RecruitingNot ApplicableNCT06020417

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

Occurrence of Pedicle Screw Malposition in Spine Arthrodesis Surgeries Performed With O-ARM-guided Navigation at a University Hospital: a Randomized Controlled Trial


Sponsor

Federal University of Piaui

Enrollment

124 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria1

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

Exclusion Criteria1

  • anatomical abnormalities that can not be used the neuronavigation.

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Interventions

DEVICEO-ARM (Medtronic, Inc, Louisville, CO)

scanner that allows imaging of screws intraoperatively

PROCEDUREConventional corrective surgery for arthrodesis

Conventional procedure without neuronavigation guide


Locations(1)

Carlos Eduardo Batista de Lima

Teresina, Piauí, Brazil

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NCT06020417


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