About this trial
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
This trial does not accept healthy volunteersQualifiers
spine deformities (spinal cord trauma, osteoarthritis, intervertebral disc degeneration, degenerative or isthmic spondylolisthesis, intervertebral disc degeneration, spinal stenosis and degenerative scoliosis).
Disqualifiers
anatomical abnormalities that can not be used the neuronavigation.
Trial design
Parallel
Treatments tested in this trial
O-ARM (Medtronic, Inc, Louisville, CO)
Devicescanner that allows imaging of screws intraoperatively
Conventional corrective surgery for arthrodesis
Procedure/SurgeryConventional procedure without neuronavigation guide
Treatment groups
Trial outcomes
Primary outcomes
misplaced implant
medial and/or lateral deviations
Secondary outcomes
recurrent pain
ocurrence of posoperative pain and persistence of symptoms after surgery
Sponsors and contacts
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