Discectomy combined with the Coflex interspinous stabilization device versus simple discectomy for lumbar disc herniation: Long-term follow-up

Discectomy combined with the Coflex interspinous stabilization device versus simple discectomy for lumbar disc herniation: Long-term follow-up | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Discectomy combined with the Coflex interspinous stabilization device versus simple discectomy for lumbar disc herniation: Long-term follow-up Yunfan Qian, Yimin Li, Xiqiang Zhong, Guangjie Shen, Chengxuan Tang, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4842535/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Objective: To evaluate the long-term efficacy of the Coflex dynamic stabilization device in the treatment of lumbar disc herniation (LDH) versus simple discectomy. Methods : We retrospectively analyzed 85 patients who underwent surgery for LDH between January 2009 and December 2013. Eligible patients with single-segment LDH were divided into two groups: discectomy with Coflex (Coflex group) and simple discectomy (SD group). The patient characteristics, surgical outcomes, operation time, blood loss, clinical and radiological features, complications, and reoperation rates were compared between both groups. In the Coflex group, the intervertebral height, intervertebral foramen height, and range of motion (ROM) of the treated segment were calculated from radiographs. Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) scores were assessed for both groups before surgery, at 1 month, one year after surgery, and at final follow-up. Results: The mean age, sex, body mass index (BMI), symptom duration, follow-up period, operated level, and Pfirrmann grade before surgery did not differ significantly between groups. The results showed significant improvements in the VAS and ODI scores in each group (P<0.05) after surgery. However, there were no significant differences in the VAS and ODI scores between both groups at 1 month or 1 year postoperatively. However, at the final follow-up, the VAS and ODI scores in the Coflex group were lower than those in the SD group(P<0.05). In the Coflex group, the anteriordisc height, posterior disc height, and intervertebral foramen height improved postoperatively. However, at the last follow-up, these values showed varying degrees of decline, returning to preoperative levels. In the flexion–extension radiographs, the ROM showed a significant decrease postoperatively, while the ROM continued to increase at the last follow-up (P<0.05). The mean operation time and blood loss were higher in the Coflex group than in the SD group(P<0.05). During the follow-up period, 3 patients (7.5%) in the Coflex group experienced complications, and 3 (7.5%) underwent secondary surgery. In the SD group, 1 patient (2.22%) experienced complications, and 5 (11.1%) underwent secondary surgery. Conclusions This study revealed that the Coflex maintains the disc height of the surgical segment for a short period and preserves a limited ROM. Both Coflex and simple discectomies proved effective in treating LDH. However, long-term follow-up indicated that discectomy combined with Coflex produced superior clinical outcomes compared to simple discectomy, with fewer complications. Consequently, Coflex is a safe and effective treatment option for LDH. Coflex discectomy lumbar disc herniation long-term efficacy Figures Figure 1 INTRODUCTION Lumbar disc herniation (LDH) is a spinal condition that occurs frequently in different age groups. 1 For patients who fail to respond favorably to conservative treatments, surgical options are available, including fenestration discectomy, minimally invasive spinal endoscopic surgery, and lumbar fusion decompression with internal fixation. 2 Posterior decompression and fusion surgery, which are the gold standard, has proven effective in relieving pain and maintaining spinal stability. However, fusion surgery has several limitations. It is not suitable for young patients, as it may restrict the motility of the fused segment, potentially leading to increased stress and motion in adjacent segments, ultimately resulting in adjacent segment degeneration (ASD). 3 ; 4 Therefore, for patients with simple disc herniation, fenestration discectomy and endoscopic minimally invasive surgery may be more suitable options. Nevertheless, it is noteworthy that these alternative surgeries have a certain recurrence rate compared to fusion surgery. 5 Segmental instability after discectomy is a risk factor for lower back pain and disc herniation recurrence. 6 Consequently, choosing an appropriate surgical approach is particularly important. The concepts of dynamic stability and non-fusion were introduced in the 1990s. As a new non-fusion system, the Coflex system is a compressible U-shaped titanium device that is inserted between the spinous processes following decompressive surgery, offering a novel approach to spinal stabilization. 7 ; 8 According to previous reports, the Coflex is primarily used as an alternative to lumbar fusion decompression surgery, which is suitable for lumbar degenerative diseases, such as lumbar spinal stenosis and disc degeneration. It can stabilize the lumbar spine after decompression and preserve the sagittal range of motion (ROM) at the index and adjacent levels. 9 ; 10 Previous studies have demonstrated positive outcomes in the treatment of lumbar spinal stenosis, with long-term follow-up validating its effectiveness. 11 However, for patients with simple LDH who are suitable for fenestration discectomy and minimally invasive endoscopic surgery, the efficacy and advantages of these surgical methods are unclear, and there is a lack of supporting literature. We therefore conducted a retrospective study to investigate the role of dynamic stabilization in the surgical treatment of LDH. To the best of our knowledge, this is the first retrospective study to compare discectomy surgery alone with the additional implantation of a Coflex interspinous device. This study aimed to assess the safety and efficacy of Coflex implants in the surgical management of LDH. MATERIALS AND METHODS Patient population We retrospectively analyzed patients with a clear diagnosis of symptomatic LDH who underwent surgery between January 2009 and January 2013. Patients with LDH of more than 2 levels, lumbar spinal stenosis (LSS), degenerative spondylolisthesis greater than grade I, prior surgical treatment, trauma, infection, or any other disease affecting the spinal column were excluded. After applying the exclusion criteria, 85 patients were enrolled in this study. Among them, 40 patients were treated with discectomy combined with Coflex dynamic stabilization (Coflex group) and 45 patients were treated with simple discectomy (SD group). The following data were collected for demographic analysis: age, sex, body mass index (BMI), symptom duration, segmental distribution, follow-up period, and the Pfirrmann grade of the intervertebral disc. Surgical procedure All procedures were performed under general anesthesia. Patients were placed in the prone position on four bolsters on a radiolucent operating table with the abdomen freely suspended. A standard midline longitudinal skin incision was made during surgery and the operated level was confirmed using fluoroscopy. The paraspinal muscles were separated from the symptomatic side to expose the vertebral plate. In the SD group, adequate decompression was achieved by removing the ligamentum flavum and resecting the herniated root, confirming freely movable exiting roots after laminotomy. For the Coflex group, decompression was similarly achieved through laminotomy; prior to Coflex implantation, the optimal size of Coflex was measured using trial molds. The proper Coflex fixator was then inserted in a stable position between the spinous processes and tightened wings with a clamp. The posterior structure was rinsed and repaired, and the fascia and supraspinatus ligament were sutured layer by layer. Finally, a drainage tube was inserted to facilitate postoperative drainage. After surgery, prophylactic antibiotics were administered to prevent infection. Additionally, mannitol and methylprednisolone were administered intravenously for 3 days to manage postoperative edema and inflammation. The drainage volume was observed and recorded, and the drainage tube was removed within 1–2 d. depending on the patient's recovery and amount of drainage. Patients were advised to start walking short distances with waist support and gradually increase exercise intensity and walking distance until they recovered their ability to perform daily activities. Clinical outcomes and radiological date measurement The clinical outcomes were analyzed before and after surgery in both groups. The visual analog scale (VAS) for lower back and leg pain was used to evaluate analgesic efficacy (on a scale of 0–10), while the Oswestry Disability Index (ODI) was used for functional assessment. Clinical outcome measures were recorded preoperatively, and at 1 month, one year after surgery, and at the last follow-up postoperatively. Simultaneously, reoperation rates were recorded. During the perioperative period, the operation time, estimated blood loss, length of hospital stay, and complications were recorded. In addition, in the Coflex group, the imaging evaluations were carefully documented. Radiological parameters were assessed, including the lumbar ROM at the index level, intervertebral anterior disc height, posterior disc height, and intervertebral foramen height, as previously described. These measurements were obtained preoperatively, at 1 month, one year after surgery, and at the last follow-up postoperatively. The methods used to measure the radiological parameters are presented in Fig. 1. Two independent spine surgeons performed clinical evaluations of the patients. Three spinal surgeons assessed the radiographs. Statistical analysis Statistical analyses were performed using the PASW Statistics for Windows (version 18.0; SPSS Inc., Chicago, IL, USA). Numeric variables are presented as means ± standard deviation. Repeated-measures analysis of variance (ANOVA) was used to analyze the differences between preoperative and postoperative VAS scores, ODI scores, vertebral disc height, vertebral foramen height, and ROM. Student’s t-test was used to compare measurements between both groups. Nominal variables (sex, operated level, and Pfirrmann grade) are presented as numbers (percentages) and compared using chi-square tests. P values < 0.05 were considered to indicate statistically significant differences. RESULTS The clinical characteristics of the 85 patients are summarized in Table 1 . The mean ages of the patients in the Coflex groups and SD groups were 52.70 ± 10.19 years and 48,22 ± 12.22 years, respectively. Age, sex, symptom duration, BMI, operated level, Pfirrmann grade, and follow-up period before surgery did not differ significantly between both groups. Table 1 Baseline patient characteristic characteristic Coflex Group SD Group t (χ2) p No. of patients 40 45 age 52.70 ± 10.19 48,22 ± 12.22 1.821 0.072 Male/female 26/14 26/19 0.465 0.495 BMI 24.02 ± 2.53 22.77 ± 3.35 1.871 0,065 Duration of symptom (months) 7.17 ± 9.07 8.86 ± 9.69 -0.828 0.410 Follow-up period (months) 102.67 ± 19.19 101.86 ± 14.38 0.221 0.826 Operated level 2.580 0.461 L2/3 1 0 L3/4 1 1 L4/5 27 25 L5/S1 11 18 Pfirmann grade 1.537 0.674 II 1 1 III 23 29 IV 16 14 V 0 1 Data are presented as mean ± standard deviation Clinical outcomes Most patients in both groups experienced excellent pain relief and improved physical ability. The low back VAS scores improved from 4.00 ± 0.96 preoperatively to 1.57 ± 1.03 postoperatively in the Coflex group (p < 0.05) and from 3.55 ± 1.00 preoperatively to 1.55 ± 0.69 postoperatively in the SD group (p < 0.05). The leg VAS scores improved from 6.75 ± 1.44 preoperatively to 2.07 ± 1.11 postoperatively in the Coflex group (p < 0.05) and from 6.91 ± 1.47 preoperatively to 1.97 ± 0.83 postoperatively in the SD group (p < 0.05). The ODI scores also improved, decreasing from 65.05 ± 12.24 preoperatively to 14.44 ± 6.95 postoperatively in the Coflex group (p < 0.05) and from 66.66 ± 13.05 preoperatively to 13.13 ± 6.73 postoperatively in the SD group (p < 0.05). There were no significant differences in the VAS and ODI scores between both groups at 1 month or 1 year postoperatively. However, the VAS and ODI scores in the Coflex group were lower than those in the SD group, indicating better outcomes. The operation time, blood loss, and lengths of hospital stay were significantly longer in the Coflex group compared to the SD group (92.25 ± 11.09 vs. 54.88 ± 12.63, 65.2 ± 41.51 vs. 45.77 ± 35.44; 16.20 ± 6.37 vs. 10.84 ± 5.36 p < 0.05). Details are presented in Tables 2 and 3 . Table 2 Patient’s perioperative parameters comparison between coflex group and simple discectomy (SD) group in this study Parameter Coflex Group SD Group T((χ2)) p Operation time(min) 92.25 ± 11.09 54.88 ± 12.63 14.406 0.000 Estimated blood loss(ml) 65.2 ± 41.51 45.77 ± 35.44 2.333 0.022 Hospital stays(days) 16.20 ± 6.37 10.84 ± 5.36 4.207 0.000 complication 3(7.5%) 1(2.22%) 2.314 0.128 Dural tear 1 0 infection 1 1 Incision hematoma 2 0 reoperation 3(7.5%) 5(11.1%) 0.324 0.569 Data are presented as mean ± standard deviation Table 3 Clinical comparisons coflex group and simple discectomy (SD) group in this study Parameter Coflex Group SD Group t p VAS(low back pain) Preoperative 4.00 ± 0.96 3.55 ± 1.00* 1.974 0.055 1month Postoperative 1.57 ± 1.03* 1.55 ± 0.69* 0.103 0.918 one year after surgery 1.42 ± 0.74* 1.55 ± 0.72* -0.817 0.416 Final follow-up 1.55 ± 0.81* 1.73 ± 0.72* -1.101 0.274 VAS(leg pain) Preoperative 6.75 ± 1.44 6.91 ± 1.47 -0.507 0.613 1month Postoperative 2.07 ± 1.11* 1.97 ± 0.83* 0.456 0.649 one year after surgery 1.80 ± 0.82* 2.00 ± 1.10* -0.935 0.354 Final follow-up 2.27 ± 1.58* 3.17 ± 1.71*△☆ -2.515 0.014 ODI Preoperative 65.05 ± 12.24 66.66 ± 13.05 -0.585 0.560 1month Postoperative 14.44 ± 6.95* 13.13 ± 6.73* 0.882 0.380 one year after surgery 13.94 ± 5.88* 15.01 ± 9.82*△ -0.598 0.551 Final follow-up 16.16 ± 18.30* 25.48 ± 21.75*△☆ -2.122 0.037 Data are presented as mean ± standard deviation Compare with preoperative: * P < 0. 05; compared with 1month postoperative: △ P < 0. 05; 与compared with one year after surgery: ☆ P < 0. 05 Radiographic evaluation The anterior, posterior dis height and Intervertebral foramen height improved from (12.43 ± 3.30, 7.76 ± 1.83 and 18.89 ± 4.07 respectively) preoperatively to (12.17 ± 2.90, 9.99 ± 2.66, and 20.05 ± 6.49 respectively) postoperatively in the Coflex group. However, at the last follow-up, these values showed varying degrees of decline, returning to approximately the preoperative levels of (10.42 ± 3.09, 6.70 ± 1.80 and 17.98 ± 3.55, respectively). In the flexion–extension radiographs, the postoperative ROM was controlled, decreasing from (7.25 ± 2.84) degrees before surgery to (3.00 ± 1.39) degrees at 1 month postoperatively and (3.70 ± 1.41) degrees at one year postoperatively, while the ROM kept increasing to (4.77 ± 1.87) at the last follow-up (p < 0.05). The radiographic results are shown in Table 4 . Table 4 Radiological of coflex group in this study characteristic preoperative 1month postoperative one year after surgery Final follow-up Anterior dis height(mm) 12.43 ± 3.30 12.17 ± 2.90 11.93 ± 2.39 10.42 ± 3.09*△☆ Posterior dis height(mm) 7.76 ± 1.83 9.99 ± 2.66* 8.58 ± 2.16△ 6.70 ± 1.80*△☆ Intervertebral foramen height(mm) 18.89 ± 4.07 21.11 ± 4.52* 19.65 ± 4.17 17.98 ± 3.55△☆ ROM( ◦) 7.25 ± 2.84 3.00 ± 1.39* 3.70 ± 1.41*△ 4.77 ± 1.87*△☆ Data are presented as mean ± standard deviation Compare with preoperative: * P < 0. 05; compared with 1month postoperative: △ P < 0. 05; 与compared with one year after surgery: ☆ P < 0. 05 Complications There were two cases of incisional hematoma and one case of wound infection in the Coflex group. Additionally, one case of wound infection was observed in the SD group. During surgery, one case of dural sac tear occurred in the Coflex group. Fortunately, all patients with complications recovered well after post-operative treatment, including anti-infective therapy and wound dressing changes. No other implant-related complications such as loosening, displacement, shedding of the Coflex device, or rupture of the spinous process were observed. The reoperation rates were 7.5% (3 of 40) in the Coflex group and 11.1% (5 of 45) in the SD group. Discussion The Coflex device (formerly Interspinous ‘U’) as One of those ‘‘dynamic’’ devices which was originally invented by the orthopedic surgeon Jacques Samani in 1994. It was designed to simulate lumbar flexion, restrict extension, and stretch posterior structures, such as the ligamentum flavum and posterior annular fibers. Specifically, Coflex was able to distract the spinous processes, enlarge the spinal canal volume, and increase the height of the intervertebral foramen, thereby preventing excessive lumbar extension. 12 While stabilizing the surgical segment of the lumbar spine, preserving a certain degree of mobility, avoiding stress concentration in adjacent segments, and subsequently delaying the degeneration of those segments. 13 Furthermore, biomechanical studies have demonstrated that Coflex restores the stability of an unstable specimen to a level comparable to that of an intact specimen in anterior flexion, posterior extension, and axial rotation, but it also effectively unloads the facet joints and significantly reduces intradiscal pressure. 14 ; 15 The recommended indications for the use of Coflex are wide and include degenerative spinal stenosis, LDH, discogenic low back pain, facet syndrome, and internal fixation after discectomy. 16 ; 17 The spine maintains its stability through the posterior structures. However, fenestration discectomy, which involves neural decompression through the resection of the ligamentum flavum, partial laminotomy, and other procedures, can damage some of these structures. This damage can lead to spinal segmental instability and degeneration, which, in turn, can compromise the outcomes of radical decompressive procedures and increase the risk of poor outcomes and LDH recurrence. 18 previous study demonstrated that a reduction in intradiscal pressure, coupled with the alteration of osseous and ligamentous structures following discectomy, can result in decreased intervertebral height and spinal stability. 19 ; 20 However, Coflex, a non-fusion technology, offers a promising alternative by providing dynamic stabilization to the affected spinal segment, thereby preserving motion and reducing the risk of adjacent segment diseases. Fenestration discectomy, a standard procedure for symptomatic LDH, offers faster pain relief and functional improvement than nonoperative treatment. 2 However, despite its efficacy in treating LDH, straightforward discectomy still leads to unsatisfactory outcomes and high reoperation rates. Additionally, according to previous long-term reports, improvement in pain did not differ significantly from conservative treatment methods. 21 Our study indicated that the VAS and ODI scores significantly improved after the first operative month and remained stable at the one year follow-up. There was no significant difference (p > 0.05) between both groups within 12 months postoperatively. However, in the long-term follow-up, a significant difference (p < 0.05) was observed in terms of pain relief and functional improvement between both groups. Specifically, in the Coflex group, the leg VAS and ODI score decreased to (2.27 ± 1.58 and 16.16 ± 18.30, respectively) at last follow-up. Meanwhile, in the SD group, the leg VAS and ODI decreased to (3.17 ± 1.71 and 25.48 ± 21.75, respectively). In our study, we found that the therapeutic effects in both groups remained stable for 12 months. However, in the long-term follow-up, the clinical effect in the SD group diminished over time, similar to previous reports. 21 – 23 In the Coflex group, a decrease in pain and functional scores was also observed during the long-term follow-up; however, compared to the simple discectomy group, the pain and functional scores remained significantly better, demonstrating a statistically significant difference. Many studies have reported the role of Coflex in the treatment of lumbar spinal stenosis (LSS). Richter 24 et al. found that there is an advantage to the use of the Coflex interspinous device because of its stabilizing effect over a 2-year period. Kumar et al. 10 reported stable results over a 2-year follow-up show that additional Coflex implantation after spinal decompression in symptomatic LSS offers better clinical outcomes than decompression alone in the short term. In contrast to our study, Du 11 et al. reported that the VAS, ODI, and Japanese Orthopaedic Association scores showed significant improvement both at 6 months post-surgery and at the final follow-up for LSS treatment, indicating stable long-term efficacy and satisfactory clinical outcomes. Our study revealed that the disc and intervertebral foramen height were better restored in the Coflex group. Additionally, the ROM at the instrumented level was significantly reduced (from 7.25 ± 2.84° to 3.00 ± 1.39°, p < 0.05). This indicates that the interspinous distractor device exerts a stabilizing effect on unstable segments, primarily by limiting flexion movement and increasing the height of the posterior edge of the vertebral body. This, in turn, reduces the stress on the posterior disc and enlarges the space within the neural root. Similarly, Previous studies have revealed that surgery with Coflex insertion can preserve or even restore disc and intervertebral foramen heights in the immediate postoperative period or during 1 year of follow-up. 25 ; 26 However, our study showed that, as the follow-up time increased, the disc height gradually decreased, while the ROM gradually increased and approached the preoperative value. Some previous studies have reached the same conclusion, Celik 27 et al. found that the height of the intervertebral foramen could be increased in the short term after Coflex surgery. With extension of the follow-up period, the height of the intervertebral foramen gradually decreased and approached the preoperative level. Du 11 et al. showed that the Coflex could only maintain the height of the intervertebral space and intervertebral foramen for a short period. At the 6-month follow-up after surgery, the intervertebral space and foramen height of the surgical segment were significantly greater than those in the preoperative period and decreased to the preoperative level at the last follow-up. Based on a previous study, we believe that the Coflex has only a transient effect on the postoperative restoration of disc height and that it is difficult to sustain the biomechanical properties of the vertebrae for a prolonged period. Over time, the effectiveness may gradually diminish. This may be primarily attributed to the decrease in the compressive resistance of the Coflex system and long-term wear at the contact point between the spinous process and the implant. However, some scholars believe that postoperative clinical efficacy is not directly related to whether the Coflex maintains the height of the intervertebral space, and the relief of postoperative clinical symptoms in patients should be attributed to the relief of nerve compression after decompression by laminectomy. 27 Although some scholars have reported that the additional implantation of a dynamic interspinous device reveals no further improvement in the clinical outcome in a short period. 10 ; 17 ; 24 However, in our long-term follow-up, the results indicated that both VAS and ODI scores in the Coflex group were superior to those in the SD group, suggesting that the Coflex maintains a certain effect in long-term follow-up. We believe that the additional implantation of the Coflex device is safe, simple, and provides good to excellent results in decompressive surgery for LDH. As a dynamic device, the Coflex can maintain the stability of the lumbar spine and reduce lumbar discomfort. We also believe that the Coflex dynamic internal fixation system, as an elastic internal fixation system, offers a compromise between simple nucleus pulposus removal and interbody fusion. The complications of the Coflex system include surgery- and device-related complications. The data from our study indicate that the complication rate in the Coflex group (7.5%) was higher than that in the SD group (2.22%). Specifically, there were two cases of incisional hematoma and one case of wound infection in the Coflex group. This could be attributed to the U-shaped design of the Coflex implant, which creates an inherent cavity between the spinous processes after implantation. Furthermore, all the patients with complications recovered well after postoperative treatment. Previous studies conducted by Bae et al. 28 revealed a surgery-related complication rate of 12.1% in the Coflex group. Similarly, Zang et al. 29 reported a complication rate of 9.8% after an average follow-up period of 27.6 months. These findings are consistent with our results. In this study, 3 patients in the Coflex group underwent secondary surgery, while 5 patients in the simple discectomy group underwent secondary surgery. This suggests a higher reoperation rate in the simple discectomy group than that in the Coflex group. Similarly, Son et al. 30 reported a reoperation rate of up to 13.9% following standard open simple discectomy after a mean follow-up period of 15 years. Additionally, in a study focusing on the Coflex treatment for lumbar spinal stenosis, Du et al. 11 reported a 10.7% reoperation rate in the Coflex group (in long-term follow-up studies). Richter et al. 24 in their study on Coflex for spinal stenosis, reported a fusion rate of approximately 8%. Therefore, we believe that the Coflex interlaminar stabilization system is safe and can be used without significant risks when a thorough intraoperative decompression is performed. Additionally, it can reduce the reoperation rate compared to simple discectomy. The current study had several limitations. First, it was conducted as a retrospective, unrandomized, case-control analysis, resulting in incomplete data for several cases, particularly within the postoperative simple discectomy group where radiological data were lacking. Additionally, the relatively small number of patients may have introduced bias into the results. Consequently, randomized controlled trials with larger sample sizes and extended follow-up periods are essential to obtain more accurate results and to support the conclusions of this study. Conclusion This study revealed that the Coflex can maintain the disc height of the surgical segment for a short period and preserve a limited ROM. Both Coflex and simple discectomy have proven effective in treating LDH. However, long-term follow-up indicated that discectomy combined with Coflex produced superior clinical outcomes compared with simple discectomy, with fewer complications. Consequently, Coflex is a safe and effective treatment option for LDH. We also believe that the Coflex dynamic internal fixation system, as an elastic internal fixation system, offers a compromise between simple nucleus pulposus removal and interbody fusion. Declarations Acknowledgements Not applicable Authors' contributions Concept: YQ and SH; Design: YQ and YL; Supervision: CT; Materials: GS and XZ; Data Collection and/or Processing: YL and GS; Analysis and/or Interpretation: YQ and YL; Literature Review: GS and CT; Writing: YQ; Critical Review: YQ and SH. All authors read and approved the final manuscript. Funding The authors declare that this study has received no financial support Availability of data and materials The datasets used and/or analyzed during the current study are available from the corresponding author on request. Ethics approval and consent to participate This study was approved by the Ethics Committee of the Third Affiliated Hospital of Wenzhou Medical University. The Committee waived the requirement for informed consent. All procedures performed on this study were in accordance with the ethical standards of the 1964 Helsinki declaration and regulations Consent for publication. Consent for publication Not applicable Competing interests The authors have no conflicts of interest to declare. Author details 1 Department of Orthopaedic Surgery, Third Afliated Hospital of Wenzhou Medical University, 108 WanSong Road, Ruian, Wenzhou, Zhejiang, China. References Peul WC, van Houwelingen HC, van den Hout WB, et al. Surgery versus prolonged conservative treatment for sciatica. 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Richter A, Halm HF, Hauck M, Quante M. Two-year follow-up after decompressive surgery with and without implantation of an interspinous device for lumbar spinal stenosis: a prospective controlled study. J Spinal Disord Tech. 2014;27:336–41. Park SC, Yoon SH, Hong YP, et al. Minimum 2-year follow-up result of degenerative spinal stenosis treated with interspinous u (coflex). J Korean Neurosurg Soc. 2009;46:292–9. Xu D, Chen YH, Zeng HB, et al. [A short-term follow-up results of lumbar disc herniation by Coflex]. Zhonghua Wai Ke Za Zhi. 2009;47:1379–82. Celik H, Derincek A, Koksal I. Surgical treatment of the spinal stenosis with an interspinous distraction device: do we really restore the foraminal height? Turk Neurosurg. 2012;22:50–4. Bae HW, Davis RJ, Lauryssen C, et al. Three-Year Follow-up of the Prospective, Randomized, Controlled Trial of Coflex Interlaminar Stabilization vs Instrumented Fusion in Patients With Lumbar Stenosis. Neurosurgery. 2016;79:169–81. Zang L, Du P, Hai Y, et al. Device related complications of the Coflex interspinous process implant for the lumbar spine. Chin Med J (Engl). 2013;126:2517–22. Son IN, Kim YH, Ha KY. Long-term clinical outcomes and radiological findings and their correlation with each other after standard open discectomy for lumbar disc herniation. J Neurosurg Spine. 2015;22:179–84. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4842535","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":346837760,"identity":"90fbc899-1fd5-4ca4-90c2-ff9ff90236b7","order_by":0,"name":"Yunfan Qian","email":"","orcid":"","institution":"Third affiliated Hospital of Wenzhou Medical University","correspondingAuthor":false,"prefix":"","firstName":"Yunfan","middleName":"","lastName":"Qian","suffix":""},{"id":346837762,"identity":"e9ed3ac0-63fe-4677-b735-e1eee4c3302b","order_by":1,"name":"Yimin Li","email":"","orcid":"","institution":"Third affiliated Hospital of Wenzhou Medical University","correspondingAuthor":false,"prefix":"","firstName":"Yimin","middleName":"","lastName":"Li","suffix":""},{"id":346837764,"identity":"28002488-1f1b-49cf-bf8f-ab200bf7dd51","order_by":2,"name":"Xiqiang Zhong","email":"","orcid":"","institution":"Third affiliated Hospital of Wenzhou Medical University","correspondingAuthor":false,"prefix":"","firstName":"Xiqiang","middleName":"","lastName":"Zhong","suffix":""},{"id":346837766,"identity":"83bdc182-e9e6-45b8-83e3-05137ea6fc1f","order_by":3,"name":"Guangjie Shen","email":"","orcid":"","institution":"Third affiliated Hospital of Wenzhou Medical University","correspondingAuthor":false,"prefix":"","firstName":"Guangjie","middleName":"","lastName":"Shen","suffix":""},{"id":346837768,"identity":"0480782b-a037-4854-8c4e-e5f23f108c6a","order_by":4,"name":"Chengxuan Tang","email":"","orcid":"","institution":"Third affiliated Hospital of Wenzhou Medical University","correspondingAuthor":false,"prefix":"","firstName":"Chengxuan","middleName":"","lastName":"Tang","suffix":""},{"id":346837769,"identity":"ada3e685-7dbd-4b5e-a21b-748e6dda99d6","order_by":5,"name":"Shaoqi He","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAu0lEQVRIiWNgGAWjYBACAwYGNhDNw8/MfPABaVok29mSDUjSwmBwnsdMgCgt5uztzx78qLCWMT7MYMbAUGMTTVCLZc8Zc8OeM+k8ZocZ0h4wHEvLbSDosBs5bBK8bYdBWo4bMDYcJkLL/efPJP8CtRg3M7ZJEKflBoOZNMgWA2ZmNiK1nMkxk5YB+kXiMBuzQQJRfjl+/Jnkmwpre/7+8x8ffKixIawFCpghVAKRypG0jIJRMApGwSjABgCx4Do/IM4zZQAAAABJRU5ErkJggg==","orcid":"","institution":"Third affiliated Hospital of Wenzhou Medical University","correspondingAuthor":true,"prefix":"","firstName":"Shaoqi","middleName":"","lastName":"He","suffix":""}],"badges":[],"createdAt":"2024-08-01 13:30:24","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4842535/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4842535/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":64167401,"identity":"eea522ad-9b23-4f61-9d74-0866133b5c1b","added_by":"auto","created_at":"2024-09-09 09:48:25","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":199655,"visible":true,"origin":"","legend":"\u003cp\u003eLegend not included with this version.\u003c/p\u003e","description":"","filename":"fig1.png","url":"https://assets-eu.researchsquare.com/files/rs-4842535/v1/e6541736a8c51008a6c79951.png"},{"id":93827946,"identity":"c876bde9-14ff-4eee-92ef-6a31bf119745","added_by":"auto","created_at":"2025-10-18 07:23:32","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":885785,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4842535/v1/2ded27d2-c651-4182-9a2b-8d6f985f1ece.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Discectomy combined with the Coflex interspinous stabilization device versus simple discectomy for lumbar disc herniation: Long-term follow-up","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eLumbar disc herniation (LDH) is a spinal condition that occurs frequently in different age groups.\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u003c/sup\u003e For patients who fail to respond favorably to conservative treatments, surgical options are available, including fenestration discectomy, minimally invasive spinal endoscopic surgery, and lumbar fusion decompression with internal fixation. \u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e Posterior decompression and fusion surgery, which are the gold standard, has proven effective in relieving pain and maintaining spinal stability. However, fusion surgery has several limitations. It is not suitable for young patients, as it may restrict the motility of the fused segment, potentially leading to increased stress and motion in adjacent segments, ultimately resulting in adjacent segment degeneration (ASD).\u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e; \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e Therefore, for patients with simple disc herniation, fenestration discectomy and endoscopic minimally invasive surgery may be more suitable options. Nevertheless, it is noteworthy that these alternative surgeries have a certain recurrence rate compared to fusion surgery. \u003csup\u003e\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u003c/sup\u003e Segmental instability after discectomy is a risk factor for lower back pain and disc herniation recurrence. \u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e Consequently, choosing an appropriate surgical approach is particularly important.\u003c/p\u003e \u003cp\u003eThe concepts of dynamic stability and non-fusion were introduced in the 1990s. As a new non-fusion system, the Coflex system is a compressible U-shaped titanium device that is inserted between the spinous processes following decompressive surgery, offering a novel approach to spinal stabilization.\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e; \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e According to previous reports, the Coflex is primarily used as an alternative to lumbar fusion decompression surgery, which is suitable for lumbar degenerative diseases, such as lumbar spinal stenosis and disc degeneration. It can stabilize the lumbar spine after decompression and preserve the sagittal range of motion (ROM) at the index and adjacent levels. \u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e; \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e Previous studies have demonstrated positive outcomes in the treatment of lumbar spinal stenosis, with long-term follow-up validating its effectiveness. \u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e However, for patients with simple LDH who are suitable for fenestration discectomy and minimally invasive endoscopic surgery, the efficacy and advantages of these surgical methods are unclear, and there is a lack of supporting literature.\u003c/p\u003e \u003cp\u003eWe therefore conducted a retrospective study to investigate the role of dynamic stabilization in the surgical treatment of LDH. To the best of our knowledge, this is the first retrospective study to compare discectomy surgery alone with the additional implantation of a Coflex interspinous device. This study aimed to assess the safety and efficacy of Coflex implants in the surgical management of LDH.\u003c/p\u003e"},{"header":"MATERIALS AND METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003ePatient population\u003c/h2\u003e \u003cp\u003eWe retrospectively analyzed patients with a clear diagnosis of symptomatic LDH who underwent surgery between January 2009 and January 2013. Patients with LDH of more than 2 levels, lumbar spinal stenosis (LSS), degenerative spondylolisthesis greater than grade I, prior surgical treatment, trauma, infection, or any other disease affecting the spinal column were excluded. After applying the exclusion criteria, 85 patients were enrolled in this study. Among them, 40 patients were treated with discectomy combined with Coflex dynamic stabilization (Coflex group) and 45 patients were treated with simple discectomy (SD group). The following data were collected for demographic analysis: age, sex, body mass index (BMI), symptom duration, segmental distribution, follow-up period, and the Pfirrmann grade of the intervertebral disc.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eSurgical procedure\u003c/h2\u003e \u003cp\u003eAll procedures were performed under general anesthesia. Patients were placed in the prone position on four bolsters on a radiolucent operating table with the abdomen freely suspended. A standard midline longitudinal skin incision was made during surgery and the operated level was confirmed using fluoroscopy. The paraspinal muscles were separated from the symptomatic side to expose the vertebral plate. In the SD group, adequate decompression was achieved by removing the ligamentum flavum and resecting the herniated root, confirming freely movable exiting roots after laminotomy. For the Coflex group, decompression was similarly achieved through laminotomy; prior to Coflex implantation, the optimal size of Coflex was measured using trial molds. The proper Coflex fixator was then inserted in a stable position between the spinous processes and tightened wings with a clamp. The posterior structure was rinsed and repaired, and the fascia and supraspinatus ligament were sutured layer by layer. Finally, a drainage tube was inserted to facilitate postoperative drainage.\u003c/p\u003e \u003cp\u003eAfter surgery, prophylactic antibiotics were administered to prevent infection. Additionally, mannitol and methylprednisolone were administered intravenously for 3 days to manage postoperative edema and inflammation. The drainage volume was observed and recorded, and the drainage tube was removed within 1\u0026ndash;2 d. depending on the patient's recovery and amount of drainage. Patients were advised to start walking short distances with waist support and gradually increase exercise intensity and walking distance until they recovered their ability to perform daily activities.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eClinical outcomes and radiological date measurement\u003c/h2\u003e \u003cp\u003eThe clinical outcomes were analyzed before and after surgery in both groups. The visual analog scale (VAS) for lower back and leg pain was used to evaluate analgesic efficacy (on a scale of 0\u0026ndash;10), while the Oswestry Disability Index (ODI) was used for functional assessment. Clinical outcome measures were recorded preoperatively, and at 1 month, one year after surgery, and at the last follow-up postoperatively. Simultaneously, reoperation rates were recorded. During the perioperative period, the operation time, estimated blood loss, length of hospital stay, and complications were recorded.\u003c/p\u003e \u003cp\u003eIn addition, in the Coflex group, the imaging evaluations were carefully documented. Radiological parameters were assessed, including the lumbar ROM at the index level, intervertebral anterior disc height, posterior disc height, and intervertebral foramen height, as previously described. These measurements were obtained preoperatively, at 1 month, one year after surgery, and at the last follow-up postoperatively. The methods used to measure the radiological parameters are presented in Fig.\u0026nbsp;1.\u003c/p\u003e \u003cp\u003eTwo independent spine surgeons performed clinical evaluations of the patients. Three spinal surgeons assessed the radiographs.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eStatistical analyses were performed using the PASW Statistics for Windows (version 18.0; SPSS Inc., Chicago, IL, USA). Numeric variables are presented as means\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation. Repeated-measures analysis of variance (ANOVA) was used to analyze the differences between preoperative and postoperative VAS scores, ODI scores, vertebral disc height, vertebral foramen height, and ROM. Student\u0026rsquo;s t-test was used to compare measurements between both groups. Nominal variables (sex, operated level, and Pfirrmann grade) are presented as numbers (percentages) and compared using chi-square tests. P values\u0026thinsp;\u0026lt;\u0026thinsp;0.05 were considered to indicate statistically significant differences.\u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cp\u003eThe clinical characteristics of the 85 patients are summarized in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. The mean ages of the patients in the Coflex groups and SD groups were 52.70\u0026thinsp;\u0026plusmn;\u0026thinsp;10.19 years and 48,22\u0026thinsp;\u0026plusmn;\u0026thinsp;12.22 years, respectively. Age, sex, symptom duration, BMI, operated level, Pfirrmann grade, and follow-up period before surgery did not differ significantly between both groups.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBaseline patient characteristic\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003echaracteristic\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCoflex Group\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSD Group\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003et (χ2)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003ep\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo. of patients\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e40\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e45\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eage\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e52.70\u0026thinsp;\u0026plusmn;\u0026thinsp;10.19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e48,22\u0026thinsp;\u0026plusmn;\u0026thinsp;12.22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1.821\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.072\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale/female\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e26/14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e26/19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.465\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.495\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBMI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e24.02\u0026thinsp;\u0026plusmn;\u0026thinsp;2.53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e22.77\u0026thinsp;\u0026plusmn;\u0026thinsp;3.35\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1.871\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0,065\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDuration of symptom (months)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7.17\u0026thinsp;\u0026plusmn;\u0026thinsp;9.07\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8.86\u0026thinsp;\u0026plusmn;\u0026thinsp;9.69\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e-0.828\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.410\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFollow-up period (months)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e102.67\u0026thinsp;\u0026plusmn;\u0026thinsp;19.19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e101.86\u0026thinsp;\u0026plusmn;\u0026thinsp;14.38\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.221\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.826\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOperated level\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e2.580\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.461\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eL2/3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eL3/4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eL4/5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eL5/S1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePfirmann grade\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1.537\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.674\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eII\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIII\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e29\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIV\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eV\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eData are presented as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eClinical outcomes\u003c/h2\u003e \u003cp\u003eMost patients in both groups experienced excellent pain relief and improved physical ability. The low back VAS scores improved from 4.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.96 preoperatively to 1.57\u0026thinsp;\u0026plusmn;\u0026thinsp;1.03 postoperatively in the Coflex group (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05) and from 3.55\u0026thinsp;\u0026plusmn;\u0026thinsp;1.00 preoperatively to 1.55\u0026thinsp;\u0026plusmn;\u0026thinsp;0.69 postoperatively in the SD group (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05). The leg VAS scores improved from 6.75\u0026thinsp;\u0026plusmn;\u0026thinsp;1.44 preoperatively to 2.07\u0026thinsp;\u0026plusmn;\u0026thinsp;1.11 postoperatively in the Coflex group (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05) and from 6.91\u0026thinsp;\u0026plusmn;\u0026thinsp;1.47 preoperatively to 1.97\u0026thinsp;\u0026plusmn;\u0026thinsp;0.83 postoperatively in the SD group (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05). The ODI scores also improved, decreasing from 65.05\u0026thinsp;\u0026plusmn;\u0026thinsp;12.24 preoperatively to 14.44\u0026thinsp;\u0026plusmn;\u0026thinsp;6.95 postoperatively in the Coflex group (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05) and from 66.66\u0026thinsp;\u0026plusmn;\u0026thinsp;13.05 preoperatively to 13.13\u0026thinsp;\u0026plusmn;\u0026thinsp;6.73 postoperatively in the SD group (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05). There were no significant differences in the VAS and ODI scores between both groups at 1 month or 1 year postoperatively. However, the VAS and ODI scores in the Coflex group were lower than those in the SD group, indicating better outcomes. The operation time, blood loss, and lengths of hospital stay were significantly longer in the Coflex group compared to the SD group (92.25\u0026thinsp;\u0026plusmn;\u0026thinsp;11.09 vs. 54.88\u0026thinsp;\u0026plusmn;\u0026thinsp;12.63, 65.2\u0026thinsp;\u0026plusmn;\u0026thinsp;41.51 vs. 45.77\u0026thinsp;\u0026plusmn;\u0026thinsp;35.44; 16.20\u0026thinsp;\u0026plusmn;\u0026thinsp;6.37 vs. 10.84\u0026thinsp;\u0026plusmn;\u0026thinsp;5.36 p\u0026thinsp;\u0026lt;\u0026thinsp;0.05). Details are presented in Tables\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e and \u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003ePatient\u0026rsquo;s perioperative parameters comparison between coflex group and simple discectomy (SD) group in this study\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eParameter\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCoflex Group\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSD Group\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eT((χ2))\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003ep\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOperation time(min)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e92.25\u0026thinsp;\u0026plusmn;\u0026thinsp;11.09\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e54.88\u0026thinsp;\u0026plusmn;\u0026thinsp;12.63\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e14.406\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e0.000\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEstimated blood loss(ml)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e65.2\u0026thinsp;\u0026plusmn;\u0026thinsp;41.51\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e45.77\u0026thinsp;\u0026plusmn;\u0026thinsp;35.44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e2.333\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e0.022\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHospital stays(days)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e16.20\u0026thinsp;\u0026plusmn;\u0026thinsp;6.37\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10.84\u0026thinsp;\u0026plusmn;\u0026thinsp;5.36\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e4.207\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e0.000\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ecomplication\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3(7.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1(2.22%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e2.314\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.128\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDural tear\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003einfection\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIncision hematoma\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ereoperation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3(7.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5(11.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.324\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.569\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eData are presented as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eClinical comparisons coflex group and simple discectomy (SD) group in this study\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eParameter\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCoflex Group\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSD Group\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003et\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003ep\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVAS(low back pain)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePreoperative\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e4.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.96\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e3.55\u0026thinsp;\u0026plusmn;\u0026thinsp;1.00*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1.974\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.055\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1month Postoperative\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e1.57\u0026thinsp;\u0026plusmn;\u0026thinsp;1.03*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e1.55\u0026thinsp;\u0026plusmn;\u0026thinsp;0.69*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.103\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.918\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eone year after surgery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e1.42\u0026thinsp;\u0026plusmn;\u0026thinsp;0.74*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e1.55\u0026thinsp;\u0026plusmn;\u0026thinsp;0.72*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e-0.817\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.416\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFinal follow-up\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e1.55\u0026thinsp;\u0026plusmn;\u0026thinsp;0.81*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e1.73\u0026thinsp;\u0026plusmn;\u0026thinsp;0.72*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e-1.101\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.274\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVAS(leg pain)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePreoperative\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e6.75\u0026thinsp;\u0026plusmn;\u0026thinsp;1.44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e6.91\u0026thinsp;\u0026plusmn;\u0026thinsp;1.47\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e-0.507\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.613\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1month Postoperative\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e2.07\u0026thinsp;\u0026plusmn;\u0026thinsp;1.11*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e1.97\u0026thinsp;\u0026plusmn;\u0026thinsp;0.83*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.456\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.649\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eone year after surgery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e1.80\u0026thinsp;\u0026plusmn;\u0026thinsp;0.82*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e2.00\u0026thinsp;\u0026plusmn;\u0026thinsp;1.10*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e-0.935\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.354\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFinal follow-up\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e2.27\u0026thinsp;\u0026plusmn;\u0026thinsp;1.58*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e3.17\u0026thinsp;\u0026plusmn;\u0026thinsp;1.71*△☆\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e-2.515\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e0.014\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eODI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePreoperative\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e65.05\u0026thinsp;\u0026plusmn;\u0026thinsp;12.24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e66.66\u0026thinsp;\u0026plusmn;\u0026thinsp;13.05\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e-0.585\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.560\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1month Postoperative\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e14.44\u0026thinsp;\u0026plusmn;\u0026thinsp;6.95*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e13.13\u0026thinsp;\u0026plusmn;\u0026thinsp;6.73*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.882\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.380\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eone year after surgery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e13.94\u0026thinsp;\u0026plusmn;\u0026thinsp;5.88*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e15.01\u0026thinsp;\u0026plusmn;\u0026thinsp;9.82*△\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e-0.598\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.551\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFinal follow-up\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e16.16\u0026thinsp;\u0026plusmn;\u0026thinsp;18.30*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e25.48\u0026thinsp;\u0026plusmn;\u0026thinsp;21.75*△☆\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e-2.122\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e0.037\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eData are presented as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eCompare with preoperative: * P \u0026lt; 0. 05; compared with 1month postoperative: △ P \u0026lt; 0. 05; 与compared with one year after surgery: ☆ P \u0026lt; 0. 05\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eRadiographic evaluation\u003c/h2\u003e \u003cp\u003eThe anterior, posterior dis height and Intervertebral foramen height improved from (12.43\u0026thinsp;\u0026plusmn;\u0026thinsp;3.30, 7.76\u0026thinsp;\u0026plusmn;\u0026thinsp;1.83 and 18.89\u0026thinsp;\u0026plusmn;\u0026thinsp;4.07 respectively) preoperatively to (12.17\u0026thinsp;\u0026plusmn;\u0026thinsp;2.90, 9.99\u0026thinsp;\u0026plusmn;\u0026thinsp;2.66, and 20.05\u0026thinsp;\u0026plusmn;\u0026thinsp;6.49 respectively) postoperatively in the Coflex group. However, at the last follow-up, these values showed varying degrees of decline, returning to approximately the preoperative levels of (10.42\u0026thinsp;\u0026plusmn;\u0026thinsp;3.09, 6.70\u0026thinsp;\u0026plusmn;\u0026thinsp;1.80 and 17.98\u0026thinsp;\u0026plusmn;\u0026thinsp;3.55, respectively). In the flexion\u0026ndash;extension radiographs, the postoperative ROM was controlled, decreasing from (7.25\u0026thinsp;\u0026plusmn;\u0026thinsp;2.84) degrees before surgery to (3.00\u0026thinsp;\u0026plusmn;\u0026thinsp;1.39) degrees at 1 month postoperatively and (3.70\u0026thinsp;\u0026plusmn;\u0026thinsp;1.41) degrees at one year postoperatively, while the ROM kept increasing to (4.77\u0026thinsp;\u0026plusmn;\u0026thinsp;1.87) at the last follow-up (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05). The radiographic results are shown in Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eRadiological of coflex group in this study\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003echaracteristic\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003epreoperative\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1month postoperative\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eone year after surgery\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eFinal follow-up\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAnterior dis height(mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e12.43\u0026thinsp;\u0026plusmn;\u0026thinsp;3.30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e12.17\u0026thinsp;\u0026plusmn;\u0026thinsp;2.90\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c4\"\u003e \u003cp\u003e11.93\u0026thinsp;\u0026plusmn;\u0026thinsp;2.39\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c5\"\u003e \u003cp\u003e10.42\u0026thinsp;\u0026plusmn;\u0026thinsp;3.09*△☆\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePosterior dis height(mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e7.76\u0026thinsp;\u0026plusmn;\u0026thinsp;1.83\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e9.99\u0026thinsp;\u0026plusmn;\u0026thinsp;2.66*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c4\"\u003e \u003cp\u003e8.58\u0026thinsp;\u0026plusmn;\u0026thinsp;2.16△\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c5\"\u003e \u003cp\u003e6.70\u0026thinsp;\u0026plusmn;\u0026thinsp;1.80*△☆\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIntervertebral foramen height(mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e18.89\u0026thinsp;\u0026plusmn;\u0026thinsp;4.07\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e21.11\u0026thinsp;\u0026plusmn;\u0026thinsp;4.52*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c4\"\u003e \u003cp\u003e19.65\u0026thinsp;\u0026plusmn;\u0026thinsp;4.17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c5\"\u003e \u003cp\u003e17.98\u0026thinsp;\u0026plusmn;\u0026thinsp;3.55△☆\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eROM( ◦)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e7.25\u0026thinsp;\u0026plusmn;\u0026thinsp;2.84\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e3.00\u0026thinsp;\u0026plusmn;\u0026thinsp;1.39*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c4\"\u003e \u003cp\u003e3.70\u0026thinsp;\u0026plusmn;\u0026thinsp;1.41*△\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c5\"\u003e \u003cp\u003e4.77\u0026thinsp;\u0026plusmn;\u0026thinsp;1.87*△☆\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eData are presented as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eCompare with preoperative: * P \u0026lt; 0. 05; compared with 1month postoperative: △ P \u0026lt; 0. 05; 与compared with one year after surgery: ☆ P \u0026lt; 0. 05\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eComplications\u003c/h2\u003e \u003cp\u003eThere were two cases of incisional hematoma and one case of wound infection in the Coflex group. Additionally, one case of wound infection was observed in the SD group. During surgery, one case of dural sac tear occurred in the Coflex group. Fortunately, all patients with complications recovered well after post-operative treatment, including anti-infective therapy and wound dressing changes. No other implant-related complications such as loosening, displacement, shedding of the Coflex device, or rupture of the spinous process were observed. The reoperation rates were 7.5% (3 of 40) in the Coflex group and 11.1% (5 of 45) in the SD group.\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe Coflex device (formerly Interspinous \u0026lsquo;U\u0026rsquo;) as One of those \u0026lsquo;\u0026lsquo;dynamic\u0026rsquo;\u0026rsquo; devices which was originally invented by the orthopedic surgeon Jacques Samani in 1994. It was designed to simulate lumbar flexion, restrict extension, and stretch posterior structures, such as the ligamentum flavum and posterior annular fibers. Specifically, Coflex was able to distract the spinous processes, enlarge the spinal canal volume, and increase the height of the intervertebral foramen, thereby preventing excessive lumbar extension.\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e While stabilizing the surgical segment of the lumbar spine, preserving a certain degree of mobility, avoiding stress concentration in adjacent segments, and subsequently delaying the degeneration of those segments.\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e Furthermore, biomechanical studies have demonstrated that Coflex restores the stability of an unstable specimen to a level comparable to that of an intact specimen in anterior flexion, posterior extension, and axial rotation, but it also effectively unloads the facet joints and significantly reduces intradiscal pressure. \u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e; \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u003c/sup\u003e The recommended indications for the use of Coflex are wide and include degenerative spinal stenosis, LDH, discogenic low back pain, facet syndrome, and internal fixation after discectomy.\u003csup\u003e\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e; \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThe spine maintains its stability through the posterior structures. However, fenestration discectomy, which involves neural decompression through the resection of the ligamentum flavum, partial laminotomy, and other procedures, can damage some of these structures. This damage can lead to spinal segmental instability and degeneration, which, in turn, can compromise the outcomes of radical decompressive procedures and increase the risk of poor outcomes and LDH recurrence.\u003csup\u003e\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e previous study demonstrated that a reduction in intradiscal pressure, coupled with the alteration of osseous and ligamentous structures following discectomy, can result in decreased intervertebral height and spinal stability. \u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e; \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u003c/sup\u003eHowever, Coflex, a non-fusion technology, offers a promising alternative by providing dynamic stabilization to the affected spinal segment, thereby preserving motion and reducing the risk of adjacent segment diseases.\u003c/p\u003e \u003cp\u003eFenestration discectomy, a standard procedure for symptomatic LDH, offers faster pain relief and functional improvement than nonoperative treatment. \u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e However, despite its efficacy in treating LDH, straightforward discectomy still leads to unsatisfactory outcomes and high reoperation rates. Additionally, according to previous long-term reports, improvement in pain did not differ significantly from conservative treatment methods. \u003csup\u003e\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u003c/sup\u003e Our study indicated that the VAS and ODI scores significantly improved after the first operative month and remained stable at the one year follow-up. There was no significant difference (p\u0026thinsp;\u0026gt;\u0026thinsp;0.05) between both groups within 12 months postoperatively. However, in the long-term follow-up, a significant difference (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05) was observed in terms of pain relief and functional improvement between both groups. Specifically, in the Coflex group, the leg VAS and ODI score decreased to (2.27\u0026thinsp;\u0026plusmn;\u0026thinsp;1.58 and 16.16\u0026thinsp;\u0026plusmn;\u0026thinsp;18.30, respectively) at last follow-up. Meanwhile, in the SD group, the leg VAS and ODI decreased to (3.17\u0026thinsp;\u0026plusmn;\u0026thinsp;1.71 and 25.48\u0026thinsp;\u0026plusmn;\u0026thinsp;21.75, respectively). In our study, we found that the therapeutic effects in both groups remained stable for 12 months. However, in the long-term follow-up, the clinical effect in the SD group diminished over time, similar to previous reports. \u003csup\u003e\u003cspan additionalcitationids=\"CR22\" citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u003c/sup\u003e In the Coflex group, a decrease in pain and functional scores was also observed during the long-term follow-up; however, compared to the simple discectomy group, the pain and functional scores remained significantly better, demonstrating a statistically significant difference. Many studies have reported the role of Coflex in the treatment of lumbar spinal stenosis (LSS). Richter \u003csup\u003e\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u003c/sup\u003e et al. found that there is an advantage to the use of the Coflex interspinous device because of its stabilizing effect over a 2-year period. Kumar et al.\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e reported stable results over a 2-year follow-up show that additional Coflex implantation after spinal decompression in symptomatic LSS offers better clinical outcomes than decompression alone in the short term. In contrast to our study, Du \u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e et al. reported that the VAS, ODI, and Japanese Orthopaedic Association scores showed significant improvement both at 6 months post-surgery and at the final follow-up for LSS treatment, indicating stable long-term efficacy and satisfactory clinical outcomes.\u003c/p\u003e \u003cp\u003eOur study revealed that the disc and intervertebral foramen height were better restored in the Coflex group. Additionally, the ROM at the instrumented level was significantly reduced (from 7.25\u0026thinsp;\u0026plusmn;\u0026thinsp;2.84\u0026deg; to 3.00\u0026thinsp;\u0026plusmn;\u0026thinsp;1.39\u0026deg;, p\u0026thinsp;\u0026lt;\u0026thinsp;0.05). This indicates that the interspinous distractor device exerts a stabilizing effect on unstable segments, primarily by limiting flexion movement and increasing the height of the posterior edge of the vertebral body. This, in turn, reduces the stress on the posterior disc and enlarges the space within the neural root. Similarly, Previous studies have revealed that surgery with Coflex insertion can preserve or even restore disc and intervertebral foramen heights in the immediate postoperative period or during 1 year of follow-up. \u003csup\u003e\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e; \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e\u003c/sup\u003e However, our study showed that, as the follow-up time increased, the disc height gradually decreased, while the ROM gradually increased and approached the preoperative value. Some previous studies have reached the same conclusion, Celik \u003csup\u003e\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e\u003c/sup\u003e et al. found that the height of the intervertebral foramen could be increased in the short term after Coflex surgery. With extension of the follow-up period, the height of the intervertebral foramen gradually decreased and approached the preoperative level. Du \u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e et al. showed that the Coflex could only maintain the height of the intervertebral space and intervertebral foramen for a short period. At the 6-month follow-up after surgery, the intervertebral space and foramen height of the surgical segment were significantly greater than those in the preoperative period and decreased to the preoperative level at the last follow-up.\u003c/p\u003e \u003cp\u003eBased on a previous study, we believe that the Coflex has only a transient effect on the postoperative restoration of disc height and that it is difficult to sustain the biomechanical properties of the vertebrae for a prolonged period. Over time, the effectiveness may gradually diminish. This may be primarily attributed to the decrease in the compressive resistance of the Coflex system and long-term wear at the contact point between the spinous process and the implant. However, some scholars believe that postoperative clinical efficacy is not directly related to whether the Coflex maintains the height of the intervertebral space, and the relief of postoperative clinical symptoms in patients should be attributed to the relief of nerve compression after decompression by laminectomy.\u003csup\u003e\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e\u003c/sup\u003e Although some scholars have reported that the additional implantation of a dynamic interspinous device reveals no further improvement in the clinical outcome in a short period. \u003csup\u003e\u003cb\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e; \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e; \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u003c/b\u003e\u003c/sup\u003e However, in our long-term follow-up, the results indicated that both VAS and ODI scores in the Coflex group were superior to those in the SD group, suggesting that the Coflex maintains a certain effect in long-term follow-up. We believe that the additional implantation of the Coflex device is safe, simple, and provides good to excellent results in decompressive surgery for LDH. As a dynamic device, the Coflex can maintain the stability of the lumbar spine and reduce lumbar discomfort. We also believe that the Coflex dynamic internal fixation system, as an elastic internal fixation system, offers a compromise between simple nucleus pulposus removal and interbody fusion.\u003c/p\u003e \u003cp\u003eThe complications of the Coflex system include surgery- and device-related complications. The data from our study indicate that the complication rate in the Coflex group (7.5%) was higher than that in the SD group (2.22%). Specifically, there were two cases of incisional hematoma and one case of wound infection in the Coflex group. This could be attributed to the U-shaped design of the Coflex implant, which creates an inherent cavity between the spinous processes after implantation. Furthermore, all the patients with complications recovered well after postoperative treatment. Previous studies conducted by Bae et al. \u003csup\u003e\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e\u003c/sup\u003e revealed a surgery-related complication rate of 12.1% in the Coflex group. Similarly, Zang et al. \u003csup\u003e\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e\u003c/sup\u003e reported a complication rate of 9.8% after an average follow-up period of 27.6 months. These findings are consistent with our results. In this study, 3 patients in the Coflex group underwent secondary surgery, while 5 patients in the simple discectomy group underwent secondary surgery. This suggests a higher reoperation rate in the simple discectomy group than that in the Coflex group. Similarly, Son et al.\u003csup\u003e\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e\u003c/sup\u003e reported a reoperation rate of up to 13.9% following standard open simple discectomy after a mean follow-up period of 15 years. Additionally, in a study focusing on the Coflex treatment for lumbar spinal stenosis, Du et al.\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e reported a 10.7% reoperation rate in the Coflex group (in long-term follow-up studies). Richter et al. \u003csup\u003e\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u003c/sup\u003e in their study on Coflex for spinal stenosis, reported a fusion rate of approximately 8%. Therefore, we believe that the Coflex interlaminar stabilization system is safe and can be used without significant risks when a thorough intraoperative decompression is performed. Additionally, it can reduce the reoperation rate compared to simple discectomy.\u003c/p\u003e \u003cp\u003eThe current study had several limitations. First, it was conducted as a retrospective, unrandomized, case-control analysis, resulting in incomplete data for several cases, particularly within the postoperative simple discectomy group where radiological data were lacking. Additionally, the relatively small number of patients may have introduced bias into the results. Consequently, randomized controlled trials with larger sample sizes and extended follow-up periods are essential to obtain more accurate results and to support the conclusions of this study.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis study revealed that the Coflex can maintain the disc height of the surgical segment for a short period and preserve a limited ROM. Both Coflex and simple discectomy have proven effective in treating LDH. However, long-term follow-up indicated that discectomy combined with Coflex produced superior clinical outcomes compared with simple discectomy, with fewer complications. Consequently, Coflex is a safe and effective treatment option for LDH. We also believe that the Coflex dynamic internal fixation system, as an elastic internal fixation system, offers a compromise between simple nucleus pulposus removal and interbody fusion.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConcept: YQ and SH; Design: YQ and YL; Supervision: CT; Materials: GS and XZ; Data Collection and/or Processing: YL and GS; Analysis and/or Interpretation: YQ and YL; Literature Review: GS and CT; Writing: YQ; Critical Review: YQ and SH. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that this study has received no financial support\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and/or analyzed during the current study are available from the corresponding author on request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was approved by the Ethics Committee of the Third Affiliated Hospital of Wenzhou Medical University. The Committee waived the requirement for informed consent. All procedures performed on this study were in accordance with the ethical standards of the 1964 Helsinki declaration and regulations Consent for publication.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors have no conflicts of interest to declare.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor details\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e1 Department of Orthopaedic Surgery, Third Afliated Hospital of Wenzhou Medical University, 108 WanSong Road, Ruian, Wenzhou, Zhejiang, China.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003ePeul WC, van Houwelingen HC, van den Hout WB, et al. Surgery versus prolonged conservative treatment for sciatica. N Engl J Med. 2007;356:2245\u0026ndash;56.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGugliotta M, da Costa BR, Dabis E, et al. Surgical versus conservative treatment for lumbar disc herniation: a prospective cohort study. BMJ Open. 2016;6:e012938.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePark P, Garton HJ, Gala VC, et al. Adjacent segment disease after lumbar or lumbosacral fusion: review of the literature. Spine (Phila Pa 1976). 2004;29:1938\u0026ndash;44.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKumar MN, Baklanov A, Chopin D. Correlation between sagittal plane changes and adjacent segment degeneration following lumbar spine fusion. Eur Spine J. 2001;10:314\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSuri P, Rainville J, Hunter DJ, et al. Recurrence of radicular pain or back pain after nonsurgical treatment of symptomatic lumbar disk herniation. Arch Phys Med Rehabil. 2012;93:690\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFu TS, Lai PL, Tsai TT, et al. Long-term results of disc excision for recurrent lumbar disc herniation with or without posterolateral fusion. Spine (Phila Pa 1976). 2005;30:2830\u0026ndash;4.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBono CM, Vaccaro AR. Interspinous process devices in the lumbar spine. J Spinal Disord Tech. 2007;20:255\u0026ndash;61.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVillarejo F, Carceller F, de la Riva AG, Budke M. Experience with coflex interspinous implant. Acta Neurochir Suppl. 2011;108:171\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKong DS, Kim ES, Eoh W. One-year outcome evaluation after interspinous implantation for degenerative spinal stenosis with segmental instability. J Korean Med Sci. 2007;22:330\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKumar N, Shah SM, Ng YH, et al. Role of coflex as an adjunct to decompression for symptomatic lumbar spinal stenosis. Asian Spine J. 2014;8:161\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDu MR, Wei FL, Zhu KL, et al. Coflex interspinous process dynamic stabilization for lumbar spinal stenosis: Long-term follow-up. J Clin Neurosci. 2020;81:462\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKhoueir P, Kim KA, Wang MY. Classification of posterior dynamic stabilization devices. Neurosurg Focus. 2007;22:E3.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChristie SD, Song JK, Fessler RG. Dynamic interspinous process technology. Spine (Phila Pa 1976). 2005;30:S73\u0026ndash;78.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTsai KJ, Murakami H, Lowery GL, Hutton WC. A biomechanical evaluation of an interspinous device (Coflex) used to stabilize the lumbar spine. J Surg Orthop Adv. 2006;15:167\u0026ndash;72.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eShen H, Fogel GR, Zhu J, et al. Biomechanical Analysis of Different Lumbar Interspinous Process Devices: A Finite Element Study. World Neurosurg. 2019;127:e1112\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKabir SM, Gupta SR, Casey AT. Lumbar interspinous spacers: a systematic review of clinical and biomechanical evidence. Spine (Phila Pa 1976). 2010;35:E1499\u0026ndash;1506.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHan B, Chen Y, Liang W, et al. Is the interspinous process device safe and effective in elderly patients with lumbar degeneration? A systematic review and meta-analysis of randomized controlled trials. 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Turk Neurosurg. 2012;22:50\u0026ndash;4.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBae HW, Davis RJ, Lauryssen C, et al. Three-Year Follow-up of the Prospective, Randomized, Controlled Trial of Coflex Interlaminar Stabilization vs Instrumented Fusion in Patients With Lumbar Stenosis. Neurosurgery. 2016;79:169\u0026ndash;81.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZang L, Du P, Hai Y, et al. Device related complications of the Coflex interspinous process implant for the lumbar spine. Chin Med J (Engl). 2013;126:2517\u0026ndash;22.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSon IN, Kim YH, Ha KY. Long-term clinical outcomes and radiological findings and their correlation with each other after standard open discectomy for lumbar disc herniation. J Neurosurg Spine. 2015;22:179\u0026ndash;84.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Coflex, discectomy, lumbar disc herniation, long-term efficacy","lastPublishedDoi":"10.21203/rs.3.rs-4842535/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4842535/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eObjective:\u003c/strong\u003eTo evaluate the long-term efficacy of the Coflex dynamic stabilization device in the treatment of lumbar disc herniation (LDH) versus simple discectomy.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: We retrospectively analyzed 85 patients who underwent surgery for LDH between January 2009 and December 2013. Eligible patients with single-segment LDH were divided into two groups: discectomy with Coflex (Coflex group) and simple discectomy (SD group). The patient characteristics, surgical outcomes, operation time, blood loss, clinical and radiological features, complications, and reoperation rates were compared between both groups. In the Coflex group, the intervertebral height, intervertebral foramen height, and range of motion (ROM) of the treated segment were calculated from radiographs. Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) scores were assessed for both groups before surgery, at 1 month, one year after surgery, and at final follow-up.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults: \u003c/strong\u003eThe mean age, sex, body mass index (BMI), symptom duration, follow-up period, operated level, and Pfirrmann grade before surgery did not differ significantly between groups. The results showed significant improvements in the VAS and ODI scores in each group (P\u0026lt;0.05) after surgery. However, there were no significant differences in the VAS and ODI scores between both groups at 1 month or 1 year postoperatively. However, at the final follow-up, the VAS and ODI scores in the Coflex group were lower than those in the SD group(P\u0026lt;0.05). In the Coflex group, the anteriordisc height, posterior disc height, and intervertebral foramen height improved postoperatively. However, at the last follow-up, these values showed varying degrees of decline, returning to preoperative levels. In the flexion–extension radiographs, the ROM showed a significant decrease postoperatively, while the ROM continued to increase at the last follow-up (P\u0026lt;0.05). The mean operation time and blood loss were higher in the Coflex group than in the SD group(P\u0026lt;0.05). During the follow-up period, 3 patients (7.5%) in the Coflex group experienced complications, and 3 (7.5%) underwent secondary surgery. In the SD group, 1 patient (2.22%) experienced complications, and 5 (11.1%) underwent secondary surgery.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions \u003c/strong\u003eThis study revealed that the Coflex maintains the disc height of the surgical segment for a short period and preserves a limited ROM. Both Coflex and simple discectomies proved effective in treating LDH. However, long-term follow-up indicated that discectomy combined with Coflex produced superior clinical outcomes compared to simple discectomy, with fewer complications. Consequently, Coflex is a safe and effective treatment option for LDH.\u003c/p\u003e","manuscriptTitle":"Discectomy combined with the Coflex interspinous stabilization device versus simple discectomy for lumbar disc herniation: Long-term follow-up","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-09-09 09:48:19","doi":"10.21203/rs.3.rs-4842535/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"e4c1f05b-a0f0-422d-ba2b-78a9da0f2d44","owner":[],"postedDate":"September 9th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-10-18T07:23:15+00:00","versionOfRecord":[],"versionCreatedAt":"2024-09-09 09:48:19","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4842535","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4842535","identity":"rs-4842535","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}