Is minimally invasive superior to traditional open technique for two-segmental transforaminal interbody fusion in the treatment of lumbar degenerative disease?

doi:10.21203/rs.3.rs-4313513/v1

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Is minimally invasive superior to traditional open technique for two-segmental transforaminal interbody fusion in the treatment of lumbar degenerative disease?

https://doi.org/10.21203/rs.3.rs-4313513/v1

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Study Design: Retrospective case‒control study.

Purpose: To compare minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) and Traditional open TLIF in the treatment of two segments lumbar degenerative diseases.

Methods:Patients who underwent two-level MIS-TLIF (n = 222) and traditional open TLIF (n = 214) for lumbar degenerative disease. Demographic characteristics, surgical information, and perioperative complications were compared between the MIS-TLIF and Open TLIF groups. The Visual Analog Scale (VAS), Oswestry Disability Index (ODI) and 36-Item Short Form Survey Instrument (SF-36) were administered for clinical evaluations.

Results: Patients who underwent MIS-TLIF had a significantly lower volume of blood loss (176.2 ± 30.4mL vs 396.4 ± 59.7mL), lower postoperative drainage (102.6 ± 22.6 mL vs 164.4 ± 26.9mL), shorter bed rest time (3.3 d vs 4.7 d), longer operative time (201.4 ± 17.6 min vs 147.7 ± 16.0 min), and the higher fluoroscopy time (45.3 ± 6.3 seconds vs. 14.0 ± 2.3 seconds) than those who underwent Open TLIF. Significant clinical improvement was observed in terms of scores on the VAS, ODI, and SF-36 when comparing the preoperativeevaluation and the final follow-up. Postoperatively, both MIS-TLIF and open TLIF groups showed significant improvement in VAS, ODI, and SF-36 scores from 3 months to 2 years. VAS, ODI, and SF-36 scores were not different between MIS-TLIF and open TLIF groups after one year follow up. No significantly difference was found when comparing the complication rate between MI-TLIF and open TLIF groups.

Conclusions:Both MIS-TLIF and Open TLIF were effective approaches for the treatment of two-level lumbar degenerative diseases. Although MIS-TLIF procedure can improve health-related quality of life for patients better than open procedure after operation, there is no significant difference in this advantage after one year operation. We decided to choose MIS-TLIF or open TLIF procedure according to the physical condition of patients and surgeons’clinical experiences.

MIS-TLIF

Open TLIF

lumbar degenerative disease

spinal fusion

Transforaminal lumbar interbody fusion (TLIF) was developed with the potential to minimize dural sac and nerve root damage compared with the extensive traction on this never root with posterior lumbar interbody fusion (PLIF)^[1]. Traditional open TLIF techniques require extensive paravertebral muscle stripping and retraction to obtain a sufficient operative field. However, this serious paravertebral muscle injury may increase postoperative low back pain, extend the duration of rehabilitation, and reduce the functional status of patients, which potentially affected the surgical outcome^[2].

Minimally invasive surgery (MIS) TLIF has gained widespread popularity in recent years, because of less soft tissue injury than traditional open TLIF technique^[3]. Meanwhile, many literatures have reported that MIS-TLIF have the advantages of less intraoperative blood loss, shorter hospitalization, less postoperative low back pain and lower rate of reoperation compared with open TLIF^[3,4,5]. However, some disadvantages have been described with the use of MIS-TLIF technique such as longer operation time, more radiation exposure and a long learning curve^[5,6].

Although several studies have compared the open approach to minimally invasive approach to TLIF in treating one-level lumbar degenerative disease, comparing the techniques using a large cohort of two-level TLIFs has not been fully explored. Hitesh et al^[7] reported that MIS-TLIF and Open TLIF are equally efficient surgical techniques with similar clinical and radiologic outcomes in double-level lumbar surgeries. Gu et al^[8] reported that the minimally invasive procedure was superior in terms of postoperative back pain and leg pain, intra-operative blood loss,transfusion and duration of hospital stay postoperatively in treatment of two-level lumbar degenerative disease in addition to much more radiation exposure. Hu et al recommend open TLIF technology for the treatment of two-level lumbar degenerative diseases^[9]. Due to differences in research factors, there is controversy between Mis-TLIF and open TLIF in the treatment of lumbar degenerative diseases of two segments. Therefore, The purpose of this study was to explore if MIS-TLIF was superior to the traditional open TLIF in the management of two-level degenerative lumbar diseases.

Setting & Patient Population

Six hundred and thirty consecutive patients who were treated with two-level TLIF between January 2014 and January 2022 were assessed for the study (Shanghai Changhai Hospital, Tongren Hospital of Shanghai Jiao Tong University School of Medicine, and Shaoxing Hospital of Zhejiang University School of Medicine). The inclusion criteria were as follows: (1) the primary diagnosis of lumbar disk herniation, lumbar spinal stenosis, spondylolisthesis, symptomatic degenerative disc disease combined with segmental instability; (2) clinical presentation of persistent or recurrent low back pain and/or lower extremity radicular symptoms and failure of conservative treatment for more than 6 months;(3) serious decline in quality of life and strong willingness for operation; (4) two-level fusion(include L3–L5 and L4–S1;and (5) the last follow up period was two years after operation. Exclusion criteria included patients with previous history of lumbar spine surgery, mental illness, lumbar infection, malignancy, spinal deformity. The study was approved by the clinical research ethics committee of our hospital.(Figure 1)

Surgical Technique

MIS-TLIF Approach

Patients were placed prone on a Jackson radiolucent spinal table after general anesthesia. C-arm fluoroscopy was used to determine the operative segment and to locate the pedicle surface.Then, a skin incision about 3.0 cm was made outside the lateral edge of the pedicle located on the body surface. After fascial incision was made, step-by-step dilatation tube of Quadrant channel was inserted and working channel was established between the multifidus and longissimus. Part of the lamina and the superior and inferior articular processes were exposed, then the inferior articular processes, the apex of the superior articular process, a small part of the lamina and ligamentum flavum were excised. After excision of the intervertebral disc and curettage of the cartilage endplate, one cage was implanted. The ipsilateral pedicle screws were placed in direct visual as in the open procedure, and the contralateral pedicle screws were percutaneously placed. Titanium rods were connected and fixed under pressure. After the negative pressure drainage tube was retained, the incision was sutured.(Figure 1)

Open TLIF

The surgeon made a posterior midline incision and dissected the paraspinal muscle to the tip of the transverse process at two levels of spinal fusion. Pedicle screws were inserted bilaterally with a free-hand technique. Decompression and intervertebral fusion are performed on the responsible segments, which is the same as MIS-TLIF. All surgeries were performed by an experienced spinal surgeon who had previously worked in the same training institution. (Figure 2)

Clinical and Radiographic Assessment ..

The operative time (OT), intraoperative blood loss (IBL),Transfusion, fluoroscopic times (FT), hospital stay (HS), postoperative drainage (PD)and bed rest time (BRT) were recorded, as well as the complications of dural tear, post-operative wound infection, screw misplacement, re-operation. SF-36, ODI and VAS questionnaire was used to assess the clinical outcomes of patients at preoperative, three months postoperative, six months, one year and two years follow-up.Anteroposterior and lateral radiographs were taken at preoperative, three months postoperative, six months, one year and two years follow-up.

Statistical Analyses

Statistical analyses were performed utilizing SPSS statistical software v. 17.0 (Chicago, IL, USA). Comparisons between MIS and open TLIF groups were performed using independent sample t-test for continuous variables. Categorical variables were analyzed with a Chi-squared test p<0.05 was considered statistically significant.

Patients Demographics

According to the inclusion and exclusion criteria, 436 patients were included in the study, 222 patients underwent two-level MIS-TLIF and 214 patients underwent open TLIF. There were no significant difference in age, gender, smokers, body mass index (BMI), preoperative diagnoses and levels of fusion between two groups before the operation. There were significant diﬀerences in terms of symptom duration between the two groups.

Clinical assessment

MIS-TLIF groups had the lower IBL (176.2 ± 30.4mL vs 396.4 ± 59.7mL, P < 0.001), and postoperative drainage (102.6 ± 22.6 mL vs 164.4 ± 26.9mL, P < 0.001). Meanwhile, patients who underwent MIS TLIF were able to bed rest time (3.3 d) earlier postoperatively than those who underwent open TLIF (4.7 d, P < 0.001) and were discharged earlier (4.6 d) than those who underwent open TLIF (6.5 d, P < 0.001), but was associated with the longer operative time (201.4 ± 17.6 min vs 147.7 ± 16.0 min,P < 0.001) and the higher fluoroscopy time (45.3 ± 6.3 seconds vs. 14.0 ± 2.3 seconds, P < 0.001). Eight patients in the open TLIF group required blood transfusion intraoperatively, whereas only three of the patients in the MIS group required transfusion.(Table 1; Table 2 )

Preoperative ODI was significantly less for the MIS group compared with the open group (46.8 ± 7.5 vs. 49.0 ± 7.8, P = 0.04). Postoperatively, both MIS-TLIF and open TLIF groups showed significant improvement in VAS back scores, VAS leg scores, ODI, and SF-36 scores from 3 months to 2 years. VAS back scores, VAS leg scores, ODI, and SF-36 scores were not different between MIS-TLIF and open TLIF groups after one year follow up. (Table 3; Figure 3 ;Figure 4; Figure 5 )

Complications

The complication for MIS and open TLIF procedure included wound infection, dural tear, screw misplacement, cage migration, and postoperative radiculopathy. No significantly difference was found when comparing the complication rate between MI-TLIF and open TLIF groups.

Since the minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) technique was first reported by Foley^[10], it has been more and more popular with the potential advantages of smaller wound size and less tissue trauma. Based on the paraspinal sacrospinalis-splitting approach to the lumbar spine, it may carry the benefits of reducing approach-related morbidity. Several studies have been showed that MIS-TLIF technique might prevent local denervation and paraspinal muscle atrophy^[11,12,13]. Putzier et al^[14]demonstrated that the paravertebral muscle sparing could be predominantly attributed to the multifidus muscle(MF) and not to the longissimus muscle(LS). Meanwhile, Li et al^[15] took biopsy of paraspinous muscle, found that striated muscle cells were swollen and the intercellular space had become indistinct in some regions after open TLIF, while the microstructure of striated muscle cells were undamaged with no evidence of cell swelling or intercellular space blurring after MIS-TLIF.

Price et al^[16]analyzed clinical results of 1 or 2-level TLIF procedure in 452 patients, including 148 patients with MIS approach and 304 patients with traditional open procedure. They reported that the average intra-operative blood loss in MIS-TLIF group was 133ml significantly less than the 411 mL in open TLIF group (P < 0.01), the average operative time (149 vs 190 min; P < 0.01) was shorter in the MIS versus open group. Djurasovic et al^[17]showed that the operative time (263.55 vs 278.69 min; p = 0.399) was similar in both MIS and Open TLIF group, while the MIS TLIF group had a significantly lower blood loss (262.42 vs 614.06 ml; p < 0.001) compared with the open TLIF group. Another study noted that the average length of surgery was significantly longer for the MIS-TLIF group (329.3 vs 234.9 minutes, P < 0.001), the average estimated blood lower was less for the MIS-TLIF group (120.2 vs 306.5 mL, P < 0.001)^[18]. In the above study, researchers believed that MIS-TLIF procedure could reduce intraoperative blood loss, but there were different opinions on operation time. However, these studies mainly focused on single- or 2-level MIS-TLIF or open TLIF. Scheufler et al^[19]found that two level MIS-TLIF group had lower blood loss(124 vs 351ml; p < 0.05) and no difference in surgical times (175 vs 192 min; p > 0.05) than the open group. Hu et al^[9] reported that MIS-TLIF procedures had longer operation time than open TLIF procedures in treating two-level lumbar degenerative disease. In our study, we considered that MIS-TLIF procedure might reduce intraoperative blood loss(176.2 ± 30.4 vs 396.4 ± 59.7ml, p < 0.001), but extend operation time(201.4 ± 17.6 vs 147.7 ± 16.0min, p < 0.001) in treatment of two-level lumbar degenerative disease compared with the open TLIF procedure. We considered the differences between these studies mainly based on the following points: First, many research objects included single and two level TLIF procedure, while single level group or two level group had different proportions in the whole in each study, that would affect research results. Second, the TLIF technology, especially MIS-TLIF procedure, has steep learning curve, requiring a different set of cognitive, psychomotor and technical skills. Surgeon have different experience and repetition might lead to different clinical effects.

Meanwhile, we found that the X‑ray exposure times in the MIS‑TLIF group was significantly increased compared with the open‑TLIF group. Reason for the longer fluoroscopic time with MIS-TLIF procedures is necessary for precise placement of tubular retractors and percutaneous pedicle screws, which may be influenced by a learning curve such that procedural efficiency may improve with increasing MIS-TLIF experience^[20]. Good X-ray fluoroscopy is very important for the successful practice of MIS-TLIF procedure. However, there have been reports of a 2.5-fold increase in millisieverts per level of surgery in MIS-TLIF cases compared with open TLIF cases^[21].The average radiation exposure in the thyroid, eyes, chest, and hand can be 10-fold to 20-fold in MIS-TLIF procedure greater than open procedure^[22]. The potential risks of ionizing radiation included solid cancer, leukemia, cataracts, and local skin or tissue damage^[23-25]. Furthermore, more fluoroscopy times lead to longer operative time. Therefore, we should pay attention to the harm of ionizing radiation in the process of MIS procedure, and minimize the radiation exposure by using new technologies and methods.

At the same time, MIS techniques was associated with less iatrogenic tissue injury during surgery, which might theoretically reduce the usage of postoperative pain medication, time to ambulation, and hospital stay^[26,27]. Our study found that the average bed rest time for MIS-TLIF procedure was 3.3 day, which was significantly shorter than the 4.7 days asked by the open procedure. Meanwhile, the average length of hospital stay in MIS-TLIF group was 4.6 days significantly less than the 6.5 days in open TLIF group. Numerous studies have been found in the literature with average bed rest time ranging from 21.86 hours to 3.8 days compared to 31.24 hours to 13.4 days, and the average length of hospital stay ranging from 1.8 days to 10.6 days compared to 3 days to 15.2 days for minimally invasive and open techniques, respectively. From the overall analysis, reducing the musculoskeletal tissue injury with MIS-TLIF procedure can get out of bed in earlier period and leave the hospital as early as possible. In a systematic review, Goldstein et al^[28] compared 3472 subjects undergoing MIS-T/PLIF fusion with 5925 having an open procedure. They found that there was no difference in variably reported VAS, ODI,and SF-36 scores between the two techniques at intermediate to long term follow-up (12–60 months). However, Wong et al^[21] reported that there was a better VAS Back pain scores for the MIS procedure at at 3 years and 4 years follow up, and a 15% better ODI score at 4-year follow-up in the MIS group(p < 0.01). In our study, we found that both MIS-TLIF and open groups showed significant improvements in ODI, VAS back and leg pain, and SF-36 scores at preoperation to 1 year postoperation. From 1 year after operation, there was no significant difference between the 2 groups for all clinical outcomes measured. In the early postoperative stage, MIS-TLIF procedure has a better quality of life for patients than open TLIF. In long-term postoperative follow-up, there may not be a significant difference in clinical efficacy between the MIS-TLIF and open TLIF procedure.

Our study have several potential limitations which should be pointed out. First, the number of cases was relatively small, and follow-up time is short. Second, although the patients were randomly assigned into MIS-TLIF and open TLIF groups, it was impossible to blind patients and doctor. In our country, patients are more willing to accept minimally invasive surgery, which may influence their subjective improvement. This could also lead to outcome bias. Third, there were significant difference in duration of low back and leg pain between MIS and open TLIF group at preoperation. This may effect postoperative recovery. Fourth, in our country, there are certain differences in medical conditions in different areas and hospitals, which may affect the operation process. Nonetheless, a larger, longer follow-up study is needed to further validate our clinical findings.

MIS-TLIF procedure is associated with lower blood loss, less bed rest time, and shorter hospital stay, but longer operative time and greater fluoroscopic times than open procedure in the treatment of two-level lumbar degenerative disease. Both MIS-TLIF and open TLIF can provide significant improvement in patient-reported outcomes. Although MIS-TLIF procedure can improve health-related quality of life for patients better than open procedure after operation, there is no significant difference in this advantage after one year operation. We decided to choose MIS-TLIF or open TLIF procedure according to the physical condition of patients and surgeons’clinical experiences.

Ethics approval and consent to participate

This study was conducted under the approval of the Ethics Committee of Shaoxing People's Hospital. All methods/protocols were performed in accordance with the relevant guidelines and regulations. Informed consent was obtained from all subjects and/or their legal guardians.

Consent for publication

Not applicable.

Availability of data and materials

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

Competing interests

None.

Funding

This work was supported by the Zhejiang Provincial Health Science and Technology Plan (2022KY1288 and 2020358236).

Authors' contributions

S.Z., B.Z.and F.W. designed this study. P.Z., L.H., K.C., X.Z., M.X., and Y.L. conducted surgeries and follow-up visits. B.C. wrote the manuscript.

Acknowledgments

None.

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No competing interests reported.

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Is minimally invasive superior to traditional open technique for two-segmental transforaminal interbody fusion in the treatment of lumbar degenerative disease?

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