Digital navigation enhances cervical pedicle screw placement accuracy and safety: study protocol of a randomized controlled trial

Abstract

Background: A unified standard for cervical pedicle screw placement does not currently exist; therefore, it is difficult to quantitatively evaluate the clinical effects of the technique. Digital navigation can provide a reference for accurate and safe location, orientation, and placement of cervical pedicle screws. We hypothesized that compared with partial cervical lamina excision or the pipeline-dredge discharge method, digital navigation can greatly increase the accuracy and safety of cervical pedicle screw placement. Methods/Design: This was a prospective, single-center, randomized controlled, open-label trial. Seventy-six patients with cervical spine fracture scheduled to receive treatment in the Department of Orthopedics, Affiliated Hospital of Nantong University, China were randomly divided into three groups to undergo cervical pedicle screw internal fixation. Patients in the cervical lamina partial excision group ( n = 26, 160 screws) underwent partial cervical lamina excision and cervical pedicle screw internal fixation; those in the pipeline-dredge discharge group ( n = 27, 156 screws) underwent pipeline-dredge discharge and cervical pedicle screw internal fixation; and those in the digital navigation group ( n = 23, 162 screws) underwent digital navigation-assisted cervical pedicle placement. All patients were evaluated at 12 and 36 months. The primary outcome was the percentage of screws graded I when evaluating the penetration degree of the cervical pedicle screws, which evaluates the accuracy of screw placement, 12 months after internal fixation. Secondary outcomes included: (1) the percentage of screws graded I when evaluating the penetration degree of cervical pedicle screws 36 months after internal fixation; (2) bony fusion rate of the atlantoaxial joint, used to evaluate fracture healing, 12 and 36 months after internal fixation; (3) Visual Analogue Scale spine score, used to evaluate cervical neck pain, prior to and 12 and 36 months after internal fixation; (4) American Spinal Injury Association Classification, used to evaluate improvement in neurological function, prior to and 12 and 36 months after internal fixation; and (5) adverse events, used to evaluate the safety of each pedicle screw implantation method, 12 and 36 months after internal fixation. Discussion: This trial protocol compared the effects of three cervical pedicle screw internal fixation methods for the treatment of cervical spine fracture, and investigated and compared the accuracy and safety of digital navigation-assisted cervical pedicle screw placement with partial cervical lamina excision and pipeline-dredge discharge. We hoped to provide quantitative evidence for the clinical use of digital navigation in orthopedics, especially in cervical pedicle screw placement. Trial registration: ClinicalTrial.gov identifier: NCT02880839; registered on 19 August 2016. Ethics: This trial protocol has been approved by Medical Ethics Committee, Affiliated Hospital of Nantong University, China, and was performed in accordance with the guidelines of the Declaration of Helsinki , formulated by the World Medical Association. Informed consent: Signed informed consent regarding trial procedure and treatment was obtained from each patient.