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Polyethylene (PE) and polyethylene terephthalate (PET) are among the most abundant plastics polluting the oceans. However, their environmental fate depends on how they have been weathered. Due to its unique geography, the Sea of Japan is a pollution hotspot where plastics accumulate. In this study, the structures of plastics, having drifted into the Sea of Japan coastline environment, were analyzed with a particular focus on examining polymer crystallization and carbonyl formation; two factors which influence microplastic formation and the adsorption of contaminants onto plastic surfaces. PE in the coastal environment did not show evidence of crystallization, although carbonyl formation did increase. By contrast, PET bottles were shown to not be uniform in structure, with unaged bottles being less crystalline in the neck component compared to the body. Because of this difference, in environmental PET bottles, it was the bottle neck that showed increases in crystallization and carbonyl group formation.

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Microplastics can be ingested by tiny detritivores such as amphipods, with potential consequences on the food chain. The present study characterizes the abundance, chemical composition, and size of microplastics in amphipods found in the Japan Sea coastal environment, which is a hotspot for microplastic accumulation. High amounts of microplastic ingestion and a large discrepancy by amphipod species, Talorchestia nipponensis, Ampithoe valida, and Trinorchestia trinitatis, were observed (between 0.2 and 76.3 particles/individual) which may be due to differences in habitat preference and background contamination. This result indicates that coastal amphipods in particular may ingest large amounts of microplastics. The average microplastic particle size in amphipods was 59 ± 8.6 µm, with 83% of particles smaller than 90 µm, and polyethylene was dominant. This study provides insights into microplastic abundance in coastal amphipods and the context for further studies on coastal amphipod microplastic ingestion.

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The goal of this study was to investigate the impact of postoperative inclination of the joint line on clinical results after total knee arthroplasty (TKA) using a prosthesis with anatomical geometry. This study included 145 primary cruciate-retaining type of knee prosthesis with anatomical geometry. Three years postoperatively, clinical outcomes including the patient-reported outcomes (PROs) were recorded. Limb alignment was evaluated by the hip-knee-ankle (HKA) axis and inclination of the joint line was assessed by the joint line orientation angle (JLOA). Knees were divided into two groups according to the HKA: in-range (- 3 to 3°) and outlier group (< - 3° or > 3°) or the JLOA: in-range (2-4°) and outlier group (< 2° or > 4°), and clinical outcomes were compared between the groups. Postoperative Knee Society Function Score (KS-FS) was significantly higher in the HKA in-range group than the outlier group (p = 0.01). The Knee Society Knee Score and all subscales of the Knee injury Osteoarthritis Outcome Score were comparable between the groups. A multivariate analysis revealed a significant association between age at operation and postoperative KS-FS > of 80 points. Neither HKA in-range nor JLOA in-range were associated with the higher knee function. In conclusion, TKA-postoperative inclination of the joint line was not relevant to the short-term PROs. Treatment strategies that attempt to make joint line inclination in order to improve postoperative PROs should be avoided, and alignment goals such as kinematic alignment should be considered carefully.

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BACKGROUND: Postoperative changes in lumbar lordosis (LL) after transforaminal lumbar interbody fusion (TLIF) and the related factors are not well-understood. Recently, the preoperative difference in LL between standing and supine positions (DiLL) was proposed as a factor for predicting postoperative radiologic outcomes after short-segment TLIF. This study investigated the influence of DiLL on mid-term radiological outcomes after short-segment TLIF. METHODS: Sixty-six patients with lumbar degenerative disease treated with short-segment TLIF (1-2 levels) who underwent lumbar spine standing radiographs at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years postoperatively were divided into DiLL (+) and DiLL (-) groups (preoperative DiLL ≥0° and <0°, respectively). Associations between the postoperative change in LL and DiLL and clinical outcomes (Oswestry disability index (ODI) and Nakai score) were evaluated. RESULTS: Temporary restoration of LL (+4.5°) until 1 year postoperatively and a subsequent decrease in LL from 1 to 5 years postoperatively (-5.3°) was observed in the DiLL (+) group. No postoperative change in LL was observed in the DiLL (-) group. Postoperative changes in LL were mainly observed in non-fused segments. The postoperative change in LL (ΔLL) until 1 year postoperatively had a significant positive association with DiLL (p = 0.00028), whereas ΔLL from 1 to 5 years postoperatively showed a significant negative association with DiLL (p = 0.010) and a positive association with Nakai score (p = 0.028). ΔLL until 5 years postoperatively showed a significant positive association with postoperative ODI improvement (p = 0.011). CONCLUSIONS: DiLL (+) patients showed a specific time course with temporary LL restoration until 1 year postoperatively and a subsequent decrease in LL from 1 to 5 years postoperatively. Patients with larger postoperative increase in LL until 5 years postoperatively and lesser decrease in LL from 1 to 5 years postoperatively tended to show better mid-term clinical outcomes.

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BACKGROUND: Total knee arthroplasty (TKA) is an established surgical treatment for advanced knee osteoarthritis by which patients can expect improvement of knee pain and function. Although many surgeons have investigated limb alignment after TKA, changes in coronal positional relation between the femur and tibia are not known well. METHODS: Radiographs of 105 knees of young Japanese patients between 20 and 49 years-old (60 men and 45 women) without osteoarthritic changes who received arthroscopic surgeries at our hospital were used in this study. Using 2D-templates of the medial pivot design (the FINE total knee), we simulated TKA on a SYNAPSE-PACS software. First, the femoral component was placed in normal knee alignment and then was merged to the medial concave of the insert where the tibial component was placed in neutral alignment. The length of the mediolateral shift of the femoral component was measured as an estimate of lateral shift of the femoral condyle, of which association with radiographic parameters including the femorotibial angle (FTA), lateral distal femoral angle (LDFA), and medial proximal tibial angle (MPTA) was analyzed. Subjects were classified into three groups according to the femoral component size that was chosen in simulation of TKA, and the lateral shift of the femoral condyle was compared between groups. RESULTS: The estimated mean lateral shift of the femoral condyle was 5.99 ± 1.98 mm and was greater in males than females (p < 0.05). Also, it was most highly correlated with the medial proximal tibial angle (MPTA) (r = - 0.553, p < 0.01). A group receiving larger component sizes significantly shifted more laterally compared with a group receiving smaller component sizes (p < 0.01). CONCLUSIONS: These results suggest that the coronal positional relation between the femur and tibia is altered and subsequent ligament imbalance may occur after mechanically aligned TKA using the medial pivot design.

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INTRODUCTION: To compare postoperative pain and discomfort between supine and lateral positions after lumbar surgery, a prospective randomized controlled study was performed. METHODS: Forty-three patients with lumbar degenerative disease, treated by decompression (n = 23) or fusion surgery (n = 20), were randomly assigned to be placed in either the supine (supine group: n = 21) or lateral (lateral group: n = 22) position postoperatively, and asked to maintain their position until a day after the surgery. Postoperative back pain and discomfort (visual analog scale [VAS], 0-100 mm) and the number of patients who could maintain their position were examined. RESULTS: The VAS scores for back pain (supine: 64.9 ± 22.0, lateral: 55.7 ± 21.4) showed no significant difference between the positions. However, the supine group showed significantly more severe discomfort (75.6 ± 15.7) than the lateral group (64.9 ± 15.7, p = 0.039). Significantly fewer patients maintained their position in the supine group (28.2%) than in the lateral group (68.2%; p = 0.022). Among patients who underwent fusion surgery, significantly fewer patients maintained their position in the supine group (10.0%) than those in the lateral group (60.0%, p = 0.029). CONCLUSION: Postoperative discomfort was significantly reduced in the lateral position than in the supine position; thus, the lateral position is more suitable after lumbar surgery in terms of postoperative discomfort.

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Although most patients who undergo transforaminal lumbar interbody fusion (TLIF) show favorable surgical results, some still have unfavorable results for various reasons. This study aimed to investigate the influence of differences in lumbar lordosis (LL) between the standing and supine positions (DiLL: supine LL-standing LL) on minimum 5-year surgical outcomes after short-segment TLIF. Ninety-one patients with lumbar degenerative disease who underwent short-segment TLIF (1-2 levels) were categorized based on preoperative differences in LL as DiLL (+) and DiLL (-). Comparison and correlation analyses were performed. The incidence of adjacent segment disease (ASD) by radiology (R-ASD) and symptomatic ASD (S-ASD), bony fusion rates, and pre- and postoperative clinical scores (visual analog scale [VAS]; Japanese Orthopaedic Association [JOA] score; Oswestry disability index (ODI); and Nakai's score) were evaluated. Postoperatively, VAS for low back pain (LBP) in the sitting position, JOA scores for LBP, lower leg pain, intermittent claudication, ODI, and Nakai's score were significantly worse in the DiLL (+) group than in the DiLL (-) group. DiLL values were significantly correlated with VAS for LBP, ODI, and Nakai's score, postoperatively. Positive DiLL values were associated with poorer postoperative outcomes. DiLL is a simple and useful method for predicting mid-term outcomes after TLIF.

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INTRODUCTION: Condoliase is a newly approved drug that improves symptoms associated with lumbar disk herniation (LDH) by intradiscal administration. This study aimed to evaluate the mid-term outcomes of condoliase injection, examine the adverse events, including cases that required surgery after condoliase administration, and verify cases in which condoliase could be effective. METHODS: We enrolled patients with LDH who were treated conservatively for at least six weeks and received condoliase. We assessed the visual analog scale (VAS) score, Japanese Orthopaedic Association Back Pain Evaluation Questionnaire, Oswestry Disability Index, disk height, and disk degeneration for up to 6 months, and we examined the complications. Furthermore, a 50% or more improvement in leg pain VAS score was considered effective. Factors related to symptom improvement were investigated by determining whether lower limb pain improved in six months. RESULTS: In total, 84 patients were recruited (52 men, 32 women; mean age, 44.2 ± 17.1 [16-86 years]). The duration of illness was 6.7 ± 6.8 (1.5-30) months. All patient-based outcomes significantly improved at 4 weeks after the administration compared with pretreatment. The intervertebral disc height decreased significantly at four weeks after condoliase administration compared with that before administration. Progression of intervertebral disc degeneration occurred in 50% of the patients. Eleven patients underwent herniotomy due to poor treatment effects. Moreover, treatment in 77.4% of the patients was considered effective. A logistic regression analysis revealed that L5/S1 disk administration (p = 0.029; odds ratio, 5.94; 95% confidence interval, 1.20-29.45) were significantly associated with clinical effectiveness. CONCLUSIONS: Condoliase disk administration improved pain and quality of life over time. Condoliase disk administration was more effective in L5/S1 intervertebral administration.

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OBJECTIVE: The authors sought to evaluate the relationship between the difference in lumbar lordosis (DiLL) in the preoperative supine and standing positions and spinal sagittal alignment in patients with lumbar spinal stenosis (LSS) and to determine whether this difference affects the clinical outcome of laminectomy. METHODS: Sixty patients who underwent single-level unilateral laminectomy for bilateral decompression of LSS were evaluated. Spinopelvic parameters in the supine and standing positions were measured preoperatively and at 3 months and 2 years postoperatively. DiLL between the supine and standing positions was determined as follows: DiLL = supine LL - standing LL. On the basis of this determination patients were then categorized into DiLL(+) and DiLL(-) groups. The relationship between DiLL and preoperative spinopelvic parameters was evaluated using Pearson's correlation coefficient. In addition, clinical outcomes such as visual analog scale (VAS) and Oswestry Disability Index (ODI) scores between the two groups were measured, and their relationship to DiLL was evaluated using two-group comparison and multivariate analysis. RESULTS: There were 31 patients in the DiLL(+) group and 29 in the DiLL(-) group. DiLL was not associated with supine LL but was strongly correlated with standing LL and pelvic incidence (PI) - LL (PI - LL). In the preoperative spinopelvic alignment, LL and SS in the standing position were significantly smaller in the DiLL(+) group than in the DiLL(-) group, and PI - LL was significantly higher in the DiLL(+) group than in the DiLL(-) group. There was no difference in the clinical outcomes 3 months postoperatively, but low-back pain, especially in the sitting position, was significantly higher in the DiLL(+) group 2 years postoperatively. DiLL was associated with low-back pain in the sitting position, which was likely to persist in the DiLL(+) group postoperatively. CONCLUSIONS: We evaluated the relationship between DiLL and spinal sagittal alignment and the influence of DiLL on postoperative outcomes in patients with LSS. DiLL was strongly correlated with PI - LL, and in the DiLL(+) group, postoperative low-back pain relapsed. DiLL can be useful as a new spinal alignment evaluation method that supports the conventional spinal sagittal alignment evaluation.

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BACKGROUND: When treating cancer patients, the progression of symptoms is accompanied by the deterioration of systemic conditions and motor function. From a risk-benefit perspective, a certain level of physical function must be maintained to continue cancer treatment. Recently, outpatient cancer treatment has become more common. Motor function is important to determine the feasibility of continuing cancer treatment. The study aimed to evaluate the motor function of patients with visceral cancer using locomo tests established by Japanese Orthopaedic Association. METHODS: Locomo tests were performed, and the results were compared with data from non-cancer individuals. Background data were matched by propensity score matching. Data from 53 cancer patients (group C) were compared with that of 75 non-cancer patients (group N). RESULTS: The average score in the two-step test of group C was lower than that of group N (1.27: 1.37, p = 0.004). The average function in the stand-up test of group C was worse than that of group N (p = 0.001). The average score in the 25-question geriatric locomotive function scale (GLFS) of group C was significantly higher than that of group N (19.92: 5.29, SE 2.21, p < 0.001). Higher 25-question GLFS scores indicate reduced mobility. The proportion of the locomo stage 2 in group C was significantly higher than in group N (51%: 13%, p < 0.001). The results of the two field tests revealed a clinically minimal difference between the two groups, but a statistically significant difference. Locomo tests may be detect potential motor dysfunction in outpatient cancer patients with apparently maintained motor function. CONCLUSIONS: Even in cancer patients who attend outpatient clinics, their motor functions could be potentially impaired. Therapeutic interventions to maintain and enhance motor function for cancer patients could be useful for continuing cancer treatment, and furthermore, improving prognosis.

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Introduction Reactive oxygen metabolites (ROMs) are metabolite hydroperoxides in the blood, and their serum levels were associated with the disease activity score 28 (DAS28) in patients with rheumatoid arthritis (RA). In this study, we aimed to investigate whether ROMs would be predictive of the clinical disease activity index (CDAI) remission, simplified disease activity index (SDAI) remission, or Boolean remission. Materials and methods Fifty-one biologic agents (BA)-naïve RA patients were included in this observational study. Associations between ROMs, C-reactive protein, matrix metalloproteinase-3, DAS28-erythrocyte sedimentation rate (ESR), CDAI, SDAI, and health assessment questionnaire (HAQ) at 12 weeks and the DAS28, CDAI, SDAI, and Boolean remission rates at 52 weeks were investigated. Results The DAS28, CDAI, SDAI, and Boolean remission rates at 52 weeks were 66.7, 52.9, 54.9, and 54.9%, respectively. A multivariate logistic regression analysis revealed that ROMs and HAQ at 12 weeks were associated with the CDAI, SDAI, and Boolean remission at 52 weeks. Receiver operating characteristic analyses demonstrated that the cut-off value for CDAI, SDAI, and Boolean remission was 389.5 U.Carr. Conclusion Reactive oxygen metabolites at 12 weeks of initial treatment with BAs was a predictor for CDAI, SDAI, and Boolean remission at 52 weeks. Serum levels of ROMs may be a useful biomarker in the current treatment strategy aiming at early remission of RA.

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INTRODUCTION: Preoperative factors that predict postoperative restoration of lumbar lordosis (LL) are not well understood. To investigate whether preoperative postural correction of LL, sagittal malalignment, or lumbar flexibility are associated with the postoperative restoration of LL in patients treated with a single-level transforaminal lumbar interbody fusion (TLIF), a retrospective cohort study was conducted. METHODS: We enrolled 104 patients (mean age: 67.5±10.7 years old; 47 men and 57 women) with lumbar degenerative diseases treated with a single-level TLIF. The pre- and postoperative LL were examined using lateral radiographs in the standing position and computed tomography (CT) images in the supine position. The correlation between postoperative LL restoration and preoperative postural correction of LL (difference in LL between the standing and supine positions: D-LL), sagittal imbalance (pelvic incidence minus LL: PI-LL), and lumbar flexibility (difference in LL between the flexion and extension postures) were analyzed. Patients were divided into two groups according to the D-LL (D-LL≥0° and D-LL<0°). The rates of postoperative LL restoration (postoperative LL-preoperative LL in standing) were compared between the two groups. RESULTS: Multiple regression analysis performed after adjustment for age, gender, body mass index, and cage angle revealed that postoperative LL restoration was significantly correlated with D-LL (p<0.001), but not with PI-LL, and lumbar flexibility. Patients with a preoperative D-LL≥0° showed a significantly greater increase of LL after TLIF (7.1°±11.2°) than those with D-LL<0° (1.4°±6.6°) (p=0.003). CONCLUSIONS: A preoperative evaluation of a lateral radiograph or CT taken in the supine position is useful in predicting postoperative improvement of sagittal alignment. Postoperative improvement of sagittal spinopelvic alignment would be expected when LL is corrected in the supine position preoperatively. Surgeons should pay attention to the postural correction of LL when performing short-segment fusion surgery for lumbar degenerative disease with sagittal malalignment.

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OBJECTIVES: To describe the novel technique of continuous local antibiotic perfusion (CLAP) for a surgical site infection (SSI) after instrumented spinal surgery. METHODS: CLAP was applied to 4 continuous patients at our institution who developed SSI after instrumented spinal surgery. RESULTS: All 4 patients were successfully treated and the infection was controlled. The implant was retained in all patients. The duration of CLAP ranged from 2 to 3 weeks. The blood level of the antibiotic used (gentamicin) at 1 week after the initiation of CLAP did not increase in any patient. No other adverse events occurred in any patient. Dramatic improvements in laboratory parameters, including the white blood cell (WBC) counts and C-reactive protein (CRP) levels were seen in every patient at 1 week after the initiation of CLAP. CONCLUSIONS: CLAP controlled the infection without severe adverse events in all 4 patients, and the implants were retained. Despite its cost and the discomfort of patients, CLAP may become an option for the treatment of SSIs after instrumented spinal surgery. A large number of case series are needed to verify the efficacy of CLAP for patients with SSIs after instrumented spinal surgery.

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INTRODUCTION: Previous studies have reported differences in lumbopelvic alignment between standing and supine positions. Computed tomography (CT) images taken in the supine position are often used for clinical studies in addition to standing radiographs, although not frequently. Our study aims to clarify normative values of CT-evaluated lumbopelvic parameters and the characteristics of age- and gender-related lumbopelvic alignment in the supine position. METHODS: Patients undergoing CT scans of abdominal or lumbar regions for reasons other than low back disorders were included (n=581). Sagittal multiplanar reconstruction CT images were obtained, and lumbar lordosis (LL), L5-S1 angle, and sacral slope (SS) were measured. Mean values of the parameters in patients aged 59 years and under, 60-69, 70-79, and 80 and over, and in males and females, were calculated. Age- and gender-related differences in these parameters were statistically analyzed. RESULTS: Among the four age groups, patients 80 years and over showed significantly lower LL and SS than patients aged 70-79. Females 80 years and over showed significantly lower LL and SS than all other age groups, but those in males did not. The comparison between males and females showed no significant differences in LL and SS; however, the L5-S1 angle was significantly higher in males than in females. In patients 80 years and over, females showed significantly lower LL and SS than in males. CONCLUSIONS: This study provides normative CT-evaluated lumbopelvic parameters, such as LL, L5-S1 angle, and SS, which will be utilized for comparisons in future studies. The present study first revealed that pelvic retroversion and lumbar kyphosis occur in elderly females in the supine position, which raised a possibility that age-related decrease of LL and SS in females occurs at an older age in the supine position than in the standing position.

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This study aimed to perform a comparative analysis of postoperative results between lumbar degenerative spondylolisthesis (LDS) treated with oblique lateral interbody fusion (OLIF) and transforaminal lumbar interbody fusion (TLIF) from the Chiba spine surgery registry database. Sixty-five patients who underwent single-level OLIF (O group) for LDS with ≥ 3 years' follow-up were retrospectively reviewed. The control group comprised 78 patients who underwent single-level TLIF (T group). The analyzed variables included global alignment, radiological parameters of fused segments, asymptomatic and symptomatic ASD incidence, clinical outcomes at 3 years postoperatively using the Japanese Orthopedic Association Back Pain Evaluation Questionnaire data, visual analogue scale scores for low back pain, lower extremity pain, and lower extremity numbness. There was no significant change in global alignment between the two groups. The rate of improvement in anterior intervertebral disc height was not significantly different between the groups at 1-month postoperatively. However, at the final evaluation, the anterior intervertebral disc height and incidence of asymptomatic ASD were significantly higher in the O group. There was no significant difference in symptomatic ASD, reoperation cases, or clinical results between groups. Thus, single-level OLIF can maintain the corrected disc height, but as it has no effect on global alignment, its benefit is limited.

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Cutamesine, a sigma-1 receptor agonist, functions in both neuroprotection and neurite outgrowth. We assessed the therapeutic effects of cutamesine in a rodent spinal cord injury (SCI) model to demonstrate pre-clinical proof-of-concept. First of all, in order to determine optimal cutamesine dose, cutamesine was administered to normal rats and BDNF protein levels in the lumbar spinal cord were assessed by Western blot. Next, for the SCI model, spinal cords of adult female Sprague-Dawley rats were contused using an Infinite Horizon Impactor. Two weeks post-injury, rats were randomly assigned to receive daily subcutaneous injections of either cutamesine (3.0 mg/kg/day) or saline (as a control) for another two weeks. Immunohistochemistry for BDNF and 5-HT was assessed at four and twelve weeks post-injury in the lumbar spinal cord. Locomotor function was assessed weekly using the BBB locomotor scale until twelve weeks after SCI and CatWalk XT 10.5 gait analysis was conducted at twelve weeks after SCI. In normal rats, cutamesine treatment (3.0 mg/kg/day) significantly up-regulated BDNF expression in the lumbar spinal cord. In SCI rats, cutamesine treatment (3.0 mg/kg/day) significantly increased the fluorescence intensity of neuronal BDNF and serotonin boutons in the injured spinal cord compared to saline. However, cutamesine treatment did not promote significant locomotor recovery. Recent work indicates that cutamesine treatment alone did not promote locomotor recovery in spite of immunohistological changes. Future work will explore the influence of combining cutamesine with other treatment promoting plasticity (e.g. rehabilitative training) in SCI rats.

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INTRODUCTION: Holospinal epidural abscess (HEA) extending from the cervical to the lumbosacral spine is an extremely rare condition. Surgical treatment of HEA, which involves extensive decompression of the spinal lesion is difficult in emergency settings. However, the authors successfully treated a case of HEA in critical condition with severe neurological deficits through a combination of skip decompression surgeries and catheter irrigation. CASE PRESENTATION: A 73-year-old man complained of neck and back pain and developed muscle weakness in the upper and lower extremities (C5 AIS D tetraplegia). When he was transferred to our hospital, a marked increase in leukocytes (13330/µL) and C-reactive protein levels (32.11 mg/dL) was observed. Magnetic resonance imaging (MRI) revealed a HEA extending from C1 to S2 levels. Therefore, an emergency posterior decompression on C4-5 and T4-7 was performed, followed by catheter irrigation using a venous catheter. Blood and intraoperative isolated microorganisms were identified as Streptococcus intermedius, which is a rare cause of spinal infection. He experienced marked improvement in pain after surgery. Two months after surgery, the epidural abscess completely disappeared. Motor weakness gradually improved, and he was able to walk without support and showed no pain recurrence during the final follow-up (20 months after surgery). DISCUSSION: Early diagnosis is important for the treatment of HEAs. Therefore, a whole spine MRI is recommended when an extensive spinal epidural abscess is suspected. Decompression surgery at limited spine levels followed by catheter irrigation should be considered in patients with HEA.

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Attenuation of the secondary injury of spinal cord injury (SCI) can suppress the spread of spinal cord tissue damage, possibly resulting in spinal cord sparing that can improve functional prognoses. Granulocyte colony-stimulating factor (G-CSF) is a haematological cytokine commonly used to treat neutropenia. Previous reports have shown that G-CSF promotes functional recovery in rodent models of SCI. Based on preclinical results, we conducted early phase clinical trials, showing safety/feasibility and suggestive efficacy. These lines of evidence demonstrate that G-CSF might have therapeutic benefits for acute SCI in humans. To confirm this efficacy and to obtain strong evidence for pharmaceutical approval of G-CSF therapy for SCI, we conducted a phase 3 clinical trial designed as a prospective, randomized, double-blinded and placebo-controlled comparative trial. The current trial included cervical SCI [severity of American Spinal Injury Association (ASIA) Impairment Scale (AIS) B or C] within 48 h after injury. Patients are randomly assigned to G-CSF and placebo groups. The G-CSF group was administered 400 µg/m2/day × 5 days of G-CSF in normal saline via intravenous infusion for five consecutive days. The placebo group was similarly administered a placebo. Allocation was concealed between blinded evaluators of efficacy/safety and those for laboratory data, as G-CSF markedly increases white blood cell counts that can reveal patient treatment. Efficacy and safety were evaluated by blinded observer. Our primary end point was changes in ASIA motor scores from baseline to 3 months after drug administration. Each group includes 44 patients (88 total patients). Our protocol was approved by the Pharmaceuticals and Medical Device Agency in Japan and this trial is funded by the Center for Clinical Trials, Japan Medical Association. There was no significant difference in the primary end point between the G-CSF and the placebo control groups. In contrast, one of the secondary end points showed that the ASIA motor score 6 months (P = 0.062) and 1 year (P = 0.073) after drug administration tend to be higher in the G-CSF group compared with the placebo control group. Moreover, in patients aged over 65 years old, motor recovery 6 months after drug administration showed a strong trend towards a better recovery in the G-CSF treated group (P = 0.056) compared with the control group. The present trial failed to show a significant effect of G-CSF in primary end point although the subanalyses of the present trial suggested potential G-CSF benefits for specific population.

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BACKGROUND: The FINE total knee was developed in Japan and clinical use began in 2001. It has unique design features, including an oblique 3o femorotibial joint line that reproduces anatomical geometry. Although 20 years have passed since the FINE knee was clinically used for the first time in Japan, a formal clinical evaluation including patient-reported and radiographic outcomes has not been undertaken. METHODS: A total of 175 consecutive primary cruciate-retaining (CR)-FINE total knee arthroplasties (TKAs) at our hospital between February 2015 and March 2017 were included in this study. Three years postoperatively, range of motion (ROM), Knee Society Score (KSS), Knee Injury and Osteoarthritis Outcome Score (KOOS) and Forgotten Joint Score (FJS) were recorded and compared with preoperative scores. Radiographic analyses including mechanical alignment, component alignment, and incidence of radiolucent lines also were undertaken based on the radiographs 3 years postoperatively. RESULTS: One-hundred twenty-two knees (70%) were available for 3-year follow-up data using KOOS, except for the sports subscale. Postoperative KOOS-symptom, -pain and -ADL were > 85 points, but KOOS-sports, -QOL and FJS were less satisfactory. ROM, KSS and all the subscales of KOOS were significantly improved compared with preoperative scores. Postoperative mean FJS was 66 and was significantly correlated with all the subscales of KOOS, but not with postoperative ROM. Radiolucent lines ≧1 mm wide were detected in five knees (4.1%). There were no major complications needing revision surgeries. CONCLUSIONS: Patient-reported outcomes (PROs) for symptoms, pain and ADL after the CR-FINE TKA were generally improved, but those for sports, QOL and FJS were improved less. The incidence of radiolucent lines was rare but detected around the femoral components. With the mid- to long-term follow-up, improvements of surgical technique will be necessary to achieve better PROs from patients receiving the FINE knee.

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BACKGROUND: There is insufficient current information regarding the prognosis of patients with lumbar spondylolysis when bone union is not achieved. To examine the number, age, and surgically treated levels of patients with lumbar degenerative disease who underwent lumbar spine surgery, and to compare the results between patients with spondylolysis and without spondylolysis, a cross-sectional study was performed. METHODS: Patients with degenerative lumbar disease who underwent lumbar spine surgery were retrospectively reviewed (n=354). The prevalence of spondylolysis was determined using CT images. Patients were divided into a spondylolysis group and a non-spondylolysis group, and the patients' age, sex, and surgically treated levels were compared between the two groups. RESULTS: The prevalence of lumbar spondylolysis in the 354 patients was 6.50% (23/354). The patients' age was significantly lower in the spondylolysis group (54.2 ± 13.5 years) than in the non-spondylolysis group (63.8 ± 14.2). The number of surgically treated levels was significantly lower in the spondylolysis group (1.33 ± 0.56 levels) than in the non-spondylolysis group (1.70 ± 0.87). The percentage of patients who underwent surgery at L5-S1 was significantly higher in the spondylolysis group; whereas the percentage of patients who underwent surgery at L3-L4 or L4-L5 was significantly higher in the non-spondylolysis group. CONCLUSIONS: Our results suggest that the presence of spondylolysis may not increase the incidence of degenerative lumbar spinal disorders requiring spinal surgery. However, spondylolysis patients frequently have severe degenerative disease at one level caudal to the spondylolysis, and infrequently have multilevel lumbar degenerative disease requiring spinal surgery.