In this study, we present a novel surgical technique that uses the UBS to effectively and safely remove large retrovertebral cervical osteophytes during ACDF. Furthermore, we investigated the safety and efficacy of the UBS by classifying patients with cervical spondylosis and large posterior cervical osteophytes into two groups: the UBS and HSD groups. Our results demonstrate that the use of the UBS resulted in shorter operation times, decreased intraoperative blood loss and comparable clinical outcomes compared to the HSD group. The clinical outcomes of this study were consistent with previous research both groups showed considerable improvements in JOA and VAS scores postsurgery, and there was no significant difference between them. Moreover, there was no significant difference in bone graft fusion between the groups.
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Regarding the removal of retrovertebral osteophytes, HSD can completely abrade them away. However, to prevent the occurrence of dural tears and spinal cord injuries, this step needs much time to complete, especially when the posterior osteophyte is large or near the dura. In addition, the use of HSD can result in several shortcomings, including direct heat injury to surrounding tissues and the need for frequent irrigation and suction during the procedure17. Regarding UBS, Grauvogel et al. conducted a study using an angled UBS to remove posterior cervical osteophytes, however, they reported prolonged operative time14.
To achieve complete, safe, and efficient removal of osteophytes, our team developed a novel surgical technique that utilizes the selective bone cutting tool of the UBS. In our study, HSD was used only to remove the anterior part of the large retrovertebral osteophytes. Then, we used the UBS to cut the large retrovertebral osteophytes and subsequently removed the entire block of the remaining retrovertebral osteophytes. Our method has four main advantages. First, our method is safer than using HSD alone, as it reduces contact with the dura and spinal cord and exploits the characteristics of tissue selectivity. This characteristic of the UBS cutting bone tissue while protecting soft tissue allows surgeons to safely remove retrovertebral osteophytes without the risk of dural tears and spinal cord injury. Second, our method saves surgical time as we remove the entire block of the remaining retrovertebral osteophytes instead of grinding it down bit by bit with HSD. Third, the UBS can remove large osteophytes under blind visualization. Due to the potential damage to surrounding tissues, HSD requires osteophyte removal under direct visualization. Due to the limited height of the intervertebral space, removing more endplates and cancellous bone is necessary to achieve direct visualization. On the other hand, the UBS, thanks to its protective characteristic toward soft tissues, can remove osteophytes without the need for direct visualization. Finally, the UBS has longer and thinner blades then the HSD, facilitating the surgical procedure.
Notably, the choice of the blade is also very important. Our technique differs from the use of an angled ultrasonic bone knife as reported by Grauvogel et al.14. We believe that without partial resection of the vertebral body, the surgeon's field of view would be limited, and the operation time and risk of dural tear and spinal cord injury would increase. Liu et al. reported the use of a spoon-shaped blade in ACDF18,19, but we believe that removing osteophytes bit by bit under direct visualization with this blade may result in suboptimal efficiency. Moreover, using a spoon-shaped blade to remove osteophytes may cause tension on the dura mater, which could be a contributing factor to the higher incidence of dural membrane injury observed in their study.
In our study, we first compared the clinical characteristics of the use of the UBS for the removal of large cervical retrovertebral osteophytes to that of the traditional HSD. Consistent with previous studies, the use of UBS can save operation time11,12,20,21,22,23,24,25,26,27. Several reasons contribute to the reduction in operation time, aside from the method used in our study of removing the entire posterior osteophytes. First, traditional tools used for laminectomy or corpectomy often lead to substantial blood loss from cancellous bone. Using the UBS can minimize bleeding and shorten the time required for hemostasis. Second, traditional tools such as HSD and laminectomy rongeurs require surgeons to exercise caution while dealing with osteophytes to prevent dural tears and spinal cord injury, which could lead to a longer operation time. Notably, a prior study that used UBS to remove retrovertebral osteophytes reported increased operation time, but no comparison was made with HSD14. The authors proposed that this could be attributed to the surgeon's insufficient familiarity with UBS, inconvenient handling, and inadequate documentation of the intraoperative use for scientific purposes14.
Our study demonstrated that using the UBS significantly reduces intraoperative blood loss, which is consistent with previous research26,27,28. The cavitation effect of using the UBS, allowing for local hemostasis, and its tissue selectivity, which reduces vascular damage are the reasons for this advantage. However, it is worth noting that a study on the treatment of thoracic ossification of the posterior longitudinal ligament with circumferential decompression showed that the UBS does not offer any advantage in reducing blood loss when vascular injury cannot be avoided29. This finding further emphasizes the fact that the UBS mainly reduces intraoperative blood loss by reducing bone bleeding. Moreover, the aforementioned time-saving advantage is also critical for reducing the amount of intraoperative blood loss.
Regarding postoperative complications, our study found no instances of dural tears or spinal cord injuries in either the UBS or HSD groups. However, it should be noted that previous studies have reported cases of UBS-induced dural tears and spinal cord injuries, highlighting the need for caution10,21,30,31. Heat injury is a potential risk to be vigilant about, although using the UBS carries a lower risk of heat injury compared to HSD due to its water-cooling system. Prolonged local retention of the UBS can still cause overheating, leading to bone necrosis, dura tear, and spinal cord injury. Chen et al. recommended that the UBS tip should not remain on one point for more than 5 s21. In our experience, moving the UBS layer by layer continuously can minimize the risk of overheating and reduce the risk of complications. Moreover, in cases of dural calcification, preoperative CT will show a prominent double-track sign, indicating that UBS should be used with caution, as it may easily cause a dural tear20,22,30. In such cases, the posterior approach may be a more appropriate choice.
Our study has some limitations that need to be acknowledged when interpreting the findings. First, it is a retrospective comparative study and not a randomized controlled trial, which could lead to selection bias and confounding factors. Second, the data were collected from one surgeon at a single medical institution, which could restrict the generalizability of the results. Therefore, future studies involving multiple surgeons from various centers are necessary to validate our findings. Finally, the sample size of this study was relatively small, and larger studies are required to further investigate the safety and efficacy of the UBS in cervical spine surgery.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License ( http://creativecommons.org/licenses/by-nc-nd/3.0/us/ ), which permits for noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited and is not altered in any way.
Funding: This study was supported by Reach Surgical, Inc., which provides advanced medical devices and equipment for surgical procedures through its product development centers and manufacturing facilities in the United States and People's Republic of China.
For 10 random cuts made in the omentum and during the hysterectomy, the ultrasonic scalpel was effective and fast, with no immediate or delayed bleeding. Bipolar energy, sutures, and hemoclips were not required to control bleeding. No bleeding was observed in sealed vessels up to 8 mm, even during BP challenges sustained for longer than 5 minutes. When testing vessels of 10 mm, bleeding occurred in 1 common iliac vein before 10 minutes of waiting (the point of bleeding was easily identified) and bleeding occurred in 1 of the common iliac arteries during the BP challenge.
One healthy female swine was used. We performed resections of the omentum, biopsies in different regions of the liver, and a hysterectomy. Vessels with diameters ranging from 2 to 10 mm were sealed with the ultrasonic scalpel under regular hemodynamic conditions and during pharmacologically induced arterial hypertension (BP challenge).
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The ultrasonically activated scalpel is a surgical instrument that is used in minimally invasive surgery to safely cut and seal vessels. This study reported the experimental observations of the use of a laparoscopic ultrasonic scalpel, including its safety and feasibility. in sealing vessels of different diameters in an in vivo animal model during both physiological and supraphysiological blood pressure (BP) conditions.
This study reports the experimental observations of the textural cutting and hemostatic effect of a laparoscopic ultrasonic scalpel device, including its safety and feasibility, for sealing arteries and veins of different diameters in an animal (porcine) model under both physiological and supraphysiological blood pressure (BP) conditions.
Multiple studies have demonstrated the superiority of the ultrasonic scalpel in comparison with conventional energy systems in several surgical subspecialties. The most valued benefits reported are shorter surgical times and less intraoperative bleeding. 5 , &#; 9
The growing use of ultrasonic energy in laparoscopic surgeries reflects the advantages enumerated here and its record as one of the safest energies. 1 The ultrasonically activated scalpel &#; also known as the ultrasonic scalpel &#; works by generating the high-frequency harmonic motion of a metallic rod, which denatures proteins. These vibrations can simultaneously cut tissues and coagulate. Cutting is very effective with less bleeding and less thermal damage to the surrounding tissues and, hence, less smoke. There is no transmission of electricity to the patient and no neuromuscular stimulation. 1 , &#; 4
This study was carried out through a partnership between Crispi Institute for Minimally Invasive Surgery and the Faculty of Medical Sciences and Health of Juiz de Fora (SUPREMA). The experimental surgery was conducted in the SUPREMA Surgical Training Center (Juiz de Fora, Minas Gerais, Brazil) with the approval of the Institutional Animal Care and Use Committee (CEUA-SUPREMA Number 004/) in accordance with the &#;Guide for the Care and Use of Laboratory Animals&#; of the National Research Ethics Commission of the Brazilian Ministry of Health. The animal used in this study had a health certificate issued by a veterinarian, which was provided by the supplier. In addition, the animal was evaluated clinically by the veterinarian responsible for the study (F.L.F.M.) before and during the experimental surgery.
In this experimental surgery, we used a CSH model ultrasonic scalpel (Reach Surgical Inc., Tianjin, China), with a 5-mm laparoscopic curved tip shear and a 36-cm pistol (ANVISA Reg. No. ), attached to the Sound Reach® model CSUS generator (ANVISA Reg. No. ). The device is composed of an ultrasonic blade that oscillates at 55 ± 1 KHz, which was configured at a power level of 3 (75% of the maximum power) or 5 (full power), following the manufacturer's operating instructions. Regarding the time for sealing vessels, the device was allowed to reach full transection, and the respective time durations (in seconds) were measured through video analysis.
One healthy female swine (Crossbreed Large White; age 6 months; weight 28 kg) that had fasted for 12 hours was premedicated with intramuscular midazolam (0.5 mg/kg) plus atropine (0.04 mg/kg) plus ketamine (2 mg/kg) plus acepromazine (0.1 mg/kg). General anesthesia was induced with intravenous propofol (4 mg/kg) and maintained with isoflurane (1.5 to 2.5 vol%) in oxygen after oral intubation (flow rate 2 L/min). Monitoring during anesthesia was provided with continuous electrocardiography, pulse oximetry, rectal thermometer, and sphygmomanometer. The ambient temperature of the operating suite was maintained between 21° and 23°C.
During laparoscopy, the animal was placed in dorsal recumbency and the CO2 pneumoperitoneum was set at 10 mm Hg. Intravenous epinephrine (total dose 1 mg) was used to increase blood pressure above the physiologic range, in order to simulate intraoperative arterial hypertension. The animals were euthanized by deep anesthesia followed by potassium chloride 19.1% (10 mL) intravenous injection.
This experimental surgery was performed by a multidisciplinary team, which included 2 surgeons (1 gynecologist [C.P.C.] and 1 proctologist [P.S.S.R.J.]) with extensive experience with complex laparoscopic procedures and 2 very experienced veterinary anesthesiologists (F.L.F.M. and M.M.F.). All the intraoperative decisions were shared with another experienced group (1 experienced anesthesiologist [M.F.F.] and 1 experienced surgeon [C.P.C.J.]) who worked as external experimental observers in order to obtain consensual conclusions and minimize biases.
Briefly, the study was carried out in 2 phases. In the first phase, the ultrasonic scalpel was used in resections in several porcine organ systems with 2 different power levels (3 and 5). These included resections of the mesosigmoid and of the omentum and performance of a total hysterectomy with resection of the ovaries, uterine ligaments, and horns. Also, although not designed for this purpose, the ultrasonic scalpel was applied in different sites of the liver (at the lower power level) in order to simulate liver biopsies, where bleeding is a paramount concern. Following the manufacturer's instructions, cuts were made using the distal two-thirds of the active portion of ultrasonic scalpel.
The second phase evaluated how well the ultrasonic scalpel (at the lower power level) cut different blood vessels (arteries and veins) and the hemostatic effect that is, the sealing of these blood vessels ( and ). After skeletonization (dissection to isolate the blood vessels), the diameter of each artery was estimated by visual inspection to compare the diameter of the vessel with the known benchmarks of the scalpel (5 and 10 mm) as shown in A, inset. The vessels were thus classified as 2 to 3 mm, 4 to 5 mm, 7 to 8 mm, and 10 mm in diameter. Even though it is uncommon to seal vessels larger than 5 mm with an energy device, we purposely exceeded this caliber to investigate if the ultrasonic scalpel was also effective in sealing larger vessels up to 10 mm in diameter. The hemostatic effect of the ultrasonic scalpel was evaluated systematically at 2 time points: immediately after cutting the vessels and up to 10 minutes after cutting. These assessments were made during normal hemodynamic conditions and after pharmacologically induced extreme arterial hypertension (blood pressure challenge).
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