Survey of patient satisfaction with genetic counseling services in Korea.

Since the 1990s, genetic clinics have been established in South Korea, enabling the provision of clinical genetics services. However, genetic counseling services are not widely used in the medical system. In contrast, recently, the demand for genetic counseling has increased due to the rapid development of genomic medicine. Therefore, it is important for medical geneticists and genetic counselors to collaboratively provide genetic counseling services. This study aimed to evaluate the perception and satisfaction of patients with rare genetic diseases and their families regarding genetic counseling services provided by a genetics team at the medical genetics center of a tertiary general hospital for rare genetic diseases. From April to November 2021, a survey was conducted with 203 individuals, including 111 and 92 individuals in the patient and family groups, respectively. Overall, 164 individuals (80.8%) responded that they were aware of genetic counseling services, and 135 individuals (66.5%) responded that they were aware of the role of genetic counselors. Patients and their families wanted to receive information about the following from genetic counseling: clinical manifestation and prognosis of the diagnosed disease (78.8%), treatment and management of the disease (60.6%), risk of recurrence within the family (55.7%), treatment options and alternatives for family and prenatal testing, and various support services. The score of satisfaction with genetic counseling services provided by the genetics team was 8.19 ± 1.68 out of 10. Patients with rare genetic diseases and their families were satisfied with genetic counseling services regarding their diseases, test results, and treatment options. Moreover, the patients could receive psychosocial support and referrals to other medical service providers and support services. As a genetic team approach, collaboration between medical geneticists and certified genetic counselors would be useful in providing information and in diagnosing, treating, and managing patients.

Maxillary Bone Necrosis in Post-COVID-19 Patients: Possibility of Medication-Related Osteonecrosis of Jaws (MRONJ) Induced by Tocilizumab.

Medication-related osteonecrosis of the jaws (MRONJ) is a serious condition often linked with antiresorptive, immune modulating, and antiangiogenic drugs, initially associated with bisphosphonates but now including a broader range of medications. Tocilizumab, an interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody used for conditions like rheumatoid arthritis and recently for COVID-19 to reduce IL-6 activity and alleviate symptoms, has raised concerns over its potential to induce MRONJ, particularly in post-COVID-19 patients. A case involving a 36-year-old male who developed tooth mobility and pain in the right maxillary posterior region after COVID-19 treatment with tocilizumab and dexamethasone is highlighted. Despite treatments like antibiotics, the necrosis persisted until more extensive surgery was performed, leading to improvement without recurrence over 2 years. This case emphasizes the need for awareness and research into the risk of MRONJ in patients treated with tocilizumab after COVID-19, underlining the importance for healthcare professionals to recognize and manage this complication.

Presurgical Reduction of the Cleft Palate: Serendipitous Benefit of the Stanford Orthodontic Airway Plate Treatment (SOAP) for Infants with Robin Sequence.

OBJECTIVE: Narrowing of the palatal cleft is often observed in infants with Robin sequence (RS) treated with the Stanford Orthodontic Airway Plate treatment (SOAP) even though SOAP is utilized primarily to establish airway patency. The current study quantified dimensional changes of the cleft palate (CP) in infants with RS treated with SOAP. DESIGN: A retrospective chart review. PATIENTS: Infants with RS and CP who completed SOAP and had maxillary arch models at both pre- and post-treatment time points at a single tertiary referral hospital between September 2019 and July 2023. SETTING AND OUTCOME MEASURE: Maxillary arch models were measured and analyzed using Bivariate statistical analysis. RESULTS: Seventeen infants were included in the study. The median age (min, max) was 6.7 weeks (1.1, 21.9) at pre-treatment and 26.6 weeks (18.7, 37.0) at post-treatment. The median Obstructive Apnea Hypopnea Index was 36.2 events/hour (8.1, 103.1) at pre-treatment and 4.1 events/hour (1.9, 8.6) at post-treatment. The pre-treatment width of CP decreased by an average (± standard diviation) of 6.37 mm (± 3.55, p < 0.001) at post-treatment. The ratio of the posterior cleft width to the total maxillary arch width decreased from 40% (± 9.1) at pre-treatment to 22% (± 11) at post-treatment (p < 0.001). CONCLUSION: The dimensions of CP reduced significantly during SOAP in infants with RS and CP treated for their severe upper airway obstruction. The findings highlight a potential benefit of SOAP that may contribute favorably to the palate repair surgery.

Can medication-related osteonecrosis of the jaw be attributed to specific microorganisms through oral microbiota analyses? A preliminary study.

BACKGROUND: Medication-related osteonecrosis of the jaw (MRONJ) can cause significant pain and loss of aesthetics and function if not treated properly. However, diagnosis still relies on detailed intraoral examinations and imaging. Prognosis varies even among patients with similar stages or conditions of MRONJ, emphasizing the need for a deeper understanding of its complex mechanisms. Thus, this study aimed to identify the oral microbiota of patients with MRONJ. METHODS: This single-center prospective cohort study included patients with confirmed MRONJ who visited the Department of Oral and Maxillofacial Surgery at Yonsei University Dental Hospital between 2021 and 2022. Oral swab samples were collected from the affected and unaffected sides of each patient. The composition and enumeration of the microbial communities were analyzed, and the diversity was compared to verify ecological changes in the groups using a next-generation sequencing-based 16S metagenomic analysis. A statistical analysis was performed using Wilcoxon signed-rank test with SPSS version 22, and values of P less than 0.05 were considered statistically significant. RESULTS: The final study sample included 12 patients. The mean age was 82.67 ± 5.73 (range, 72-90) years. Changes in microbial composition were observed at different taxonomic levels (phylum, genus, and species). The identified microorganisms were commonly associated with periodontitis, gingival disease, and endodontic infection, suggesting a multifactorial etiology of MRONJ. CONCLUSIONS: Although this study is based on a small number of cases, it shows that MRONJ is not caused by a specific microorganism but can rather be caused by a variety of factors. By addressing these findings in large-scale studies, the significance of oral microbiome in pathogenesis can be further elucidated and can facilitate the development of effective therapeutic interventions for patients with MRONJ.

Divine mathematics: Leibniz's combinatorial theory of compossibility.

Leibniz's famous proposition that God has created the best of all possible worlds holds a significant place in his philosophical system. However, the precise manner in which God determines which world is the best remains somewhat ambiguous. Leibniz suggests that a form of "Divine mathematics" is employed to construct and evaluate possible worlds. In this paper, I uncover the underlying mechanics of Divine mathematics by formally reconstructing it. I argue that Divine mathematics is a one-player combinatorial game, in which God's goal is to find the best combination among many possibilities. Drawing on the combinatorial theory, I provide new solutions to some puzzles of compossibility.

Randomly Disassembled Nanostructure for Wide Angle Light Extraction of Top-Emitting Quantum Dot Light-Emitting Diodes.

The quantum dot light-emitting diode (QLED) represents one of the strongest display technologies and has unique advantages like a shallow emission spectrum and superior performance based on the cumulative studies of state-of-the-art quantum dot (QD) synthesis and interfacial engineering. However, research on managing the device's light extraction has been lacking compared to the conventional LED field. Moreover, relevant studies on top-emitting QLEDs (TE-QLEDs) have been severely lacking compared to bottom-emitting QLEDs (BE-QLEDs). This paper demonstrates a novel light extraction structure called the randomly disassembled nanostructure (RaDiNa). The RaDiNa is formed by detaching polydimethylsiloxane (PDMS) film from a ZnO nanorod (ZnO NR) layer and laying it on top of the TE-QLED. The RaDiNa-attached TE-QLED shows significantly widened angular-dependent electroluminescence (EL) intensities over the pristine TE-QLED, confirming the effective light extraction capability of the RaDiNa layer. Consequently, the optimized RaDiNa-attached TE-QLED achieves enhanced external quantum efficiency (EQE) over the reference device by 60%. For systematic analyses, current-voltage-luminance (J-V-L) characteristics are investigated using scanning electron microscopy (SEM) and optical simulation based on COMSOL Multiphysics. It is believed that this study's results provide essential information for the commercialization of TE-QLEDs.

Effects of the Mandibular Functional Units and Soft Tissue on Facial Asymmetry.

Mandibular asymmetry has a variety of patterns because they are affected the position and the shape of mandible in addition to the overlying soft tissue. This study aimed to assess the factor in mandibular asymmetry, focusing on each mandibular functional units and the soft tissue thickness in the mandibular angle area. Forty patients who were diagnosed with facial asymmetry and undergone the orthognathic surgery without genioplasty were enrolled in this study. The skeletal patterns of the patients were analyzed by using cone-beam computed tomography data and 3D virtual images divided into 2 categories; the mandibular functional unit length and the soft tissue depth. All difference in bilateral mandibular functional unit lengths had a statistically significant with chin top deviation ( P <0.05). The greatest correlation was the condylar unit length compared with other functional units. The soft tissue thickness in the mandibular angle area was not statistically related to chin top deviation ( P >0.05), and the soft tissue did not change remarkably after orthognathic surgery ( P >0.05). This study suggests that the considerations of a surgical plan for treatment based on the mandibular asymmetry.

Which Skeletal Factors Can Affect Lip Canting in Facial Asymmetry?: Statistical Analysis.

Lip canting, which is a noticeable factor in patients with facial asymmetry, can be influenced by the dentofacial skeleton. During orthognathic surgery, postoperative changes in facial soft tissue occur along the newly positioned hard tissue. Therefore, the evaluation of soft tissue before surgery is important. The purpose of this study was to investigate the skeletal factors that can affect lip canting by statistically comparing 2 facial horizontal planes using a three-dimensional reconstruction model. The findings of the present study showed a statistical correlation between lip canting and 3 skeletal factors: menton deviation, maxillary canting, and ramal length differences. Furthermore, a statistical correlation was identified between the Frankfort Horizontal plane and the intercanthal plane compared with the lip canting line. This result suggests that the intercanthal plane could be a standard horizontal plane in three-dimensional reconstruction model analysis.

Dermatophagoides farinae Extract Induces Interleukin 33-Mediated Atopic Skin Inflammation via Activation of RIP1.

Receptor-interacting protein kinase (RIP) family 1 signaling has complex effects on inflammatory processes and cell death, but little is known concerning allergic skin diseases. We examined the role of RIP1 in Dermatophagoides farinae extract (DFE)-induced atopic dermatitis (AD)-like skin inflammation. RIP1 phosphorylation was increased in HKCs treated with DFE. Nectostatin-1, a selective and potent allosteric inhibitor of RIP1, inhibited AD-like skin inflammation and the expression of histamine, total IgE, DFE-specific IgE, IL-4, IL-5, and IL-13 in an AD-like mouse model. The expression of RIP1 was increased in ear skin tissue from a DFE-induced mouse model with AD-like skin lesions and in the lesional skin of AD patients with high house dust mite sensitization. The expression of IL-33 was down-regulated after RIP1 inhibition, and the levels of IL-33 were increased by over-expression of RIP1 in keratinocytes stimulated with DFE. Nectostatin-1 reduced IL-33 expression in vitro and in the DFE-induced mouse model. These results suggest that RIP1 can be one of the mediators that regulate IL-33-mediated atopic skin inflammation by house dust mites.

Ameloblastoma modifies tumor microenvironment for enhancing invasiveness by altering collagen alignment.

Tumor progression is profoundly affected by crosstalk between cancer cells and their stroma. In the past decades, the development of bioinformatics and the establishment of organoid model systems have allowed extensive investigation of the relationship between tumor cells and the tumor microenvironment (TME). However, the interaction between tumor cells and the extracellular matrix (ECM) in odontogenic epithelial neoplasms and the ECM remodeling mechanism remain unclear. In the present study, transcriptomic comparison and histopathologic analysis revealed that TME-related genes were upregulated in ameloblastoma compared to in odontogenic keratocysts. Tumoroid analysis indicated that type I collagen is required for ameloblastoma progression. Furthermore, ameloblastoma shows the capacity to remodel the ECM independently of cancer-associated fibroblasts. In conclusion, ameloblastoma-mediated ECM remodeling contributes to the formation of an invasive collagen architecture during tumor progression.

Rag2 Deficiency Enhances Susceptibility to Systemic Mouse Adenovirus Type 1 Infection.

INTRODUCTION: Recombination-activating gene (Rag) 1 and Rag2, which are essential in V(D)J recombination, play a crucial role in B- and T-cell maturation. METHOD: We investigated the effects of Rag2 deficiency in clustered regularly interspaced short palindromic repeats/Cas9-mediated FVB-Rag2 knockout (KO) and wild-type (WT) mice infected with mouse adenovirus type 1 (MAV-1) via the intranasal route. RESULTS: MAV-1 infection caused more severe histopathological changes in FVB-Rag2 KO mice than in WT mice. FVB-Rag2 KO mice exhibited moderate to severe inflammation on day 4 and severe inflammation on day 8 post infection. In contrast, WT mice showed mild inflammation on day 4 and mild to severe inflammation on day 8 post infection, including interstitial pneumonia and inflammatory cell infiltration in the lungs and liver. Viral loads in the spleen and kidneys were significantly higher in FVB-Rag2 KO mice than in WT mice on day 8 post infection. Levels of cytokines and chemokines, including macrophage inflammatory protein-1α, induced protein 10, interferon (IFN)-α, IFN-γ, and tumor necrosis factor alpha, were upregulated in the spleens of FVB-Rag2 KO mice compared with those of WT mice. The upregulation of several cytokines occurred concurrently with the histopathological changes. MAV-1 infection induced more severe systemic infection in FVB-Rag2 KO mice than in WT mice. CONCLUSION: In mice, Rag2 deficiency induces inflammatory cell recruitment via the upregulation of cytokine and chemokine levels. The MAV-1 infection model can be utilized to assess the efficacy and safety of therapeutic agents for human adenoviral diseases.

A preoperative risk prediction model for high malignancy potential gastrointestinal stromal tumors of the stomach.

BACKGROUND: Gastric gastrointestinal stromal tumors (GISTs) exhibit various degrees of aggression and malignant potential. However, no systematic preoperative evaluation strategy to predict the malignancy potential of gastric GISTs has yet been developed. This study aimed to develop a reliable and easy-to-use preoperative risk-scoring model for predicting high malignancy potential (HMP) gastric GISTs. METHODS: The data of 542 patients with pathologically confirmed gastric GISTs who underwent resection were reviewed. Multivariate logistic regression analysis was used to identify significant predictors of HMP. The risk-scoring system (RSS) was based on the predictive factors for HMP, and its performance was validated using a split-sample approach. RESULTS: A total of 239 of 542 (44.1%) surgically resected gastric GISTs had HMP. Multivariate analysis demonstrated that tumor size, location, and surface changes were independent risk factors for HMP. Based on the accordant regression coefficients, the presence of surface ulceration was assigned 1 point. Tumor sizes of 4-6 cm and > 6 cm were assigned 2 and 5 points, respectively. Two points were assigned to cardia or fundus locations. A score of 3 points was the optimal cut-off value for HMP prediction. HMP were found in 19.8% and 82.7% of the low and high-risk groups of the RSS, respectively. The area under the receiver-operating characteristic curve for predicting HMP was 0.81 (95% confidence interval (CI) 0.75-0.86). Discrimination was good after validation (0.75, 95% CI 0.69-0.81). CONCLUSION: This simple RSS could be useful for predicting the malignancy potential of gastric GISTs and may aid preoperative clinical decision making to ensure optimal treatment.

Evaluation of Atopic Dermatitis Improvement Caused by Low-Level, Low-Frequency Pulsed Electromagnetic Fields.

This study aimed to evaluate the effectiveness of using low-level, low-frequency pulsed electromagnetic field (LLLF_PEMF) stimulation to improve atopic dermatitis induced by 2,4-dinitrochlorobenzene (DNCB). Twenty 6-week-old hairless mice were randomly divided into Normal (n = 5), PEMF 15 Hz (n = 5), PEMF 75 Hz (n = 5), and Sham (n = 5) groups. Following the onset of atopic dermatitis symptoms, PEMF groups (15 and 75 Hz) were stimulated with LLLF_PEMF (15 mT) for 8 h per day for 1 week. Sensory evaluation analysis revealed a significant difference between the PEMF 15 Hz group and Sham group (P < 0.05), but these differences were not visually obvious. While both the PEMF and Sham groups had atopic dermatitis lesions, lesion size was significantly smaller in the two PEMF groups than in the Sham group (P < 0.001). Additionally, changes in epithelial thickness because of skin inflammation significantly decreased for both PEMF groups, compared with the Sham group (P < 0.001). In conclusion, these results suggest that PEMF stimulation in vivo triggers electro-chemical reactions that affect immune response. © 2022 Bioelectromagnetics Society.

Posttreatment stability of an anterior open-bite by molar intrusion compared with 2-jaw surgery - a retrospective study.

OBJECTIVES: This study aimed to compare post-treatment stability in patients with anterior open-bite (AOB) between those treated surgically (orthognathic 2-jaw surgery) and non-surgically (molar intrusion using orthodontic miniscrews). MATERIALS AND METHODS: All subjects had initial overbite (OB) < -1 mm and lateral cephalograms taken before treatment (T0), immediately after AOB correction (T1), after orthodontic treatment (T2), and at least 1 year after treatment (T3). The non-surgical group was enrolled retrospectively; then, the surgical group was matched by OB, sex, and age to the non-surgical group (n = 21 each). Changes in cephalometric measurements during treatment (T1-T0), finishing (T2-T1), and retention (T3-T2) periods were compared between two groups. RESULTS: OB increased by 4.5-5.1 mm during the treatment period with 3.3 mm upward movement of the maxillary first molar (U6) in both groups. Changes in OB were not significantly different between the groups: 0.5-0.9 mm increase during the finishing period but 1.0 mm decrease during the retention period (P > 0.05). U6 moved 0.5 mm downward in non-surgical group and 0.1 mm upward in the surgical group during the finishing period, and 1.0 mm and 0.4 mm downward in the non-surgical and surgical groups, respectively, during the retention period. CONCLUSIONS: Post-treatment stability of AOB was similar for surgical and non-surgical methods (76.8 - 78.7%), although U6 moved more downward in the non-surgical group than in the surgical group. CLINICAL RELEVANCE: AOB without severe skeletal deformity can be treated by either molar intrusion or orthognathic surgery with similar treatment outcome and stability.

Reliability of Anterior Nasal Spine as a Reference Point After LeFort I Surgery Using Three-Dimensional Analysis.

ABSTRACT: To evaluate the stability of maxilla following orthognathic surgery, it is necessary to consider the positional change of various landmarks according to bone remodeling of the maxilla. This study aimed to evaluate the stability of the anterior nasal spine (ANS) as a reliable landmark after orthognathic surgery. Forty-seven patients with skeletal class III malocclusion who underwent bimaxillary orthognathic surgery were included. Skeletal changes were measured using cone-beam computerized tomography at 3 time points: preoperative (T0), 1-month postoperative (T1), and 12-month postoperative (T2). Linear changes of the 6 landmark points of the maxilla were measured in 3 directions: anteroposterior, vertical, and transverse. The data were analyzed with paired t tests, independent t tests, and multiple regression analysis. At 12-month postoperatively, the ANS showed mean (standard deviation) 1.23 (1.07) mm posterior movement ( P = 0.00), while other landmarks did not show positional changes, implying bony resorption of ANS. Multiple regression test showed surgical forward movements of ANS (T1-0) affect the postoperative backward changes (ß = -0.05, P < 0.05). There was a negative correlation between the surgical movement and postoperative change of ANS by Pearson correlation test ( r = -0.38, P < 0.05). The ANS is not a reliable measurement point in three-dimensional superimposition after orthognathic surgery. Therefore, in studying the stability and positional change pattern after LeFort I surgery, it is not recommended to use ANS as a reference point, as changes can occur in the measurement point itself.

Personalized 3D-printed Titanium Cutting Guide and Prefabricated Osteosynthesis Plate for Mandibular Step Osteotomy to Treat Severe Mandibular Prognathism.

Mandibular step osteotomy, performed for mandibular prognathism, is a difficult and time-consuming procedure. Virtual computer surgery and computer-aided design & computer-aided manufacturing have demonstrated accurate results in orthognathic surgery, though not used for mandibular step osteotomy yet. In this study, the authors report the case of a 21-year-old man with severe mandibular prognathism, with a reverse overjet of 12 mm. Step osteotomy, a modified method of body osteotomy, was planned virtually and performed using 3-dimensional (3D) printed titanium surgical guides and osteosynthesis plates, using computer-aided design & computer-aided manufacturing. At the 6-month postoperative follow-up, there were no notable complications, and normal healing was observed. Each segment was stably in place with the prefabricated plates. The proximal segments were not sagged medially or laterally. With 3D-printed surgical guides and osteosynthesis plates, intraoperative complications, such as injury to adjacent teeth and nerves, could be avoided. They also showed reasonable accuracy and helped reduce operative time and improve outcomes. Unlike surgical guides made of resin/polyamide, titanium surgical guides can be made thinner, which can reduce the extent of detachment. They also did not undergo any deterioration during the operation. Cutting guides and prefabricated plates using virtual surgical planning and 3D printing have many advantages, including reduced preoperative preparation time and operative time, reduced incidence of intraoperative complications, and improved outcomes. However, limitations still exist and further studies are required.

Predictors of Blood Loss During Orthognathic Surgery and the Need for Pre-Deposit Autologous Blood Donation.

ABSTRACT: The aim of this study was to identify the clinicolaboratory predictors of relative blood loss (RBL) during orthognathic surgery and determine the need for predeposit autologous blood donation (PABD) for the surgery. Using a retrospective study design, 297 patients who underwent bimaxillary orthognathic surgery between 2016 and 2020 were enrolled. To investigate patient-specific risk factors, we calculated the allowable blood loss (ABL) for each patient and RBL as the ratio of estimated intraoperative blood loss (EiBL) to ABL. The correlations between the clinico-laboratory variables and EiBL and RBL were analyzed using stepwise multivariate regression analysis, and independent t test and one-way ANOVA were performed.There was no significant difference in transfusion rate between the PABD group (N = 202/279) and non-PABD group (N = 77/279) ( P   =  0.052). Sex ( P   <  0.001), body mass index class ( P   =  0.001), operative time ( P  < 0.001), and baseline hematocrit ( P  < 0.001) were significant predictors of EIBL and RBL. EIBL exceeded ABL in only 2 patients. The significant factors of RBL in orthognathic surgery were hematocrit, body mass index, and operative time. Clinicians should be more careful about bleeding in patients with low baseline hematocrit level or high body mass index, or those expected to undergo prolonged surgeries owing to a complicated surgical plan. The need for PABD before orthognathic surgery is low.

New Bithiophene Extended IDIC-Based Non-Fullerene Acceptors and Organic Photovoltaics Thereof.

We developed new bithiophene extended electron acceptors based on m-alkoxythenyl-substituted IDIC with three different end groups, named as IDT-BT-IC, IDT-BT-IC4F, and IDT-BT-IC4Cl, respectively. The ultraviolet absorption maximum was redshifted and the bandgap was decreased as the strong electron accepting ability of the end group increased. A differential scanning calorimetry thermogram analysis revealed that all the new acceptors have a crystalline character. Using these acceptors and a bulk heterojunction structure using PBDB-T, inverted organic photovoltaic (OPV) devices were fabricated, and their performance was analyzed. Due to the red shift of the electron acceptors, the OPV active layer particularly, which was derived from IDT-BT-IC4F, exhibited increased absorption at long wavelengths over 800 nm. The OPV prepared using IDT-BT-IC exhibited a short-circuit current density (Jsc) of 2.30 mA/cm2, an open-circuit voltage (Voc) of 0.95 V, a fill factor (FF) of 45%, and a photocurrent efficiency (PCE) of 1.00%. Using IDT-BT-IC4F, the corresponding OPV device showed Jsc = 8.31 mA/cm2, Voc = 0.86 V, FF = 47%, and PCE = 3.37%. The IDT-BT-IC4Cl-derived OPV had Jsc = 3.00 mA/cm2, Voc = 0.89 V, FF = 29%, and PCE = 0.76%. When IDT-BT-IC4F was used as the electron acceptor, the highest Jsc and PCE values were achieved. The results show that the low average roughness (0.263 nm) of the active layer improves the extraction of electrons.

Effect of pulsed electromagnetic fields stimulation on ischemic skin model.

This study aimed to evaluate the effect of Pulsed Electromagnetic Fields (PEMF) in improving blood flow reduction and tissue necrosis of ischemic animal induced by skin flap. In each experiment, twenty rats (280-320 g) were randomly divided into control group (n = 10) and PEMF (n = 10) group. All of the rats were performed skin flap in back. In the PEMF group, PEMF (1 Hz, 10 mT) was performed in each experiment. In Experiment-1 (n = 20), PEMF was performed for 90 minutes. In Experiment-2 (n = 20), additionally, a blocking film was inserted, and suture was performed to induce necrosis. PEMF was performed for 30 minutes each day for 7 days. As a result of Speckle-Flow Index (SFI) analysis, in the control group, blood flow continued to decrease immediately after the procedure. In the PEMF group, blood flow was remained constant after 30 minutes and increased after 60 minutes. The blood flow in a specific region substantially increased from the initial state. As a result of skin necrosis analysis, the progression rate in the PEMF group was slower than that of the control group. The rate of necrosis in the PEMF group decreased dramatically from the 6th day, and there was a statistically significant difference between the two groups at the 7th day (p < .05). In this study, it was confirmed that PEMF (1 Hz, 10 mT) has a blood flow improvement and skin tissue necrosis alleviation in the ischemic flap animal model.

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).