A novel visualized foraminoplasty technique in patients with lumbar disc herniation with lumbar foraminal stenosis

doi:10.21203/rs.3.rs-1662053/v1

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Research Article

A novel visualized foraminoplasty technique in patients with lumbar disc herniation with lumbar foraminal stenosis

https://doi.org/10.21203/rs.3.rs-1662053/v1

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OBJECTIVE: To introduce a novel visualized foraminoplasty technique in patients with lumbar disc herniation with lumbar foraminal stenosis.

METHODS: We retrospectively analyzed patients who had undergone surgery in our hospital for lumbar disc herniation with foraminal stenosis. We enrolled 35 patients who received the traditional TESSYS technique and 70 who received the new technique. We compared the foraminalplasty time, fluoroscopy times, intraoperative blood loss, intraoperative dural and nerve root injuries, length of postoperative hospital stay, clinical outcome according with modified MacNab criteria, Visual Analog Scale (VAS) and Oswestry Disability Index (ODI)between the new technique group and the traditional TESSYS technique group.

RESULTS: The intraoperative VAS score(1.84±0.96) and fluoroscopic times(13.30±3.79) in the new technique group were significantly lower than those in the traditional TESSYS group (intraoperative VAS score,3.60±1.09,P=0.000;fluoroscopic times,20.00±4.24,P=0.000).The foraminalplasty time in the TESSYS group(17.60±3.46) was significantly shorter than that in the new technique group (22.81±4.86)(P=0.000).There were no significant differences in length of hospital stay after surge, postoperative VAS score and postoperative ODI score between the two groups (P=0.835, P=0.779, P=0.350). In addition, the amount of blood loss during foraminoplasty could not be calculated due to the presence of continuous saline irrigation in the new technique group. In the conventional TESSYS technique group, there was 1 patient with exiting nerve root injury who developed significant leg pain after surgery.

CONCLUTIONS: The novel visualized foraminoplasty technique is a safe and effective surgical method. Compared with traditional surgical methods, it has obvious advantages in reducing intraoperative pain and radiation exposure.

foraminoplasty

lumbar disc herniation

foraminal stenosis

percutaneous endoscopic lumber discectomy

In 1970s, Hijikata et al. [1] developed the technique of percutaneous discectomy. Subsequently, Kambin and Sampson [2] proposed percutaneous endoscopic lumber discectomy (PELD).In recent years, with the development of minimally invasive spinal endoscopy and the continuous development of surgical instruments, PELD has gradually become a mature technique for the treatment of lumbar disc herniation(LDH).Compared with traditional open surgery, PELD has the advantages of less intraoperative blood loss, more anatomical structure of spinal and surrounding tissues preserved, shorter hospital stay, lowest postoperative movement restriction, faster recovery, smaller probability of iatrogenic injury, and relatively less postoperative pain [3, 4, 5].Therefore, many scholars believe that PELD is a better choice for treating LDH [6, 7, 8].There are two kinds of surgical approaches for PELD surgery, namely, the intervertebral approach and the transforaminal approach. In patients with foraminal stenosis, it is difficult to completely remove the dissected disc using the traditional transforaminal percutaneous endoscopic lumber discectomy (TF-PELD) approach, resulting in disc residue and even secondary open surgery. And if the cannula is inserted into the narrow foramen, the cannula may compress the exiting nerve root, causing postoperative dysesthesia. To prevent this complication, foraminoplastic TF-PELD was established [9, 10]. Foraminoplasty is defined as “the ventral partial excision of the foraminal ligament through the superior articular process (SAP), with the use of a bone trephines or endoscopic drill and a side-firing laser to enlarge the foramina to reveal the anterior epidural space and its contents” [11].

With the traditional TESSYS technique, the foramina was enlarged by isocentric reamers to remove part of the SAP after positioning with a puncture needle [12]. Puncture and foraminalplasty using reamers can be a very dangerous procedure because nerve roots also exist in the limited volume of the foraminal space. The traditional TESSYS technique has a steep learning curve [13, 14]. Inappropriate foraminoplasty can easily result in intraoperative nerve root injury, and the removal of excessive superior facet with reamers can affect the stability of the spine [15], the removal of too little will not be exposed nerve root enough cause disc herniation cannot be removed, which can be challenging for even experienced surgeons.

In order to perform foraminoplasty more safely and effectively, Knight et al. [16] performed endoscopic laser foraminoplasty for foraminal nerve root entrapment syndrome in the 1990s. In 2003, Ahn et al. [17] described an endoscopic reamer and laser foraminoplasty. In 2018, some scholars have proposed new instruments for foraminalplasty [18]. In this study, we proposed A novel visualized foraminoplasty technique. And we compared the foraminalplasty time, fluoroscopy times, intraoperative blood loss, intraoperative dural and nerve root injuries, length of postoperative hospital stay, clinical outcome according with modified MacNab criteria, Visual Analog Scale (VAS) and Oswestry Disability Index (ODI)between the new technique group and the traditional TESSYS technique group.

We retrospectively analyzed patients who were treated with TF-PELD at our hospital for symptomatic L4/5-disc herniation. Thirty-five patients underwent traditional TESSYS technique and 70 underwent the new foraminoplasty technique. Inclusion criteria were: (1) Chinese citizens; (2) typical symptoms of disc herniation; (3) L4/5 single-segment disc herniation demonstrated by CT or MRI; (4) diagnosis of lateral foraminal stenosis with LDH symptoms：4mm or less for the posterior disc height and 15 mm or less for the foraminal height^[19], and distance between posterior edge of the disc and ventral aspect of the facet joint was less than 8 mm^[30]. Exclusion criteria included: (1) radio-graphic evidence of protrusion in the remaining segments, even if there were no symptoms; (2) spinal instability; (3) history of spinal surgery; (4) history of spinal trauma, tumor, tuberculosis, and infection.

Ethics statement

This study was conducted in accordance with the guidelines of the 1964 Helsinki declaration. Since it is a retrospective study, informed consent from patients is not required after the ethics committee of the First Affiliated Hospital of Wenzhou Medical University has been obtained.

Surgical techinal

All procedures were performed in lateral decubitus position on a radiolucent table using C-arm fluoroscopy under local anesthesia. Patients could communicate with the surgeon during the entire procedure, which enabled the surgeon to avoid damaging to the neural tissues. The skin puncture point was the intervertebral space plane tilted 15 degrees toward the patient's head. The distance from the skin entry point to midline was 2cm from the posterior axillary line。

The Traditional TESSYS Technique Group

After local anesthesia, a needle is inserted into the selected skin puncture point, just past the surface of the superior articular process tip, and further local anesthesia is performed. The final target points of the tip should be very accurate: the upper edge of the pedicle on the anteroposterior radiograph and the posterior upper edge of the vertebral body on the lateral radiograph. There are 3 grades of reamers: 5.0 mm, 6.5 mm, and 7.5 mm. The 5.0mm reamer was positioned using the puncture guide wire and rotated clockwise to extend the hole when in contact with the bone. The reamer was then replaced step by step to enlarge the foramina. In foraminoplasty, the depth of the reamer should be carefully controlled under fluoroscopy and the patient needs to be continually fluorinated anteroposterior and laterally. On anteroposterior radiographs, the depth of the reamer should not exceed the medial edge of the pedicle. (Figure1). Then put in the working cannula and the tip of the working cannula is placed directly into the spinal canal [12].

The New Technique Group

After local anesthesia, the puncture needle was pierced into the selected skin puncture point. During the operation, C-arm fluoroscopy was used to locate the puncture needle. The puncture needle just passes through the tip of the superior articular process. The tip of puncture needle is located outside the spinal canal and above and outside the pedicle on the anteroposterior radiograph and should be posterior and upper part of the vertebral body on the lateral radiograph. Subsequently, the patient was anesthetized further, and after soft tissue reaming, a working cannula was placed, and fluoroscopy was performed again. The cannula was found to be in the same position as the original puncture needle. The tip of the working cannula should be completely outside the foramina. (Figure 2)

The endoscopic system was then placed, followed by continuous irrigation with normal saline, and the external foraminal vessels, ligaments and soft tissues were gradually separated under the endoscope. At the same time, the bleeding vessels and soft tissues were stopped by radiofuncency electrodes, and the intersection points of the SAP, the intervertebral disc and the upper edge of the pedicle were searched (Figure 3, a). The foraminoplasty was subsequently performed under endoscopy with a bone chisel. The chisels included the ventral side of the SAP, the inner upper margin of the lower pedicle, and the posterior upper margin of the lower vertebral body, thereby increasing the width of the foramina and exposing the ventral epidural space. During the process, the soft tissue was carefully separated, and the chiseled bone was carefully removed to avoid damage to the exiting root and foraminal vessels (Figure 3, b). Under the endoscope, use a chisel to gradually enlarge the intervertebral foramen, slowly (Figure 3, c, d). The foramina is progressively enlarged to expose the junction of the superior articular process with the pedicle, or, when exposed to sufficient visual field, to remove the herniated disc (Figure 3, e). In this process, the nerve root is in our vision all the time, but our surgical instruments do not touch or squeeze the nerve root. Finally, we remove the disc (Figure 3, f).

Statistical annalysis

SPSS 17.0 software was used for statistical analysis. The independent sample t-test was used to compare the statistical differences in preoperative information, clinical outcomes, foraminalplasty time, number of fluoroscopic tests, and length of postoperative hospital stay between the two groups. Paired sample t-test was used to compare the differences in ODI scores and VAS scores between the groups before and after surgery. The full score of ODI was 45. Since many patients refused to score the item of sexual life, we removed this item. The foraminalplasty time in the traditional TESSYS technique group included the time of puncture and removal of the SAP with reamers and did not include the time of placement of the working cannulas. The foramination time in the new technique group included puncture fluoroscopy and bone chiseling under the working cannulas until sufficient field of view was exposed to remove the herniated disc.Statistical significant difference was established at P<0.05 in every analysis.

Preoperative and Postoperative Clinical Assessments

Preoperative ODI score and VAS score were not significantly different between the two groups (P=0.468, P=0.126).Similarly, there was no significant difference in postoperative ODI and VAS scores between the two groups (P=0.779, P=0.350).The mean ODI score in the traditional TESSYS technique group decreased from 19.03±3.81 preoperatively to 4.31±1.55 postoperatively (P < 0.001), and the mean VAS score decreased from 7.46±4.04 preoperatively to 1.29±0.67 postoperatively (P < 0.001).The mean ODI score in the new technique group decreased from 19.51±2.89 preoperatively to 4.40±1.43 postoperatively (P < 0.001), and the mean VAS score decreased from 7.10±1.16 preoperatively to 1.14±0.77 postoperatively (P < 0.001).

As shown in Table 1, the intraoperative VAS score of the new technology group was significantly lower than that of the TESSYS group (P=0.000). Similarly, the number of intraoperative fluoroscopy in the new technology group was also significantly lower than that of the TESSYS group (P=0.000).However, the foraminalplasty time in the TESSYS group was significantly shorter than that in the new technique group (P=0.000).There were no significant differences in length of hospital stay after surge, postoperative VAS score and postoperative ODI score between the two groups (P=0.835, P=0.779, P=0.350).In addition, the amount of blood loss during foraminoplasty could not be calculated due to the presence of continuous saline irrigation in the new technique group.

Complications

As shown in Table 2, both techniques have good clinical outcomes. But in the conventional TESSYS technique group, there was 1 patient with exiting nerve root injury who developed significant leg pain after surgery. But the pain improved with medication.

With the development of surgical instruments and surgical techniques, PELD has gradually become one of the mainstream operations for the treatment of lumbar disc herniation. In patients with lumbar degenerative disease, the nerve root outlet is often narrowed due to reduced disc height, osteoarthritic changes in the facet joints, cephalad subluxation of the SAP. Therefore, most of these patients are associated with foraminal stenosis. In this study, foraminal stenosis was defined as “4mm or less for the posterior disc height and 15 mm or less for the foraminal height [19], and distance between posterior edge of the disc and ventral aspect of the facet joint was less than 8 mm [20]”. For patients with foraminal stenosis, the diameter of the foraminal is often smaller than that of the diameter of our surgical endoscope. If the cannula is inserted into the narrow orifice, the cannula may compress the existing nerve root and cause postoperative dysesthesia. To prevent this complication, foraminal plasty is a routine procedure.

Hoogland et al. [12, 21, 22] established the existing TESSYS system, which is a technique for enlarging foramen by using staged reamers. The PELD technique has a very steep learning curve [5], and likewise the TESSYS technique has a very steep learning curve [23, 24]. Different from the YESS technique proposed by Yeung in 2002 [25], the TESSYS technique follows an "outside-in" approach, in which the disc herniation into the spinal canal is removed directly under the endoscope through an enlarged foramen. The decompression process looks directly into the nerve root. However, foraminal plasty should not be performed in the same way for different foraminal sites, and the desired foraminal procedure should be performed for each patient. In addition, there are disadvantages such as instability in the direction of the reamer when using it, such as improper operation, and the risk that the reamers may touch the soft tissue, dura and nerve roots at the edge of the foramina and cause unnecessary injury.

The intervertebral foramen and its adjacent area are the main areas of our surgical operation. However, there are a large number of ligaments and vessels in this area. Surgeons usually pay attention to whether the nerve root is hurt during the operation, thus neglecting the protection of blood vessels and ligaments. An anatomical study shows that, a large number of ligaments exist inside and outside the intervertebral foramen [26]. In these ligament spaces, there are many nerve branches and blood vessel branches. The traditional TESSTYS technology is to constantly adjust the angle and depth of the reamer under fluoroscopy. When the reamer reaches the desired position, the intervertebral foramoplasty is completed. But the whole process of this technique is blind, emphasizing the position of the bony and neglecting the protection of nerves, blood vessels and soft tissue. Some studies have shown that dysesthesia may occur after TESSYS surgery due to the irritation of nerve root associated with the approach [27]. Meanwhile, some scholars found that TESSYS was associated with a high probability of nerve root injury [28]. Wang et al. reported that 3 cases of nerve root injury in 207 cases of TF-PELD operation [29]. Another scholar reported a case of destruction of the radicular artery accompanied by the right L4 exiting nerve root during foramen plasty, followed by bleeding [30].

TF-PELD is operated through Kambin triangle, which is considered to be a safe operation [31]. This area is generally thought of as a blank area with no important organization. However, some scholars have found branches of ascending lumbar vein and intervertebral vein in Kambin triangle [32]. Therefore, blind foraminoplasty is dangerous because the inside and outside of the intervertebral foramen are filled with nerves and blood vessels. For these reasons, we proposed a novel visualized foraminoplasty technique.

Like the traditional TESSYS technique, our proposed new visual foramoplasty technique is a more thorough "outside-in" principle. Our puncture site and first placement of the working cannula were completely outside the spinal canal. After the working cannula was placed, the external foraminal vessels, ligaments and other tissues were clearly visible (Fig. 4). Careful dissection of these ligaments and blood vessels during foraminal plasty can achieve further hemostasis and preserve maximum anatomical integrity. Although the PELD procedure itself has the advantage of low blood loss, our surgical approach further reduces blood loss. The exact amount of blood loss cannot be calculated due to the presence of continuous irrigation with normal saline during the operation. Our technique greatly avoids the injury of large blood vessels and minimizes the possibility of postoperative epidural hematoma. The traditional TESSYS technique neglected the protection of soft tissues and blood vessels inside and outside the foramina due to its emphasis on preventing the reamers from entering too deep into the spinal canal through fluoroscopy in the process of foramina, which may increase the possibility of postoperative wound exudation and delay wound healing.

In our study, intraoperative pain scores were significantly reduced, and radiation exposure was significantly reduced in the new technique group compared to the traditional TESSYS group technique, suggesting that this technique is a good option for patients. Ideally, our new visual foramoplasty technique requires only four fluorograms to achieve our desired puncture location. However, the traditional TESSYS technique not only requires a large number of fluoroscopic positioning to reach the appropriate position of the puncture needle during the puncture process, but also requires continuous fluoroscopy in the anteroposterior and lateral position during the process of the reamers expanding the foramina to ensure that the reamers will not enter the spinal canal too deep and damage the nerve root and dural sac. In addition, a significant reduction in pain during foramoplasty also contributed to increased patient compliance. In the process of foraminal plasty, patients may change their position due to pain, which will affect the smooth progress of puncture positioning and even increase the number of fluoroscopies. Previously, some scholars have pointed out that repeated puncture will increase the risk of radiation exposure of patients and medical staff [33]. In order to reduce the number of fluoroscopy, some scholars have pointed out that the use of ultrasound-assisted needle insertion and foraminalplasty in TF-PELD can reduce the radiation exposure of medical personnel [34], while our technology can well reduce the radiation exposure without the assistance of external equipment.

Our technique allows individualized foraminalplasty according to the characteristics of the patient's foraminal stenosis, thereby reducing articular surface damage caused by excessive removal of bony tissue like the traditional TESSYS technique [35], and avoiding the failure to completely remove the herniated disc due to inadequate foraminalplasty. No nerve root or dural injury occurred in the 70 patients in our new technique group. Furthermore, none of the hundreds of patients who underwent the new technique but were not included in the study had any nerve root damage. In addition, our technique allows arbitrary adjustment of the position and orientation of the tip of the working cannula, using the surrounding skin and muscle tissue as elastic fulcrum, to perform foraminal shaping at the desired angle (Fig. 5). Therefore, for the high-grade migrated herniated discs and even contralateral herniated discs, the surgeon could lever the cannula to make it more horizontal, upward or downward tilting, even contralateral. In addition, one patient in the new technology group who had significant discomfort in the leg after the placement of the working cannula reported improved discomfort after changing the working cannula angle.

Our technology also has the following limitations. First, the new visualized foraminoplasty technique has a significantly longer foraminal shaping time than the traditional technique. Due to the continuous saline irrigation during the operation, too long operation time may have a certain impact on the intracranial pressure of the patients, and the patients may have symptoms of increased intracranial pressure such as headache after the operation. At the same time, prolonged placement of the working cannula increases the possibility of compression of the nerve root. Thirdly, in order to obtain a clearer field of vision, radiofrequency hemostasis will be performed on the bleeding bone surface during foraminoplasty, which will undoubtedly increase the risk of thermal injury in patients. Fourth, in the foraminal shaping process, we need an assistant to assist with the use of the dynamic system under the endoscope, which also has a certain test for the proficiency of the assistant. And finally, we have a very steep learning curve for this technique, which is very demanding for surgeons. However, the effects of both procedures on spinal stability still require many patients to be followed for a long time.

The novel visualized foraminoplasty technique is a safe and effective surgical method. Compared with traditional surgical methods, it has obvious advantages in reducing intraoperative pain and radiation exposure.

VAS: Visual Analog Scale; ODI: Oswestry Disability Index; PELD: percutaneous endoscopic lumber discectomy; LDH: lumbar disc herniation; TF-PELD: traditional transforaminal percutaneous endoscopic lumber discectomy; SAP: superior articular process.

Acknowledgements

Not applicable.

Authors’ contributions

Author Peng Zhang design the surgical plan, conceive and write the paper. Author Chao-wei Lin participates in surgery and paper writing. Author Minghang Chen, Yaozhi He, Xin Yan, Jiaxin Lai, Shikang Fan and Sheng Li collected the clinical data and analysis, interpretation of data. Author Honglin Teng accomplishes the operation and supervise and project administration. All authors read and approved the final manuscript.

Funding

Not applicable.

Availability of data and materials

The datasets used or analyzed during the current study are available from the corresponding author on reasonable request.

Ethics approval and consent to participate

This research was approved by the ethics committee of the First Affiliated Hospital of Wenzhou Medical University.

Consent for publication

Not applicable.

Competing interests

None declared

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TABLE1: Comparison of Clinical Outcomes in the TESSYS and NEW TECHONOLOGY Groups
	TESSYS GROUP	NEW TECHONOLOGY Group	P VALUE
VAS
Preoperative	7.46±4.04	7.10±1.16	P=0.126
Intraoperative	3.60±1.09	1.84±0.96	P=0.000
Postoperative	1.29±0.67	1.14±0.77	P=0.350
ODI
Preoperative	19.03±3.81	19.51±2.89	P=0.468
Postoperative	4.31±1.55	4.40±1.43	P=0.779

Foraminoplasty time(min)	17.60±3.46	22.81±4.86	P=0.000

Hospital stay after surge（day）	2.02±0.74	2.00±0.64	P=0.835

Radiation exposure times	20.00±4.24	13.30±3.79	P=0.000

TABLE2: Comparison of MacNab Evaluation, and Complications in the 2 Groups
	TESSYS GROUP	NEW TECHONOLOGY Group
MacNab evaluation
Excellence	31	64
Good	2	3
Fair	1	3
Poor	1	0
Excellence/good rate	94.29%	95.71%
Nerve root injury	1	0

No competing interests reported.

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A novel visualized foraminoplasty technique in patients with lumbar disc herniation with lumbar foraminal stenosis

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