Using O-ARM navigation to improve screw placement in spine surgeries
Occurrence of Pedicle Screw Malposition in Spine Arthrodesis Surgeries Performed With O-ARM-guided Navigation at a University Hospital: a Randomized Controlled Trial
This study is testing if using O-ARM technology during spine surgery helps doctors place screws more accurately for patients with spinal deformities compared to traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Federal University of Piaui Academic / other |
| Locations | 1 site (Teresina, Piauí) |
| Trial ID | NCT06020417 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of O-ARM-guided navigation in reducing the incidence of misplaced screws during spinal arthrodesis surgeries. It is a prospective and randomized study conducted at the University Hospital of the Federal University of Piauí, focusing on patients with spinal deformities. Participants will be divided into two groups: one receiving surgery with O-ARM technology and the other undergoing conventional surgery without it. The study aims to compare the outcomes of screw placement accuracy between the two approaches.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with surgical indications for spine arthrodesis due to spinal deformities.
Not a fit: Patients with anatomical abnormalities that prevent the use of neuronavigation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of complications associated with misplaced screws in spinal surgeries.
How similar studies have performed: Other studies have shown promising results with neuronavigation techniques in spinal surgeries, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * spine deformities (spinal cord trauma, osteoarthritis, intervertebral disc degeneration, degenerative or isthmic spondylolisthesis, intervertebral disc degeneration, spinal stenosis and degenerative scoliosis). Exclusion Criteria: * anatomical abnormalities that can not be used the neuronavigation.
Where this trial is running
Teresina, Piauí
- Carlos Eduardo Batista de Lima — Teresina, Piauí, Brazil (Recruiting)
Study contacts
- Principal investigator: Carlos Eduardo B Lima, MD, PhD — Federal University of Piaui
- Study coordinator: Carlos E Lima, MD, PhD
- Email: carlos.lima@ufpi.edu.br
- Phone: +5586981805000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.