Clinical Trial

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

Study acronym: NoHARM

Recruiting

Record status

This record was last updated September 25, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 3 amendments

This ClinicalTrials.gov record has been amended 3 times since 2023-08-28; most recent amendment 2024-09-24.

Status change: Not Yet Recruiting → Recruiting 2024-09-24

Trial Details

NCT Number	NCT06020417
Lead Sponsor	Federal University of Piaui
Conditions	Spinal Fusion, Spinal Deformity, Spine Injury
Enrollment	124 participants
Start Date	2024-08-01
Primary Completion	2024-12-31 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2024-09-25