Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06020417

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

Led by Federal University of Piaui · Updated on 2024-09-25

124

Participants Needed

1

Research Sites

73 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Diagnosed with spinal deformities including spinal cord trauma, osteoarthritis, intervertebral disc degeneration, degenerative or isthmic spondylolisthesis, spinal stenosis, or degenerative scoliosis
  • Scheduled for spine arthrodesis surgery
  • Willing to provide informed consent
Not Eligible

You will not qualify if you...

  • Presence of anatomical abnormalities that prevent the use of neuronavigation guidance during surgery
  • Inability or refusal to provide informed consent
  • Inadequate medical records that do not allow analysis for this research

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Carlos Eduardo Batista de Lima

Teresina, Piauí, Brazil, 64048-350

Actively Recruiting

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Research Team

C

Carlos E Lima, MD, PhD

CONTACT

D

Denilson G Italiano, Sr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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