A comparative study on the clinical efficacy of UBETlif and Mis-Tlif in the treatment of degenerative Lumbar Stenosis with Instability

doi:10.21203/rs.3.rs-3224971/v1

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A comparative study on the clinical efficacy of UBETlif and Mis-Tlif in the treatment of degenerative Lumbar Stenosis with Instability

https://doi.org/10.21203/rs.3.rs-3224971/v1

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Purpose

To compare the clinical efficacy of unilateral biportal endoscopic technique transforaminal lumbar interbody fusion (UBE-TLIF) and minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) in treating degenerative lumbar stenosis with instability.

Methods

A retrospective study was performed on 64 patients with degenerative lumbar stenosis with instability admitted between January 2018 and December 2021 and divided into UBE-TLIF and MIS-TLIF groups. Comparison of data; surgical index; postoperative complications; the visual analogue scale (VAS) score for back pain and leg pain, Oswestry disability index (ODI), and MOS 36-Item Short-Form health survey (SF-36) were used to evaluate the function before surgery, 1 and 3 months after surgery, and at the last follow-up; and adult spinal deformity (ASD) at the last follow-up.

Results

All patients successfully completed the surgery, with a follow-up time of 6 to 16 months. There were no statistical differences in general data between groups. Reagarding surgical indicators: the UBE-TLIF group had more advantages in terms of intraoperative blood loss, surgical incision length, and postoperative hospital stay, although the operation time was longer. Regarding clinical efficacy evaluation indicators: the VAS, ODI, and SF-36 in both groups significantly improved at each time point after surgery, there was no difference in other time points. Compared with the MIS-TLIF group, there was no significant difference in the VAS or SF-36. The ODI of the UBE-TLIF group was better than the MIS-TLIF group 1 month after surgery, with no statistical difference at other time points. ASD incidence in both groups was 3.125%, the difference was not statistically significant.

Conclusion

Compared with MIS-TLIF, UBE-TLIF achieved a similar interbody fusion effect in the treatment of degenerative lumbar instability with spinal stenosis, optimised surgical indicators, and reduced postoperative stress response.

Degenerative lumbar instability

spinal stenosis

UBE-TLIF

MIS-TLIF

clinical efficacy

With the rapid growth of China's aging population and the increase in the overall life expectancy of the population, degenerative diseases associated with the spine have increased significantly, with degenerative lumbar instability and spinal stenosis being important causes of low back pain in older adults. Traditional open surgery is regarded as the standard procedure for treating degenerative lumbar stenosis with instability over the past decades. Common open procedures include posterior lumbar interbody fusion (PLIF) and posterior posterolateral transforaminal lumbar interbody fusion (TLIF). In 2003, minimally invasive transforaminal lumbar interbody fusion (MIS-TILF) was first proposed and performed by Foley [1]. In recent years, with the rapid development of spinal endoscopic techniques, microscopic decompression of the spinal canal and intervertebral fusion have been achieved. The Unilateral Biportal Endoscopic technique (UBE) is also gradually becoming favoured by spine surgeons due to its efficiency and simplicity, the procedure is carried out through two discrete little surgical incisions on either side of the spinous process. UBE-TLIF and Quadrant-channel MIS-TLIF are minimally invasive procedures for treating degenerative lumbar instability with spinal stenosis; however, there are few studies have compared the clinical efficacy of these two procedures. In this retrospective case-control study, we compared the clinical efficacy of UBE and TLIF via quadrant access to provide a reference for a reasonable procedure for treating various degenerative lumbar instabilities with spinal stenosis.

Objects

A total of 64 patients at our hospital from 2018 to 2021 were enrolled in this study. The inclusion criteria was as follows: (1) Clinical manifestations of typical lumbar spinal stenosis, unilateral and/or bilateral lower extremity neurological symptoms, low back pain, and/or ineffective intermittent claudication after standard conservative treatment for 3–6 months. (2) Imaging examination of the lumbar spine showed moderate to severe central canal stenosis and bilateral recess stenosis, with or without lumbar spondylolisthesis of grade II or lower, and with surgical indications for spinal canal decompression and interbody fusion. (3) Severe single-segment intervertebral disc degeneration identified via lumbar computed tomography and multiple resonance imaging, consistent with clinical symptoms and signs. The exclusion criteria were as follows: (1) severe scoliosis, deformity, lumbar spondylolisthesis of grade III and above, and severe bilateral foraminal stenosis; (2) lumbar spine infection, tumour, severe osteoporosis, motor neuron disease; (3) those who had undergone lumbar surgery or radiation therapy with extensive adhesion of the lesion segment; and (4) those with incomplete imaging data and who were lost during follow-up. According to different surgical methods, eligible patients were divided into the UBE-TLIF and MIS-TLIF groups (32 cases in each group). Among them, the UBE-TLIF group was aged 55–92 years old (average age: 68.29 ± 13.86 years); sex (male/female: 15/17 cases); body mass index (23.13 ± 1.91 kg/m2); disease duration 4–37 months (average disease duration 9.88 ± 6.68 months); and operative segment (L2/3/L3/4/L4/5: 3/7/22 cases). The MIS-TLIF group was aged 55–94 years (mean age 68.36 ± 13.87 years); sex (male/female: 13/19 cases); body mass index (23.89 ± 1.98 kg/m2); disease duration 4–36 months (average disease duration 9.59 ± 6.62 months); and operative segment (L2/3/L3/4/L4/5: 3/8/21 cases). There were no significant differences in age, sex, body mass index, disease course, or surgical segment between the two groups (P > 0.05). This study complied with the relevant requirements of the Declaration of Helsinki (revised in 2013) and the medical ethics of our hospital, and all patients provided informed consent for the surgical plan.

Surgical plan

UBE-TLIF group: General anaesthesia was administered, and the patient was placed in the prone position. The vertebral space of the diseased segment was fluoroscopically located with the assistance of a C-arm X-ray machine, and the vertebral space of this segment was centered on a paracentral opening of approximately 2 cm, with one transverse incision mark drawn 1.0-1.5 mm above and below the midline of the diseased vertebral space. The lumbodorsal fascia was incised longitudinally, and the soft tissue overlying the bony surface of the vertebral plate was bluntly separated by stepwise expansion to form an observation and working channel. The observation channel was placed in the arthroscopic system, and isotonic saline irrigation was selected and flushed until the visual field was clear. The soft tissue on the surface of the vertebral plate was applied via the working channel with a radiofrequency plasma knife to achieve haemostasis. The inferior margin of the superior vertebral lamina and the superior margin of the inferior vertebral lamina were removed from the target intervertebral space using gun forceps and power abrasive drills to access the spinal canal. The upper and lower edges of the ligamentum flavum were gradually freed, and the excess ligamentum flavum was removed. A portion of the inferior articular eminence of the superior vertebral body was removed laterally, and the nerve root canal was shaped. The nerve roots and dural sac were retracted using a nerve puller to expose the intervertebral disc, and the disc was removed using a reamer and nucleus pulposus. Autologous bone was fragmented and implanted into the intervertebral space, and the cage is placed microscopically to avoid the nerve roots and dural sac. Finally, a surgical incision was made to place pedicle screws for fixation. The surgical incision was flushed, a drainage tube was placed to drain the incision, the incision was closed layer-by-layer, the subcutaneous tissue was sutured to complete the surgery, and postoperative frontal and lateral radiographs were taken. (A typical case is illustrated in Fig. 1)

MIS-TLIF group: After tracheal intubation and general anaesthesia, the patient was placed in the prone position. With the assistance of C-arm X-ray fluoroscopy, the projection point on the surface of the pedicle of the diseased segment was confirmed and marked, the operation was performed according to the projection point, and the incision was made. The subcutaneous tissue, multifidus muscle, and related spaces were exposed behind the skin, the direct articular process and lamina were separated, the soft tissue spreader was placed in the quadrant channel step-by-step. The free arm was fixed, and the operating area was exposed to a cold light source. Residual soft tissue of the lamina and articular process was removed, surgical site was exposed, the upper and lower articular facet joints were fixed with pedicle screws, the lamina and lower articular process of the responsible segment was removed, and the ligamentum flavum and hyperplastic bone were removed. Partial exposure of the intervertebral disc, incision of the annulus fibrosus, excision of the nucleus pulposus tissue, and simultaneous treatment of the intervertebral space endplates were performed. Autologous bone fragments were crushed and placed in the intervertebral space, and an intervertebral cage was implanted. According to the pedicle screw standard, two guide pins were placed in a satisfactory position under the fluoroscopy of the C-arm machine, and then two pedicle screws of appropriate length were placed in the diseased pedicle and fixed under pressure. Finally, it was confirmed that the internal fixation position was good under C-arm fluoroscopy, the surgical incision was rinsed, drainage tube was placed, surgical incision was closed layer-by-layer, and the subcutaneous tissue was sutured. (A typical case is illustrated in Fig. 2)

Postoperative treatment

The patients were treated with antibiotics to prevent infection during and after the operation, and the activities were carried out in strict accordance with the physician's instructions.

Observation indicators

General data of the two groups of patients (age, sex, disease duration, BMI, surgical segment); surgical index (operation time, intraoperative blood loss, incision length, postoperative hospital stay); postoperative complications; the visual analogue scale[2] (VAS) score for back pain and leg pain, Oswestry disability index [3] (ODI), and MOS 36-Item Short-Form health survey [4] (SF-36) were measured before surgery, 1 and 3 months after surgery. At the last follow-up; and additional adult spinal deformity [5] was recorded.

Statistical analysis

SPSS 22.0 software was used for the statistical analysis. Data were expressed as the mean ± standard deviation (χ ± s), and enumeration data were expressed as n (%). The general data of the patients and postoperative clinical indicators were compared using the chi-squared (x²) or independent sample t-test. Functional scores were compared using repeated measures analysis of variance. Statistical significance was set at P < 0.05.

Comparison of patient information between groups(Table 1)

Compared to the MIS-TLIF group, the UBE-TLIF group had more advantages in terms of intraoperative blood loss, surgical incision length, and postoperative hospital stay, although the operation time was longer (P < 0.05).

Comparison of intraoperative and postoperative complication rates between groups

In the UBE-TLIF group, one case of dural tear occurred during the operation, with an overall complication rate of 3.125% (1/32 cases). In the MIS-TLIF group, one case of dural tear occurred during the operation, one case of superficial incision infection occurred after the operation, with an overall complication rate of 6.25% (2/32 cases). All patients showed improvements after symptomatic treatment, and there was no significant difference in the incidence of intraoperative and postoperative complications between the two groups (x² = 0.421, P = 0.536).

Comparison of VAS of low back pain and leg pain between groups at each time point(Tabel 2)

The VAS scores for low back pain and leg pain in the two groups at 1 and 3 months after the operation and at the last follow-up were significantly lower than before the operation (P < 0.05). There was no difference in the VAS scores for low back and leg pain between groups before surgery and at 1, 3, and 12 months after surgery (P > 0.05).

Comparison of ODI between groups at each time point(Tabel 3)

The ODI index of the two groups at 1 and 3 months after surgery and at the last follow-up was significantly lower than before surgery (P < 0.05). The ODI index of the UBE-TLIF group was better than the MIS-TLIF group 1 month after surgery (P < 0.05). However, there were no statistical differences between the other time points (P > 0.05).

Comparison of SF-36 scale scores between groups at each time point

The SF-36 of both groups at 1 and 3 months postoperatively and at the last follow-up were significantly lower than before surgery (P < 0.05). There was no difference in the SF-36 scale scores between the two groups before surgery and at 1, 3, and 12 months after surgery.(P > 0.05).

Comparison of adjacent segment degeneration between the two groups at the last follow-up

At the last follow-up, there was one case of intervertebral disc degeneration in the UBE-TLIF group. and the incidence of ASD was 3.125% (1/32 cases). Additionally, there was one case of adjacent segment instability in the MIS-TLIF group, and an ASD incidence of 3.125% (1/32 cases). There was no significant difference in the incidence of postoperative ASD between the two groups.

Degenerative lumbar stenosis with instability gradually increases with age and often occurs after the age of 50 years. Lumbar vertebral tissue needs to be flexed, extended, and twisted repeatedly to cause degeneration of the lumbar facet joints, intervertebral discs, and intervertebral ligaments, and results in intervertebral instability and thickening of the ligamentum flavum. Therefore, lower back pain, sciatica, and intermittent claudication are typical behavioural symptoms. In the early stages, patients will have low back pain and unfavourable activities in the morning, but the pain is often relieved after activities. In the development stage, there will be severe pain and discomfort on one or both sides of the waist and legs, which usually occurs after prolonged standing or walking. Tenderness of the supraspinous ligament or interspinous ligament may also be present. Additionally, most patients experience significant pain when passively stretched in the prone position [6].

Limitations of conservative treatment versus conventional surgery

Conservative treatment usually includes oral non-steroidal anti-inflammatory drugs, acupuncture, and low back muscle exercises to relieve pain and discomfort. The most suitable population is patients with mild illness or older patients with various underlying diseases who are not suitable for surgery. The treatment improvement rate is approximately 60–80%. A Japanese study showed that acupuncture treatment was more effective in terms of the overall treatment effect [7]. However, in general, conservative treatment takes a long time, and 80% of pain relief usually takes 16.1 ± 7 weeks [8]. If the treatment effect is poor, surgical decompression should be performed as soon as possible to reduce the rate of disability.

Traditional open vertebral fusion is often suitable for spinal function limitations caused by neurological deficits or accompanied by lumbar instability, lumbar scoliosis, or rotational slippage [9]. Open surgery is an effective method for the treatment; however, injuries to muscles and paravertebral ligaments due to large incisions during surgery may induce increased postoperative back pain and muscle atrophy [10, 11]. One study showed that most open vertebral fusion procedures have longer hospital stays and may require more time for muscle recovery after surgery than minimally invasive fusion procedures [12].

Advantages and comparison of MIS-TLIF under UBE and Quadrant channels

Studies have shown that for patients with preoperative spondylolisthesis treated with MIS-TLIF, the reoperation and postoperative instability rates are lower than those of open surgery, and MIS-TLIF does not significantly increase surgery-related complications [13, 14]. In addition, a two-year follow-up study conducted by Wu et al. [15] confirmed that MIS-TLIF significantly reduced paraspinal muscle injury compared with open TLIF.

Currently, UBE is continuously optimised with the rapid development of endoscopes and surgical instruments. Two separate incisions were made on the ipsilateral side of the spine with a length of approximately 1 cm and an interval of approximately 2–3 cm. One incision was used to place the endoscope, and the other was the Perform Instrument Operation. Under the dual channel, the surgical field of view is close to that of traditional open surgery, which avoids mutual constraints between the endoscope and the operating instruments, making the operation process more convenient. Moreover, the use of intraoperative high-pressure saline and plasma radiofrequency cutter head greatly reduces intraoperative blood oozing and ensures a clear surgical field of vision, thereby making nerve decompression and cartilage endplate treatment more intuitive and accurate [16]. If the operator has poor control over the operation time and is not skilled in the use of surgical instruments, complications, such as epidural haematoma and dural tear, may occur. In this study, one case occurred during the surgery. Therefore, when vertebral body fusion is performed through UBE, it is necessary to fully understand the structure of the surrounding tissues of the spine and to be familiar with the space and distance judgment of the microscopic field of view, at the same time, uilizing blunt neural dissectors and preserving the ligamentum flavum properly can lower the risk of intraoperative complications [16–17]. The water pressure is typically controlled between 25–30 mmHg [18]. Therefore, it is recommended that the operator should have rich experience in endoscopic surgery before attempting endoscopic fusion surgery.

MIS-TLIF under quadrant access is entered through the physiological gap between the longest and multifidus muscles. The Wiltse approach, precisely positioned at the affected area by placing expansion sleeves step-by-step, preserves the integrity of the paravertebral muscles to a greater extent and reduces damage to the surrounding soft tissues. However, compared to open surgery, the operation is performed under a small channel, which requires precise positioning; otherwise, it is limited by the visual field and may lead to insufficient decompression [19]. In addition, the operator can see the fusion site directly under the quadrant channel, and this method can be used to perform vertebral fusion surgery by operators who are not skilled in microscopic surgery. However, the disadvantage is that the operating time is longer due to the limited space for sleeve placement. Additionally, ischaemic necrosis of the skin and subcutaneous tissues of the incision from prolonged skin pulling may occur during the operation, which affects postoperative recovery [20].

In this study, both minimally invasive vertebral fusion procedures had the advantages of less intraoperative bleeding and drainage, smaller incisions, less damage to the muscle tissue around the spine, faster postoperative recovery time, and less painful wounds. From the comparison data of the two groups, in terms of surgical indicators, the operation time in the UBE-TLIF group was longer than that in the MIS-TLIF group; however, there were more advantages in terms of intraoperative blood loss, surgical incision length, and postoperative hospital stay. In conclusion, both UBE-TLIF and MIS-TLIF have good clinical efficacy in treating degenerative lumbar instability with spinal stenosis, although UBE has more advantages in the treatment and can be widely used.

Long-term blinded, randomized case-control studies are required to demonstrate the effectiveness and clinical value of the biportal technique, because the sample size of this study is small and the observation time is not long enough, the long-term prognosis of UBE-Tilf in treatment of degenerative lumbar instability and spinal stenosisstill needs to be further explored.

Ethics approval and Consent to participate: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the Bioethics Committee of the Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine. Informed consent was obtained from all patients to participate in the study.

Competing interests: The authors did not receive support from any organization for the submitted work and have no relevant fnancial or non-fnancial interests to disclose.

Author contributions: YZ:writing—original draft. WQ: writing—review and editing. JZ: methodology. DL: data curation. All authors read and approved the fnal manuscript

Funding: The authors received support from ‘Jiangsu Provincial Ministry of Science and Technology Provincial Social Priority Development Project (BE20200625)’ for the submitted work

Availability of data and materials: All data generated or analyzed during this study are included in this published article.

Consent for publication: Patients signed informed consent regarding publishing their data andphotographs.

Compliance with Ethical Standards: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the Bioethics Committee of the Nanjing Hospital of Chinese Medicine Afliated to Nanjing University of Chinese Medicine. Informed consent was obtained from all patients to participate in the study.

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Table 1

Comparison of surgical indicators between the two groups(χ±S)
group	Number of cases	operation time	Intraoperative blood loss	incision length	postoperative hospital stay
UBE	32	164.61 ± 19.60	173.75 ± 30.44	1.23 ± 0.82	6.57 ± 1.14
MIS_TLIF	32	154.58 ± 17.52	203.65 ± 33.62	2.35 ± 1.30	7.58 ± 1.07
t		3.179	6.881	8.652	4.452
p		0.012	0.000	0.000	0.002

Table 2

Comparison of VAS scores of low back pain and leg pain between the two groups at each time point
group(n)	Preoperative		1 month after surgery		3 months after surgery		last follow-up
	low back pain	leg pain	low back pain	leg pain	low back pain	leg pain	low back pain	leg pain
UBE-TLIF(32)	3.89±1.16	5.52±1.09	0.69±0.63*	0.49±0.57#	0.29±0.44*	0.32±0.51#	0.21±0.41*	0.16±0.37#
MIS-TLIF(32)	3.94±1.33	5.42±0.98	0.78±0.73*	0.45±0.52#	0.47±0.62*	0.51±0.48#	0.32±0.52*	0.25±0.44#
t	0.251	0.433	-1.932	0.633	-1.277	-0.512	-0.592	-1.002
P	0.802	0.676	0.612	0.534	0.217	0.622	0.562	0.321
Note: Comparison of low back pain VAS and preoperative * P < 0.05, Leg pain VAS compared with preoperative # P < 0.05.

Table 3

Comparison of ODI between the two groups at each time point(χ±S)
group	case(n)	Preoperative	1 month after surgery	3 months after surgery	last follow-up
UBE-TLIF	32	57.36 ± 12.28	10.41 ± 5.91*	9.46 ± 4.82*	8.41 ± 4.46*
MIS-TLIF	32	58.33 ± 12.13	12.33 ± 5.26*	10.96 ± 4.52*	9.12 ± 3.78*
t		-0.011	1.521	1.412	0.978
P		0.989	0.142	0.161	0.325
Note: Comparison of ODI between two groups with preoperative*P＜0.05.

No competing interests reported.

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Version 1

posted

You are reading this latest preprint version

A comparative study on the clinical efficacy of UBETlif and Mis-Tlif in the treatment of degenerative Lumbar Stenosis with Instability

Status:

Version 1

Abstract

Purpose

Methods

Results

Conclusion

Figures

Introduction

Materials and methods

Objects

Surgical plan

Postoperative treatment

Observation indicators

Statistical analysis

Results

Comparison of patient information between groups(Table 1)

Comparison of intraoperative and postoperative complication rates between groups

Comparison of ODI between groups at each time point(Tabel 3)

Comparison of SF-36 scale scores between groups at each time point

Comparison of adjacent segment degeneration between the two groups at the last follow-up

Discussion

Limitations of conservative treatment versus conventional surgery

Advantages and comparison of MIS-TLIF under UBE and Quadrant channels

Declarations

References

Tables

Additional Declarations

Status:

Version 1