Elsevier

World Neurosurgery

Volume 116, August 2018, Pages 433-443.e8
World Neurosurgery

Literature Review
Pedicle Screw Revision in Robot-Guided, Navigated, and Freehand Thoracolumbar Instrumentation: A Systematic Review and Meta-Analysis

https://doi.org/10.1016/j.wneu.2018.05.159Get rights and content

Highlights

  • Clinically relevant intraoperative and postoperative pedicle screw revision was the primary end point.

  • We compared robot-guided, navigated, and freehand thoracolumbar fusion procedures.

  • 37 controlled studies with 7095 patients were included in the quantitative meta-analysis.

  • Both robotic guidance and navigation reduced the incidence of postoperative revisions.

  • Higher-powered clinical trials are necessary to validate our findings with more confidence.

Objective

Various computer-based guidance systems have been devised to reduce costly screw-related complications, yet their clinical effectiveness has never been comparatively assessed in a meta-analysis. We aimed to evaluate the incidence of clinically relevant pedicle screw revisions among robot-guided, navigated, and freehand spinal instrumentation.

Methods

Controlled trials comparing robot-guided, navigated, or freehand spinal instrumentation for any indication and that specifically reported the proportion of patients who experienced pedicle screw revisions were included. Estimates were pooled using random-effects meta-analyses. Sensitivity analyses including zero-event trials and assessing per screw incidences were carried out.

Results

Among 37 studies (7095 patients), intraoperative revisions in robot-guided (odds ratio [OR], 3.6; 95% confidence interval [CI], 0.7–19.4; P = 0.14) and navigated (OR, 1.5; 95% CI, 0.3–7.2; P = 0.64) procedures were comparable to freehand. Although postoperative revisions were reduced in robot-guided (OR, 0.3; 95% CI, 0.1–0.9; P = 0.04) and navigated (OR, 0.3; 95% CI, 0.2–0.5; P < 0.001) procedures, statistical significance was lost in sensitivity analyses for robotic guidance, but not for navigation. The pooled incidence of malpositioned screws requiring postoperative revision was 2.1%.

Conclusions

Based on the available data in the peer-reviewed literature, computer assistance in the form of robotic guidance or navigation has the potential to reduce the incidence of costly and clinically relevant postoperative revisions for screw malposition. It is essential to further investigate on a higher level of evidence if the clinical benefits of computer assistance warrant the high acquisition and maintenance costs inherent to these systems.

Introduction

An estimated 3.6 million spinal instrumentations were performed in the United States between 2001 and 2010, creating >$287 billion in total charges, with a steadily increasing trend.1 Although computer-based navigation (NV) systems have long been established as standards in certain cranial procedures, adoption in spinal instrumentation has been slow.2 To operate safely and efficiently in minimally invasive procedures, in which the line of sight is limited or even nonexistent, surgeons must rely on imaging, NV, and other methods of guidance. Therefore, an abundance of systems have been developed to assist in pedicle screw placement.

Conventionally, pedicle screws have been placed without guidance by relying on anatomic landmarks, with or without the use of fluoroscopic control.3 In 1995, the concept of NV was introduced to spine surgery.4 These NV systems can approximately be divided into 2 different principles: one principle is based on matching preoperative computed tomography (CT) images with real-time intraoperative fluoroscopy, which then allows visualization of screw trajectories in real time using reference arrays.5, 6, 7, 8 The other principle instead relies on intraoperative CT or three-dimensional fluoroscopic (3DFL) imaging with landmark-based registration. However, in these NV systems, establishment of the final trajectories for drilling and screw insertion has to be made by the surgeon on the spot. Robotic guidance (RG), first introduced in 2006, allows for preoperative planning of transpedicular trajectories.9 This preoperative blueprint encompasses not only the ideal trajectory but also optimal screw angulation, length, and thickness. During surgery, an overlay of the preoperatively planned trajectories and intraoperative imaging is produced, and a stable working channel, through which screws are manually inserted, moves into position by use of a robotic arm.9, 10

Malpositioned pedicle screws cause significant added use of health resources.11 Overt malposition is usually revised intraoperatively. This situation prolongs operative time, adds radiation and tissue trauma, and has been shown to reduce pullout strength.10, 12 Screws may require revision surgery if a patient presents with postoperative neurovascular complications, which produces additional costs and perioperative morbidity.11 However, not all malpositioned pedicle screws require revision.13, 14, 15

There is some evidence that NV and RG improve the accuracy of screw placement as assessed by various radiologic grading scales.16, 17, 18 However, data on the clinical impact of malpositioned pedicle screws causing neurologic complications and associated revision surgeries is sparse in the peer-reviewed literature, and no meta-analysis has been performed on this matter.10, 13, 15 Although improved radiologic accuracy should be pursued, it is debatable that radiologic accuracy directly translates into an improved clinical outcome or a lower incidence of screw-related neurovascular complications requiring revision, especially when considering the substantial costs associated with these devices.

The aim of this meta-analysis was to evaluate all data on the incidence of pedicle screw revision using freehand (FH), NV, or RG techniques in the peer-reviewed literature.

Section snippets

Overview

A systematic review and meta-analysis of all controlled studies that compare at least 2 techniques of pedicle screw insertion (RG, NV, or FH) was carried out. The outcomes of interest were 1) the occurrence of intraoperative revisions of pedicle screws and 2) the occurrence of revision surgery (postoperative revision) for 1 or more malpositioned screws. Title and abstract screening, full-text review, and data extraction were handled independently by 2 reviewers (V.E.S. and A.M.K.), and

Literature Search

The results of the literature searches are presented in Figure 1. Our electronic literature searches yielded a combined 4655 records, with 902 excluded as duplicates. A further 3 records were identified during manual review of reference lists. After title and abstract review, 125 records remained eligible for inclusion, and their full-text records were obtained and reviewed. Thirty-seven studies (7095 patients) were included in the analysis, of which 9 (588 patients), 29 (6507 patients), and 1

Discussion

This is the first systematic review and meta-analysis to look at clinically relevant outcomes measures. Although previous analyses have focused on preclinical radiologic accuracy, we used pedicle screw revision events as a measure of clinical effectiveness of computer assistance in thoracolumbar instrumentation. We evaluated 9 studies including 588 patients that compared RG and FH procedures, and 29 studies including 6507 patients that compared NV and FH procedures. Only 1 study with all 3 arms

Conclusions

Based on the available data in the peer-reviewed literature, computer assistance in the form of RG or NV has the potential to reduce the incidence of costly and clinically relevant postoperative revisions for screw malposition. There is insufficient evidence to conclude that either RG or NV is superior to FH in terms of pedicle screw revision events. It is essential to further investigate on a higher level of evidence if the clinical benefits of computer assistance warrant the high acquisition

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      The current study represents the first reported case of minimally invasive placement of pedicle screws using augmented reality and confirms a high level of efficiency, intra-operative screw revision rate of 0.49%, and no cases of postoperative instrumentation revision. The rate of accurate pedicle screws placement using CT-based spinal navigation may be considered to lie between 89%–100% based on the best available metadata [7–9] Methods of defining accuracy and the clinical impact of screws that do not achieve radiographic perfection is of course variable and debated [4,23,24]. In our series, 3 pedicle screws were revised intraoperatively[F1] [25].

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      These prior investigations as well as the present study, further suggests the potential of iCT-Nav to reduce revision surgery-associated cost, and morbidity, by enabling the early detection of high-grade pedicle breach before the patient leaves the operating room. When a screw is observed to be inaccurately placed intraoperatively by iCT-Nav, the screw may be revised, though the process of screw revision itself adds time to the procedure, exposes the patient to more radiation and tissue trauma, may reduce the new screw's pullout strength, and can lead to new neurologic complications.29-31 If a patient presents with postoperative pain or neurologic deficit secondary to screw malposition, screw revision surgery is generally warranted.

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    Supplementary digital content available online.

    Conflict of interest statement: M.S. declares having received travel and presentation compensation from Mazor Robotics, Ltd. in the past. The other authors declare that the article and its content were composed in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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