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

NCT06020417 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-09-25

No results posted yet for this study

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.

Conditions

  • Spinal Fusion
  • Spinal Deformity
  • Spine Injury

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

Sponsors & Collaborators

  • Federal University of Piaui

    lead OTHER

Principal Investigators

  • Carlos Eduardo B Lima, MD, PhD · Federal University of Piaui

  • Denilson G Italiano, Sr. · Federal University of Piaui

  • Mauricio Giraldi, MD, MSc · University Hospital of Federal University of Piaui

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2024-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06020417 on ClinicalTrials.gov