Literature DB >> 29343756

Radiological and clinical differences among three assisted technologies in pedicle screw fixation of adult degenerative scoliosis.

Yong Fan1, Jin Peng Du1,2, Ji Jun Liu1, Jia Nan Zhang1, Shi Chang Liu1, Ding Jun Hao3,4.   

Abstract

The purpose of this study was to compare the clinical and radiological differences among three advanced guided technologies in adult degenerative scoliosis. A total of 1012 pedicle screws were inserted in 83 patients using a spine robot (group A), 886 screws were implanted in 75 patients using a drill guide template (group B), and 1276 screws were inserted in 109 patients using CT-based navigation (group C). Screw positions were evaluated using postoperative CT scans according to the Gertzbein and Robbins classification. Other relevant data were also collected. Perfect pedicle screw insertion (Grade A) accuracy in groups A, B, and C was 91.3%, 81.3%, and 84.1%, respectively. Clinically acceptable accuracy of screw implantation (Grades A + B) respectively was 96.0%, 90.6%, and 93.0%. Statistical analysis showed the perfect and clinically acceptable accuracy in group A was significant different compared with groups B and C. Group A exhibited the lowest intra-op radiation dose and group B showed the shortest surgical time compared with the other two groups. Robotic-assisted technology demonstrated significantly higher accuracy than the drill guide template or CT-based navigation systems for difficult screw implantations in adult degenerative scoliosis and reduced the intra-op radiation dose, although it failed to reduce surgery time.

Entities:  

Mesh:

Year:  2018        PMID: 29343756      PMCID: PMC5772356          DOI: 10.1038/s41598-017-19054-7

Source DB:  PubMed          Journal:  Sci Rep        ISSN: 2045-2322            Impact factor:   4.379


Introduction

Recently, major advances in biotechnology, such as image-guided, computer-assisted and robot-assisted systems, have been introduced in spine surgery, potentially resulting in better surgical outcomes with higher accuracy, smaller incisions, faster healing times, reduced trauma to normal tissues, and better pain relief[1,2]. In particular, the introduction of a robot-assisted pedicle screw fixation system (Renaissance™, Mazor Robotics, Caesarea, Israel, https://www.mazorrobotics.com/index.php), a spinous process-mounted miniature robot, holds great potential as an advanced idea, with a nearly 99% accuracy of clinically acceptable screw implantation. Though robotic-assisted surgery is an emerging field, similar to a baby making its first steps[3], some superior features, such as minimal invasiveness and a high accuracy of screw implantation, are critical reasons why some “pioneering” surgeons are dedicated to this new field. Other guided methods, such as patient-specific templates and CT-based navigation systems, provide increased accuracy compared with conventional fluoroscopy guided methods, as demonstrated by a series of low- to high-level studies[4,5]. These methods have been used for spine diseases such as fractures, degenerative diseases and so on, providing surgeons with visualization and guidance both preoperatively and intraoperatively in situations of normal spinal anatomy structures. However, it is unknown whether advanced RenaissanceTM will continue to maintain its advantages in adult degenerative scoliosis with difficult screw insertions when compared with patient-specific drill guide templates or image-guided navigation systems. Adult degenerative scoliosis is a complicated spinal disorder, resulting from a combination of osteoporosis and asymmetric disc degeneration, with rotatory subluxation of multiple lumbar functional spinal units[6]. Prior characterization of vertebra deformities leads to difficult screw implantations; therefore, the purpose of this study was to investigate clinical and radiological differences between three advanced technologies in scoliosis by reviewing recorded information.

Methods

Subjects and study design

A careful search of the Case Review Digital system of our hospital found that between 2009 and 2016, 286 patients were diagnosed with severe adult degenerative scoliosis. Patients meeting the following characteristics were eligible: (1) degenerative scoliosis often superimposed on a preexisting scoliosis with greater rotational deformity and a greater loss of lordosis; (2) imbalance in the coronal and sagittal planes; (3) Cobb angle >30°; and (4) obvious lower back pain and radiculopathy. Nineteen patients were excluded for several reasons, as follows: (1) degenerative scoliosis with a fracture, infection, tumor, discitis, or vertebral tuberculosis; (2) previous surgery; or (3) incomplete data in the review case. Finally, 3174 pedicle screws were inserted in 267 adult patients (113 male; 154 female) to reestablish both regional and global spinal balance in the frontal and sagittal planes and reconstruct three-column stability of the vertebral body (Fig. 1). Digital medical records, including demographic, clinical and diagnostic data, intraoperative and postoperative measurements, and radiology images, were retrospectively reviewed. Eighty-three patients underwent open robot-posterior lumbar interbody fusion (PLIF) surgery, 75 patients underwent patient-specific drill guide template-PLIF surgery, and 109 patients underwent CT-based navigation system-assisted PLIF surgery. All included patients underwent decompression and PLIF surgery for 1–3 fusion levels (Table 1). A total of 5 senior surgeons from the Department of Spine Surgery were qualified to perform intraoperatively demanding, assisted technology surgeries, and the decision-making process for choosing the technique for screw placement was based on the judgement of the senior surgeon. Hospital review board approval was obtained for all aspects of this study. Patients with severe degenerated scoliosis pathology that showed obvious clinical symptoms or neurological deficits were identified as candidates for surgical interventions for instrumentation, decompression and fusion.
Figure 1

Diagram showing the process of patient selection.

Table 1

Detail baseline characteristics.

GroupsP value
ParameterRobot-PLIFTemplate-PLIFCT-based PLIFRP vs TPRP vs CPTP vs CP
No. of patients8375109
Females, n (%)48 (58)41 (55)65 (60)0.6890.8020.503
Age (years)61.6 ± 9.164.0 ± 7.763.9 ± 8.40.1770.3070.668
Mean BMI25.8 ± 3.626.3 ± 4.227.3 ± 3.90.422 <0.01 0.099
No. of screws10128861276
Mean no. of screws/case12.2 ± 2.511.8 ± 2.311.7 ± 2.70.2990.1910.794
Mean no. of fixed segment6.6 ± 1.56.8 ± 1.46.5 ± 1.70.3890.6720.209
Mean no of fusion level*2.1 ± 0.62.1 ± 0.72.0 ± 0.71.0000.2990.342
Fusion level (n)
one level1315220.4760.4220.976
two levels5241600.3080.2900.959
three levels1819270.5890.6170.931
Screw diameter (n)
6.5 mm7086388940.3270.9580.327
5.5 mm94621440.0700.120 0.001
Upper-instrumented vertebra (n)
T93290.7340.1880.116
T10710240.321 0.011 0.136
T111912300.2760.4660.067
T123329300.8880.0740.112
L12122160.5700.065 0.016
Lower-instrumented vertebra (n)
L3810130.4650.6150.777
L42114170.3160.0950.585
L54132440.3970.2120.756
S11319350.131 0.009 0.321

*No of fusion level mean the number of intervertebral space that require bone graft and the cage placement. RP: Robot-PLIF; TP: Drill guide Template-PLIF; CP: CT-based PLIF. Values that appear in boldface are statistically significant (p < 0.05).

Diagram showing the process of patient selection. Detail baseline characteristics. *No of fusion level mean the number of intervertebral space that require bone graft and the cage placement. RP: Robot-PLIF; TP: Drill guide Template-PLIF; CP: CT-based PLIF. Values that appear in boldface are statistically significant (p < 0.05).

Robot-PLIF procedure

In the robot-PLIF cohort, preoperative computed tomography (CT) slice scans 1 mm thick were obtained for the 3D-reconstruction of the target level. CT data were transferred to a personal computer and imported in the RenaissanceTM planning software to design the screw trajectories, insertion points and implant sizes; these plans then were transferred to the RenaissanceTM workstation in the operating room. The preoperative CT scans were matched with intraoperative fluoroscopy images (anteroposterior and 60° oblique to the lateral plan marker X-rays) that were acquired of the patient’s anatomy for registration of the robot. Basic steps in the RenaissanceTM open-PLIF operation are summarized as follows: 1. preoperative planning; 2. posterior exposure and approach establishment; 3. attachment to the spinous process; 4. image acquisition and registration; 5. robot assembly and motion; 6. drilling and tubing system placement; 7. cannula introduction and K-wire placement; and 8. screw insertion. This was followed by decompression or posterior osteotomy for mobilization of the curves, interbody cage insertion and rod fixation after correction.

Drill guide template-PLIF surgery procedure

The major procedures of patient-specific drill guide template assistance for screw implantation are as follows: 1. CT scanning with thin slices to target the spinal vertebral body; 2. reconstruction of captured data as a three-dimensional pattern to identify an optimal entry hole and calculation of the width, height and length of the target pedicle using special software; 3. design of a digital template contrary to the anatomical structure of the target level; 4. printing of the digital template, except a pre-reserved column, by a 3D-printer; 5. preoperative sterilization of the solid template; 6. Intraoperative clearance of the soft tissue behind the intended vertebral plate and spinous process; and 7. attachment of the template to the bone structure, followed by the insertion of screws through the pre-designed trajectory. Decompression and fusion procedures were performed, if necessary, along with a subsequent osteotomy for better scoliosis correction. More detailed surgical procedures have been described in a previous study[7].

CT-based PLIF surgery process

The assistance of a CT-based navigation system for surgery included 4 steps: 1. a reference clamp was attached to the spinous process of the vertebra; 2. intraoperative all-spine scanning; 3. obtained CT data were automatically matched in the navigation system; 4. fiberoptic markers were fixed on the navigation instrument; 5. the entry point was identified using a marked navigation probe; 6. screw trajectory was established during real-time visualization of the intraosseous position of the navigation tip; and 7. pedicle screw placement. If necessary, a subsequent osteotomy was performed for better scoliosis correction, followed by decompression and fusion, interbody cage insertion and rod fixation. More detailed surgical procedures have been described in a previous study[8].

Outcome measures

The primary measure was screw accuracy, which was assessed according to the Gertzbein and Robbins A to E classification system[9] using axial, coronal and sagittal reconstruction views of the CT scans (Fig. 2). The grading system included the following levels: Grade A: the screw is completely within the pedicle; Grade B, the screw breaches the pedicle’s cortex by <2 mm; Grade C, pedicle cortical breach <4 mm; Grade D, pedicle cortical breach <6 mm; and Grade E, pedicle cortical breach >6 mm. Meanwhile, Grade R means a screw trajectory was proposed by the guidance device but had to be revised manually; therefore, such intraoperatively revised screw placements were considered to be inaccurate. Two spine surgeons (Yong Fan, Jin Peng Du) independently evaluated all postoperative CT scans blind to three groups, where screws graded A were “perfect”, those graded A + B were “clinically acceptable”, and those graded C-E had a significant deviation from the intended trajectory and were also considered to be inaccurate.
Figure 2

Gertzbein and Robbins classification scores are shown based on CT scans to reflect the deviation of the screw from the optimal trajectory. Grade (A): screw is completely within the pedicle; Grade (B), screw breaches the pedicle’s cortex by <2 mm; Grade (C), pedicle cortical breach <4 mm; Grade (D), pedicle cortical breach <6 mm; Grade (E), pedicle cortical breach >6 mm.

Gertzbein and Robbins classification scores are shown based on CT scans to reflect the deviation of the screw from the optimal trajectory. Grade (A): screw is completely within the pedicle; Grade (B), screw breaches the pedicle’s cortex by <2 mm; Grade (C), pedicle cortical breach <4 mm; Grade (D), pedicle cortical breach <6 mm; Grade (E), pedicle cortical breach >6 mm. Other secondary radiological measurements were also collected, such as proximal facet joint violations, the orientation of pedicle encroachment and intra-op fluoroscopic dose (mSv). Scoliosis correction parameters were assessed with plain radiographs preoperatively and postoperatively, which included measurements of the coronal plane deformity according to the Cobb method and the evaluation of spinopelvic parameters such as pelvic tilt (PT), lumbar lordosis (LL), and sacral slope (SS). We also collected the time of surgery, adverse events, cases of revision surgeries and intraoperative blood loss.

Statistical analysis

Categorical and continuous variables were respectively analyzed by ANOVA and SNK tests. Mean values are presented as the mean ± SD. All statistical analyses were performed using the SPSS 20.0.0 statistics package (SPSS, Inc., Chicago, IL, USA), with an alpha level of significance set at 0.05.

Results

Baseline characteristics

The mean patient age was 63.2 years (range: 45–80), and the gender ratio (m/f) was 113/154. The average BMI was 26.5. The mean BMI between group A and group C, the number of 5.5 mm screws between group B and group C and the number of upper or lower instrumented vertebra between three groups showed significant differences. The rest of the baseline parameters did not significantly differ between the 3 groups. The screw diameter varied from 5.5 to 6.5 mm, and the fusion level varied from 1–3 levels. Detailed parameters are shown in Table 1.

Accuracy of pedicle screw placement

As shown in Table 2, “perfect” accuracy of pedicle screw insertion (Grade A) in groups A, B, and C was 91.3%, 81.3%, and 84.1%, respectively. “clinically acceptable” screw implantation (Grade A + B) accuracy in groups A, B, and C was 96.0%, 90.6%, and 93.0%, respectively. Possible breaches (Grades C + E) respectively were 3.4%, 6.0%, and 5.5%; all primary endpoints are summarized as a column graph in Supplementary Figure S1. The rate of intraoperative screw revisions was 0.6%, 3.4%, and 1.6%, respectively, which were revised because the screw did not have sufficient bone grip or a lateral fluoroscopy showed the entry point was not pointing directly on the craniocaudal center of the pedicle; a new trajectory then had to be re-identified based on open fluoroscopy guidance. Therefore, every revised screw was considered to be inaccurate and clinically unacceptable. Statistical analysis showed group A had statistically significant superiority (P < 0.05) in “perfect and clinically acceptable” accuracy compared with groups B and C, but there was no significant difference in the “perfect” accuracy between group B and group C, while group C seemed to exhibit higher “clinically acceptable” accuracy than group B (P < 0.05). Meanwhile, the robot-PLIF group exhibited the lowest rate of manual screw revisions compared other two groups, while the drill guide template-PLIF group showed the highest.
Table 2

Accuracy of pedicle screw placement among three assisted technologies.

Screw Position*Robot-PLIF (n [%])Template-PLIF (n [%])CT-based PLIF (n [%])P value
RP vs TPRP vs CPTP vs CP
A924 (91.3)720 (81.3)1073(84.1) <0.001 <0.001 0.062
B48 (4.7)83 (9.4)114 (8.9) <0.001 <0.001 0.730
A + B972 (96.0)803(90.6)1187(93.0) <0.001 0.019 0.043
C28 (2.8)33 (3.7)56 (4.4)0.238 0.040 0.445
D6 (0.6)14 (1.6)11 (0.9) 0.036 0.4560.125
E0 (0.0)6 (0.7)2 (0.2) 0.009 0.2080.050
R6 (0.6)30 (3.4)20 (1.6) <0.001 0.029 0.006
Total10128861276

*Screw position identified according to Gertzbein and Robbins A to E classification; RP: Robot-PLIF; TP: Drill guide Template-PLIF; CP: CT-based PLIF. Values that appear in boldface are statistically significant (p < 0.05). Grade “R” means some screws trajectory were proposed by the guided device but had to be revised manually.

Accuracy of pedicle screw placement among three assisted technologies. *Screw position identified according to Gertzbein and Robbins A to E classification; RP: Robot-PLIF; TP: Drill guide Template-PLIF; CP: CT-based PLIF. Values that appear in boldface are statistically significant (p < 0.05). Grade “R” means some screws trajectory were proposed by the guided device but had to be revised manually.

Secondary results

Facet joint violations were evaluated according to the classification described by Kim et al.[10] (Table 3), where Grade 0 (group A-C: 98.9%, 98.0%, 97.6%), Grade 1 (group A-C: 1.1%, 1.8%, 2.1%), and Grade 2 (group 1–3: 0%, 0.2%, 0.3%) did not show a significant difference between groups (P > 0.05). The robot-PLIF group showed fewer hazardous orientations because the orientations of pedicle encroachment were all integrated into a lateral approach; however, the other groups exhibited pedicle encroachment in four orientations.
Table 3

Secondary radiological results.

Robot-PLIFTemplate-PLIFCT-based PLIF
Proximal facet joint violation*
Grade 01001 (98.9%)868 (98.0%)1245 (97.6%)
Grade 111 (1.1%)16 (1.8%)27 (2.1%)
Grade 20 (0)2 (0.2%)4 (0.3%)
Orientation of pedicle encroachment
Medial021
Lateral887276
Superior047
Inferior055

*Facet joint violation was evaluated according to the classification described by Kim et al. Grade 0 = no impingement, Grade 1 = screw head in contact/suspected to be in contact with facet joint, Grade 2 = screw clearly invaded the facet joint.

Secondary radiological results. *Facet joint violation was evaluated according to the classification described by Kim et al. Grade 0 = no impingement, Grade 1 = screw head in contact/suspected to be in contact with facet joint, Grade 2 = screw clearly invaded the facet joint. In the scoliosis-relevant parameter measures, as shown in Table 4, there were no differences in changes in the Cobb angle value, PT, LL or SS between the three groups, except in group B vs. group C in changes in the Cobb angle value (P = 0.02).
Table 4

Measurements of scoliosis correction by X-ray plain film.

Cobb (°)LL (°)SS (°)PT (°)
PrePost p Δ PrePost p Δ PrePost p PrePost p Δ
Robot-PLIF (n = 83)46 ± 811 ± 7 <0.001 36 ± 723 ± 1154 ± 6 <0.001 32 ± 911 ± 640 ± 6 <0.001 30 ± 528 ± 324 ± 4 <0.001 4 ± 4
Template-PLIF (n = 75)44 ± 910 ± 8 <0.001 35 ± 925 ± 1056 ± 8 <0.001 31 ± 810 ± 639 ± 7 <0.001 29 ± 729 ± 425 ± 3 <0.001 5 ± 4
CT-based PLIF (n = 109)49 ± 912 ± 9 <0.001 38 ± 822 ± 1356 ± 9 <0.001 33 ± 810 ± 541 ± 6 <0.001 31 ± 728 ± 424 ± 4 <0.001 4 ± 3
p (RP VS TP)0.140.370.40.240.080.140.30.340.260.080.080.12
p (RP VS CP) 0.01 0.40.070.570.070.410.210.250.22111
p (TP VS CP) <0.001 0.12 0.02 0.080.070.11 0.04 0.060.1 0.05 0.07

RP: Robot-PLIF; TP: Drill guide Template-PLIF; CP: CT-based PLIF; Δ = |Post-Pre|, Cobb: Cobb angle; LL: lumbar lordosis angle; SS: Sacral slope; PL: Pelvic tilt; Bold values are statistically significant (P < 0.05).

Measurements of scoliosis correction by X-ray plain film. RP: Robot-PLIF; TP: Drill guide Template-PLIF; CP: CT-based PLIF; Δ = |Post-Pre|, Cobb: Cobb angle; LL: lumbar lordosis angle; SS: Sacral slope; PL: Pelvic tilt; Bold values are statistically significant (P < 0.05). The overall surgical times from skin to skin are shown in Table 5 for group A (239 ± 52 minutes), group B (191 ± 48 minutes) and group C (228 ± 43 minutes). Clearly, group A showed more surgical time than group B but was not significantly different from group C. The prevalence of total adverse events in group A (6 [7.23%]) showed no difference compared with group B (9 [12.00%]) or group C (9 [8.23%]), as well as dural tears, surgical wound revisions, wound infections and neurological complications. Regarding intra-op radiation dose (group A-C: 0.41 ± 0.39 mSV; 0.34 ± 0.36 mSV; 5.68 ± 2.66 mSV), the robot-PLIF group showed less than the CT-based PLIF group (P < 0.05) but was not different from the template-PLIF group. Blood loss (group A-C: 681 ± 277 ml; 611 ± 272 ml; 669 ± 250 ml) and postoperative stay (group A-C: 9.3 ± 2.2 d; 8.8 ± 1.9 d; 9.5 ± 2.0 d) demonstrated no significant differences between the three groups. Several cases required postoperative revision surgeries, mainly for cage dislodgement or screw malpositioning, but there were no differences in the revised rate between groups. Some clinical results of the continuous variables are integrated into four column graphs shown in Fig. 3.
Table 5

Secondary endpoints for clinical outcomes.

Robot-PLIFTemplate-PLIFCT-based PLIFP value
RP vs TPRP vs CPTP vs CP
Time for surgery (min)239 ± 52191 ± 48228 ± 43 <0.001 0.111 <0.001
Intra-op radiation dose (mSv)0.41 ± 0.390.34 ± 0.365.68 ± 2.660.244 <0.001 <0.001
Blood loss (ml)681 ± 277611 ± 272669 ± 2500.1120.7540.138
Postoperative stay (d)9.3 ± 2.28.8 ± 1.99.5 ± 2.00.1300.512 0.018
Revision surgery (n)
Cage dislodgement2120.6210.7820.792
Screw malposition0320.0660.2150.375
Total2440.3370.6190.587
Adverse events (n)
Dural tears1210.4940.8460.351
Surgical wound revision4560.6170.8320.744
Wound Infections1110.9420.8460.789
Neurological complications0110.2910.3820.789
Total6 (7.23%)9 (12.00%)9 (8.23%)0.4450.7930.579

RP: Robot-PLIF; TP: Drill guide Template-PLIF; CP: CT-based PLIF; Bold values are statistically significant (P < 0.05).

Figure 3

Column graph of the comparisons of time of surgery, radiation dose, blood loss and postoperative stay between the three assistive technologies.

Secondary endpoints for clinical outcomes. RP: Robot-PLIF; TP: Drill guide Template-PLIF; CP: CT-based PLIF; Bold values are statistically significant (P < 0.05). Column graph of the comparisons of time of surgery, radiation dose, blood loss and postoperative stay between the three assistive technologies.

Discussion

Adult scoliosis is a complex three-dimensional deformity of the spine that is the result of a progressive, coupled, asymmetrical degeneration of the intervertebral discs and facet joint complexes[11]. In addition, some patients may undergo both an asymmetrical collapse of the vertebral bodies and lateral slippage, subsequently developing multisegmental involvement with sagittal and coronal unbalance. Moreover, severe adult scoliosis is often superimposed on preexisting scoliosis, with greater rotational deformity and greater loss of lordosis[12]. It always requires surgical treatment with long-level pedicle screw instrumentation with posterior lumbar interbody fusion; however, the complex anatomical structures of deformed vertebra add extra difficulty in screw placement, which prevents the first step of spine balance reconstruction. Therefore, many advanced technologies were developed to focus on this problem. The RenaissanceTM system-based accurate auxiliary measures were designed to ensure the safety and accuracy of pedicle screw insertion, although this is doubted by experienced Chinese doctors who are good at free-hand screw insertion, mainly because of the high confidence in their technique or a dislike for complicated procedures. However, drill guide templates and CT-based navigation have been confirmed to have sufficient safety and accuracy levels for spine surgery by several high-level clinical studies[10,13,14]. A retrospective series study by Devito summarized the first experiences with the RenaissanceTM robot from 14 spine centers worldwide and found a 98% rate of clinically acceptable screw insertion, with no permanent nerve damage occurring. However, 9% of the screws showed a minor pedicle breach, which may still have excellent biomechanical properties without the potential of clinically apparent neurological or vascular impairment, which can surely be evaluated as safe, clinically acceptable malpositioning. Another strong statement was offered by Hyun[15], who designed a prospective randomized clinical trial between minimally invasive robotic- and open fluoroscopic-guided spinal instrumented fusions. Pedicle screw positions were classified using a modification of the Gertzbein-Robbins scale, and 97.7% of screws were completely within the pedicle, although 2.3% of screws breached the pedicle’s cortex by <2 mm; all screws were clinically acceptable without screw-related neurological damage. Whether spine robot-guidance continues to maintain its advantages in open surgery for adult degenerative scoliosis with difficult screw insertions compared to patient-specific drill guide templates or image-guided navigation system is an interesting question demanding research. Certainly, other factors, such as surgical time, intra-op radiation dose, adverse events, scoliosis correction outcomes, blood loss, and length of day, must also be comprehensively considered as important attentional points. In our review, RenaissanceTM succeeded in showing a sufficient difference in terms of the accuracy of “perfect” and “clinically acceptable” pedicle screw insertions compared with the other two techniques. High accuracy of pedicle screw placements associated with low risk of revision surgery due to the screw relevant neurological complications. In total, 96.0% of the screws (Grade A + Grade B) in the robot-PLIF group in this study were considered to be “clinically acceptable” by us, less than the 98% reviewed by Devito because he identified pedicle cortical breaches <4 mm without neurological complications as clinically acceptable accuracy; on the other hand, he used the robot technique only for normal lumbar pedicle screw insertion. Strictly speaking, a screw that breaches the pedicle’s cortex by ≥2 mm is subject to a risk of long-term screw-related neurological complications. In our experience, we only classify Grade A + B as an appropriate accuracy criterion for “clinically acceptable” screw placement. Interestingly, the accuracy of perfect placements in the drill guide template group (81.3%) was not significantly different compared with the robot-assisted group (84.1%), possibly because, during the last decade, gradual advances in computer and additive manufacturing technologies have resulted in a more practical and sophisticated application of individual templates in spine surgery, with hopeful outcomes[16]. Otherwise, three-dimensional fluoroscopic image guidance systems demonstrated a significantly higher pedicle screw placement accuracy than CT-based navigation system and 2D fluoroscopic image guidance methods, what is the result when it is compared with the spine robot, this is a subject worth further studying[4,17]. We also wonder if an association exists between the accuracy of screw placement and results of scoliosis correction, but it seems that differences in accuracy did not lead to variations in Cobb angle, PT, LL or SS. Though Group B showed differences in the changes of the Cobb angle values compared to Group C, this may because the preoperative Cobb angles were not aligned. Proximal facet joint violations still failed to be identified as different between the three groups, and it is unclear that if this situation results from the high accuracy of screw insertions. As shown in Fig. 3, the robot-assisted method and CT-based navigation required more time for surgery from skin to skin, and this may result from their complicated procedures. There was the point that the routine use of some systems may further reduce the operating time, but current systems do not meet spine surgeon’s expectations in terms of ease of use and integration into the surgical work flow, factors limited the routine use include the lack of equipment, inadequate training, and high costs[18]. We also found this issue in the research process, but due to the above mentioned reasons for these systems, the routine usage rate is relatively low in our health care, system need continuous improvement to increase its use. The robot-PLIF group showed a small intra-op radiation dose that was similar to the template-PLIF group, and they all demand fluoroscopy for preoperative location and postoperative confirmation of the placement of every screw as well as the extra fluoroscopy needed for matching in the robotic process[19,20]. Regarding adverse events, blood loss, revision surgery and length of stay, the open robot technique failed to show an advantage over the other two techniques, but the lowest rate of intraoperative revision of screws occurred in the robot-PLIF; surely, the high accuracy of screw implantation reduces screw revisions due to malpositioning. Revised screws were included in the analysis as poor screw positioning that was clinically unacceptable. The RenaissanceTM platform uses a computerized mechanical positioning system that assists surgeons in inserting implants along the planned trajectory. There are two advantages; first, it requires registration without using bony landmarks that can be applied even in difficult insertions and deformities of the spine. Second, the robot system works without relying on a camera tracking mechanism and avoids all the problems of reconnaissance between cameras and navigation instruments or targets[21]. Drawbacks in the process of the robotic system usage include a few patients with severe degenerative scoliosis who were operated on but failed to match the preoperative CT scanning with the intraoperative fluoroscopy images; some time was wasted, and the surgeon had to change the surgical technique to free hand. Involving all search processes from the Case Review Digital system, 8 such cases occurred. Although there is good registration, there could still be a possible phenomenon where the cannula slides off an angled bone surface, resulting in difficult-to-prevent lateral screw inaccuracies[22]. Normally, when this occurs lateral to the facet joint, it demands careful attention when using the robot. In addition, the relatively expensive costs for the robot’s supplies and maintenance add an extra financial burden to patients. Two limitations of our study should be mentioned. The first limitation is that patient characteristics, such as mean BMI, did not align between group A and group C, and a similar condition occurred with screw diameter and upper/lower instrumented vertebra. Another limitation is that all studies derived from a database that included four spine surgeries, nearly 40 surgeons participated in the employment of the three assistive tools, and the variances in the proficiency of tool employment and surgical skills may add a slight bias to the primary or secondary endpoints. Therefore, additional prospective, randomized, controlled studies are required.

Conclusions

Robotic-assisted technology showed obviously higher accuracy than drill guide template or CT-based navigation systems for difficult screw implantations in adult degenerative scoliosis; the method also reduced intra-op radiation dose, but it did not reduce time for surgery. Supplementary Figure S1
  20 in total

1.  Minimally Invasive Robotic Versus Open Fluoroscopic-guided Spinal Instrumented Fusions: A Randomized Controlled Trial.

Authors:  Seung-Jae Hyun; Ki-Jeong Kim; Tae-Ahn Jahng; Hyun-Jib Kim
Journal:  Spine (Phila Pa 1976)       Date:  2017-03-15       Impact factor: 3.468

Review 2.  The accuracy of pedicle screw placement using intraoperative image guidance systems.

Authors:  Alexander Mason; Renee Paulsen; Jason M Babuska; Sharad Rajpal; Sigita Burneikiene; E Lee Nelson; Alan T Villavicencio
Journal:  J Neurosurg Spine       Date:  2013-12-20

3.  Clinical pedicle screw accuracy and deviation from planning in robot-guided spine surgery: robot-guided pedicle screw accuracy.

Authors:  Joris D van Dijk; Roy P J van den Ende; Stefano Stramigioli; Matthias Köchling; Norbert Höss
Journal:  Spine (Phila Pa 1976)       Date:  2015-09-01       Impact factor: 3.468

4.  Preliminary application of a multi-level 3D printing drill guide template for pedicle screw placement in severe and rigid scoliosis.

Authors:  Kun Liu; Qiang Zhang; Xin Li; Changsong Zhao; Xuemin Quan; Rugang Zhao; Zongfeng Chen; Yansheng Li
Journal:  Eur Spine J       Date:  2016-12-27       Impact factor: 3.134

5.  Spinal robotics: current applications and future perspectives.

Authors:  Florian Roser; Marcos Tatagiba; Gottlieb Maier
Journal:  Neurosurgery       Date:  2013-01       Impact factor: 4.654

6.  A multi-level rapid prototyping drill guide template reduces the perforation risk of pedicle screw placement in the lumbar and sacral spine.

Authors:  Matjaz Merc; Igor Drstvensek; Matjaz Vogrin; Tomaz Brajlih; Gregor Recnik
Journal:  Arch Orthop Trauma Surg       Date:  2013-04-30       Impact factor: 3.067

7.  Surgical treatment of patients with lumbar spinal stenosis with associated scoliosis.

Authors:  E D Simmons
Journal:  Clin Orthop Relat Res       Date:  2001-03       Impact factor: 4.176

8.  Are pedicle screw perforation rates influenced by registered or unregistered vertebrae in multilevel registration using a CT-based navigation system in the setting of scoliosis?

Authors:  Masayuki Shimizu; Jun Takahashi; Shota Ikegami; Shugo Kuraishi; Toshimasa Futatsugi; Hiroyuki Kato
Journal:  Eur Spine J       Date:  2014-08-10       Impact factor: 3.134

9.  Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison.

Authors:  Bawarjan Schatlo; Granit Molliqaj; Victor Cuvinciuc; Marc Kotowski; Karl Schaller; Enrico Tessitore
Journal:  J Neurosurg Spine       Date:  2014-04-11

10.  Lumbar and sacral pedicle screw placement using a template does not improve the midterm pain and disability outcome in comparison with free-hand method.

Authors:  Matjaz Merc; Gregor Recnik; Zmago Krajnc
Journal:  Eur J Orthop Surg Traumatol       Date:  2017-01-19
View more
  10 in total

1.  Impact of robot-assisted spine surgery on health care quality and neurosurgical economics: A systemic review.

Authors:  Brian Fiani; Syed A Quadri; Mudassir Farooqui; Alessandra Cathel; Blake Berman; Jerry Noel; Javed Siddiqi
Journal:  Neurosurg Rev       Date:  2018-04-03       Impact factor: 3.042

2.  Robotic-guided placement of cervical pedicle screws: feasibility and accuracy.

Authors:  Stanley Kisinde; Xiaobang Hu; Shea Hesselbacher; Alexander M Satin; Isador H Lieberman
Journal:  Eur Spine J       Date:  2022-01-12       Impact factor: 3.134

3.  The accuracy of robot-assisted S2 alar-iliac screw placement at two different healthcare centers.

Authors:  Nathan J Lee; Asham Khan; Joseph M Lombardi; Venkat Boddapati; Paul J Park; Justin Mathew; Eric Leung; Jeffrey P Mullin; John Pollina; Ronald A Lehman
Journal:  J Spine Surg       Date:  2021-09

4.  Decreasing radiation dose with FluoroLESS Standalone Anterior Cervical Fusion.

Authors:  Kingsley R Chin; Fabio J R Pencle; Kathleen A Quijada; Moawiah S Mustafa; Luai S Mustafa; Jason A Seale
Journal:  J Spine Surg       Date:  2018-12

5.  Robot-assisted orthopedic surgery in the treatment of adult degenerative scoliosis: a preliminary clinical report.

Authors:  Xiuyuan Chen; Fan Feng; Xiaosheng Yu; Shurong Wang; Zhipeng Tu; Yingchao Han; Quan Li; Hao Chen; Zhi Chen; Lifeng Lao; Hongxing Shen
Journal:  J Orthop Surg Res       Date:  2020-07-25       Impact factor: 2.359

6.  Accuracy of Robot-Assisted Percutaneous Pedicle Screw Placement under Regional Anesthesia: A Retrospective Cohort Study.

Authors:  Shangju Gao; Jingchao Wei; Wenyi Li; Long Zhang; Can Cao; Jinshuai Zhai; Bo Gao
Journal:  Pain Res Manag       Date:  2021-12-20       Impact factor: 3.037

7.  Rates and risk factors of intrapedicular accuracy and cranial facet joint violation among robot-assisted, fluoroscopy-guided percutaneous, and freehand techniques in pedicle screw fixation of thoracolumbar fractures: a comparative cohort study.

Authors:  Ren-Jie Zhang; Lu-Ping Zhou; Hua-Qing Zhang; Peng Ge; Chong-Yu Jia; Cai-Liang Shen
Journal:  BMC Surg       Date:  2022-02-11       Impact factor: 2.102

8.  Accuracy of vertebral puncture in percutaneous vertebroplasty.

Authors:  Tomoyuki Noguchi; Koji Yamashita; Yoshitaka Shida; Takashi Okafuji; Ryotaro Kamei; Junki Maehara; Tsuyoshi Tajima
Journal:  Jpn J Radiol       Date:  2021-11-05       Impact factor: 2.374

9.  Intraoperative CT-guided navigation versus fluoroscopy for percutaneous pedicle screw placement in 192 patients: a comparative analysis.

Authors:  Giuseppe La Rocca; Edoardo Mazzucchi; Fabrizio Pignotti; Luigi Aurelio Nasto; Gianluca Galieri; Alessandro Olivi; Vincenzo De Santis; Pierluigi Rinaldi; Enrico Pola; Giovanni Sabatino
Journal:  J Orthop Traumatol       Date:  2022-09-01

10.  Robotic Spine Surgery and Augmented Reality Systems: A State of the Art.

Authors:  Gianluca Vadalà; Sergio De Salvatore; Luca Ambrosio; Fabrizio Russo; Rocco Papalia; Vincenzo Denaro
Journal:  Neurospine       Date:  2020-03-31
  10 in total

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