Introduction. Acta Medica Mediterranea, 2018, 34: 1429

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1 Acta Medica Mediterranea, 2018, 34: 1429 POSTERIOR LUMBAR SPINE FUSION VERSUS INTERSPINOUS PROCESS DECOMPRESSION IN THE TREATMENT OF PATIENTS WITH THE SINGLE-LEVEL DEGENERATIVE LUMBAR SPINE DISORDERS XIAO TENG, ZHAOBO ZHANG*, LINGZHI DING, JINGSHENG ZHANG, CHI YUAN, MEIZI YANG Department of orthopedics, Taizhou Central Hospital Taizhou City, Zhejiang Province China ABSTRACT Objective: We treated patients suffering from degenerative lumbar spine disorder with minimally invasive and traditional open transforaminal lumbar interbody fusion to evaluate clinical efficacy of patients through influences on imageological examination and the whole recovery. Method: We selected 120 cases of patients suffering from single-level degenerative lumbar spine disorder and treated in our hospital from January, 2012 to January, 2016, and all patients received complete follow-up. Before treatment, all patients were averagely divided into two groups based on number table method. Minimally invasive transforaminal interbody fusion (MIS- TLIF) was used for treatment on 60 cases in A, while traditional transforaminal interbody fusion (TLIF) was used for treatment on remaining 60 cases in B. Results: With comparison on duration, in- blood volume and post- drainage volume between two groups of patients, the duration of A is obviously longer than that of B, while the in- blood volume and post- drainage volume of A are distinctly less than these of B, and the difference has statistical significance (p<0.05). The VAS score on lumbago and leg pain at 1 week and 8 weeks of post- for A is significantly lower than that for B, and the difference has statistical significance (p<0.05); the VAS score on lumbago and leg pain in six months of post- for A is slightly lower than that for B, and the difference has statistical significance (p<0.05). The ODI functional disability scores under follow-up in 2 months, 4 months and 6 months of post- for both A and B are distinctly lower than these of pre-, and JOA score is obviously higher than that of pre-, so the difference has statistical significance (p<0.05). Conclusion: the clinical effect of minimally invasive transforaminal lumbar interbody fusions to treat single-level degenerative lumbar spine disorder is much better and the vertebral fusion rate is higher, while the minimally invasive technique needs to be completed in the working aisle for its narrowness. Keywords: Single segment, Degenerative lumbar spinedisease, Posterior lumbar spine fusion, Interspinous process decompression, Clinical effect. DOI: / _2018_5_217 Received January 30, 2017; Accepted March 20, 2018 Introduction At present, the occurrence rate of degenerative lumbar spine disorder is relatively high, and the main method is open transforaminal lumbar interbody fusion (TLIF). Such method is characterized by less vertebrae plate resection and small traction of nerve root, etc. (1). However, many clinical data have indicated that this method needs to dissect and stretch spinalis, which might cause ischemic necrosis of paravertebral muscle and eneurosis obstacle, and finally the failed back surgery syndrome may be triggered after lumbar. Minimally invasive transforaminal lumbar interbody fusion (MIS- TLIF) has been widely used for treatment of degenerative lumbar spine disorder (2, 3). Interbody spinal fusion has important influence function on post efficacy of patients. The research makes clinical efficacy evaluation on all patients on the

2 1430 Xiao Teng, Zhaobo Zhang et Al basis of influences on imageological examination and the whole recovery through treatment to 120 cases of patients suffering from degenerative lumbar spine disorder and received by our hospital respectively with minimally invasive and traditional open transforaminal lumbar interbody fusion. Data and method General data Inclusive criteria: clinical symptoms, i.e., serious lumbago and leg pain or intermittent claudication, occurring for all patients, and those not obviously improved under conservative treatment for 3-6 months; single-level degenerative lumbar spine disorders (lumbar spinal stenosis, lumbar disc herniation, lumbar spondylolisthesis, combination symptom of lumbar spinal stenosis and lumbar disc herniation, lumbar disc herniation with degree of I-II) which have been diagnosed with radiological examination; recurrence and re- of original segment of lumbar disc herniation. Exclusive criteria: adjacent-level degenerative spine disorder under radiological examination lumbar fracture and tumor malformation infection, etc. accompanied; those with lumbar history for half a year before admission to hospital; patients suffering from serious dysfunction disease of parenchymal organs of brain, liver and kidney, etc.; patients with coagulation disorders or immune system disease accompanied; those of mental abnormality. Select 120 cases of patients suffering from single-level degenerative lumbar spine disorder and treated in our hospital from January, 2012 to January, 2016, and all patients shall receive complete follow-up. Before treatment, all patients are averagely divided into two groups based on number table method. Minimally invasive transforaminal interbody fusion (MIS-TLIF) is used for treatment on 60 cases in A, while traditional transforaminal interbody fusion (TLIF) is used for treatment on remaining 60 cases in B. In the A, the number of case of male and female is respectively 32 and 28, and the age ranges from 27 to 68 (the average age is 48.09±5.37). In the B, the number of case of male and female is respectively 31 and 29, and the age ranges from 25 to 66 (the average age is 49.17±4.28). With comparison on general data (including gender, age, body mass index, and lesion segment location, etc) between two groups, the difference has no statistical significance (P>0.05), which is shown in Table 1. Type Gender A (60 cases) B (60 cases) Male % % >0.05 Female % % >0.05 Age 48.09± ± >0.05 Lesion segment location L3-L % % >0.05 L4-L % % >0.05 L5-S % % >0.05 Body mass index 26.9± ± >0.05 Table 1: Comparison on general data of patients in two groups. Therefore, the patients and families of these patients have signed informed consent form and agreement, and contents and process of the research have been approved and completely supervised by Medical Ethics Committee. Treatment method A: The anesthesia method was general anesthesiaand body position was prone position. We determinedthe lesion vertebral body location under x-ray machine perspective with C separation, and made signs on body surface. We cut multifidus muscle with longitudinal incision outside at the front of lumbar region, and performed percutaneous puncture and implant two pedicle screws under x- ray machine perspective with C separation. Then we cut multifidus muscle with longitudinal incision outside at the side of pressure reduction; and completely installedthe working passage (The lumbar vertebral plate for pressure reduction and zygopophysis were required for full exposure of passage). Gradually we cut and removed the upper and lower zygopophysis and a part of vertebral plate, and made dural sac and nerve root exposed. We protected the nerve, cut and removed intervertebral disc, and cut off the upper and lower vertebral cartilage plates with ring scoop. t/x² p

3 Posterior lumbar spine fusion versus interspinous process decompression in the treatment of patients We trimmedthe autogenous bone that had been cut off and selected cage with suitable size for filling of autogenous crush bone. Then we placed it in the interbody and took working passage out. With the same method, we implanted pedicle screw at the same side, installed screw rod, and tightened screw cover after longitudinal pressure on screw. B: the anesthesia method and body position werethe same with A. We treated the patients with posterior median cut and exposed the vertebral plate and zygopophysis of lumbar degenerative changes.we firstly implanted 4 vertebral arch screws, cut off the upper and lower vertebral plates and unilateral zygopophysis of lesion segments, exposed dural sac and nerve root, cut and removed cartilage plates of lumbar intervertebral disk and the upper and lower vertebral body. We trimmedthe bone that had been cut off, and implanted it to interbody. We selected the cage with suitable size, and placed crush bone that had been trimmed into it. Then, we put it to interbody, installed screw rod, and tightened screw cover after longitudinal pressure on screw. Index observation We observed duration, in- blood volume and post- drainage volume of patients in two groups, visual analogue scores (VAS) on lumbar disease and leg disease under follow-up during 1week, 8weeks, 6 months and the last time of pre- and post-, and under the last follow-up, observed Oswestry disability indexes (ODI) and JOA scores during 2 months, 4 months and 6 months of pre and post- of patients, and c- reactive protein and white blood cell count level indexes at 1d and 7d of pre- and post of patients in two groups. Bone-graft fusion standard: x-ray evaluation is in accordance with SUK Standard (4, 5), i.e., there is continuous trabecula between bone graft and interbody, and the activity of interbody at the extension side is <4. So it can prove that the bone graft has been fused. The continuous trabecula between bone graft and interbody is unclearly observed, and the activity of interbody at the extension side is <4. So it can prove that the bone graft could not be fused. If the continuous trabecula is not found and fusion area has gap or trabecula is unclear, and the activity of interbody at the extension side >4. Thenthe incapability of fusion may be considered. CT examination and evaluation are in accordance with BSF Standard (6, 7) : for BSF-1, under the phenomena of vertebral interspace collapse and absorption, bone graft subsidence, internal fixation loosening, euphotic cystic change and interbody spondylolisthesis, etc, it means iconography pseudoarthrosis; for BSF-2, when the bone trabecula through interbody fusion cage connecting with the upper and lower end plates has completely traverse transparent tape in fusion cage, it means iconography pseudoarthrosis; for BSF-3, when the full continuous trabecula connecting the upper and lower end plates of interbody in fusion cage or outside fusion cage can be seen under CT reconstruction state or in coronal view, and the wide surrounding osteogenesis appears under horizontal observation, it means iconography pseudoarthrosis. Statistical method We establish database and make analysis with SPSS19.0 data statistical software; measurement data are expressed with (x), - and isusedforinspection; while enumeration data are expressed with (%), and use χ 2 for inspection and comparison. When P 0.05, the statistical significance exists. Results Through comparison of the duration, in- blood volume and post- drainage volume among the patients of the two groups, it is shown that the duration of A is significantly more than that of B, while the post- drainage volume of A is evidently less than that of B. The difference has statistical significance (p 0.05), which is shown in Table 2. Operation Duration (min) In- Blood Volume (ml) Post- Drainage Volume(ml) A ± ± ±41.69 B ± ± ± t P <0.05 <0.05 <0.05 Table 2: Comparison of duration, in- blood volume and post- drainage volume among the patients of the two groups. Score comparison of lumbago and leg pain VAS between pre- and post- of the two groups of patients. There is no significant difference between the pre- lumbago and

4 1432 Xiao Teng, Zhaobo Zhang et Al leg pain of A and B, the comparison has no statistical significance(p>0.05); the VAS score of lumbago and leg pain of in the first week and eighth week after the is significantly lower than that of B, the difference has statistical significance (p 0.05). The VAS score of lumbago and leg pain of in the half a year after the is slightly lower than that of B, the difference has statistical significance (p 0.05). In half a year after the, the VAS score of lumbago and leg pain in last follow-up of A and B has significant difference (p>0.05), which is shown in Table 3 and Table 4. Pre- First week Eighth week Half a year A 5.03± ± ± ± ±0.97 B 4.98± ± ± ± ±0.81 t P >0.05 <0.05 <0.05 >0.05 >0.05 Table 3: VAS score comparison between pre- and post- lumbago of two groups of patients. Pre- First week Eighth week Half a year A 6.78± ± ± ± ±0.86 B 6.59± ± ± ± ±0.67 t P >0.05 <0.05 <0.05 <0.05 >0.05 Table 4: VAS score comparison between pre- and post- leg pain of two groups of patients. Comparison of pre- and post- ODI score and JOA score of two groups of patient. The ODI functional disability score within 2 months, 4 months, half a year and last follow-up after the of A and B is significantly lower than that of pre- and the JOA scores are significantly higher than that of pre-, the difference has statistical significance (p 0.05). The ODI functional score and JOA score in each time quantum of pre- and post- between the two groups is compared, the difference has no statistical significance (p>0.05), which is shown in Table 5 and Table 6. The osseous fusion condition of two groups of patientswas compared. The x-ray radiological examination was conducted for patients for the two groups within 8 to 12 months after the, of which there were 28 cases of posterior lumber intervertebral fusion, 29 cases of possible fusion and 3 cases of non-fusion in A. The bone-graft fusion rate of post- of A is 46.67%. There are 41 cases of posterior lumber intervertebral fusion, 17 cases of possible fusion and 2 cases of non-fusion. The bone-graft fusion rate of post- of B is 68.33%. The x-ray examination results show that the bonegraft fusion rate of post- of B is significantly higher than that of A, the difference has statistical significance (x 2 =3.0925, p 0.05)), as shown in Figure 1. Pre- 2 months after 4 months after Half a year after A 23.75± ± ± ± ±5.61 B 23.41± ± ± ± ±4.28 t P >0.05 >0.05 >0.05 >0.05 >0.05 Table 5: ODI score comparison between pre- and post- of two groups of patient. Pre- 2 months after 4 months after Half a year after A 14.66± ± ± ± ±5.43 B 14.31± ± ± ± ±4.56 t P >0.05 >0.05 >0.05 >0.05 >0.05 Table 6: JOAscore between pre- and post- of two groups of patient. Fig. 1: Patients with postoperative bone fusion in two groups. CT three-dimensional reconstruction was conducted for the two groups of patient in 8 to 12 months after the to inspect and assess the intervertebral osseous fusion condition. The results show that there are 50 cases reaching BSF-3 level, 10 cases reaching BSF-1level of A. CT evaluation shows that the vertebral fusion rate of A is 83.33% The results show that there are 57 cases reaching BSF-3 level, 2cases reaching BSF-2 level, 1 case reaching BSF-1 level of B,CT

5 Posterior lumbar spine fusion versus interspinous process decompression in the treatment of patients evaluation shows that the vertebral fusion rate of A is 95.0%.The CT evaluation result demonstrates that the vertebral fusion rate of B is slightly higher than that of A, the difference has statistical significance (x 2 =2.4917, p 0.05), as shown in Figure 2. Figure 3-6: The X-ray and CT examination of patients with traditional open transforaminal lumbar interbody fusion (TLIF). Fig. 2: Patients after 8-12 months in the two groups with three-dimensional CT reconstruction to evaluate the interbody fusion. According to the C-reactive protein in seven days before and after the of two groups of patient, there is no significance in the count level indicators of white blood cell. The comparison has no statistical significance (p 0.05). In the c-reactive protein at 1d after the of A, the count level of white blood cell is lower than that of B, and at 1d after the of the two groups, the count level of white blood cell is evidently higher than that of pre-, the difference has statistical significance (p 0.05), which is shown in Table 7 and Table 8. Pre- 1d 7d A 1.95± ± ±3.26 B 2.11± ± ±2.91 t P >0.05 <0.05 >0.05 Table 7: 7 Indicator comparison of C - reactive protein of pre- and first day and seventh day of two groups of patient (ng/l). Pre- 1d 7d A 4.83± ± ±1.42 B 5.04± ± ±1.76 t P >0.05 <0.05 >0.05 Table 8: Count level comparison of white blood cell at 1d and 7d before and of two groups of patient (x10 9 /L). Figure 7-10: The X-ray and CT examination of patients with minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF). Discussions The clinical application rate of posterior lumbar interbody fusion is higher previously and the rate of lumbar interbody fusion is much better. While the dural sac and nerve root is pulled greatly during, which results in the increasing damage to the never of segment above lumbar. Meanwhile the adoption of posterior lumbar interbody fusion usually leads to the scar healing at dural sac, increasing the risk of second revision (8.9). The open transforaminal lumbar interbody fusion has the characteristic of small excision of vertebral plate and small traction for nerve root (10). Relevant literature study shows (11) that the rate of lumbar interbody fusion by adopting open TLIF reaches up to 89%. The minimally invasive TLIF adopted by the Research has little injury on the soft tissue of lumbar vertebra while treating lumbar degenerative disease and the in- blood volume and post- drainage volume is evidently less than that of open TLIF. While it needs to be operated in the channel, which has certain limit on the treatment of graft bed, reducing the volume of bone grafting and possibly affecting the bone graft fusion. There is dispute on the rate of lumbar interbody fusion by such method in present clinical research. The research considers that the inconsistent opinions for the rate of lumbar interbody fusion after minimally invasive TLIF mainly relate to the different evaluation methods after the

6 1434 Xiao Teng, Zhaobo Zhang et Al. The rate of lumbar interbody fusion after the of A and B by applying X-ray evaluation is 46.67% and 68.33% respectively, while the rate of lumbar interbody fusion after the of A and B by CT evaluation is 83.33% and 95.0% respectively. The main reason is that it is more difficult to find the bone trabecula by adopting X-ray evaluation. The posterior lumber intervertebral fusion condition is harder to be found due to the shelter of iliac in L5-S1 segment, provided that the changes of vertebral angle of extension and flexion position are treated as the standard of evaluating the fusion condition. The research results show (17) that after the traditional open TLIF is used to treat lumbar degenerative disease, follow-up of 16 to 18 months is conducted for all the patients, the vertebral fusion rate through X-ray and CT evaluation reaches 94% - 96%. Although the research method is similar to that of the Research, after the X-ray evaluation is conducted to judge the posterior lumber intervertebral fusion, the CT evaluation is conducted to check the fusion, the false positive rate of X-ray is higher. In the Research, there is one case of BSF- 1 level patient after traditional open TLIF ; his bone trabecula is totally connected with the upper and lower end plate of vertebrae. The completely traverse linear translucency is seen in the cage. Because its traverse bright line transects in the cage, the bone trabecula connects with the end plate and cage firmly, constituting stable structure. It is locking pseudarthrosis phenomenon (16), and literature report declares that the phenomenon is related to the consistence between crawling speed of bone and local bone absorption after reconstruction of blood supply. During final follow-up, parts of patient have formed perfect bony connection (19). The zone in early period of post is represented as inflammatory reaction, including tissue necrosis and regeneration and repair, during which various inflammatory medium are released. C-reactive protein and white blood cell count could reflect the inflammatory reaction degree of full body to some extent (20). Research shows (21) that the minimally invasive could reduce the inflammatory reaction degree after the and decreases the occurrence of postoperative complications. In the Research, there is no evident difference (p 0.05) of C-reactive protein and count level of white blood cell of pre- of two groups of patient. The C-reaction protein and count level of white blood cell of A in 1d is significantly lower than that of B. The difference has statistical significance (p 0.05). The reason is that there is no need to pull musculus sacrospinalis strongly during minimally invasive. The minimally invasive operative method has little injury on the patient, which benefits for the recovery. The results of the research show that there is no significance difference (p 0.05) of VAS score between pre- lumbago and leg pain of two groups of patient. While the VAS score of lumbago and leg pain of A in first week and eighth week is evidently lower than that of B and the VAS score of leg pain of A in half a year is slightly lower than that of B. The difference has statistical significance (p 0.05). It may be related to small injury, little bleeding, little texture peeling and lower degree of muscle injury of minimally invasive method. From the aspect of ODI and JOA score, the ODI functional disability score in 2 months, 4 months, half a year and last follow-up of A and B is significantly less than that of pre- and the JOA score is significantly higher than that of pre (p 0.05). It fully demonstrates that the effect of post- life and functional recovery is better for the patient by adopting the minimally invasive method. In conclusion, the clinical effect of minimally invasive transforaminal lumbar interbody fusions to treat single-level degenerative lumbar spine disorder is much better and the vertebral fusion rate is higher, while the minimally invasive technique needs to be completed in the working aisle for its narrowness. The Research holds that the clinicians need to improve the vertebral fusion technique and further to increase the vertebral fusion rate, providing reference basis for the method selection of clinical treatment.

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