Effects of Cerclage Cabling on Preventing Periprosthetic Femoral Fractures When Using Cementless Stems for Unstable Femoral Neck Fractures.

BACKGROUND: Periprosthetic femoral fractures (PFFs) are serious complications in hip arthroplasty for femoral neck fractures. The rates of intraoperative and postoperative PFFs are higher in cementless stem cases than in cemented cases. This study aimed to investigate the effects of cerclage cabling on PFF prevention in cementless arthroplasty for femoral neck fractures. METHODS: This retrospective study included 329 consecutive patients who underwent hip arthroplasty using a cementless stem for femoral neck fractures. A total of 159 and 170 patients were in the non-cabling and cabling groups, respectively. Patient characteristics were comparable in both groups. The PFF occurrence (intraoperative PFF [iPFF] and postoperative PFF [pPFF]) rates, reoperation rates, operative time, and blood loss volume were compared between the groups. RESULTS: The iPFF rate was significantly higher in the non-cabling group (6.3%) than in the cabling group (0%, P < 0.001). The rate of pPFF was significantly higher in the non-cabling group (5.1%) than in the cabling group (0.6%; P = 0.016). All patients in the non-cabling group required reoperation (5.1%), whereas the patient in the cabling group was an ambulatory case and required no reoperation (0%, P = 0.003). No significant difference in either operative time or blood loss volume was observed between the non-cabling (50 minutes, 133 mL) and cabling (52 minutes, P = 0.244; 149 mL, P = 0.212, respectively) groups. CONCLUSION: When a cementless stem is used to treat unstable femoral neck fractures, cerclage cabling effectively prevents iPPF and pPPF without increasing surgical time or blood loss volume.

A Case of Persistent Hiccups Induced by an Enlarging Hepatic Cyst Underneath the Diaphragm.

Although hiccups are regularly self-limited and rarely life-threatening, prolonged hiccups are bothersome, which can significantly decrease the quality of life. Here, we report a case of persistent hiccups coexisting with an enlarging liver cyst situated just below the diaphragm in a patient with autosomal dominant polycystic kidney disease (ADPKD). No other underlying etiologies related to the symptoms were suspected. The cyst was difficult to drain surgically and the patient continued with symptomatic treatment. Although rare, hepatic cysts should be considered a potential cause of prolonged hiccups in patients with ADPKD. We emphasize the significance of systematically excluding potential etiologies that cause prolonged hiccups and considering appropriate therapeutic interventions.

Assessing the utility of osteoporosis self-assessment tool for Asians in patients undergoing hip surgery.

Objectives: Diagnosis and treatment of osteoporosis are instrumental in obtaining good outcomes of hip surgery. Measuring bone mineral density (BMD) using dual-energy X-ray absorptiometry (DXA) is the gold standard for diagnosing osteoporosis. However, due to limited access to DXA, there is a need for a screening tool to identify patients at a higher risk of osteoporosis. We analyzed the potential utility of the Osteoporosis Self-assessment Tool for Asians (OSTA) as a screening tool for osteoporosis. Methods: A total of 1378 female patients who underwent hip surgery at 8 institutions were analyzed. For each patient, the BMD of the proximal femoral region was measured by DXA (DXA-BMD), and the correlation with OSTA score (as a continuous variable) was assessed. Receiver operating characteristic (ROC) curve analysis was performed to assess the ability of OSTA score to predict osteoporosis. Lastly, the OSTA score was truncated to yield an integer (OSTA index) to clarify the percentage of patients with osteoporosis for each index. Results: DXA-BMD showed a strong correlation with OSTA (r = 0.683; P < 0.001). On ROC curve analysis, the optimal OSTA score cut-off value of -5.4 was associated with 73.8% sensitivity and 80.9% specificity for diagnosis of osteoporosis (area under the curve: 0.842). A decrease in the OSTA index by 1 unit was associated with a 7.3% increase in the probability of osteoporosis. Conclusions: OSTA is a potentially useful tool for screening osteoporosis in patients undergoing hip surgery. Our findings may help identify high-risk patients who require further investigation using DXA.

Time elapsed from definitive diagnosis to surgery for osteonecrosis of the femoral head: a nationwide observational study in Japan.

OBJECTIVES: This study documents the time elapsed from the diagnosis of osteonecrosis of the femoral head (ONFH) to surgery, exploring the factors that influence ONFH severity. DESIGN: Retrospective observational study of a nationwide database. SETTING: The Kaplan-Meier method with log-rank tests was applied to examine the period from definitive diagnosis of ONFH to surgery using any surgery as the end point. For bilateral cases, the date of the first surgery was the endpoint. PARTICIPANTS: This study included 2074 ONFH cases registered in 34 university hospitals and highly specialised hospitals of the multicentre sentinel monitoring system of the Japanese Investigation Committee between 1997 and 2018. MAIN OUTCOME MEASURE: The primary outcome was the time from diagnosis to surgery. The secondary outcome was the proportion of subjects remaining without surgery at 3, 6 and 9 months, and at 1, 2 and 5 years after diagnosis. RESULTS: The median time to surgery was 9 months (IQR 4-22 months) after diagnosis of ONFH. The time to surgery was significantly shorter in the alcohol alone group and the combined corticosteroid and alcohol group than in the corticosteroid alone group (p=0.018 and p<0.001, respectively), in early stage ONFH with no or mild joint destruction (stages II and III, p<0.001), and with joint preserving surgery (p<0.001). The proportion without surgery was 75.8% at 3 months, 59.6% at 6 months, 48.2% at 9 months, 40.5% at 1 year, 22.2% at 2 years and 8.3% at 5 years. CONCLUSION: ONFH has been considered to be an intractable disease that often requires surgical treatment, but the fact that surgery was performed in more than half of the patients within 9 months from diagnosis suggests severe disease with a significant clinical impact. TRIAL REGISTRATION NUMBER: Chiba University ID1049.

Matrix metalloproteinase­1 and microRNA­486­5p in urinary exosomes can be used to detect early lung cancer: A preliminary report.

The present study describes a novel molecular-genetic method suitable for lung cancer (LC) screening in the work-place and at community health centers. Using urinary-isolated exosomes from 35 patients with LC and 40 healthy volunteers, the expression ratio of MMP-1/CD63, and the relative expression levels of both microRNA (miRNA)-21 and miRNA-486-5p were measured. MMP-1/CD63 expression ratio was significantly higher in patients with LC than in the healthy controls {1.342 [95% confidence interval (CI): 0.890-1.974] vs. 0.600 (0.490-0.900); P<0.0001}. The relative expression of miRNA-486-5p in male healthy controls was significantly different from that in female healthy controls, whereas there was no significant difference in miRNA-21. Receiver operating characteristic curve (ROC) analysis of MMP-1/CD63 showed 92.5% sensitivity and 54.3% specificity, whereas miRNA-486-5p showed 85% sensitivity and 70.8% specificity for men, and 70.0% sensitivity and 72.7% specificity for women. The logistic regression model used to evaluate the association of LC with the combination of MMP-1/CD63 and miRNA-486-5p revealed that the area under the ROC curve was 0.954 (95% CI: 0.908-1.000), and the model had 89% sensitivity and 88% specificity after adjusting for age, sex and smoking status. These data suggested that the combined analysis of MMP-1/CD63 and miRNA-486-5p in urinary exosomes may be used to detect patients with early-stage LC in the work-place and at community health centers, although confirmational studies are warranted.

Leg length discrepancy should be assessed based on the whole length of the lower limb in patients with osteoarthritis secondary to developmental dysplasia of the hip.

Aims: This study aimed to investigate the incidence of ≥ 5 mm asymmetry in lower and whole leg lengths (LLs) in patients with unilateral osteoarthritis (OA) secondary to developmental dysplasia of the hip (DDH-OA) and primary hip osteoarthritis (PHOA), and the relationship between lower and whole LL asymmetries and femoral length asymmetry. Methods: In total, 116 patients who underwent unilateral total hip arthroplasty were included in this study. Of these, 93 had DDH-OA and 23 had PHOA. Patients with DDH-OA were categorized into three groups: Crowe grade I, II/III, and IV. Anatomical femoral length, femoral length greater trochanter (GT), femoral length lesser trochanter (LT), tibial length, foot height, lower LL, and whole LL were evaluated using preoperative CT data of the whole leg in the supine position. Asymmetry was evaluated in the Crowe I, II/III, IV, and PHOA groups. Results: The incidences of whole and lower LL asymmetries were 40%, 62.5%, 66.7%, and 26.1%, and 21.7%, 20.8%, 55.6%, and 8.7% in the Crowe I, II/III, and IV, and PHOA groups, respectively. The incidence of tibial length asymmetry was significantly higher in the Crowe IV group (44.4%) than that in the PHOA group (4.4%). In all, 50% of patients with DDH-OA with femoral length GT and LT asymmetries had lower LL asymmetry, and 75% had whole LL asymmetry. The incidences of lower and whole LL asymmetries were 20% and 42.9%, respectively, even in the absence of femoral length GT and LT asymmetries. Conclusion: Overall, 43% of patients with unilateral DDH-OA without femoral length asymmetry had whole LL asymmetry of ≥ 5 mm. Thus, both the femur length and whole LL should be measured to accurately assess LL discrepancy in patients with unilateral DDH-OA.

The regenerative treatment of costal osteochondral graft implantation for partial growth arrest using a rabbit model.

PURPOSE: To investigate the feasibility of cylindrical costal osteochondral graft transplantation as a novel regenerative treatment in growth arrest. METHODS: The medial portion of the proximal tibial growth plate of 6-week-old male New Zealand White rabbits was resected to establish an experimental model of partial growth plate injury. The rabbits were divided into four groups: no-treatment, bone wax transplantation, costal chondral graft, and costal osteochondral graft groups. Radiographic and micro-computed tomography scan results were analyzed to evaluate angular deformity of the tibia and bony bridge formation at the injury site. In addition, repair of the injured growth plate cartilage was assessed histologically at 4, 8, and 12 weeks postoperatively. RESULTS: Radiographic examination revealed that bone wax transplantation continuously decreased the medial proximal tibial angle (MPTA) while the costal chondral graft implantation reduced the decrease of MPTA at 12 weeks postoperatively. The costal osteochondral graft implantation recovered the MPTA, close to the normal. Histologically, the costal osteochondral grafts retained the MPTA in the injured site compared to costal chondral grafts. Additionally, hypertrophic chondrocytes were observed at the graft site in the costal osteochondral graft group at 12 weeks, suggesting that endochondral ossification may occur at the graft site similar to normal ossification. The fluorescence in situ hybridization analysis of osteochondral grafts transplanted from male to female rabbits indicated that they were replaced by cells of host origin. CONCLUSION: The costal osteochondral graft can achieve regeneration without bony bridge formation in partial growth plate injury.

Therapeutic efficacy of vancomycin-loaded carbon fiber-reinforced polyetheretherketone hip stem for periprosthetic joint infection: A pilot study.

A carbon fiber-reinforced polyetheretherketone (CFR/PEEK) hip stem with a special antibiotic elution mechanism is under development to treat periprosthetic joint infection (PJI). The antibiotic elution characteristics of intramedullary implants were experimentally investigated, and the efficacy of revision surgery using a therapeutic stem in treating ovine PJI was examined. To evaluate elution characteristics, the intramedullary vancomycin-loaded CFR/PEEK cylindrical implants were inserted in the distal femur of nine sheep, and the vancomycin elution rate was measured at 2, 7, and 21 days. To evaluate therapeutic efficacy, the PJI model with staphylococcus aureus was attempted to create for five sheep. Moreover, the therapeutic vancomycin-loaded CFR/PEEK stem was implanted during one-stage revision surgery. Three weeks after revision surgery, the treatment efficacy was evaluated based on bacterial cultures and wound findings. In addition, the vancomycin elution rate from the stem was measured. On average, the cylindrical implants eluted approximately 70% vancomycin in 21 days. Of the five sheep attempting to create a PJI model, three were successfully infected with S. aureus as intended for verification of treatment efficacy. In all three joints, negative bacterial cultures and no purulence were observed 3 weeks after revision surgery. The vancomycin elution rates from the stems were >70%. Efficient elution of vancomycin was confirmed by the experimental implant inserted into the bone marrow and the stem in actual PJI treatment. Using a novel therapeutic stem with an antibiotic elution mechanism in one-stage revision surgery, successful treatment was demonstrated in all S. aureus-induced PJIs.

The Influence of Titanium-coated Poryetheretherketone Cages in Fusion Status after Posterior Lumbar Interbody Fusion with Cortical Bone Trajectory Screw Fixation.

OBJECTIVE: Posterior lumbar interbody fusion (PLIF) with cortical bone trajectory (CBT) screw fixation (CBT-PLIF) shows potential for reducing adjacent segmental disease. Previously, our investigations revealed a relatively lower fusion rate with the use of carbon fiber-reinforced polyetheretherketone (CP) cages in CBT-PLIF compared with traditional pedicle screw fixation (PS-PLIF) using CP cages. This study aims to evaluate whether the implementation of titanium-coated polyetheretherketone (TP) cages can enhance fusion outcomes in CBT-PLIF. METHODS: A retrospective analysis was conducted on 68 consecutive patients who underwent CBT-PLIF with TP cages (TP group) and 89 patients who underwent CBT-PLIF with CP cages (CP group). Fusion status was assessed using computed tomography at 1 year postoperatively and dynamic plain radiographs at 2 years postoperatively. RESULTS: No statistically significant differences in fusion rates were observed at 1 and 2 years postoperatively between the TP group (86.8% and 89.7%, respectively) and the CP group (77.5% and 88.8%, respectively). Notably, the CP group exhibited a significant improvement in fusion rate from 1 to 2 years postoperatively (P = 0.002), while no significant improvement was observed in the TP group. CONCLUSIONS: Examination of temporal changes in fusion rates reveals that only the TP group achieved a peak fusion rate 1 year postoperatively. This implies that TP cages may enhance the fusion process even after CBT-PLIF. Nevertheless, the definitive efficacy of TP cages for CBT-PLIF remains uncertain in the context of overall fusion rates.

Cup safe zone and optimal stem anteversion in total hip arthroplasty for patients with highly required range of motion.

To avoid dislocation after total hip arthroplasty, it is desirable to avoid implant impingement during activities of daily living. Numerous simulation studies have been performed at 30° of internal rotation (IR) with 90° of flexion. However, these studies may not reflect the impingement that occurs during activities such as floor sitting, which require a larger IR during flexion. The purpose of this study was to assess the impact of varying IR angles during flexion on the impingement-free safe zone and optimal stem anteversion. In this study, implant impingement simulation was evaluated in computer simulation. The prosthesis used a flat liner, and a 32- or 40-mm femoral head and stem. Three patterns of required IR angle (30° IR/40° IR/50° IR with 90° flexion) combined with 13 directions of the required range of motion were simulated. The optimal stem anteversion to maximize the safe zone was analyzed. Increasing the required IR at 90° flexion decreased the safe zone, particularly with small stem anteversion angles. With a 32-mm head, the desirable stem anteversion at 40° of cup inclination was 15°/25°/35° in required 30° IR/40° IR/50° IR with 90° flexion, respectively. The safe zone area of the 32-mm head was smaller than that of the 40-mm head. For patients who require a larger IR with 90° flexion, the stem and cup target anteversion should be adjusted according to the implant design, head diameter, and patient's required IR at flexion in their lifestyle.

Repair of osteochondral defects: efficacy of a tissue-engineered hybrid implant containing both human MSC and human iPSC-cartilaginous particles.

Both mesenchymal stromal cells (MSC) and induced pluripotent stem cells (iPSC) offer the potential for repair of damaged connective tissues. The use of hybrid implants containing both human MSC and iPSC was investigated to assess their combined potential to yield enhanced repair of osteochondral defects. Human iPSC-CP wrapped with tissue engineered constructs (TEC) containing human MSC attained secure defect filling with good integration to adjacent tissue in a rat osteochondral injury model. The presence of living MSC in the hybrid implants was required for effective biphasic osteochondral repair. Thus, the TEC component of such hybrid implants serves several critical functions including, adhesion to the defect site via the matrix and facilitation of the repair via live MSC, as well as enhanced angiogenesis and neovascularization. Based on these encouraging studies, such hybrid implants may offer an effective future intervention for repair of complex osteochondral defects.

MRI screening for osteonecrosis of the femoral head after COVID-19.

OBJECTIVES: Systemic steroid administration has been suggested for the treatment of coronavirus disease 2019 (COVID-19), but the occurrence of osteonecrosis of the femoral head (ONFH) was one of the concerns for this treatment. This study aimed to use magnetic resonance imaging (MRI) to assess the incidence of ONFH after treatment COVID-19. METHODS: The study included 41 patients who were hospitalized and treated for pneumonia or other COVID-19-induced diseases. We conducted interviews with these patients regarding hip pain and performed MRI screenings for ONFH. The incidence and timing of ONFH after COVID-19 treatment were investigated. RESULTS: Of the 41 patients, one died of pneumonia, and the remaining patients did not complain of hip pain. MRI screening of 26 patients was performed, and asymptomatic ONFH was detected in one patient (3.8%) whose ONFH appeared 1 month after the COVID-19 infection. CONCLUSION: Our MRI screening of ONFH in post-COVID-19 patients revealed asymptomatic ONFH, which would not have been identified without active screening. Physicians should be aware that ONFH may occur in patients after treating COVID-19.

Five-Year Outcomes After Implantation of a Scaffold-Free Tissue-Engineered Construct Generated From Autologous Synovial Mesenchymal Stromal Cells for Repair of Knee Chondral Lesions.

Background: In an earlier study, a scaffold-free tissue-engineered construct (TEC) derived from autologous synovial membrane mesenchymal stromal cells (MSCs) was developed and demonstrated to be safe and effective for cartilage repair at 2 years postoperatively. Purpose: To investigate clinical outcomes and magnetic resonance imaging (MRI) findings at 5 years after implantation. Study Design: Case series; Level of evidence, 4. Methods: This was an observational first-in-human study limited to 5 patients (age, 28-46 years) with symptomatic knee chondral lesions (size, 1.5-3.0 cm2) on the medial femoral condyle, lateral femoral condyle, or femoral groove. Synovial MSCs were isolated from arthroscopic biopsy specimens and cultured to develop a TEC that matched the lesion size. The TECs were then implanted into chondral defects without fixation and assessed at up to 5 years postoperatively. The patients were clinically evaluated using the visual analog scale for pain, Lysholm score, Tegner score, and Knee injury and Osteoarthritis Outcome Score. An MRI scan evaluation was also performed for morphologic and compositional quality of the repair tissue at both 2 and 5 years of follow-up. Results: All clinical scores were significantly improved from the preoperative evaluation to the 2- and 5-year follow-ups and the results were stable over time. The MRI scan evaluation showed cartilage defects filled with newly generated tissues with good tissue integration to adjacent host cartilage over time. The cartilage thickness and surface smoothness of the repair cartilage were maintained up to 5 years postoperatively. The MOCART (magnetic resonance observation of cartilage repair tissue) 2.0 Knee Scores remained high at 5 years, although the total points decreased slightly. Conclusion: The results highlight the efficacy and feasibility of autologous scaffold-free TEC derived from synovial MSCs for regenerative cartilage repair via a sutureless and simple implantation procedure, showing good clinical outcomes and MRI findings with stable results at midterm follow-up. Further follow-up will be needed to assess the long-term quality of the repair tissue.

Risk analysis of COVID-19 hospitalization and critical care by race and region in the United States: a cohort study.

BACKGROUND: This study aimed to identify the current risk factors for coronavirus disease 2019 severity and examine its association with medication use. METHODS: We used data from a large United States electronic health record database to conduct an anonymized cohort study of 171,491 patients with coronavirus disease 2019. The study was conducted from January 1, 2020, to August 27, 2021. Data on age, race, sex, history of diseases, and history of medication prescriptions were analyzed using the Cox proportional hazards model analysis to calculate hazard ratios for hospitalization and severe risk. RESULTS: Factors that increased the risk of hospitalization and critical care were age ≥ 65 years, male sex, type 2 diabetes, hypertension, interstitial pneumonia, and cardiovascular disease. In particular, age ≥ 65 years significantly increased the risk of hospitalization (hazard ratio, 2.81 [95% confidence interval, 2.58-3.07]; P < 0.001) and critical care (hazard ratio, 3.45 [2.88-4.14]; P < 0.001). In contrast, patients with hyperlipidemia had a reduced risk. However, patients with hyperlipidemia who were not taking statins had a significantly increased risk of hospitalization (hazard ratio, 1.24 [1.16-1.34]; P < 0.001). Sodium-glucose cotransporter-2 inhibitors, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, glucocorticoids, and statins significantly reduced the risk of hospitalization and critical care. The risk of hospitalization and critical care increased in patients of all ethnicities with type 2 diabetes. The factors that significantly increased the risk of hospitalization in all regions were older age, hypertension, chronic obstructive pulmonary disease, and cardiovascular disease. CONCLUSION: This study identified factors that increase or reduce the risk of severe coronavirus disease. The provision of appropriate drug treatment and modification of lifestyle-related risk factors may reduce coronavirus disease severity.

Optimizing vancomycin release from novel carbon fiber-reinforced polymer implants with small holes: periprosthetic joint infection treatment.

Periprosthetic joint infection (PJI) is a catastrophic complication after total hip arthroplasty. A new drug-loaded carbon fiber-reinforced polymer (CFRP) prosthesis with a sustained drug-release mechanism is being developed for one-stage surgery. We aimed to examine the diffusion dynamics of vancomycin from vancomycin paste-loaded CFRP implants. The differences in the in vitro diffusion dynamics of vancomycin paste were investigated using the elution test by varying parameters. These included the mixing ratio of vancomycin and distilled water (1:0.8, 1:1.2, and 1:1.4) for vancomycin paste, and hole diameter (1 mm and 2 mm) on the container. The in vivo diffusion dynamics were investigated using a rabbit model with vancomycin-loaded CFRP implants placed subcutaneously. The in vitro experiments showed that the diffusion effect of vancomycin was highest in the parameters of vancomycin paste with distilled water mixed in a ratio of 1:1.4, and with a 2 mm hole diameter. The in vivo experiments revealed diffusion dynamics similar to those observed in the in vitro study. The drug diffusion effect tended to be high for vancomycin paste with a large water ratio, and a large diameter of holes. These results indicate that the drug diffusion dynamics from a CFRP implant with holes can be adjusted by varying the water ratio of the vancomycin paste, and the hole size on the CFRP implant.

Small extracellular vesicles derived from human adipose-derived mesenchymal stromal cells cultured in a new chemically-defined contaminate-free media exhibit enhanced biological and therapeutic effects on human chondrocytes in vitro and in a mouse osteoarthritis model.

Human small extracellular vesicles (sEVs) derived from adipose-derived mesenchymal stromal cells (ASC) have been reported to suppress the progression of osteoarthritis (OA) in animal studies and subsequently, translation of this potential to assess their clinical efficacy is anticipated. However, fabrication protocols for sEVs to eliminate potential contamination by culture medium-derived components need to be established prior to their clinical use. The purpose of the present studies was to elucidate the influence of medium-derived contaminants on the biological effects of sEVs, and to establish isolation methods for sEVs using a new clinical grade chemically-defined media (CDM). The quantity and purity of ASC-derived sEVs cultured in four different CDMs (CDM1, 2, 3 and 4) were evaluated. The concentrates of the four media incubated without cells were used as the background (BG) control for each set of sEVs. The biological effect of sEVs fabricated in the four different CDMs on normal human articular chondrocytes (hACs) were evaluated in vitro using a variety of methodological assessments. Finally, the sEVs with the highest purity were tested for their ability to suppress the progression of knee OA mouse model. Analysis of the BG controls revealed that CDM1-3 contained detectable particles, while there was no visible contamination of culture media-derived components detected with CDM4. Accordingly, the sEVs fabricated with CDM4 (CDM4-sEVs) exhibited the highest purity and yield. Notably, the CDM4-sEVs were the most efficient in promoting the cellular proliferation, migration, chondrogenic differentiation, and anti-apoptotic activity of hACs. Furthermore, CDM4-sEVs significantly suppressed the osteochondral degeneration in vivo model. Small EVs derived from ASCs cultured in a CDM without detectable contaminants demonstrated enhanced biological effects on hACs and the progression of OA. Thus, sEVs isolated with CDM4 most optimally meet the requirements of efficacy and safety for assessment in their future clinical applications.

Freeze-dried noncoagulating platelet-derived factor concentrate is a safe and effective treatment for early knee osteoarthritis.

PURPOSE: While a wide variety of platelet-rich plasma (PRP) solutions has been developed, innovation continues. In this case, the freeze-dried platelet factor concentrate (PFC-FD) represents another step in PRP refinement. The preparation of PFC-FD at a central laboratory with freeze drying for shelf stabilization should provide additional quality improvements if clinical effectiveness can be demonstrated. Therefore, this study was undertaken to assess the safety and effectiveness of PFC-FD in a prospective open-label trial of patients suffering from knee osteoarthritis (OA). METHODS: 312 consecutive knee OA patients (67% female, mean age 63 ± 10 years), were prospectively recruited in an outpatient knee clinic in Japan. Of these, 10 (3.2%) were lost to follow-up at < 12 months and 17 (5.5%) sought additional knee therapy during the follow-up period. The primary outcome of interest was achievement of the OMERACT-OARSI responder criteria with secondary outcomes of adverse events and PROMs scores 1, 3, 6, 12 months following a single PFC-FD injection. RESULTS: 285 patients (91%) completed 12 month PROMs. The 17 who sought additional therapy were considered failures leaving an effective sample size of 302 for our primary outcome in which 62% of patients achieved OMERACT-OARSI responder status by 12 months. This varied by OA class with Kellgren-Lawrence grade 4 patients 3.6 times less likely to be responders than grade 1-2 patients. 6% of patients experienced a non-serious adverse event, primarily pain or swelling at the injection site. CONCLUSIONS: PFC-FD provides an observable clinical improvement in 62% of knee OA patients at 12 months post-injection with very little risk of any clinically relevant adverse event. Of course, nearly 40% of patients did not experience an observable clinical improvement, primarily among those with worse KL grades. LEVEL OF EVIDENCE: Therapeutic, Level II.

The effect of patient positioning on measurements of bone mineral density of the proximal femur: a simulation study using computed tomographic images.

The patient's position may affect the bone mineral density (BMD) measurements; however, the extent of this effect is undefined. This CT image-based simulation study quantified changes in BMD induced by hip flexion, adduction, and rotations to recommend appropriate patient positioning when acquiring dual-energy x-ray absorptiometry images. PURPOSE: Several studies have analyzed the effect of hip rotation on the measurement of bone mineral density (BMD) of the proximal femur by dual-energy x-ray absorptiometry (DXA). However, as the effects of hip flexion and abduction on BMD measurements remain uncertain, a computational simulation study using CT images was performed in this study. METHODS: Hip CT images of 120 patients (33 men and 87 women; mean age, 82.1 ± 9.4 years) were used for analysis. Digitally reconstructed radiographs of the proximal femur region were generated from CT images to calculate the BMD of the proximal femur region. BMD at the neutral position was quantified, and the percent changes in BMD when hip internal rotation was altered from -30° to 15°, when hip flexion was altered from 0° to 30°, and when hip abduction was altered from -15° to 30° were quantified. Analyses were automatically performed with a 1° increment in each direction using computer programming. RESULTS: The alteration of hip angles in each direction affected BMD measurements, with the largest changes found for hip flexion (maximum change of 17.7% at 30° flexion) and the smallest changes found for hip rotation (maximum change of 2.2% at 15° internal rotation). The BMD measurements increased by 0.34% for each 1° of hip abduction, and the maximum change was 12.3% at 30° abduction. CONCLUSION: This simulation study quantified the amount of BMD change induced by altering the hip position. Based on these results, we recommend that patients be positioned carefully when acquiring DXA images.

Feasibility of robot­assisted radical cystectomy in a patient with an ectopic kidney: A case report.

An ectopic kidney is a rare congenital defect in which the kidney does not migrate to its normal anatomical position. In the present study, a robot-assisted radical cystectomy and intracorporeal urinary diversion were performed for a patient with an ectopic kidney. The present study describes the case of a 72-year-old male patient who was diagnosed with a bladder tumor by magnetic resonance imaging and cystoscopy. A transurethral resection of the bladder tumor was performed. The pathological examination revealed an invasive urothelial carcinoma. Contrast-enhanced computed tomography revealed an ectopic left kidney in the upper pelvis. A robot-assisted radical cystectomy, extended lymph node dissection and intracorporeal urinary diversion were performed. On the whole, as demonstrated herein, a robot-assisted radical cystectomy with intracorporeal urinary diversion is a feasible approach for muscle-invasive bladder cancer complicated by an ectopic kidney.