Pedicle Screw Malposition in Spine Arthrodesis Surgeries With O-ARM-guided Navigation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFederal University of Piaui

About this trial

Background: Throughout the history of spinal deformity there have been continuous advances in the surgical treatment. Although many techniques have been successfully developed despite the anatomy complex, screw placement still remains difficult with a significant risk of misplaced implants. The O-ARM guided Navigation is a scanner that allows imaging of screws intraoperatively and could be a tool to facilitate screw revision and reduce the occurrence of misplaced implants. Methods: This is a prospective and randomized clinical study that will be carried out at the University Hospital of the Federal University of Piaui, which provides exclusive assistance to patients of the Unified Health System (UHS), in northeastern Brazil.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

spine deformities (spinal cord trauma, osteoarthritis, intervertebral disc degeneration, degenerative or isthmic spondylolisthesis, intervertebral disc degeneration, spinal stenosis and degenerative scoliosis).

Disqualifiers

anatomical abnormalities that can not be used the neuronavigation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • O-ARM (Medtronic, Inc, Louisville, CO)

    Device

    scanner that allows imaging of screws intraoperatively

  • Conventional corrective surgery for arthrodesis

    Procedure/Surgery

    Conventional procedure without neuronavigation guide

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: O-Arm neuronavigatorActive comparator 1 intervention
Group B: ConventionalPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

misplaced implant

medial and/or lateral deviations

Time frame
30 days

Secondary outcomes

1

recurrent pain

ocurrence of posoperative pain and persistence of symptoms after surgery

Time frame
30 days

Other outcomes

Sponsors and contacts

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