NCT06020417 Pedicle Screw Malposition in Spine Arthrodesis Surgeries With O-ARM-guided Navigation
| NCT ID | NCT06020417 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federal University of Piaui |
| Condition | Spinal Fusion |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 124 participants in total. It began in 2024-08-01 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Carlos Eduardo B Lima, MD, PhD
PRINCIPAL INVESTIGATOR
Federal University of Piaui
Frequently Asked Questions
Who can join the NCT06020417 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Fusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06020417 currently recruiting?
Yes, NCT06020417 is actively recruiting participants. Contact the research team at carlos.lima@ufpi.edu.br for enrollment information.
Where is the NCT06020417 trial being conducted?
This trial is being conducted at Teresina, Brazil.
Who is sponsoring the NCT06020417 clinical trial?
NCT06020417 is sponsored by Federal University of Piaui. The principal investigator is Carlos Eduardo B Lima, MD, PhD at Federal University of Piaui. The trial plans to enroll 124 participants.