Association of Omega-3 Polyunsaturated Fatty Acids with Sarcopenia in Liver Cirrhosis Patients with Hepatocellular Carcinoma.

Background and Aims: Sarcopenia is associated with the prognosis of patients with liver cirrhosis and hepatocellular carcinoma (HCC). Given their diverse physiological activities, we hypothesized that plasma fatty acids might influence the progression of sarcopenia. This study aimed to clarify the association between fatty acids and sarcopenia in cirrhotic patients with HCC. Methods: In this single-center retrospective study, we registered 516 cases and analyzed 414 cases of liver cirrhosis and HCC. The skeletal muscle mass index was measured using a transverse computed tomography scan image at the third lumbar vertebra. The cutoff value for sarcopenia followed the criteria set by the Japan Society of Hepatology. Fatty acid concentrations were measured by gas chromatography. Results: Fatty acid levels, particularly omega-3 (n-3) polyunsaturated fatty acid (PUFA), were lower in patients with poor liver function (Child-Pugh grade B/C) and were negatively correlated with the albumin-bilirubin score (p<0.0001). The prognosis of HCC patients with low PUFA levels was significantly worse. Among the different fatty acid fractions, only n-3 PUFAs significantly correlated with skeletal muscle mass index (p=0.0026). In the multivariate analysis, the n-3 PUFA level was an independent variable associated with sarcopenia (p=0.0006). Conclusions: A low level of n-3 PUFAs was associated with sarcopenia in patients with liver cirrhosis and HCC.

Changes in mutations of cell-free DNA and liver tumor tissue in patients with advanced hepatocellular carcinoma before and after introduction of lenvatinib.

INTRODUCTION: Cell-free DNA (cfDNA) is expected to contribute to the decision for treatment and prediction of effects with minimally invasion. We investigated the correlation between gene mutations before and after lenvatinib (LEN) treatment and its effectiveness, in order to find advanced hepatocellular carcinoma (HCC) patients who would benefit greatly from the therapy. METHODS: We analyzed cfDNA before and 6-8 weeks after the start of treatment in 20 advanced HCC patients started LEN. A next-generation sequencer was used for CTNNB1 and TP53. Concerning TERT promoter, -124C>T and -146C>T mutations are researched using digital PCR. In addition, we examined liver tumor biopsy tissues by the same method. CT evaluation was performed at 6-8 weeks and 3-4 months, to assess the efficacy. RESULTS: Frequencies of TERT promoter, CTNNB1 and TP53 mutations in pretreatment cfDNA were 45%, 65% and 65%, but 53%, 41% and 47% in HCC tissues, respectively. There were no clear correlations between these gene mutations and the disease-suppressing effect or progression-free survival. Overall, there were many cases showing a decrease in mutations after LEN treatment. Integrating the reduction of CTNNB1 and TP53 genetic mutations increased the potential for disease suppression. CONCLUSION: This study suggests that analysis of cfDNA in advanced HCC patients may be useful for identifying LEN responders and determining therapeutic efficacy. Furthermore, it has potential for selecting responders for other molecular-targeted drugs.

A predictive model for HIV-related lymphoma.

OBJECTIVES: To address the paucity of HIV-related lymphoma (HRL)-specific prognostic scores for the Japanese population by analyzing domestic cases of HRL and constructing a predictive model. DESIGN: A single-center retrospective study coupled with a review of case reports of HRL. METHODS: We reviewed all patients with HRL treated at our hospital between 2007 and 2023 and conducted a comprehensive search for case reports of HRL from Japan using public databases. A multivariate analysis for overall survival (OS) was performed using clinical parameters, leading to the formulation of the HIV-Japanese Prognostic Index (HIV-JPI). RESULTS: A total of 19 patients with HRL were identified in our institution, whereas the literature review yielded 44 cases. In the HIV-JPI, a weighted score of 1 was assigned to the following factors: age at least 45 years, HIV-RNA at least 8.0×10 4  copies/ml, Epstein-Barr virus-encoded small RNA positivity, and Ann Arbor classification stage IV. The overall score ranged from 0 to 4. We defined the low-risk group as scores ranging from 0 to 2 and the high-risk group as scores ranging from 3 to 4. The 3-year OS probability of the high-risk group [30.8%; 95% confidence interval (CI): 9.5-55.4%) was significantly poorer than that of the low-risk group (76.8%; 95% CI: 52.8-89.7%; P  < 0.01). CONCLUSION: This retrospective analysis established pivotal prognostic factors for HRL in Japanese patients. The HIV-JPI, derived exclusively from Japanese patients, highlights the potential for stratified treatments and emphasizes the need for broader studies to further refine this clinical prediction model.

Pioneering cord blood transplantation in relapsed/refractory HIV-related lymphoma: a case study with concurrent intramuscular antiretroviral therapy.

A 44-year-old HIV-positive man diagnosed with diffuse large B-cell lymphoma in 2021 achieved complete remission with six cycles of R-CHOP therapy but had a relapse in November 2022. ESHAP therapy failed to induce remission, leading to complete remission with four cycles of Pola-BR therapy. Post-failure of autologous stem cell harvest, cord blood transplantation (CBT) was performed in June 2023. Notably, this case used recently approved intramuscular antiretroviral therapy (ART) with cabotegravir and rilpivirine, addressing gastrointestinal complications during CBT. This innovative use of intramuscular ART in the treatment of malignancy represents a first in the field, offering a pioneering approach to HIV-related lymphoma.

An indocyanine green fluorescence-guided operation for diagnosing and treating pleuroperitoneal communication.

Pleuroperitoneal communication occurs when ascites moves from the abdominal cavity to the pleural cavity via a diaphragmatic fistula. Managing large pleural fluid volumes is challenging, often requiring an operation. Identifying small diaphragmatic fistulas during the operation can be problematic, but ensuring their detection improves outcomes. This video tutorial presents a recent empirical case in which we successfully identified and closed a pleuroperitoneal contact using a thoracoscopic surgical procedure aided by indocyanine green fluorescence imaging. The patient, a 66-year-old woman, was hospitalized due to acute dyspnoea from a right thoracic pleural effusion during hepatic ascites treatment for cirrhosis. Because ascites decreased with pleural fluid drainage, surgical intervention was considered due to suspicion of a pleuroperitoneal connection. During the operation, indocyanine green was injected intraperitoneally, and near-infrared fluorescence-guided thoracoscopy pinpointed the location of the diaphragmatic fistula. The fistula was sutured and reinforced with a polyglycolic acid sheet and fibrin glue. Detecting the fistula intraoperatively is crucial to prevent recurrence, and the indocyanine green fluorescence method is a safe and effective technique for detecting small fistulas.

Correlation between preoperative CT scan of the paraspinal, psoas, and gluteus muscles and postoperative ambulatory status in patients with femoral neck fractures.

BACKGROUND: This study aimed to investigate the relationship between femoral neck fractures and sarcopenia. METHODS: This was a retrospective analysis of 92 patients with femoral neck fractures, from September 2017 to March 2020, who were classified into high ambulatory status (HG) and low ambulatory status (LG) groups. Ambulatory status was assessed before surgery, one week after surgery, at discharge, and during the final follow-up. To evaluate sarcopenia, muscle mass and fatty degeneration of the muscles were measured using preoperative CT. An axial slice of the superior end of the L5 vertebra was used to evaluate the paraspinal and psoas muscles, a slice of the superior end of the femoral head for the gluteus maximus muscle, and a slice of the inferior end of the sacroiliac joint for the gluteus medius muscle. The degeneration of the muscles was evaluated according to the Goutallier classification. RESULTS: The cross-sectional area of the gluteus medius and paraspinal muscles was significantly correlated with ambulatory status before the injury, at discharge, and during the final follow-up. CONCLUSIONS: Measurement of the gluteus medius and paraspinal muscles has the potential to evaluate sarcopenia and predict ambulatory status after femoral neck fractures.

Usefulness of the Fibrosis-4 index and alanine aminotransferase at 1 year of nucleos(t)ide analog treatment for prediction of hepatocellular carcinoma in chronic hepatitis B patients.

AIM: Nucleos(t)ide analogs do not completely prevent hepatocellular carcinoma (HCC) in chronic hepatitis B virus infection. This study aimed to evaluate the dynamics of a non-invasive liver fibrosis marker, the Fibrosis-4 (FIB-4) index, for predicting HCC development. METHODS: Among a total of 882 chronically hepatitis B virus infection-infected patients who were treated with nucleos(t)ide analogs, 472 patients without HCC history whose FIB-4 at baseline and 1 year of treatment was obtained were evaluated for the incidence of HCC. RESULTS: The median FIB-4 was 2.00 at baseline and was significantly reduced to 1.58 at 1 year (P < 0.001), but the reduction was small at 2 years or later. When a receiver operating characteristic analysis of FIB-4 was performed to predict HCC within 5 years, the area under the curve of FIB-4 at 1 year was higher than that at baseline (0.676 vs. 0.599). The HCC incidence was significantly higher in patients with FIB-4 ≥1.58 than in those with FIB-4 <1.58 (14.8% vs. 3.6% at 10 years, P < 0.001). Additionally, an abnormal alanine aminotransferase (≥31 U/L) at 1 year was an independent risk for HCC. When a fibrosis and alanine aminotransferase-1 (FAL-1) score was evaluated as an applicable number of FIB-4 ≥1.58, and alanine aminotransferase ≥31 as 0, 1, and 2, the HCC risk in patients with score 2 was significantly higher than in those with score 1 or score 0 (24.1% vs. 9.8% vs. 0.7% at 10 years, P < 0.001). CONCLUSIONS: FIB-4 ≥1.58 and alanine aminotransferase ≥31 at 1 year of nucleos(t)ide analog was an independent risk factor for HCC development, and a score using these factors stratified the risk of HCC.

Comparing Bone Fusion Rates Between Novel Unidirectional Porous Tricalcium Beta-Phosphate and Autologous Bone in Lumbar Lateral Interbody Fusion: A Two-Year Radiographic Outcome Study.

This retrospective cohort study aims to examine the potential differences in bone fusion between autologous bone and artificial bone in the lumbar lateral interbody fusion at 2two years post-surgery. The bone fusions performed in 15 cases and at 34 intervertebral levels were compared to assess the differences between the artificial bone, Affinos® (Kuraray Co., Tokyo, Japan), and autogenous bone. Two years post-surgery, we evaluated computed tomography (CT) multi-planar reconstruction images in the coronal and sagittal planes. One year after surgery, out of the 24 windows, 17 (70.8%) windows transplanted with autologous bones showed bone fusion. Additionally, out of the 38 windows, 18 (47.4%) windows transplanted with Affinos® showed bone fusion. Two years post-surgery, out of the 24 windows, 19 (79.2%) windows transplanted with autologous bones showed bone fusion. Additionally, out of the 38 windows, 30 (79.0%) windows transplanted with Affinos® showed bone fusion, and no difference was observed in the fusion rate at two years post-surgery (P = 0.238). In cases using Affinos® for transplanted bone, the bone fusion rate increased between one and two years. The rate of bony fusion using Affinos® in lateral lumbar interbody fusion (LLIF) cages is at par with that of autologous bone grafts at two years post-surgery. Affinos® is a promising candidate for graft material in LLIF surgery.

A new model to estimate duration of survival in patients with hepatocellular carcinoma with BCLC intermediate stage.

It is difficult to determine whether an individual therapy contributes to the elongation of survival because of the difficulty of organizing clinical research in patients who receive multiple treatments in HCC. We aimed to establish a new model of survival prediction in patients with intermediate stage HCC to establish standards in the recent and coming multi-MTA era. This analysis was prepared using a data set of 753 patients diagnosed HCC prior to 2017. Multiple regression analysis showed age, naïve or recurrence, the size of the largest tumor nodule, the number of nodules, total bilirubin, albumin and α-fetoprotein as independent predictors of survival. A Weibull model had the best fit and, based on these predictors, we established a new predicted survival model. The survival duration can be predicted the proposed model; EXP (4.02580 + (- 0.0086253) × age + (- 0.34667) × (naïve/recurrence) + (- 0.034962) × (number of nodules) + (- 0.079447) × (the size of the largest nodule) + (- 0.21696) × (total bilirubin) + 0.27912 × (albumin) + (- 0.00014741) × (α-fetoprotein)) × (- natural logarithm(0.5))^0.67250. This model is useful for the planning and evaluating the efficacy of recent sequential therapies in multi-MTA era.

Effect of platelet-rich plasma on the acceleration of graft bone catabolism in lateral lumbar interbody fusion in a short-term assessment.

This study aimed to demonstrate whether impregnating the graft bone with platelet-rich plasma (PRP) accelerates graft bone catabolism in lateral lumbar interbody fusion (LLIF). Consecutive patients who underwent LLIF were assessed. Of the two spaces for bone grafts in the intervertebral cage, one space was filled with graft bone impregnated with PRP, and the other was filled with graft bone without PRP, which divided the graft bones into PRP and non-PRP groups. The mean Hounsfield units (HU) of the graft bone at the center of the cage space in the coronal and axial slices were measured using computed tomography (CT) images 1 week and 6 months after surgery. The delta value of HU from 1 week to 6 months after surgery was calculated for the PRP and non-PRP groups. We compared the delta values of the HU between the two groups. The PRP and non-PRP groups comprised 16 bone grafts. In the coronal slices, the HU value in the PRP group (delta value: 526.1 ± 352.2) tended to have a greater decrease at 6 months after surgery compared with that in the non-PRP group (delta value: 217.6 ± 240.4) (p = 0.065). In the axial slices, the HU value in the PRP group (delta value: 501.3 ± 319.6) was significantly decreased at 6 months after surgery compared with that in the non-PRP group (delta value: 159.2 ± 215.3) (p = 0.028). Impregnating the graft-bone with PRP accelerated graft bone catabolism in LLIF within 6 months after surgery.

Effectiveness of tacrolimus in a case of immune checkpoint inhibitor-induced hepatotoxicity that was refractory to steroids and mycophenolate mofetil.

Immune checkpoint inhibitors (ICIs) sometimes induce immune-mediated hepatotoxicity (IMH), and corticosteroids and mycophenolate mofetil (MMF) are recommended for the treatment of IMH. However, there is no consensus on the treatment of IMH refractory to these drugs. Here, we report a case of refractory IMH that was successfully treated with tacrolimus. A 69-year-old man presented with liver injury after receiving durvalumab, an ICI, for lung cancer. He was diagnosed with IMH and received corticosteroids including methylprednisolone pulses and MMF, but his liver damage did not improve. Liver histology showed infiltration of inflammatory cells, mainly CD8 + T cells, in the portal area. Tacrolimus was added to corticosteroid and MMF to suppress mainly T cells. After the tacrolimus administration, the liver damage promptly improved. Since IMH is thought to be caused by activated CD8 + T-cell infiltration, T-cell suppression may be an effective treatment. This case suggests that tacrolimus may be an effective option for IMH refractory to corticosteroids or MMF if CD8 + T-cell infiltration is confirmed in the liver tissue.

Preoperative cross-sectional area of psoas muscle correlates with short-term functional outcomes after posterior lumbar surgery.

PURPOSE: To determine the optimal level for the measurement of psoas cross-sectional area and examine the correlation with short-term functional outcomes of posterior lumbar surgery. METHODS: Patients who underwent minimally invasive posterior lumbar surgery were included in this study. The cross-sectional area of psoas muscle was measured at each intervertebral level on T2-weighted axial images of preoperative MRI. Normalized total psoas area (NTPA) (mm2/m2) was calculated as total psoas area normalized to patient height. Intraclass Correlation Coefficient (ICC) was calculated for the analysis of inter-rater reliability. Patient reported outcome measures including Oswestry disability index (ODI), visual analog scale (VAS), short form health survey (SF-12) and patient-reported outcomes measurement information system were collected. A multivariate analysis was performed to elucidate independent predictors associated with failure to reach minimal clinically important difference (MCID) in each functional outcome at 6 months. RESULTS: The total of 212 patients were included in this study. ICC was highest at L3/4 [0.992 (95% CI: 0.987-0.994)] compared to the other levels [L1/2 0.983 (0.973-0.989), L2/3 0.991 (0.986-0.994), L4/5 0.928 (0.893-0.952)]. Postoperative PROMs were significantly worse in patients with low NTPA. Low NTPA was an independent predictor of failure to reach MCID in ODI (OR = 2.68; 95% CI: 1.26-5.67; p = 0.010) and VAS leg (OR = 2.43; 95% CI: 1.13-5.20; p = 0.022). CONCLUSION: Decreased psoas cross-sectional area on preoperative MRI correlated with functional outcomes after posterior lumbar surgery. NTPA was highly reliable, especially at L3/4.

The relationship between spinal alignment and activity of paravertebral muscle during gait in patients with adult spinal deformity: a retrospective study.

BACKGROUND: Spinal alignment in patients with adult spinal deformity (ASD) changes between rest and during gait. However, it remains unclear at which point the compensated walking posture breaks down and how muscles respond. This study used time-synchronized electromyography (EMG) to investigate the relationship between dynamic spinal alignment and muscle activity during maximum walking duration to reveal compensation mechanisms. METHODS: This study collected preoperative three-dimensional gait analysis data from patients who were candidates for corrective surgery for ASD from April 2015 to May 2019. We preoperatively obtained dynamic spinal alignment parameters from initiation to cessation of gait using a motion capture system with time-synchronized surface integrated EMG (iEMG). We compared chronological changes in dynamic spinal alignment parameters and iEMG values 1) immediately after gait initiation (first trial), 2) half of the distance walked (half trial), and 3) immediately before cessation (last trial). RESULTS: This study included 26 patients (22 women, four men) with ASD. Spinal sagittal vertical axis distance during gait (SpSVA) increased over time (first vs. half vs. last, 172.4 ± 74.8 mm vs. 179.9 ± 76.8 mm vs. 201.6 ± 83.1 mm; P < 0.001). Cervical paravertebral muscle (PVM) and gluteus maximus activity significantly increased (P < 0.01), but thoracic and lumbar PVM activity did not change. Dynamic spinal alignment showed significant correlation with all muscle activity (cervical PVM, r = 0.41-0.54; thoracic PVM, r = 0.49-0.66; gluteus maximus, r = 0.54-0.69; quadriceps, r = 0.46-0.55) except lumbar PVM activity. CONCLUSION: Spinal balance exacerbation occurred continuously in patients with ASD over maximum walking distance and not at specific points. To maintain horizontal gaze, cervical PVM and gluteus maximus were activated to compensate for a dynamic spinal alignment change. All muscle activities, except lumbar PVM, increased to compensate for the spinal malalignment over time.

Unidirectional porous beta-tricalcium phosphate as a potential bone regeneration material for infectious bony cavity without debridement in pyogenic spondylitis.

An 81-year-old man was initially diagnosed with T11 osteoporotic vertebral fracture. The fractured vertebral body was filled with unidirectional porous beta-tricalcium phosphate (ß-TCP) granules, and posterior spinal fixation was conducted using percutaneous pedicle screws. However, the pain did not improve, the inflammatory response increased, and bone destructive changes extended to T10. The correct diagnosis was pyogenic spondylitis with concomitant T11 fragility vertebral fracture. Revision surgery was conducted 2 weeks after the initial surgery, the T10 and T11 pedicle screws were removed, and refixation was conducted. After the revision surgery, the pain improved and mobilization proceeded. The infection was suppressed by the administration of sensitive antibiotics. One month after surgery, a lateral bone bridge appeared at the T10/11 intervertebral level. This increased in size over time, and synostosis was achieved at 6 months. Resorption of the unidirectional porous ß-TCP granules was observed over time and partial replacement with autologous bone was evident from 6 months after the revision surgery. Two years and 6 months after the revision surgery, although there were some residual ß-TCP and bony defect in the center of the vertebral body, the bilateral walls have well regenerated. This suggested that given an environment of sensitive antibiotic administration and restricted local instability, unidirectional porous ß-TCP implanted into an infected vertebral body may function as a resorbable bone regeneration scaffold without impeding infection control even without debridement of the infected bony cavity.

Duodenal Variceal Rupture during Atezolizumab and Bevacizumab Treatment for Hepatocellular Carcinoma.

Duodenal varices are detected infrequently, and their rupture is very rare. We encountered an 87-year-old man who developed duodenal varices rupture during chemotherapy with atezolizumab and bevacizumab (ATZ/BV) for hepatocellular carcinoma. We identified massive bleeding of a ruptured varix in the horizontal portion of the duodenum with emergency esophagogastroduodenoscopy (EGD). Successful hemostasis was achieved by endoscopic injection sclerotherapy with Histoacryl. Although ATZ/BV can cause esophageal varices rupture, there have been no cases of duodenal varices rupture. We should take care to check the duodenal varices as well as esophagogastric varices before ATZ/BV treatment.

Prevalence of pleural injury in an extrapleural approach to adolescent idiopathic scoliosis and association of pleural injury with postoperative respiratory function.

BACKGROUND: The prevalence of pleural injury during surgery for adolescent idiopathic scoliosis using an extrapleural approach and the association of pleural injury with postoperative pulmonary function remain unclear. We sought to determine the prevalence of pleural injury associated with an extrapleural approach to adolescent idiopathic scoliosis, and to determine any difference in respiratory function between patients with or without pleural injury. METHODS: Data from consecutive patients with scoliosis of the thoracolumbar/lumbar spine who underwent anterior spinal fusion using an extrapleural approach were assessed in this retrospective study. We had diagnosed and treated pleural injury according to our algorithm. Pre- and postoperative values of pulmonary function tests and postoperative change rates were compared between patients with and without pleural injury. FVC, %FVC, FEV1.0, and FEV1.0% were evaluated from pulmonary function tests. RESULTS: We included data from 51 patients with adolescent idiopathic scoliosis (45 female and 6 male) with a mean age of 17.2 ± 3.5 years in this retrospective study. The group with pleural injury comprised 31 patients and the group without 20. Therefore, the prevalence of pleural injury during an extrapleural approach was 61%. We found no significant differences in preoperative FVC, %FVC, FEV1.0, and FEV1.0% between the groups. We found no significant differences in FVC, %FVC, FEV1.0, and FEV1.0% between the groups at 3 months or 1 year postoperatively. Furthermore, we found no significant differences in the postoperative change ratio of FVC, %FVC, FEV1.0, and FEV1.0% between the groups. CONCLUSION: The prevalence of pleural injury associated with an extrapleural approach to scoliosis was 61%. Pleural injury was not associated with a decrease in postoperative pulmonary function in patients with scoliosis treated using an extrapleural approach.

Switching to Tenofovir Alafenamide Fumarate in Chronic Hepatitis B Patients Who Had Detectable HBV DNA during Treatment with Entecavir.

Nucleos(t)ide analogues (NAs) suppress hepatitis B virus (HBV) replication, but the risk of hepatocellular carcinoma still remains. The presence of detectable HBV DNA in the serum during NA therapies for chronic hepatitis B patients has been reported to be associated with the risk of hepatocellular carcinoma. In this study, we investigated the antiviral effect of switching from entecavir (ETV) to tenofovir alafenamide fumarate (TAF) in chronic hepatitis B patients who had detectable HBV DNA in the serum at least once within a year. Among a total of 77 cases in 7 hospitals that switched NAs from ETV to TAF, 23 patients with detectable HBV DNA in a year before switching were analyzed. When the detection frequencies of HBV DNA in the 1st and 2nd years after switching to TAF were analyzed, they were significantly lower than those in the year before switching (68.8% vs. 34.1% for the 1st year and 21.3% for the 2nd year, P < 0.001 for both). The HBsAg decline tended to be larger after switching than before (-2.5% vs. -3.0% for 1st year and -3.1% for 2nd year), but the difference was not significant. One patient died of a cardiovascular event 11 months after the treatment switch, but no adverse effects due to TAF including renal function were observed. In conclusion, it was suggested that switching from ETV to TAF might be effective to suppress the HBV DNA level further in patients whose HBV DNA is detectable, even if at a very low level.

Can Proximal Junctional Kyphosis after Surgery for Adult Spinal Deformity Be Predicted by Preoperative Dynamic Sagittal Alignment Change with 3D Gait Analysis? A Case-Control Study.

BACKGROUND: Severe spinal deformity is a risk factor for proximal junctional kyphosis (PJK) in surgery for adult spinal deformity (ASD). However, standing X-ray imaging in patients with dynamic spinal imbalance can underestimate the risk of PJK because of compensation mechanisms. This study aimed to investigate whether preoperative dynamic spinal alignment can be a predictive factor for PJK. METHODS: We retrospectively included 27 ASD patients undergoing three-dimensional (3D) gait analysis before surgery. Dynamic spinal parameters were obtained using a Nexus motion capture system (Vicon, Oxford, UK). The patients were instructed to walk as long as possible around an oval walkway. The averaged dynamic parameters in the final lap were compared between patients with PJK (+) and with PJK (-). RESULTS: PJK occurred in seven patients (26%). The dynamic angle between the thoracic spine and pelvis was larger in patients with PJK (+) than in those with PJK (-) (32.3 ± 8.1 vs. 18.7 ± 13.5 °, p = 0.020). Multiple logistic regression analysis identified this angle as an independent risk factor for PJK. CONCLUSIONS: Preoperative thoracic anterior inclination exacerbated by gait can be one of preoperative independent risk factors for PJK in patients undergoing corrective surgery for ASD.

Efficacy of platelet-rich plasma impregnation for unidirectional porous ß-tricalcium phosphate in lateral lumbar interbody fusion: study protocol for a prospective controlled trial.

BACKGROUND: The use of platelet-rich plasma has been increasing in spinal fusion surgery. However, the efficacy of platelet-rich plasma in lateral lumbar interbody fusion is unclear. In Japan, Affinos,® (Kuraray Co., Tokyo, Japan), a ß-tricalcium phosphate artificial bone, has been increasingly used for spinal fusion. The purpose of this trial is to demonstrate whether Affinos® impregnated with platelet-rich plasma can achieve a higher fusion rate and better clinical outcomes than Affinos® alone. METHODS: The current study is a prospective randomized controlled trial. This trial will include consecutive patients scheduled for lateral lumbar interbody fusion. An intervertebral cage for lateral lumbar interbody fusion has two spaces for bone grafts. As a consequence, two bone grafts are inserted at each intervertebral level. In this study, an artificial bone with platelet-rich plasma will be inserted into one space, and an artificial bone without platelet-rich plasma will be inserted into the other space. We will compare the fusion rates between the bone grafts with and without platelet-rich plasma. Our primary endpoint will be the interbody fusion rate at 1 year after surgery. DISCUSSION: This trial will verify the efficacy of platelet-rich plasma with Affinos® for bony fusion in lateral lumbar interbody fusion. It will also provide substantial evidence for the effectiveness and safety of platelet-rich plasma in spinal fusion surgery. TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT) jRCTb032200199 . First registered on 13 November 2020. jRCT is approved as a member of the Primary Registry Network of WHO ICTRP.