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minhas
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© © All Rights Reserved
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Journal of Robotic Surgery (2020) 14:199–203

https://doi.org/10.1007/s11701-019-00959-6

ORIGINAL ARTICLE

Robotic‑assisted navigated minimally invasive pedicle screw


placement in the first 100 cases at a single institution
Kade T. Huntsman1 · Leigh A. Ahrendtsen2 · Jessica R. Riggleman2 · Charles G. Ledonio2

Received: 28 February 2019 / Accepted: 9 April 2019 / Published online: 23 April 2019
© The Author(s) 2019

Abstract
Proper pedicle screw placement is an integral part of spine fusion requiring expertly trained spine surgeons. Advances in
medical imaging guidance have improved accuracy. There is high interest in the emerging field of robot-assisted spine surgery;
however, safety and accuracy studies are needed. This study describes the pedicle screw placement of the first 100 cases in
which navigated robotic assistance was used in a private practice clinical setting. A single-surgeon, single-site retrospec-
tive Institutional Review Board-exempt review of the first 100 navigated robot-assisted spine surgery cases was performed.
An orthopaedic surgeon evaluated screw placement using plain film radiographs. In addition, pedicle screw malposition,
reposition, and return to operating room (OR) rates were collected. Results demonstrated a high level (99%) of successful
surgeon assessed pedicle screw placement in minimally invasive navigated robot-assisted spine surgery, with no malposi-
tions requiring return to the OR.

Keywords Robotic-navigated · Pedicle screw placement · Minimally invasive · Spine surgery

Introduction 6]. The procedure, benefits, and limitations of each method,


as well as comparisons between different approaches, have
Pedicle screw constructs are widely used for posterior been widely published [7, 8]. Advances in medical imag-
fixation in spinal surgery because of their biomechanical ing have improved the accuracy of pedicle screw placement
superiority and significant correction. However, safe pedi- from fluoroscopic-guided to computer-aided navigation
cle screw placement is paramount to achieving successful [8]. The most recent advancement is the use of a navigated
spine surgery [1]. Specialty training is required to avoid robotic-assisted spine surgery system designed to increase
the catastrophic neurovascular complications of misplaced the accuracy of pedicle screw placement compared to free-
screws, which occur in about 4.2% of patients [2]. Neverthe- hand placement. Clinical outcome studies are required to
less, pedicle screws are widely used in both young and adult determine pedicle screw placement accuracy when mini-
patients, with numerous articles documenting a favorable mally invasive navigated robotic-assisted spine surgery was
risk-to-benefit ratio for spinal treatment [3]. performed on the first 100 patients at a single institution.
Various techniques have been used to guide and con-
firm pedicle screw placement [4]. The use of anatomic
landmarks, plain film radiography, fluoroscopic imaging Methods
(standard or image guidance), and computed tomography
(CT) image guidance are examples of these techniques [5, An Institutional Review Board-exempt retrospective chart
review was conducted from October 2017 to September
2018 on the first 100 navigated robotic-assisted spine sur-
* Leigh A. Ahrendtsen
[email protected] geries. The demographic, intraoperative, and periopera-
tive data of 100 patients who underwent lumbosacral pedi-
1
Salt Lake Orthopaedic Clinic, Suite 500, 1160 East 3900 cle screw placement with minimally invasive navigated
South, Salt Lake City, UT 84124, USA robotic guidance using preoperative or intraoperative CT
2
Musculoskeletal Education and Research Center (MERC), were analyzed. Pedicle screw malposition and reposition
A Division of Globus Medical, Inc., 2560 General Armistead rates based on the surgeon’s intraoperative radiographic
Avenue, Audubon, PA 19403, USA

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200 Journal of Robotic Surgery (2020) 14:199–203

observations were collected. Secondary outcome measures Surgical technique


included patient demographics, robot workflow, length of
surgery, length of hospital stay, and intraoperative blood A surgeon-controlled foot pedal activated and positioned the
loss. robot arm to the planned pedicle trajectory. Stab incisions
were made on the skin using a scalpel. Pedicle screws were
inserted under neuromonitoring using navigated instruments
Navigated robot‑assisted pedicle screw positioning guided by the robotic arm. This sequence was repeated until
system all pedicle screws had been placed. Rods were then placed in
a standard fashion. Locking caps were set once the rods were
The robotic positioning system (Excelsius ­GPS®; Globus in their proper position. Intraoperative fluoroscopy images
Medical, Inc. Audubon, PA, USA) (Fig. 1) uses either were taken to verify the screw and rod position. Pedicle
preoperative CT, intraoperative CT, or fluoroscopy, along screw placement was qualitatively assessed using postop-
with a patient reference base and positioning camera to erative X-rays. Following screw and rod placement, lumbar
guide pedicle screw placement in real time. interbody fusion was performed using 1 of 3 approaches:
lateral, anterior, and posterior. The endplates were prepared
and the interbody spacer was manually inserted. In the lat-
Preoperative CT workflow eral approach, pedicle screws were placed, while patient
remained in the lateral decubitus position. In ALIF, patient
A computed tomography (CT) scan of the spinal levels was repositioned from supine to prone position after inter-
in the operative field was taken prior to the patient enter- body placement from the anterior approach. Screws and rods
ing the operating room (OR) and screw placement plan- were then placed for posterior supplemental fixation.
ning was completed. The CT data set was transferred into
the robotic positioning system, and then, registration was
completed for vertebral levels. Statistical analysis

Statistical analysis was performed using SPSS Statistics


Intraoperative CT workflow Version 25 software (IBM, Armonk, NY, USA). Data were
presented as mean ± standard deviation. The level of statisti-
In intraoperative CT mode, the image coordinate system cal significance was set to p < 0.05 for all statistical analysis.
was obtained from a portable intraoperative CT (e.g.,
O-arm, Medtronic SNT, Louisville, CO, USA) or stand-
ard CT scan was taken at the time of surgery, with the
patient already in position on the OR table. Spinal levels Results
were identified and a CT scan was taken. Pedicle screw
trajectories were planned and saved. In the first 100 robotic cases, the average age was
63 ± 8 years and 48% (48/100) were female. The aver-
age body mass index was 30 kg/m2 (range 17–44 kg/m2).
Twenty-five percent of patients were either current or for-
mer smokers. Forty-two percent of patients were retired
(Table 1). Of the 100 cases, 55 were lateral lumbar interbody
fusion (LLIF), 16 were anterior lumbar interbody fusion
(ALIF), and 29 were posterior lumbar interbody fusion
(PLIF). The three most common numbers of vertebral lev-
els with pedicle screws inserted were 2-level (36%), 3-level
(39%), and 4-level (20%). Intraoperative CT was used in
73 cases, while preoperative CT was used in the remaining
27 cases (Table 2). The most common level with screws
inserted was either L4 (30%) or L5 (30%) (Fig. 2). Among
the 100 cases, the majority of diagnoses for surgery was
degenerative spondylolisthesis with neurogenic claudication
(45%) and degenerative spondylolisthesis (17%). A total of
582 pedicle screws were placed. Of the 582 screws, 20 were
Fig. 1  Screw planning with the robotic positioning system placed without the robot due to surgeon discretion, leaving

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Journal of Robotic Surgery (2020) 14:199–203 201

Table 1  Baseline characteristics


Parameter Overall

Number of patients 100


Gender
Female, n (%) 48 (48%)
Male, n (%) 52 (52%)
Age, mean (SD, range) 63 (8) (26–82)
BMI, mean (SD, range) 30 (6) (18–44)
Smoker, n (%)
Current 8 (8%)
Former 17 (17%)
Never 75 (75%)
Work status, n (%)
Retired 42 (42%)
Full time 41 (41%) Fig. 2  A pie chart depicts the breakdown of vertebral levels among
Part time 7 (7%) 100 spinal surgery cases. The most common levels with screws
Unemployed 4 (4%) inserted are L4 and L5
Disabled 3 (3%)
Unknown 3 (3%) minimally invasive navigated robotic-assisted spine sur-
gery. In contrast, the pedicle screw accuracy rate reported
by Kosmopoulos and Schizas [10] in a review of 130 studies
Table 2  Procedure characteristics with 37,337 pedicle screws was 95% with navigation and
Parameter Overall
90% without navigation [11]. According to Tang et al. [12],
pedicle screw placement is variable even with new technolo-
Type of surgery, n (%) gies; however, when compared to freehand screw placement,
LLIF 55 (55%) computer-navigated screws had substantially less risk of cor-
PLIF 29 (29%) tical damage [13]. Some inaccuracies may be attributed to
ALIF 16 (16%) a learning curve and adapting to a new workflow such as
Number of levels with screws inserted, n (%) three-dimensional (3D) navigation. The 99% pedicle screw
1 1 (1%) placement success rate using navigated robotic guidance
2 36 (36%) recorded in the current study of the first 100 cases seems to
3 39 (39%) indicate an extremely short learning curve.
4 20 (20%) Technological advances including navigation have
5 3 (3%) improved the safety and accuracy of pedicle screw fixation.
6 1 (1%) In a meta-analysis by Mason et al. [14], data were gathered
Workflow, n (%) from over 30 studies analyzing 9000 pedicle screws and
Preoperative CT 27 (27%) found that the traditional fluoroscopy had an accuracy of
Intraoperative CT 73 (73%) 63.1%, two-dimensional navigation had 84.3% accuracy, and
3D navigation was most accurate at 95.5%. Gelalis et al. [15]
performed similar analyses and concluded that navigation
562 pedicle screws inserted by navigated robotic guidance. provides pedicle screw placement with higher accuracy. Jin
Of the 562 screws, only 7 had to be repositioned manually et al. [16] reported a malposition rate of 9.8% in a series of
due to surgeon discretion to reach a screw placement suc- 1145 screws placed with an intraoperative 2D/3D imaging
cess rate of 99% (Fig. 3). There were no returns to the OR navigation system.
reported for screw-related complications. This initial study of the first 100 cases at a single institu-
tion in the clinical use of navigated, robot-assisted spine
surgery demonstrated a high pedicle screw placement suc-
Discussion cess rate. There were no postoperative screw malpositions
requiring a return to the OR. While this is a single-surgeon,
Navigated robotic-assisted spine procedures are in the early single-site retrospective study, the pedicle screw placement
development [9]. In this study, a 99% screw placement suc- success rate is better than the rates reported in the literature
cess rate was reported for pedicle screw placement using using robot-assisted techniques.

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202 Journal of Robotic Surgery (2020) 14:199–203

Fig. 3  A consortium diagram shows the overall distribution of 100 562 pedicle screws were repositioned manually after the initial inser-
spinal surgeries using navigated robotic-assisted guidance and pedicle tion attempt with the robot. Twenty pedicle screws were placed with-
screws. A total of 582 pedicle screws were placed. Five-hundred and out the robot due to surgeon discretion
sixty-two pedicle screws were placed using the robot. Seven of the

Conclusion 2. Hicks JM, Singla A, Shen FH, Arlet V (2010) Complications of


pedicle screw fixation in scoliosis surgery: a systematic review.
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Navigated robotic guidance provides successful pedicle 3. Ledonio CG, Polly DW Jr, Vitale MG, Wang Q, Richards BS
screw placement at a rate of 99% at this single institution, (2011) Pediatric pedicle screws: comparative effectiveness and
with a 0% return to OR rate. safety: a systematic literature review from the Scoliosis Research
Society and the Pediatric Orthopaedic Society of North America
task force. J Bone Jt Surg Am 93:1227–1234
4. Schatlo B, Molliqaj G, Cuvinciuc V, Kotowski M, Schaller K,
Compliance with ethical standards Tessitore E (2014) Safety and accuracy of robot-assisted ver-
sus fluoroscopy-guided pedicle screw insertion for degenerative
Conflict of interest Author KTH receives royalties from and is a con- diseases of the lumbar spine: a matched cohort comparison. J
sultant for NuVasive, and receives royalties from Titan Spine and Neurosurg Spine 20:636–643
ODC. Authors LAA, JRR, and CGL are salaried employees (with 5. Manbachi A, Cobbold RS, Ginsberg HJ (2014) Guided pedicle
stock options) of Globus Medical, Inc. The Excelsius GPS™ robot de- screw insertion: techniques and training. Spine J 14:165–179
scribed in this manuscript is manufactured by Globus Medical, Inc., 6. van Dijk JD, van den Ende RP, Stramigioli S, Kochling M, Hoss
(GMI) where authors LAA, JRR, and CGL are employees. KTH was a N (2015) Clinical pedicle screw accuracy and deviation from
paid consultant to GMI at the time of writing, is a consultant with roy- planning in robot-guided spine surgery: robot-guided pedicle
alties to NuVasive, and receives royalties from Titan Spine and ODC. screw accuracy. Spine (Phila Pa 1976) 40:E986–E991
7. Kim YJ, Lenke LG, Cheh G, Riew KD (2005) Evaluation of
Informed consent As the research conducted for this manuscript was a pedicle screw placement in the deformed spine using intraopera-
retrospective study on patient data, compliance with the ethical stand- tive plain radiographs: a comparison with computerized tomog-
ards of the responsible committee on human experimentation (insti- raphy. Spine (Phila Pa 1976) 30:2084–2088
tutional and national) and the Helsinki Declaration of 1975 were not 8. Verma R, Krishan S, Haendlmayer K, Mohsen A (2010) Func-
required. tional outcome of computer-assisted spinal pedicle screw
placement: a systematic review and meta-analysis of 23 studies
including 5992 pedicle screws. Eur Spine J 19:370–375
Open Access This article is distributed under the terms of the Crea- 9. Khan A, Meyers JE, Siasios I, Pollina J (2018) Next-gener-
tive Commons Attribution 4.0 International License (http://creat​iveco​ ation robotic spine surgery: first report on feasibility, safety,
mmons​.org/licen​ses/by/4.0/), which permits unrestricted use, distribu- and learning curve. Oper Neurosurg (Hagerstown). https​://doi.
tion, and reproduction in any medium, provided you give appropriate org/10.1093/ons/opy28​0
credit to the original author(s) and the source, provide a link to the 10. Kosmopoulos V, Schizas C (2007) Pedicle screw placement
Creative Commons license, and indicate if changes were made. accuracy: a meta-analysis Spine (Phila Pa 1976) 32:E111–E120
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(2015) Computer-aided surgery does not increase the accuracy
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