Occurrence of Pedicle Screw Malposition in Spine Arthrodesis Surgeries Performed With O-ARM-guided Navigation at a University Hospital: a Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the use of O-ARM guided navigation, a scanner that provides real-time imaging of screws during spine surgeries, to reduce the risk of misplaced implants in patients with spinal deformities. This prospective, randomized clinical study is conducted at the University Hospital of the Federal University of Piauí, Brazil, focusing on patients aged 18 and older undergoing spine arthrodesis surgery. The study compares surgeries performed with O-ARM technology to conventional surgeries without navigation guidance. Participants are randomly assigned to one of two groups: one receiving corrective spine surgeries with O-ARM neuronavigation, which allows real-time imaging to verify implant placement during surgery, and the other undergoing conventional spine arthrodesis procedures without this navigation aid. Conventional surgery involves disc removal, bone surface preparation, bone graft placement, and fixation of vertebrae using rods, screws, or plates. The study collects detailed surgical data including the number and position of screws and any invasion of the pedicle cortex. During the study, researchers will gather data from medical records and imaging to analyze screw placement accuracy and related outcomes. The primary outcome is the occurrence of misplaced implants evaluated within 30 days after surgery, along with secondary outcomes such as recurrent pain. Safety and ethical guidelines are followed, with participant information kept confidential. The study aims to enroll sufficient patients to compare the incidence of screw misplacement between the two surgical methods.

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