Clinical StudyEconomic evaluation comparing intraoperative cone beam CT-based navigation and conventional fluoroscopy for the placement of spinal pedicle screws: a patient-level data cost-effectiveness analysis
Section snippets
Background
The insertion of pedicle screws within the thoracolumbar spine is routinely performed. There are two main methods of spinal pedicle screw insertion: the computer-assisted surgery (CAS) (“navigated”) technique and the traditional free-hand (“non-navigated”) method. Fluoroscopy-assisted screw insertion is the most popular method when intraoperative navigation is not used. The CAS technique involves the use of intraoperative navigation that necessitates preoperative or intraoperative 2-D or 3-D
Research objective or hypothesis
The goal of this study was to perform a patient-level cost-effectiveness analysis to determine the value of a navigation system coupled with intra-operative 3-D imaging (O-arm and the S7 StealthStation navigation system, Medtronic, Louisville, CO, USA) in adult spinal surgery. By potentially preventing reoperation for symptomatic hardware malposition, we hypothesized that the use of the O-arm and the StealthStation navigation system would be associated with better outcomes and decreased costs
Methods
A patient-level data cost-effectiveness analysis was conducted as described below. This study was based on a single center observational study of prospectively collected data.
Results
Our study comprised a total of 502 patients in whom 5,132 pedicle screws were inserted. The mean age of the study population was 55 years and 51% of the population was male. There were 253 patients who had 2,682 screws inserted using the O-arm or StealthStation navigation system (Group 1), whereas 249 patients had 2,450 screws inserted with the conventional fluoroscopy-assisted method (Group 2). As per our case-matching process, there were no significant differences in age, sex, number of
Discussion
Using rigorous patient-level data and outcomes methodology, we showed that the use of a more accurate technology for spine pedicle screw placement is more cost-effective than previously anticipated. To our knowledge, this report is the first full economic evaluation comparing the usage of cone-beam CT-guided navigation and conventional fluoroscopy for the placement of pedicle screws. Numerous other economic evaluations of adjunct technologies for pedicle screw insertion placement have been
Conclusions
Computer-assisted spinal surgery has the potential to reduce reoperation rates and thus to have important cost-effectiveness implications. High acquisition and maintenance costs of CAS can be offset by high reoperation costs. Our cost-effectiveness analysis has also shown that for high-volume centers (greater than 250 spinal instrumentations annually) with a case-mix and complexity similar to the patient cohort of the present study, this technology is economically justified. We believe that
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Cited by (0)
FDA device/drug status: Approved (O-Arm Imaging system, StealthStation S7 Navigation System, C-Arm Imaging System).
Author disclosures: ND: Grant: Medtronic (E, Paid directly to institution/employer), pertaining to the submitted work; Speaking and/or Teaching Arrangements (B, Paid directly to author), outside the submitted work. CGF: Board membership: Medtronic, Inc (Grant, Personal fees, Non-financial support, Other), outside the submitted work. JB: Nothing to disclose. JS: Nothing to disclose. DM: Nothing to disclose. SJP: Grant: Medtronic Navigation (F, Paid directly to institution/employer), pertaining to the submitted work. BKK: Grant: Medtronic Navigation (F, Paid directly to institution/employer), pertaining to the submitted work; Fellowship Support: Medtronic, Depuy-Synthes (F, Paid directly to institution/employer), outside the submitted work. MDB: Nothing to disclose. MFSD: Grant: Medtronic (Personal fees, Non-financial support), outside the submitted work. JTS: Grant: Medtronic, Inc, (F, during conduct of the study).
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