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RECRUITING
NCT06020417
NA

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

Sponsor: Federal University of Piaui

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2024-08-01

Completion Date

2025-12-31

Last Updated

2024-09-25

Healthy Volunteers

No

Interventions

DEVICE

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

scanner that allows imaging of screws intraoperatively

PROCEDURE

Conventional corrective surgery for arthrodesis

Conventional procedure without neuronavigation guide

Locations (1)

Carlos Eduardo Batista de Lima

Teresina, Piauí, Brazil