatment:
Procedure: Conventional

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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