CT-to-fluoroscopy registration versus scan-and-plan registration for robot-assisted insertion of lumbar pedicle screws

OBJECTIVE Pedicle screw insertion for stabilization after lumbar fusion surgery is commonly performed by spine surgeons. With the advent of navigation technology, the accuracy of pedicle screw insertion has increased. Robotic guidance has revolutionized the placement of pedicle screws with 2 distinct radiographic registration methods, the scan-and-plan method and CT-to-fluoroscopy method. In this study, the authors aimed to compare the accuracy and safety of these methods. METHODS A retrospective chart review was conducted at 2 centers to obtain operative data for consecutive patients who underwent robot-assisted lumbar pedicle screw placement. The newest robotic platform (Mazor X Robotic System) was used in all cases. One center used the scan-and-plan registration method, and the other used CT-to-fluoroscopy for registration. Screw accuracy was determined by applying the Gertzbein-Robbins scale. Fluoroscopic exposure times were collected from radiology reports. RESULTS Overall, 268 patients underwent pedicle screw insertion, 126 patients with scan-and-plan registration and 142 with CT-to-fluoroscopy registration. In the scan-and-plan cohort, 450 screws were inserted across 266 spinal levels (mean 1.7 ± 1.1 screws/level), with 446 (99.1%) screws classified as Gertzbein-Robbins grade A (within the pedicle) and 4 (0.9%) as grade B (< 2-mm deviation). In the CT-to-fluoroscopy cohort, 574 screws were inserted across 280 lumbar spinal levels (mean 2.05 ± 1.7 screws/ level), with 563 (98.1%) grade A screws and 11 (1.9%) grade B (p = 0.17). The scan-and-plan cohort had nonsignificantly less fluoroscopic exposure per screw than the CT-to-fluoroscopy cohort (12 ± 13 seconds vs 11.1 ± 7 seconds, p = 0.3). CONCLUSIONS Both scan-and-plan registration and CT-to-fluoroscopy registration methods were safe, accurate, and had similar fluoroscopy time exposure overall.

A novel 3D-vision–based collaborative robot as a scope holding system for port surgery: a technical feasibility study

OBJECTIVE A clear, stable, suitably located vision field is essential for port surgery. A scope is usually held by hand or a fixing device. The former yields fatigue and requires lengthy training, while the latter increases inconvenience because of needing to adjust the scope. Thus, the authors innovated a novel robotic system that can recognize the port and automatically place the scope in an optimized position. In this study, the authors executed a preliminary experiment to test this system’s technical feasibility and accuracy in vitro. METHODS A collaborative robotic (CoBot) system consisting of a mechatronic arm and a 3D camera was developed. With the 3D camera and programmed machine vision, CoBot can search a marker attached to the opening of the surgical port, followed by automatic alignment of the scope’s axis with the port’s longitudinal axis so that optimal illumination and visual observation can be achieved. Three tests were conducted. In test 1, the robot positioned a laser range finder attached to the robot’s arm to align the sheath’s center axis. The laser successfully passing through two holes in the port sheath’s central axis defined successful positioning. Researchers recorded the finder’s readings, demonstrating the actual distance between the finder and the sheath. In test 2, the robot held a high-definition exoscope and relocated it to the setting position. Test 3 was similar to test 2, but a metal holder substituted the robot. Trained neurosurgeons manually adjusted the holder. The manipulation time was recorded. Additionally, a grading system was designed to score each image captured by the exoscope at the setting position, and the scores in the two tests were compared using the rank-sum test. RESULTS The CoBot system positioned the finder successfully in all rounds in test 1; the mean height errors ± SD were 1.14 mm ± 0.38 mm (downward) and 1.60 mm ± 0.89 mm (upward). The grading scores of images in tests 2 and 3 were significantly different. Regarding the total score and four subgroups, test 2 showed a more precise, better-positioned, and more stable vision field. The total manipulation time in test 2 was 20 minutes, and for test 3 it was 52 minutes. CONCLUSIONS The CoBot system successfully acted as a robust scope holding system to provide a stable and optimized surgical view during simulated port surgery, providing further evidence for the substitution of human hands, and leading to a more efficient, user-friendly, and precise operation.

Collaborative spinal robot system for laminectomy: a preliminary study

OBJECTIVE The application of robots in the field of pedicle screw placement has achieved great success. However, decompressive laminectomy, a step that is just as critical as pedicle screw placement, does not have a mature robot-assisted system. To address this lack, the authors designed a collaborative spine robot system to assist with laminectomy. In this study, they aimed to investigate the reliability of this novel collaborative spinal robot system and compare it with manual laminectomy (ML). METHODS Thirty in vitro porcine lumbar vertebral specimens were obtained as experimental bone specimens. Robot-assisted laminectomy (RAL) was performed on the left side of the lamina (n = 30) and ML was performed on the right side (n = 30). The time required for laminectomy on one side, whether the lamina was penetrated, and the remaining thickness of the lamina were compared between the two groups. RESULTS The time required for laminectomy on one side was longer in the RAL group than in the ML group (median 326 seconds [IQR 133 seconds] vs 108.5 seconds [IQR 43 seconds], p < 0.001). In the RAL group, complete lamina penetration occurred twice (6.7%), while in the ML group, it occurred 9 times (30%); the difference was statistically significant (p = 0.045). There was no statistically significant difference in the remaining lamina thickness between the two groups (median 1.035 mm [IQR 0.419 mm] vs 1.084 mm [IQR 0.383 mm], p = 0.842). CONCLUSIONS The results of this study confirm the safety of this novel spinal robot system for laminectomy. However, its efficiency requires further improvement.

Robot-guided versus freehand fluoroscopy-guided minimally invasive transforaminal lumbar interbody fusion: a single-institution, observational, case-control study

OBJECTIVE The use of robotics in spinal surgery has gained popularity because of its promising accuracy and safety. ROSA is a commonly used surgical robot system for spinal surgery. The aim of this study was to compare outcomes between robot-guided and freehand fluoroscopy-guided instrumentation in minimally invasive surgery (MIS)–transforaminal lumbar interbody fusion (TLIF). METHODS This retrospective consecutive series reviewed 224 patients who underwent MIS-TLIF from March 2019 to April 2020 at a single institution. All patients were diagnosed with degenerative pathologies. Of those, 75 patients underwent robot-guided MIS-TLIF, and 149 patients underwent freehand fluoroscopy-guided MIS-TLIF. The incidences of pedicle breach, intraoperative outcomes, postoperative outcomes, and short-term pain control were compared. RESULTS The patients who underwent robot-guided surgery had a lower incidence of pedicle breach (0.27% vs 1.75%, p = 0.04) and less operative blood loss (313.7 ± 214.1 mL vs 431.6 ± 529.8 mL, p = 0.019). Nonsignificant differences were observed in operative duration (280.7 ± 98.1 minutes vs 251.4 ± 112.0 minutes, p = 0.056), hospital stay (6.6 ± 3.4 days vs 7.3 ± 4.4 days, p = 0.19), complications (intraoperative, 1.3% vs 1.3%, p = 0.45; postoperative surgery-related, 4.0% vs 4.0%, p = 0.99), and short-term pain control (postoperative day 1, 2.1 ± 1.2 vs 1.8 ± 1.2, p = 0.144; postoperative day 30, 1.2 ± 0.5 vs 1.3 ± 0.7, p = 0.610). A shorter operative duration for 4-level spinal surgery was found in the robot-guided surgery group (388.7 ± 107.3 minutes vs 544.0 ± 128.5 minutes, p = 0.047). CONCLUSIONS This retrospective review revealed that patients who underwent robot-guided MIS-TLIF experienced less operative blood loss. They also benefited from a shorter operative duration with higher-level (> 3 levels) spinal surgery. The postoperative outcomes were similar for both robot-guided and freehand fluoroscopy-guided procedures.

Evaluating robotic pedicle screw placement against conventional modalities: a systematic review and network meta-analysis

OBJECTIVE Several approaches have been studied for internal fixation of the spine using pedicle screws (PSs), including CT navigation, 2D and 3D fluoroscopy, freehand, and robotic assistance. Robot-assisted PS placement has been controversial because training requirements, cost, and previously unclear benefits. This meta-analysis compares screw placement accuracy, operative time, intraoperative blood loss, and overall complications of PS insertion using traditional freehand, navigated, and robot-assisted methods. METHODS A systematic review was performed of peer-reviewed articles indexed in several databases between January 2000 and August 2021 comparing ≥ 2 PS insertion methods with ≥ 10 screws per treatment arm. Data were extracted for patient outcomes, including PS placement, misplacement, and accuracy; operative time, overall complications, intraoperative blood loss, postoperative hospital length of stay, postoperative Oswestry Disability Index (ODI) score, and postoperative visual analog scale (VAS) score for back pain. Risk of bias was assessed using the Newcastle-Ottawa score and Cochrane tool. A network meta-analysis (NMA) was performed to estimate PS placement accuracy as the primary outcome. RESULTS Overall, 78 studies consisting of 6262 patients and > 31,909 PSs were included. NMA results showed that robot-assisted and 3D-fluoroscopy PS insertion had the greatest accuracy compared with freehand (p < 0.01 and p < 0.001, respectively), CT navigation (p = 0.02 and p = 0.04, respectively), and 2D fluoroscopy (p < 0.01 and p < 0.01, respectively). The surface under the cumulative ranking (SUCRA) curve method further demonstrated that robot-assisted PS insertion accuracy was superior (S = 0.937). Optimal screw placement was greatest in robot-assisted (S = 0.995) placement, and misplacement was greatest with freehand (S = 0.069) approaches. Robot-assisted placement was favorable for minimizing complications (S = 0.876), while freehand placement had greater odds of complication than robot-assisted (OR 2.49, p < 0.01) and CT-navigation (OR 2.15, p = 0.03) placement. CONCLUSIONS The results of this NMA suggest that robot-assisted PS insertion has advantages, including improved accuracy, optimal placement, and minimized surgical complications, compared with other PS insertion methods. Limitations included overgeneralization of categories and time-dependent effects.

Clinical results following robotic navigation guidance for sacroiliac joint fusion in 36 patients

OBJECTIVE In this study, the authors aimed to describe a new technique of sacroiliac joint (SIJ) fusion using a robotic navigation guidance system and to document clinical results with patient-reported visual analog scale (VAS) scores. METHODS Patients diagnosed with SIJ dysfunction were surgically treated using 2 hydroxyapatite (HA)–coated, threaded screws with the aid of the robotic navigation system. In a total of 36 patients, 51 SIJs were fused during the study period. Patients’ VAS scores were used to determine clinical improvement in pain. Postoperative imaging at routine intervals during the follow-up period was also performed for assessment of radiological fusion. In addition, complication events were recorded, including reoperations. RESULTS All 36 patients had successful fusion evidenced by both CT and clinical assessment at the final follow-up. Two patients underwent reoperation because of screw loosening. The mean preoperative VAS score was 7.2 ± 1.1, and the mean 12-month postoperative VAS score was 1.6 ± 1.46. This difference was statistically significant (p < 0.05) and demonstrated a substantial clinical improvement in pain. CONCLUSIONS Robotic navigation–assisted SIJ fusion using 2 HA-coated, threaded screws placed across the joint was an acceptable technique that demonstrated reliable clinical results with a significant improvement in patient-reported VAS pain scores.

Workflow and performance of intraoperative CT, cone-beam CT, and robotic cone-beam CT for spinal navigation in 503 consecutive patients

OBJECTIVE A direct comparison of intraoperative CT (iCT), cone-beam CT (CBCT), and robotic cone-beam CT (rCBCT) has been necessary to identify the ideal imaging solution for each individual user’s need. Herein, the authors sought to analyze workflow, handling, and performance of iCT, CBCT, and rCBCT imaging for navigated pedicle screw instrumentation across the entire spine performed within the same surgical environment by the same group of surgeons. METHODS Between 2014 and 2018, 503 consecutive patients received 2673 navigated pedicle screws using iCT (n = 1219), CBCT (n = 646), or rCBCT (n = 808) imaging during the first 24 months after the acquisition of each modality. Clinical and demographic data, workflow, handling, and screw assessment and accuracy were analyzed. RESULTS Intraoperative CT showed image quality and workflow advantages for cervicothoracic cases, obese patients, and long-segment instrumentation, whereas CBCT and rCBCT offered independent handling, around-the-clock availability, and the option of performing 2D fluoroscopy. All modalities permitted reliable intraoperative screw assessment. Navigated screw revision was possible with each modality and yielded final accuracy rates > 92% in all groups (iCT 96.2% vs CBCT 92.3%, p < 0.001) without a difference in the accuracy of cervical pedicle screw placement or the rate of secondary screw revision surgeries. CONCLUSIONS Continuous training and an individual setup of iCT, CBCT, and rCBCT has been shown to permit safe and precise navigated posterior instrumentation across the entire spine with reliable screw assessment and the option of immediate revision. The perceived higher image quality and larger scan area of iCT should be weighed against the around-the-clock availability of CBCT and rCBCT technology with the option of single-handed robotic image acquisition.

Rediscovery of the transcerebellar approach: improving the risk-benefit ratio in robot-assisted brainstem biopsies

OBJECTIVE Conventional frame-based stereotaxy through a transfrontal approach (TFA) is the gold standard in brainstem biopsies. Because of the high surgical morbidity and limited impact on therapy, brainstem biopsies are controversial. The introduction of robot-assisted stereotaxy potentially improves the risk-benefit ratio by simplifying a transcerebellar approach (TCA). The aim of this single-center cohort study was to evaluate the risk-benefit ratio of transcerebellar brainstem biopsies performed by 2 different robotic systems. In addition to standard quality indicators, a special focus was set on trajectory selection for reducing surgical morbidity. METHODS This study included 25 pediatric (n = 7) and adult (n = 18) patients who underwent 26 robot-assisted biopsies via a TCA. The diagnostic yield, complication rate, trajectory characteristics (i.e., length, anatomical entry, and target-point location), and skin-to-skin (STS) time were evaluated. Transcerebellar and hypothetical transfrontal trajectories were reconstructed and transferred into a common MR space for further comparison with anatomical atlases. RESULTS Robot-assisted, transcerebellar biopsies demonstrated a high diagnostic yield (96.2%) while exerting no surgical mortality and no permanent morbidity in both pediatric and adult patients. Only 3.8% of cases involved a transient neurological deterioration. Transcerebellar trajectories had a length of 48.4 ± 7.3 mm using a wide stereotactic corridor via crus I or II of the cerebellum and the middle cerebellar peduncle. The mean STS time was 49.5 ± 23.7 minutes and differed significantly between the robotic systems (p = 0.017). The TFA was characterized by longer trajectories (107.4 ± 11.8 mm, p < 0.001) and affected multiple eloquent structures. Transfrontal target points were located significantly more medial (−3.4 ± 7.2 mm, p = 0.042) and anterior (−3.9 ± 8.4 mm, p = 0.048) in comparison with the transcerebellar trajectories. CONCLUSIONS Robot-assisted, transcerebellar stereotaxy can improve the risk-benefit ratio of brainstem biopsies by avoiding the restrictions of a TFA and conventional frame-based stereotaxy. Profound registration and anatomical-functional trajectory selection were essential to reduce mortality and morbidity.

Robot-assisted frontofacial correction in very young children with craniofacial dysostosis syndromes: a technical note and early functional outcome

OBJECTIVE In this study, the authors aimed to 1) retrospectively analyze the early functional outcomes in a cohort of very young children with craniofacial dysostoses who underwent robot-assisted frontofacial advancement (RAFFA) or robot-assisted midface distraction (RAMD), and 2) analyze the utility of robotic assistance in improving the accuracy and safety of performing transfacial pin insertion for RAFFA or RAMD. METHODS A retrospective analysis of a cohort of 18 children (age range 1–42 months at presentation), who underwent RAFFA or RAMD from February 2015 to February 2021 in the craniofacial unit at Amrita Institute of Medical Sciences and Research Centre in Kochi, India, was performed. Inclusion criteria were patients who had undergone RAFFA in a single stage or RAMD where the cranial vault had been addressed earlier, had been addressed on follow-up, or had not been addressed and had follow-up of at least 6 months. RESULTS Overall, 18 children with syndromic craniosynostosis underwent LeFort level III midface distraction, with or without RAFFA, from February 2015 to February 2021 at a single center in India. The patients’ ages ranged from 6 to 47 months at the time of the procedure. All patients had significant obstructive sleep apnea (OSA), significant ocular issues, and disturbed sleep as determined by the authors’ preoperative protocol. Clinically significant intracranial pressure issues were present in 17 patients. None of the patients had injury due to the transfacial pin trajectory such as globe injury, damage to the tooth buds, or the loss of purchase during the active distraction phase. The mean distraction achieved was 23 mm (range 18–30 mm) (n = 16/18). Of the 18 patients, 10 (56%) had an excellent outcome and 6 (33%) had a satisfactory outcome. In all cases, the degree of OSA had significantly reduced after surgery. Eye closure improved in all patients, and complete closure was seen in 11 patients. On follow-up, the functional gain remained in 14 of 16 patients at the final follow-up visit. The distraction results were stable during the follow-up period (mean 36 months [range 6–72 months]). CONCLUSIONS The early RAFFA and RAMD protocols investigated in this study gave a significant functional advantage in very young patients with craniofacial dysostoses. The results have demonstrated the accuracy and safety of robotic assistance in performing transfacial pin insertion for RAFFA or RAMD.