Transpedicular Intravertebral Cage Augmentation Using Expandable Cage in Kummell Disease: Technical Note and Case Series.

OBJECTIVE: To demonstrate the surgical techniques for transpedicular intravertebral cage augmentation (TPICA) using an expandable cage for Kummell disease, which requires posterior surgical stabilization, and provide the preliminary surgical outcomes. METHODS: Six consecutive patients undergoing TPICA surgery using an expandable cage with a minimum 6-month follow-up were evaluated. Radiographic analysis to evaluate the local kyphosis angle, restoration ratio of anterior vertebral height of the index vertebra, and clinical outcomes including the Oswestry Disability Index, EuroQol 5-dimension instrument, and visual analog scale for back and leg pain, were compared between the preoperative and final follow-ups. RESULTS: All patients showed improvements in all clinical outcomes and were able to walk independently without support at the last follow-up. In radiographic evaluation, the mean preoperative restoration ratio of anterior vertebral height was 41.2 ± 15.6%, which increased postoperatively to 70.3 ± 20.5% (1.70 times) and 62.4 ± 20.0% at the last follow-up (1.51 times). The mean preoperative local kyphosis angle was 10.5 ± 14.8 and was corrected to 6.0 ± 10.0 at the last follow-up. A slight loss of correction was observed between the postoperative period and the last follow-up; however, there was no clinical significance. CONCLUSIONS: Expandable cages in TPICA may allow easier surgical manipulation for cage insertion around the pedicle entrance, minimizing damage to the fractured vertebral body's end plates while achieving satisfactory height restoration compared to static cages, and may also provide wider indications for TPICA surgery.

Feasibility of Non-window Three-Dimensional-Printed Porous Titanium Cage in Posterior Lumbar Interbody Fusion: A Pilot Trial.

Background: The commercially available design of a three-dimensional (3D)-printed titanium (3D-Ti) cage can be divided into two types according to the presence of a window: a cage with a window that allows filling of bone graft materials and a non-window cage for stand-alone use. This prospective observational case series study aimed to explore the clinical feasibility of using a non-window type 3D-Ti cage in cases of combined window and non-window cage implantation. Furthermore, we evaluated the bone in growth patterns of non-window cages and their correlation with published fusion grading systems. Methods: A total of 31 consecutive patients who underwent single-level posterior lumbar interbody fusion surgery were included. Two 3D-Ti cages with different designs were inserted: a non-window cage on the left side and a window cage on the right side. Radiographic fusion was defined by the segmental angle between flexion and extension radiographs (F-E angle) and cage bridging bone (CBB) scores on computed tomography. The association between the F-E angle and osteointegration scoring system including the surface osteointegration ratio (SOR) score was analyzed. Results: Radiographic fusion was achieved in 27 of 31 patients (87%) at 12 months postoperatively. Among the non-window cages, 23 of 31 (74.2%) had fair SOR scores, while 19 of 31 (61.3%) window cages had fair intra-cage CBB scores. The higher the SOR score was, the smaller the flexion-extension angle (SOR 0 vs. SOR 1: 6.30° ± 2.43° vs. 1.95° ± 0.99°, p < 0.001; SOR 0 vs. SOR 2: 6.03° ± 2.43° vs. 0.99°± 0.74°, p < 0.001). Conclusions: The clinical feasibility of using a non-window 3D-Ti cage during lumbar interbody fusion might be acceptable. Furthermore, a newly suggested fusion criterion for the use of the non-window cage, the SOR score, showed a significant association with the published fusion grading systems, demonstrating its feasibility in determining interbody fusion in lumbar spinal surgery.

A Beginner's Perspective on Biportal Endoscopic Spine Surgery in Single-Level Lumbar Decompression: A Comparative Study with a Microscopic Surgery.

Background: The application of biportal endoscopic spinal surgery (BESS) in spine surgery is increasing. However, the clinical results of related studies have been inconsistent. In this study, the perioperative and clinical outcomes of two techniques in single-level lumbar decompression surgery were compared using the perspective of a spine surgeon experienced in microscopic surgery but inexperienced in BESS. Methods: This is a retrospective study performed with prospectively collected data. From April 2019, 50 consecutive patients who underwent a single-level lumbar decompression surgery with BESS were evaluated. Additionally, the data of 150 consecutive patients who underwent the same microscopic surgery before April 2019 were collected. We performed 1 : 1 ratio propensity score matching for these two groups to adjust for baseline variables. The postoperative patient-reported outcome measures included the Oswestry Disability Index (ODI) and numeric rating scale for the back and leg preoperatively and at 6 months after surgery. The laboratory data (C-reactive protein [CRP, mg/L] and hemoglobin [Hb, g/dL]) were measured preoperatively and 3 times (1, 2, and 3 or 4 days) postoperatively. In these periods, the peak and lowest CRP and Hb concentrations were evaluated. The perioperative outcomes, operation time (from skin incision to dressing), length of hospital stay, drainage (for 24 hours after surgery), and surgery-related complications were also evaluated. Results: Forty-seven patients (27 men and 20 women) were included in each group. The postoperative 6-month ODI was significantly lower in the BESS group than in the microscope group (6.90 ± 5.98 vs. 11.54 ± 9.70). The peak CRP concentration (16.63 ± 19.41 vs. 42.40 ± 37.73, p < 0.001) and CRP increment (peak CRP minus preoperative CRP, 14.69 ± 19.47 vs. 40.71 ± 37.32, p < 0.001) were significantly higher in the microscope group. Operation time (83.72 ± 35.71 vs. 70.27 ± 23.24, p = 0.047) was significantly longer in the BESS group. Surgery-related complications were found in 6 and 3 cases in the BESS group (3 revisions, 2 dural tears, and 1 conversion to open surgery) and microscope group (2 revisions and 1 hematoma), respectively. Conclusions: BESS as a new technique resulted in satisfying short-term outcomes. It was a well-tolerated option for surgical treatment of single-level lumbar degenerative disease. The relatively high incidence of recurrence at the index level and incidental dural tears should be considered for surgeons new to BESS; however, these were manageable complications.

Measurement of interspinous motion in dynamic cervical radiographs using a deep learning-based segmentation model.

OBJECTIVE: Interspinous motion (ISM) is a representative method for evaluating the functional fusion status following anterior cervical discectomy and fusion (ACDF) surgery, but the associated measuring difficulty and potential errors in the clinical setting remain concerns. The aim of this study was to investigate the feasibility of a deep learning-based segmentation model for measuring ISM in patients who underwent ACDF surgery. METHODS: This study is a retrospective analysis of flexion-extension dynamic cervical radiographs from a single institution and a validation of a convolutional neural network (CNN)-based artificial intelligence (AI) algorithm for measuring ISM. Data from 150 lateral cervical radiographs from the normal adult population were used to train the AI algorithm. A total of 106 pairs of dynamic flexion-extension radiographs from patients who underwent ACDF at a single institution were analyzed and validated for measuring ISM. To evaluate the agreement power between human experts and the AI algorithm, the authors assessed the interrater reliability using the intraclass correlation coefficient and root mean square error (RMSE) and performed a Bland-Altman plot analysis. They processed 106 pairs of radiographs from ACDF patients into the AI algorithm for autosegmenting the spinous process created using 150 normal population radiographs. The algorithm automatically segmented the spinous process and converted it to a binary large object (BLOB) image. The rightmost coordinate value of each spinous process from the BLOB image was extracted, and the pixel distance between the upper and lower spinous process coordinate value was calculated. The AI-measured ISM was calculated by multiplying the pixel distance by the pixel spacing value included in the DICOM tag of each radiograph. RESULTS: The AI algorithm showed a favorable prediction power for detecting spinous processes with an accuracy of 99.2% in the test set radiographs. The interrater reliability between the human and AI algorithm of ISM was 0.88 (95% CI 0.83-0.91), and its RMSE was 0.68. In the Bland-Altman plot analysis, the 95% limit of interrater differences ranged from 0.11 to 1.36 mm, and a few observations were outside the 95% limit. The mean difference between observers was 0.02 ± 0.68 mm. CONCLUSIONS: This novel CNN-based autosegmentation algorithm for measuring ISM in dynamic cervical radiographs showed strong agreement power to expert human raters and could help clinicians to evaluate segmental motion following ACDF surgery in clinical settings.

Network pharmacology-based identification of bioavailable anti-inflammatory agents from Psoralea corylifolia L. in an experimental colitis model.

ETHNOPHARMACOLOGICAL RELEVANCE: In traditional oriental medicine, the dried seeds of Psoralea corylifolia L. (PC) have been used to treat various diseases, including gastrointestinal, urinary, orthopedic, diarrheal, ulcer, and inflammatory disorders. AIM OF THE STUDY: Although its various biological properties are well-known, there is no information on the therapeutic effects and bioavailable components of PC against inflammatory bowel disease. Therefore, we focused on the relationship between hydroethanolic extract of PC (EPC) that ameliorates colitis in mice and bioactive constituents of EPC that suppress pro-inflammatory cytokines in macrophages. MATERIALS AND METHODS: We investigated the therapeutic effects of EPC in a dextran sulfate sodium-induced colitis mouse model and identified the orally absorbed components of EPC using UPLC-MS/MS analysis. In addition, we evaluated and validated the mechanism of action of the bioavailable constituents of EPC using network pharmacology analysis. The effects on nitric oxide (NO) and inflammatory cytokines were measured by Griess reagent and enzyme linked immunosorbent assay in lipopolysaccharide (LPS)-induced macrophages. RESULTS: In experimental colitis, EPC improved body weight loss, colon length shortening, and disease activity index. Moreover, EPC reduced the serum levels of pro-inflammatory cytokines and histopathological damage to the colon. Network pharmacological analysis identified 13 phytochemicals that were bioavailable following oral administration of EPC, as well as their potential anti-inflammatory effects. 11 identified EPC constituents markedly reduced the overproduction of NO, tumor necrosis factor-α, and/or interleukin-6 in macrophages induced by LPS. The LPS-induced expression of the nuclear factor kappa-light-chain-enhancer of activated B cells reporter gene was reduced by the 4 EPC constituents. CONCLUSIONS: The results indicate that the protective activity of EPC against colitis is a result of the additive effects of each constituent on the expression of inflammatory cytokines. Therefore, it suggests that 11 bioavailable phytochemicals of EPC could aid in the management of intestinal inflammation, and also provides useful insights into the clinical application of PC for the treatment of inflammatory bowel diseases.

Postoperative Segmental Motion up to 1 Year Following Single-Level Anterior Cervical Discectomy and Fusion: Plate versus Non-plate.

STUDY DESIGN: Retrospective observational study. PURPOSE: This study aimed to investigate the impact of plating on postoperative serial segmental motion and its correlation with clinical outcomes in single-level anterior cervical discectomy and fusion (ACDF) for up to 1 year. OVERVIEW OF LITERATURE: The advantages and disadvantages of using cervical plating in ACDF have been well discussed; however, few studies compared the early serial segmental motions at the postoperative level between plating and non-plating. METHODS: In retrospectively collected data, 149 patients who underwent single-level ACDF for degenerative disease were enrolled and divided into non-plating (n=66) and plating (n=83). Interspinous motion (ISM) at the arthrodesis segment, Numeric Rating Scale (NRS) for neck pain, and Neck Disability Index (NDI) were serially evaluated at 3, 6, and 12 months postoperatively. Predictable factors for fusion, including age, sex, plating, diabetes, smoking, and type of grafts, were investigated, and fusion was defined as ISM <1 mm. RESULTS: In both groups, ISM was the highest at 3 months and gradually decreased thereafter, and the plating group showed significantly lower serial ISM than the non-plating group at 12 months. The plating group had lower NRS and NDI scores than the nonplating group at 12 months, and the difference in the NRS scores was statistically significant, particularly at 3 and 6 months, although that of the NDI scores was not. In a multivariate analysis, plating was the most powerful predictor for fusion. CONCLUSIONS: Plating significantly decreases the serial ISM compared with non-plating in single-level ACDF, and such decreased motion is correlated with decreased neck pain until 12 months postoperatively, particularly at 3 and 6 months. Given that plating was the most predictive factor for fusion, we recommend plating even in single-level ACDF for better early clinical outcomes.

Effects of Alginate Oligosaccharide on Testosterone-Induced Benign Prostatic Hyperplasia in Orchiectomized Rats.

Benign prostatic hyperplasia (BPH) is an age-related disease of the urinary system that affects elderly men. Current treatments for BPH are associated with several adverse effects, thus highlighting the need for alternative agents. Alginate oligosaccharide (AOS), a water-soluble functional oligomer derived from brown algae, inhibits prostate cancer cell proliferation. However, the effects of AOS on BPH and the underlying molecular mechanisms remain unclear. Therefore, here, we aimed to investigate the therapeutic potential of AOS in BPH by using human benign prostatic epithelial cells (BPH-1) and a rat model of testosterone-induced BPH. Treatment with AOS inhibited in vitro and in vivo proliferation of prostatic epithelial cells and the testosterone-induced expression of androgen receptor (AR) and androgen-associated genes, such as those encoding 5α-reductase type 2 and prostate-specific antigen. Oral administration of AOS remarkably reduced the serum levels of dihydrotestosterone (DHT) and testosterone as well as the expression of proliferating cell nuclear antigen, inflammatory cytokines, and enzymes, which showed increased levels in prostatic tissues of rats with testosterone-induced BPH. Taken together, these data demonstrate that AOS suppresses testosterone-induced BPH in rats by downregulating AR and the expression of androgen-associated genes, supporting the hypothesis that AOS might be of potential use for the treatment of BPH.

A Combined In Vitro and In Vivo Assessment of the Safety of the Yeast Strains Kluyveromyces marxianus A4 and A5 Isolated from Korean Kefir.

Kefir is a traditional fermented milk containing beneficial bacteria and yeasts. Despite Kluyveromyces marxianus, isolated from kefir, gaining increasing attention as a potential probiotic yeast owing to its biological function, Saccharomyces boulardii is the only species considered as a probiotic yeast. We evaluated the safety of K. marxianus strains A4 and A5, isolated from Korean kefir, in comparison with that of S. boulardii. Virulence attributes were preliminarily assessed in vitro including their ability of gelatin hydrolysis, pseudohyphae formation, and hemolysis. To evaluate in vivo safety, the strains were challenged in a healthy animal model, four-week-old female BALB/c mice. Mice were orally administered 0.2 mL of 0.9% sterilized saline (NC_S; n = 6), S. boulardii ATCC MYA-796 (high concentration, S.b_H; low concentration, S.b_L; n = 6 for each), K. marxianus A4 (high concentration, A4_H; low concentration, A4_L; n = 6 for each), or K. marxianus A5 (high concentration, A5_H; low concentration, A5_L; n = 6 for each) for 2 weeks. At study end, body weight, spleen and liver weights, and blood parameters were assessed. K. marxianus A4 and A5 were tested negative for gelatinase and hemolysis. Overall, hematological, plasma biochemical, and cytokine (interleukin-1ß and tumor necrosis factor-α) parameters were comparable between the experimental and negative control (NC) groups. Notably, the interleukin-6 level of the A5_H group was significantly lower than that of the NC group (p < 0.05), suggesting anti-inflammatory potential of K. marxianus A5.

Evaluation of the efficacy and safety of Escherichia coli-derived recombinant human bone morphogenetic protein-2 in transforaminal lumbar interbody fusion to treat degenerative spinal disease: a protocol of prospective, randomized controlled, assessor-blinded, open-label, multicenter trial.

BACKGROUND: Recombinant human bone morphogenetic protein-2 (rhBMP-2) has been widely used as an alternative bone graft in spine fusion surgery. However, clinical outcome such as effects and complications has not yet been revealed for transforaminal lumbar interbody fusion (TLIF). Although previous studies have reported some results, the evidence is weak. Therefore, the purpose of this trial is to evaluate the effectiveness and safety of Escherichia coli-derived rhBMP-2 combined with hydroxyapatite (HA) in TLIF. METHODS: This trial is designed as a prospective, assessor-blinded, open-label, multicenter, randomized controlled study. Participants will be recruited from six tertiary teaching hospitals. All randomized participants will be undergoing one- or two-level TLIF with rhBMP-2 (77 participants) as the active experimental group or with an auto-iliac bone graft (77 participants) as the control group. The primary interbody fusion rate outcome will be evaluated using computed tomography (CT) 12 months after surgery. The secondary outcomes will be as follows: clinical outcomes (visual analog scale score, EuroQol-5-dimensions-5-level score, Oswestry Disability Index score, and some surgery-related variables) and adverse effects (radiculitis, heterotrophic ossification, endplate resorption, and osteolysis). Radiological outcomes will be evaluated using simple radiography or CT. All outcomes will be measured, collected, and evaluated before surgery and at 12, 24, and 52 weeks postoperatively. DISCUSSION: This study will be the primary of its kind to evaluate the effectiveness and safety of E. coli-derived rhBMP-2 with HA in one- or two-level TLIF. It is designed to evaluate the equivalence of the results between rhBMP-2 with HA and auto-iliac bone graft using an appropriate sample size, assessor-blinded analyses, and prospective registration to avoid bias. This study will set up clear conclusions for using E. coli-derived rhBMP-2 with HA in TLIF. TRIAL REGISTRATION: This study protocol was registered at Korea Clinical Research Information Service ( https://cris.nih.go.kr ; number identifier: KCT0005610) on 19 November 2020. And protocol version is v1.1, January 2022.

Terminalia chebula Retz. extract ameliorates the symptoms of atopic dermatitis by regulating anti-inflammatory factors in vivo and suppressing STAT1/3 and NF-ĸB signaling in vitro.

BACKGROUND: Terminalia chebula (TC) is a traditional medicinal plant used for treating various diseases in humans. However, pharmacological mechanisms underlying the effects of TC in atopic treatment remain unelucidated. HYPOTHESIS/PURPOSE: We investigated the therapeutic effects of TC extract in a mouse model of atopic dermatitis (AD) in vivo and the anti-inflammatory mechanism in vitro. STUDY DESIGN/METHODS: For the in vivo study, AD was induced by Dermatophagoides farinae extract (Dfe) in NC/Nga mice. After 14 days of oral administration, the effects of TC concentrations of 30, 100, and 300 mg/kg were analyzed by assessing morphological changes visually; measuring serum levels of inflammatory chemokines/cytokines, IgE, histamine, MDC, TARC, RANTES, and TSLP using ELISA kits; and counting infiltrated mast cells. For in vitro analyses, we used IFNγ/TNF-α-stimulated human keratinocyte cell lines to study the mechanism of action. The production of chemokines/cytokines in the IFNγ/TNF-α-stimulated HaCaT cells was measured using ELISA and a bead array kit. The signaling pathways were analyzed by western blotting and the expression of the transcriptional factors using RT-PCR and luciferase assay. RESULTS: Administration of TC significantly alleviated AD-like symptoms in vivo and decreased the ear thickness, dermatitis score, keratinization, and mast cell infiltration. It also resulted in decreased serum levels of IgE, histamine, and inflammation-related mediators MDC, TARC, RANTES, and TSLP compared with those in the Dfe treatment group. Moreover, TC downregulated the expression of the inflammatory chemokines RANTES and MDC in IFNγ/TNF-α-stimulated HaCaT cells. TC inhibited phosphorylated STAT1/3 and NK-κB subunits and nuclear translocation of NF-κB. It also suppressed the transcription of IFNγ, IL-6, IL-8 and MCP-1 in the IFNγ/TNF-α-stimulated HaCaT cells. TC and its constituents, chebulic acid, gallic acid, corlagin, chebulanin, chbulagic acid, ellagic acid, and chebulinic acid, strongly inhibited the nuclear translocation of NF-κB, STAT1, and STAT3 and decreased the expression of inflammatory cytokines at the mRNA level. CONCLUSIONS: Overall, TC extract alleviated AD-like symptoms by regulating anti-inflammatory factors in vivo and suppressing STAT1/3 and NF-κB signaling in vitro. In addition, our results show the in vivo effect of partial improvements in AD, as well as the in vitro effect on inflammatory factors by the constituents of TC. This finding provides that TC extract and its components could be potential therapeutic drugs for AD.

A time-dependently regulated gene network reveals that Aspergillus protease affects mitochondrial metabolism and airway epithelial cell barrier function via mitochondrial oxidants.

The airway epithelium maintains tight barrier integrity to prevent penetration of pathogens; thus, impairment of the barrier function is an important and common histological feature in asthmatic patients. Proteolytic allergens from fungi, pollen, and house dust mites can disrupt epithelial barrier integrity, but the mechanism remains unclear. Aspergillus oryzae protease (AP)-induced mitochondrial reactive oxygen species (ROS) contribute to the epithelial inflammatory response. However, as mitochondrial ROS affect various cellular functions, such as metabolism, cell death, cell proliferation, and redox homeostasis through signal transduction, it is difficult to understand the detailed action mechanism of AP by measuring changes in a single gene or protein of a specific signaling pathway. Moreover, mitochondrial ROS can directly oxidize DNA to activate transcription, thereby affecting the expression of various genes at the transcriptional level. Therefore, we conducted whole-genome analysis and used a network-based approach to understand the effect of AP and AP-induced mitochondrial ROS in human primary airway epithelial cells and to evaluate the mechanistic basis for AP-mediated epithelial barrier dysfunction. Our results indicate that production of mitochondrial ROS following AP exposure induce mitochondrial dysfunction at an early stage. Over time, changes in genome expression were further expanded without remaining mitochondrial ROS. Specifically, genes involved in the apoptotic functions and intercellular junctions were affected, consequently impairing the cellular barrier integrity. This change was recovered by scavenging mitochondrial ROS at an early point after exposure to AP. In conclusion, our findings indicate that instantly increased mitochondrial ROS at the time of exposure to allergenic proteases consequently induces epithelial barrier dysfunction at a later time point, resulting in pathological changes. These data suggest that antioxidant therapy administered immediately after exposure to proteolytic antigens may be effective in maintaining epithelial barrier function.

Comparing the efficacy and safety of minimally invasive biportal endoscopic spine surgery versus conventional microscopic discectomy in single-level lumbar herniated intervertebral disc (ENDO-BH Trial): a multicenter, prospective, randomized controlled equivalence trial study protocol.

BACKGROUND: Biportal endoscopic surgery has recently been performed in lumbar discectomy, with advantages over conventional surgery, such as less skin scarring and muscle damage. However, the clinical results have not been established. Although previous studies reported no difference between the biportal endoscopic and microscopic discectomy clinical results, the evidence was weak. Therefore, this study aims to evaluate the efficacy and safety of the biportal endoscopic discectomy versus the microscopic discectomy. METHODS: This prospective multicenter randomized controlled equivalence trial is designed to compare the efficacy and safety outcomes of patients who underwent lumbar discectomy using biportal endoscopy or microscopy. We will include 100 participants (50 per group) with a lumbar herniated disc. The primary outcome will be the Oswestry Disability Index (ODI) score 12 months after surgery based on a modified intention-to-treat strategy. The secondary outcomes will include the visual analog scale score for low back and lower extremity radiating pain, the ODI score, the Euro-Qol-5-Dimensions score, surgery satisfaction, walking time, postoperative return to daily life period, postoperative surgical scar, and surgery-related variables, such as postoperative drainage, operation time, admission duration, postoperative creatine kinase, and implementation status of conversion to open surgery. Radiographic outcomes will also be analyzed using magnetic resonance imaging (MRI) or computed tomography (CT) and simple radiographs. Safety will be assessed by evaluating all adverse and severe adverse events and surgery-related effects. The participants will be assessed by a blinded assessor before surgery (baseline) and 2 weeks and 3, 6, and 12 months after surgery. DISCUSSION: This trial will be the first prospective, multicenter, randomized controlled trial to analyze the efficacy and safety of biportal endoscopic discectomy in lumbar herniated disc. This trial is designed for evaluating the equivalence of the results between biportal endoscopic and microscopic discectomy including adequate sample size, blinded analyses, and prospective registration to reduce bias. This trial will provide enough data on the effectiveness and safety of biportal endoscopic surgery and will be an important study that allows clear conclusions. TRIAL REGISTRATION: Clinical Research Information Service (cris.nih.go.kr.) ( KCT0006191 ). Registered on 27 March 2021.

Proximal Junctional Kyphosis in Adult Spinal Deformity: Definition, Classification, Risk Factors, and Prevention Strategies.

Proximal junctional problems are among the potential complications of surgery for adult spinal deformity (ASD) and are associated with higher morbidity and increased rates of revision surgery. The diverse manifestations of proximal junctional problems range from proximal junctional kyphosis (PJK) to proximal junctional failure (PJF). Although there is no universally accepted definition for PJK, the most common is a proximal junctional angle greater than 10° that is at least 10° greater than the preoperative measurement. PJF represents a progression from PJK and is characterized by pain, gait disturbances, and neurological deficits. The risk factors for PJK can be classified according to patient-related, radiological, and surgical factors. Based on an understanding of the modifiable factors that contribute to reducing the risk of PJK, prevention strategies are critical for patients with ASD.

Evaluation of the efficacy and safety of conventional and biportal endoscopic decompressive laminectomy in patients with lumbar spinal stenosis (ENDO-B trial): a protocol for a prospective, randomized, assessor-blind, multicenter trial.

BACKGROUND: Recent studies on biportal endoscopic spine surgery in patients with lumbar spinal stenosis have reported good clinical results. However, these studies have been limited by the small sample sizes and use of a retrospective study design. Therefore, we aim to compare the efficacy and safety of biportal endoscopic decompressive laminectomy with those of conventional decompressive laminectomy in a multicenter, prospective, randomized controlled trial. METHODS: This study will include 120 patients (60 per group, aged 20-80 years) with 1- or 2-level lumbar spinal stenosis, who will be recruited from six hospitals. The study will be conducted from July 2021 to December 2024. The primary outcome (Oswestry Disability Index at 12 months after surgery) will be evaluated through a modified intention-to-treat method. The secondary outcomes will include the following: visual analog scale score for low back and lower extremity radiating pain, EuroQol 5-dimensions score, surgery satisfaction, walking time, postoperative return to daily life period, postoperative surgical scars, and some surgery-related variables. Radiographic outcomes will be analyzed using magnetic resonance imaging or computed tomography. All outcomes will be evaluated before the surgery and at 2 weeks, 3 months, 6 months, and 12 months postoperatively. This protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for reporting of clinical trial protocols. DISCUSSION: It is hypothesized that the efficacy and safety of biportal endoscopic and conventional decompressive laminectomy will be comparable in patients with lumbar spinal stenosis. The results of this trial will provide a high level of evidence for the efficacy and safety of the biportal endoscopic technique in patients with lumbar spinal stenosis and facilitate the development of clinical practice guidelines. Furthermore, the results of this study may indicate the feasibility of the biportal endoscopic technique for other types of spinal surgery. TRIAL REGISTRATION: The ENDO-B trial is registered at Clinical Research Information Service (CRIS, cris.nih.go.kr ) (KCT0006057; April 52,021).

Long-Term Influence of Paraspinal Muscle Quantity in Adolescent Idiopathic Scoliosis Following Deformity Correction by Posterior Approach.

Pedicle screw instrumentation (PSI) through posterior approach has been the mainstay of deformity correction for adolescent idiopathic scoliosis (AIS). However, changes in the quantity of paraspinal muscles after AIS surgery has remained largely unknown. The aim of this study was to investigate long-term follow-up changes in paraspinal muscle volume in AIS surgery via a posterior approach. Forty-two AIS patients who underwent deformity correction by posterior approach were analyzed through a longitudinal assessment of a cross-sectional area (CSA) in paraspinal muscles with a minimum five-year follow-up. The CSA were measured using axial computed tomography images at the level of the upper endplate L4 by manual tracing. The last follow-up CSA ratio of the psoas major muscle (124.5%) was significantly increased compared to the preoperative CSA ratio (122.0%) (p < 0.005). The last follow-up CSA ratio of the multifidus and erector spine muscles significantly decreased compared to the preoperative CSA ratio (all p < 0.005). The CSA ratio of the erector spine muscle was correlated with the CSA ratio of the psoas major (correlation coefficient = 0.546, p < 0.001). Therefore, minimizing the injury to the erector spine muscle is imperative to maintaining psoas major muscle development in AIS surgery by posterior approach.

Minimally invasive plate osteosynthesis of clavicular midshaft fractures under insertion guide.

BACKGROUND: The less invasive stabilization systems for the distal femur and proximal lateral tibia have been developed to simplify the surgical technique of minimally invasive plate osteosynthesis (MIPO). MIPO, however, has simply been introduced into clavicular midshaft fixation without the aid of insertion guide though the procedure for midshaft clavicular fractures was found to produce satisfactory clinical and radiologic outcomes without serious complications. The purpose of this study was to determine the outcome of MIPO of clavicular midshaft fractures using an insertion guide. METHODS: A total of 15 patients with clavicular midshaft fractures treated by MIPO using insertion guide between September 2016 and September 2018 were included. We assessed bony union, shoulder function by the Constant score, and complications at a mean follow-up of 15.4 months (ranged from 12 to 24 months). RESULTS: The mean surgical time 55.9±9.4 min (ranged from 50 to 70 min) and the fluoroscopic time was 146.5±29.0 s (ranged from 110 to 190 s). In all patients, the bony union was achieved at 8.8±1.0 weeks (ranged from 8 to 10 weeks) with no delayed unions or nonunions. The average Constant score was 99.1±1.2 (ranged from 96 to 100) at follow-up. Postoperative complications including infections, screw pull-out, hardware prominence, and neurovascular injury were not observed, however, one patient complained of mild plate discomfort. CONCLUSION: MIPO using insertion guide is believed to be an acceptable and effective choice in the operative treatment of clavicular midshaft fractures.

Oncologic comparison between nonradical management and total mesorectal excision in good responders after chemoradiotherapy in patients with mid-to-low rectal cancer.

PURPOSE: This study was performed to compare the oncologic outcomes between nonradical management and total mesorectal excision in good responders after chemoradiotherapy. METHODS: We analyzed 75 patients, who underwent 14 watch-and-wait, 30 local excision, and 31 total mesorectal excision, in ycT0-1N0M0 based on magnetic resonance imaging after chemoradiotherapy for advanced mid-to-low rectal cancer in 3 referral hospitals. The nonradical management group underwent surveillance with additional sigmoidoscopy and rectal magnetic resonance imaging every 3-6 months within the first 2 years. RESULTS: Nonradical management group had more low-lying tumors (P < 0.001) and less lymph node metastasis based on magnetic resonance imaging (P = 0.004). However, cT stage, ycT, and ycN stage were not different between the 2 groups. With a median follow-up period of 64.7 months, the 5-year locoregional failure rate was higher in the nonradical management group than in the total mesorectal excision group (16.7% vs. 0%, P = 0.013). However, the 5-year overall survival and disease-free survival rates of the nonradical management and total mesorectal excision groups were not different (95.2% vs. 93.5%, P = 0.467; 76.4% vs. 83.6%, P = 0.665; respectively). CONCLUSION: This study shows that nonradical management for ycT0-1N0 mid-to-low rectal cancer may be an alternative treatment to total mesorectal excision under proper surveillance and management for oncologic events.

Anterior Bridging Bone in a Newly Designed Cage for Lumbar Interbody Fusion: Radiographic and Finite Element Analysis.

OBJECTIVE: To evaluate the distribution of multiple anterior bridging bone (ABB) patterns using a newly designed interbody cage with 4 anterior holes that enable communication between the inside and outside of the cage and to estimate its mechanical effect by finite element analysis (FEA). METHODS: Patients underwent single-level lumbar interbody fusion using ABB cages. Two raters evaluated the distribution patterns of ABB on computed tomography scans 1 year after surgery. We defined the term H-fusion as the presence of complete anterior extracage and intracage bone bridging, with ≥1 ABBs between them. We performed finite element analysis to investigate the effect of ABB on maximal stiffness. RESULTS: The study enrolled 98 patients. ABB was most frequently observed in the medial hole of the cages (73.7%). The mean number of ABBs was 3.65, and H-fusion was observed at 135 levels (34%). Postoperative improvement in the Oswestry Disability Index was significantly higher in patients who achieved interbody fusion and H-fusion than in patients who did not. As ABB was added, the increment in the relative maximal stiffness was most affected under flexion and extension forces. CONCLUSIONS: We observed an average of 3.65 complete ABBs. Finite element analysis demonstrated that ABB could increase the stability in fused segments, especially under flexion and extension stress. Our results suggest that the ABB cage, which allows communicating cross-bridging between inside and outside of the cage, may facilitate a more stable fusion process than a conventionally designed cage.

Extracts of Phyllostachys pubescens Leaves Represses Human Steroid 5-Alpha Reductase Type 2 Promoter Activity in BHP-1 Cells and Ameliorates Testosterone-Induced Benign Prostatic Hyperplasia in Rat Model.

Benign prostatic hyperplasia (BPH) is the most common symptomatic abnormality of the human prostate characterized by uncontrolled proliferation of the prostate gland. In this study, we investigated the effect of bamboo, Phyllostachys pubescens, leaves extract (PPE) on human 5α-reductase type 2 (SRD5A2) gene promoter activity in human prostate cell lines and the protective effect of PPE on a testosterone-induced BPH rat model. PPE repressed human SRD5A2 promoter activity and its mRNA expression. The rats treated with PPE for 4 weeks showed a significantly attenuated prostate weight compared to vehicle control. PPE-treated rats also showed reduced serum dihydrotestosterone, testosterone, prostate-specific antigen, and SRD5A2 levels by testosterone injection. Quantitative real-time polymerase chain reaction showed that PPE treatment significantly decreased mRNA expression of SRD5A2, androgen receptor (AR), proliferating cell nuclear antigen (PCNA), and fibroblast growth factor 2 compared with the vehicle-treated, testosterone-injected rats in the prostate. Furthermore, PPE treatment showed reduced AR, PCNA, and tumor necrosis factor alpha expression in the prostate via immunohistofluorescence staining. In conclusion, oral administration of PPE prevented and inhibited the development and progression of enlarged prostate lesions in testosterone-induced animal models through various anti-proliferative and anti-inflammatory pharmacological effects and induced suppression of SRD5A2 gene expression.

MR Imaging Characteristics of Primary T-Cell Lymphoma of the Cauda Equina: A Case Report and Literature Review.

Primary central nervous system lymphoma is a rare form of extranodal non-Hodgkin lymphoma, and primary T-cell lymphoma of the cauda equina is extremely rare. We describe a case involving a 56-year-old female who presented with low back pain and radiating leg pain for 4 months. MRI of the lumbar spine revealed an elongated, multinodular intradural lesion of approximately 10 cm from the L4 body to the S2 body level with iso-signal intensity on T1-weighted imaging, heterogeneous iso- and high-signal intensity on T2-weighted imaging, and a heterogeneous intense enhancement on gadolinium contrast-enhanced T1-weighted imaging. A peripheral T-cell lymphoma of the cauda equina was diagnosed on the basis of immunohistochemical and T-cell receptor gamma gene rearrangement analysis after intradural biopsy of the mass.