Progressive spinal destruction secondary to minimal vertebral fracture in a patient with diffuse idiopathic skeletal hyperostosis: a case report.

Early operative fixation is widely recognized as essential for managing spinal fractures in patients with diffuse idiopathic skeletal hyperostosis (DISH). However, no report to date has addressed the occurrence of minimal vertebral fractures diagnosable only through magnetic resonance imaging (MRI) in these patients and the associated temporal changes in the fracture site. In this report, we describe a rare clinical case involving an 81-year-old man who developed progressive spinal destruction secondary to a minimal vertebral fracture. MRI showed minimum-intensity changes in the T12 vertebral body, whereas X-ray and computed tomography examinations showed DISH and no spinal fracture. Despite experiencing severe low back pain, the patient did not undergo operative therapy for 2 months, resulting in progressive spinal destruction. Spinal fusion with posterior instrumentation was performed, and the patient was followed for 1 year with no symptoms and good functional status. This case emphasizes the importance of clinicians being cautious to avoid overlooking and undervaluing minimal vertebral fractures diagnosable only through MRI in patients with DISH.

Frequency-response relationship between exercise and locomotive syndrome across age groups: Secondary analysis of a nationwide cross-sectional study in Japan.

OBJECTIVES: This study aimed to clarify the frequency-response relationship between exercise habits and locomotive syndrome (LS) in different age groups. METHODS: We analysed 8681 independent community dwellers who participated in a nationwide cross-sectional LS study. Participants were divided into young (20-39 years), middle (40-64 years), and old (≥ 65 years) groups. The presence of LS was evaluated using the LS risk tests. Exercise habits were assessed by exercise frequency (almost every day/sometimes/occasionally/never). The association between LS and exercise was assessed using the multiple logistic regression analysis adjusted for participant characteristics for each age category. RESULTS: Overall, 3528 (41%) participants had LS. In the old group, the risk of LS was lower with an increased exercise frequency. However, this dose-response relationship was not found in the young group. The proportion of LS was lower even in participants who occasionally exercised (1-3 days/month) than those who never exercise in the young and middle age groups. CONCLUSIONS: Regular exercise reduced the risk of LS not only in middle and older adults but also in young adults. Moreover, increasing exercise frequency may provide benefits for LS prevention, especially among older adults.

Two-level Posterior Lumbar Interbody Fusion at the Lumbosacral Segment has a High Risk of Pseudarthrosis and Poor Clinical Outcomes: Comparison Between the Lumbar and Lumbosacral Segments.

STUDY DESIGN: This was a retrospective study. OBJECTIVES: The purposes of this study were to investigate the fusion rate and clinical outcomes of 2-level posterior lumbar interbody fusion (PLIF). SUMMARY OF BACKGROUND DATA: PLIF provides favorable clinical outcomes and a high fusion rate. However, most extant studies have been limited to the results of single-level PLIF. Clinical outcomes and fusion rate of 2-level PLIF are unknown. MATERIALS AND METHODS: In total, 73 patients who underwent 2-level PLIF below L3 between 2008 and 2016 (follow-up period >2 y) were included. Patients were divided into the 2 groups on the basis of surgical level. The lumbar group included 48 patients who underwent L3/4/5 PLIF, and the lumbosacral group included 25 patients who underwent L4/5/S PLIF. Fusion rate and clinical outcomes were compared. The Japanese Orthopedic Association Back Pain Evaluation Questionnaire (JOABPEQ) and a visual analog scale were used for evaluation. RESULTS: Fusion rate was significantly lower in the lumbosacral group (lumbar 96% vs. lumbosacral 64%; P<0.001). Eight of 9 cases of pseudarthrosis occurred at the lumbosacral segment. Improvement in the mental health domain of the JOAPEQ was significantly lower in the lumbosacral group (lumbar 16 vs. lumbosacral 10; P=0.02). The VAS data showed that improvements in the following variables were significantly lower in the lumbosacral group than in the lumbar group: pain in low back (lumbar -38 vs. lumbosacral -23; P=0.004), pain in buttocks or lower leg (lumbar -48 vs. lumbosacral -29; P=0.04), and numbness in buttocks or lower leg (lumbar -44 vs. lumbosacral -33; P=0.04). CONCLUSIONS: Two-level PLIF at the lumbosacral segment demonstrated a significantly lower fusion rate and poorer clinical outcomes than that at the lumbar-only segments. Some reinforcement for the sacral anchor is recommended to improve fusion rate, even for short fusion like 2-level PLIF, if the lumbosacral segment is included. LEVEL OF EVIDENCE: Level III.

Reference values for the locomotive syndrome risk test quantifying mobility of 8681 adults aged 20-89 years: A cross-sectional nationwide study in Japan.

BACKGROUND: The locomotive syndrome risk test was developed to quantify the decrease in mobility among adults, which could eventually lead to disability. The purpose of this study was to establish reference values for the locomotive syndrome risk test for adults and investigate the influence of age and sex. METHODS: We analyzed 8681 independent community dwellers (3607 men, 5074 women). Data pertaining to locomotive syndrome risk test (the two-step test, the stand-up test, and the 25-question geriatric locomotive function scale [GLFS-25]) scores were collected from seven administrative areas of Japan. RESULTS: The reference values of the three test scores were generated and all three test scores gradually decreased among young-to-middle-aged individuals and rapidly decreased in individuals aged over 60 years. The stand-up test score began decreasing significantly from the age of 30 years. The trajectories of decrease in the two-step test score with age was slightly different between men and women especially among the middle-aged individuals. The two physical test scores were more sensitive to aging than the self-reported test score. CONCLUSION: The reference values generated in this study could be employed to determine whether an individual has mobility comparable to independent community dwellers of the same age and sex.

Early cephalad adjacent segment degeneration after posterior lumbar interbody fusion: a comparative study between cortical bone trajectory screw fixation and traditional trajectory screw fixation.

OBJECTIVE: Cortical bone trajectory (CBT) screw insertion through a caudomedial starting point provides advantages in limiting dissection of the superior facet joints and reducing muscle dissection and the risk of superior-segment facet violation by the screw. These advantages of the cephalad CBT screw can result in lower rates of early cephalad adjacent segment degeneration (ASD) after posterior lumbar interbody fusion (PLIF) with CBT screw fixation (CBT-PLIF) than those after PLIF using traditional trajectory screw fixation (TT-PLIF). Here, the authors investigated early cephalad ASD after CBT-PLIF and compared these results with those after TT-PLIF. METHODS: The medical records of all patients who had undergone single-level CBT-PLIF or single-level TT-PLIF for degenerative lumbar spondylolisthesis (DLS) and with at least 3 years of postsurgical follow-up were retrospectively reviewed. At 3 years postoperatively, early cephalad radiological ASD changes (R-ASD) such as narrowing of disc height (> 3 mm), anterior or posterior slippage (> 3 mm), and posterior opening (> 5°) were examined using lateral radiographs of the lumbar spine. Early cephalad symptomatic adjacent segment disease (S-ASD) was diagnosed when clinical symptoms such as leg pain deteriorated during postoperative follow-up and the responsible lesion suprajacent to the fused segment was confirmed on MRI. RESULTS: One hundred two patients underwent single-level CBT-PLIF for DLS and were followed up for at least 3 years (CBT group). As a control group, age- and sex-matched patients (77) underwent single-level TT-PLIF for DLS and were followed up for at least 3 years (TT group). The total incidence of early cephalad R-ASD was 12.7% in the CBT group and 41.6% in the TT group (p < 0.0001). The incidence of narrowing of disc height, anterior slippage, and posterior slippage was significantly lower in the CBT group (5.9%, 2.0%, and 4.9%) than in the TT group (16.9%, 13.0%, and 14.3%; p < 0.05). Early cephalad S-ASD developed in 1 patient (1.0%) in the CBT group and 3 patients (3.9%) in the TT group; although the incidence was lower in the CBT group than in the TT group, no significant difference was found between the two groups. CONCLUSIONS: CBT-PLIF, as compared with TT-PLIF, significantly reduced the incidence of early cephalad R-ASD. One of the main reasons may be that cephalad CBT screws reduced the risk of proximal facet violation by the screw, which reportedly can increase biomechanical stress and lead to destabilization at the suprajacent segment to the fused segment.

Randomized phase 2 trial comparing JNJ-9375, a thrombin-directed antibody, with apixaban for prevention of venous thrombosis.

BACKGROUND: JNJ-9375 is an antibody against exosite 1 on thrombin, inhibits substrate binding but not catalytic activity. OBJECTIVE: To examine the possibility that JNJ-9375 attenuates thrombosis without affecting hemostasis, we compared the efficacy and safety of JNJ-9375 and apixaban. METHODS: In this double-blind, double-dummy phase 2 trial, 308 patients undergoing knee arthroplasty were randomized to receive either a single postoperative intravenous infusion of JNJ-9375 in doses ranging from 0.3 to 1.8 mg/kg or apixaban (2.5 mg twice daily). The primary efficacy endpoint was the incidence of venous thromboembolism (assessed by mandatory unilateral venography or confirmed symptomatic events). The primary safety outcome was the composite of major, clinically relevant nonmajor, and minimal bleeding. Thrombin times were measured to assess JNJ-9375 activity. RESULTS: A total of 239 of the 308 patients (77.6%) were included in the modified intention-to-treat analysis. Of these, 238 had evaluable venograms and one had symptomatic deep-vein thrombosis confirmed by ultrasound. Despite dose-dependent thrombin time prolongation, the primary efficacy outcome occurred in 59 of 190 patients (31.1%) in the combined JNJ-9375 groups as compared with 6 of 49 patients (12.2%) given apixaban (odds ratio 3.2; two-sided 80% confidence interval 1.8-5.8; P = .011). The excess events with JNJ-9375 compared with apixaban were consistent across all JNJ-9375 dosing cohorts and there was no evidence of improved efficacy with higher JNJ-9375 doses. There were no major bleeds with JNJ-9375 or apixaban, and rates of any bleeding were similar with the highest and lowest JNJ-9375 doses. CONCLUSIONS: JNJ-9375 was safe but less effective than apixaban. This may reflect weak thrombin inhibition or inability of JNJ-9375 to attenuate the growth of thrombi that formed before drug administration.

Abdominal Aortic Calcification Is a Significant Poor Prognostic Factor for Clinical Outcomes After Decompressive Laminotomy for Lumbar Spinal Canal Stenosis.

STUDY DESIGN: Retrospective study. OBJECTIVE: To examine whether the presence of chronic kidney disease (CKD) or advanced abdominal aortic calcification (AAC) negatively affects clinical outcomes after decompression surgery for lumbar spinal canal stenosis (LSCS). METHODS: The subjects comprised 143 patients who underwent decompressive laminotomy for LSCS and were followed for ≥2 years. Fifty-five patients had CKD (Stage 3-4). Clinical outcome was assessed using the Japanese Orthopaedic Association (JOA) score before surgery and at 2-year postoperatively. According to the scoring system by Kauppila et al, the AAC score (a surrogate marker of systemic atherosclerosis) was assessed using preoperative lateral radiographs of the lumbar spine. RESULTS: Patient age had weak but significantly negative correlations with both the preoperative JOA score and the JOA score at 2 years after surgery, but did not have a significant correlation with the recovery rate of the JOA score at 2 years postoperatively. The JOA score before surgery, the JOA score at 2-year follow-up, and the recovery rate of the JOA score were slightly lower in the CKD patients than in those without CKD, although there were no significant differences between the 2 groups. On the contrary, the AAC score had a weak but significantly negative correlation with the preoperative JOA score, and had relatively strong and significantly negative correlations with both the JOA score at 2 years after surgery and the recovery rate of the JOA score. CONCLUSIONS: At 2 years after surgery, advanced AAC was a significant poor prognostic factor for clinical outcomes of decompression surgery for LSCS.

Bone stock reconstruction for huge bone loss using allograft-bones, bone marrow, and teriparatide in an infected total knee arthroplasty.

Bone stock reconstruction using allograft-bones, bone marrow (BM), and teriparatide (TPTD) is reported. Huge and extensive bone losses occurred in the medullary cavity of the femur and tibia of a 55-year-old female rheumatoid arthritis patient with severe osteoporosis after debridement of her infected total knee arthroplasty. Because of the risks of unstable prosthetic fixation and intra-operation fracture, we first reconstructed the bone stock. Chipped allograft bones mixed with BM were implanted in the bone defects, and TPTD was administrated for the osteoporosis therapy. Good bone formation was found by computed tomography after 4 months. Bone turnover markers and bone mineral density (BMD) were increased at 6 months. We confirmed good bone formation at the re-implantation surgery. The newly formed bone harvested during the re-implantation surgery showed active osteoblast-like lining cells. TPTD is known to enhance allograft bone union, mesenchymal stem cell differentiation into osteoblasts, and BMD. This tissue engineering-based technique might be improved by the various effects of TPTD. This method without any laboratory cell culture might be a good option for bone stock reconstruction surgery in ordinary hospitals.

Introduction of integrated dental training jaw models and rubric criteria.

OBJECTIVE: The objective of the present study was to evaluate the effectiveness of introducing integrated jaw models, rubric criteria and homework tasks to a total clinical simulation training course to improve the clinical competence of preclinical dental students. METHODS: A total simulation training course, which involved six clinical dentistry departments, was held for 110 preclinical students in 2014 and 2015. We prepared integrated jaw models having several morbidities along with corresponding medical information and homework tasks. The students formulated diagnoses and devised treatment plans before performing dental treatment on the mannequin under the direction of instructors from the respective clinical departments. Their performance was assessed by both students and instructors using the rubric criteria. RESULTS: Based on quantitative evaluations, the introduction of integrated jaw models appeared to improve the students' ability to formulate diagnoses and devise dental treatment plans and to understand the respective clinical dentistry disciplines. The rubric criteria provided immediate feedback for the students. Based on a comparison of rubric scores, students tended to significantly underestimate their own performance compared with instructors. Moreover, the introduction of homework tasks improved student seriousness. CONCLUSION: Introducing integrated jaw models, rubric criteria and homework tasks to a total simulation training course may be a good approach for improving student performance in terms of dental diagnoses and treatment.

Chronological Changes in Axial Alignment of the Ipsilateral Hip and Knee After Total Hip Arthroplasty.

BACKGROUND: Internal rotation of the hip and lateral patellar tilt increases after total hip arthroplasty (THA). However, it remains unknown whether these parameters change with time after the index THA. METHODS: A total of 91 patients undergoing 2-stage bilateral primary THAs between January 2008 and May 2014 were included to assess the association of chronological changes in internal rotation of the hip or lateral patellar tilt with anthropometric and perioperative parameter and changes in alignment after the index THA. Chronological changes were assessed as changes between postoperative computed tomography on the index surgery and the preoperative computed tomography on the contralateral THA. Internal rotation of the hip was defined as the angle between the posterior intercondylar line and a line passing through the posterior inferior iliac spines. Lateral patellar tilt was defined as the angle between the posterior intercondylar line and a line joining the medial and lateral edges of the patella. RESULTS: Internal rotation of the hip and lateral patellar tilt changed until 2 years after the index surgery by a mean of -2° (range -17.3° to 17.7°) and -2° (range -18.2° to 5.3°), respectively. Adductor tenotomy was associated with increasing internal rotation of the hip with time (adjusted R2 0.076); leg lengthening and larger preoperative femorotibial angle were associated with decreasing lateral patellar tilt with time (adjusted R2 0.159). CONCLUSION: Both internal rotation of the hip at rest and lateral patellar tilt decreased by approximately 2° until 2 years after surgery and there was a large variation in chronological change.

Practice-Based Longitudinal Study of Multifactorial Risk Assessment for Periodontal Condition and Survival of Remaining Teeth in Patients with Removable Partial Dentures.

PURPOSE: This retrospective cohort study examined factors affecting the periodontal condition and survival of remaining teeth 5 years after removable partial denture (RPD) placement using multivariate analyses. MATERIALS AND METHODS: Of 231 patients who received RPDs at Tohoku University Hospital, 108 patients who had agreed to undergo a 5-year follow-up were examined. The outcomes of RPD treatment were assigned to one of three categories: successful (n = 58), remake (n = 36), and failure (n = 14). A total of 80 patients in the successful and remake groups were included in this study. The parameters analyzed to evaluate the periodontal condition were probing depth, Miller index of tooth mobility, and bone resorption level. Criterion variables were the outcome of each periodontal condition, deterioration, and tooth loss. Independent variables were sex, age, smoking habit, number of periodic maintenance appointments, location of RPD, number of abutment teeth, denture base material, design, and existence of a denture in the opposite jaw. Bivariate analyses were performed using chi-square test, and multivariate regression analysis was used to assess significance. RESULTS: Sex and frequency of maintenance care were independently associated with deterioration of the periodontal condition. Sex and existence of a denture in the opposite jaw were independently associated with tooth loss. CONCLUSION: The findings suggest that periodic maintenance care and condition of the opposite jaw are essential for maintaining the condition of the remaining teeth.

Incidence of venous thromboembolism and bleeding events in patients with lower extremity orthopedic surgery: a retrospective analysis of a Japanese healthcare database.

BACKGROUND: Orthopedic surgeries of lower extremities such as total knee arthroplasty (TKA), total hip arthroplasty (THA), and hip fracture surgery (HFS) are widely considered to carry a high risk of developing deep venous thrombosis (DVT) and pulmonary thromboembolism (PTE). Growing attention to epidemiological studies using a healthcare database led us to quantify the risks using a Japanese database to reveal recent medical care for such events. METHODS: The study comprised 36,947 patients who had undergone orthopedic surgeries of the lower extremities and whose medical information from April 2008 to September 2013 was available. The source population of the database was derived from 100 acute-care hospitals with Diagnosis Procedure Combination. The events were defined by diagnosis, medication, imaging, and laboratory tests. RESULTS: A breakdown of patients who underwent orthopedic surgeries by type of surgery showed 13.6% for TKA, 10.4% for THA, 56.8% for HFS, 1.5% for rupture of Achilles tendon, and 18.0% for simple fracture of lower extremities. The incidence for DVT, PTE, and bleeding events by type of surgery was 1.3, 0.2, and 1.0% for TKA; 0.9, 0.2, and 1.1% for THA; and 0.4, 0.1, and 1.8% for HFS, respectively. The population for risk factor analysis consisted of patients with similar background factors who underwent TKA, THA, or HFS. The statistically significant risk factors for PTE analyzed by the backward elimination procedure in a multivariate model were female sex, history of venous thromboembolism (VTE), thrombophilia, and varicose veins of lower extremity. CONCLUSIONS: The incidence of DVT, PTE, and bleeding events and the risk factors for DVT and PTE in patients by type of orthopedic surgeries of lower extremities found in our study are considered to be rational as they reflect evidence from real-world cases. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry UMIN000012667.

Clinical Outcomes After Posterior Lumbar Interbody Fusion: Comparison of Cortical Bone Trajectory and Conventional Pedicle Screw Insertion.

STUDY DESIGN: This study is a retrospective cohort study using prospectively collected data. OBJECTIVE: To compare the effectiveness of posterior lumbar interbody fusion (PLIF) using the cortical bone trajectory (CBT) and conventional pedicle screw (PS) techniques. SUMMARY OF BACKGROUND DATA: There are few published studies to date comparing PLIF using CBT technique with PLIF using the conventional PS technique. METHODS: We studied 119 consecutive patients who underwent single-level PLIF between 2010 and 2014 with a minimum 12-month follow-up. Forty-two patients underwent CBT-PLIF (the CBT group) and 77 underwent conventional PS-PLIF (the PS group). Clinical outcomes were assessed by the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) and visual analog scale (VAS). To assess perioperative pain, a 6-point Numeric Rating Scale score and the total amount of diclofenac sodium suppositories used were recorded. The operative time and blood loss were recorded. Muscle damage was evaluated by serum creatine kinase concentrations. Fusion status was evaluated using 3-dimensional computed tomography 12 months postoperatively. We used inverse probability of treatment weighting based on the propensity score to reduce confounding factors. RESULTS: There were no significant between-group differences in operative time or fusion rates, whereas the CBT group experienced significantly less blood loss, lower postoperative creatine kinase levels, less diclofenac sodium suppositories, and lower Numeric Rating Scale scores than the PS group did. The change in the JOABPEQ subdomain score for social life function 1 month postoperatively was the only significantly different factor among the JOABPEQ and VAS scores. CONCLUSIONS: Both procedures were comparable in terms of clinical outcomes and fusion rates, but CBT-PLIF provided the additional benefits of less blood loss, less intraoperative muscle damage, less perioperative pain, and earlier recovery to normal activities.

Preoperative retrolisthesis as a predictive risk factor of reoperation due to delayed-onset symptomatic foraminal stenosis after central decompression for lumbar canal stenosis without fusion.

BACKGROUND CONTEXT: For patients diagnosed with lumbar central canal stenosis with asymptomatic foraminal stenosis (FS), surgeons occasionally only decompress central stenosis and preserve asymptomatic FS. These surgeries have the potential risk of converting preoperative asymptomatic FS into symptomatic FS postoperatively by accelerating spinal degeneration, which requires reoperation. However, little is known about delayed-onset symptomatic FS postoperatively. PURPOSE: This study aimed to evaluate the rate of reoperation for delayed-onset symptomatic FS after lumbar central canal decompression in patients with preoperative asymptomatic FS, and determine the predictive risk factors of those reoperations. STUDY DESIGN: This study is a retrospective cohort study. PATIENT SAMPLE: Two hundred eight consecutive patients undergoing posterior central decompression for lumbar canal stenosis between January 2009 and June 2014 were included in this study. OUTCOME MEASURES: The number of patients who had preoperative FS and the reoperation rate for delayed-onset symptomatic FS at the index levels were the outcome measures. METHODS: Patients were divided into two groups with and without preoperative asymptomatic FS at the decompressed levels. The baseline characteristics and revision rates for delayed-onset symptomatic FS were compared between the two groups. Predictive risk factors for such reoperations were determined using multivariate logistic regression and receiver operating characteristics analyses. RESULTS: Preoperatively, 118 patients (56.7%) had asymptomatic FS. Of those, 18 patients (15.3%) underwent reoperation for delayed-onset symptomatic FS at a mean of 1.9 years after the initial surgery. Posterior slip in neutral position and posterior extension-neutral translation were significant risk factors for reoperation due to FS. The optimal cutoff values of posterior slip in neutral position and posterior extension-neutral translation for predicting the occurrence of such reoperations were both 1 mm; 66.7% of patients who met both of these cutoff values had undergone reoperation. CONCLUSIONS: This study demonstrated that 15.3% of patients with preoperative asymptomatic FS underwent reoperation for delayed-onset symptomatic FS at the index levels at a mean of 1.9 years after central decompression, and preoperative retrolisthesis was a predictive risk factor for such a reoperation. These findings are valuable for establishing standards of appropriate treatment strategies in patients with lumbar central canal stenosis with asymptomatic FS.

Edoxaban versus enoxaparin for the prevention of venous thromboembolism after total knee or hip arthroplasty: pooled analysis of coagulation biomarkers and primary efficacy and safety endpoints from two phase 3 trials.

BACKGROUND: The objective of this analysis was to assess the effects of edoxaban compared with enoxaparin on key coagulation biomarkers and present pooled primary efficacy and safety results from phase 3 STARS E-3 and STARS J-V trials for prevention of venous thromboembolism (VTE) after total knee arthroplasty (TKA) or total hip arthroplasty (THA). METHODS: In the randomized, double-blind, double-dummy, multicenter, STARS E-3 and STARS J-V trials, patients received edoxaban 30 mg or enoxaparin 2000 IU (20 mg) twice daily for 11 to 14 days. The studies were conducted in Japan and Taiwan; enoxaparin dosing was based on Japanese label recommendations. The primary efficacy endpoint was incidence of VTE; the safety endpoint was major or clinically relevant nonmajor (CRNM) bleeding. Blood samples were taken at presurgical evaluation, pretreatment (postsurgery), predose on day 7, predose on completion of treatment, and at a follow-up examination 25 to 35 days after the last dose of study drug for D-dimer, prothrombin fragment 1 + 2 (F1+2), and soluble fibrin monomer complex (SFMC) measurement. RESULTS: A total of 716 patients enrolled in STARS E-3 and 610 patients enrolled in STARS J-V; 1326 patients overall. This analysis included 657 patients who received edoxaban 30 mg QD and 650 patients who received enoxaparin 20 mg BID. Incidence of VTE was 5.1 and 10.7% for edoxaban and enoxaparin, respectively (P <0.001). Incidence of combined major and CRNM bleeding was 4.6 and 3.7% for edoxaban and enoxaparin, respectively (P = 0.427). On day 7, mean D-dimer (4.4 vs 5.5 µg/mL), F1+2 (363 vs 463 pmol/L), and SFMC (5.7 vs 6.8 µg/mL) were lower in edoxaban-treated patients relative to enoxaparin-treated patients, respectively (P <0.0001 for all). At end of treatment, mean D-dimer (5.4 vs 6.2 µg/mL), F1+2 (292 vs 380 pmol/L), and SFMC (6.2 vs 7.2 µg/mL) were lower in edoxaban-treated patients relative to enoxaparin-treated patients (P <0.0001 for all). CONCLUSIONS: Edoxaban was superior to enoxaparin in prevention of VTE following TKA and THA, with comparable rates of bleeding events. Relative to enoxaparin, edoxaban significantly reduced D-dimer, F1+2, and SFMC. TRIAL REGISTRATION: Clintrials.gov NCT01181102 and NCT01181167. Both registered 8/12/2010.

Clinical benefit of graduated compression stockings for prevention of venous thromboembolism after total knee arthroplasty: post hoc analysis of a phase 3 clinical study of edoxaban.

BACKGROUND: Guidelines from the Japanese Circulation Society recommend prophylaxis with anticoagulation plus intermittent pneumatic compression or graduated compression stockings (GCS) among patients at the highest risk for developing venous thromboembolism (VTE). However, the benefits of concomitant GCS use for patients undergoing total knee arthroplasty (TKA) and receiving anticoagulation remain unknown. In this study, the efficacy of GCS plus anticoagulation compared with anticoagulation alone was evaluated among patients undergoing TKA. METHODS: This study is a post hoc analysis of a previously reported phase 3 trial involving patients undergoing TKA. In the primary study, which permitted the use of GCS for mechanical prophylaxis, patients were randomized to receive edoxaban 30 mg once daily or enoxaparin 20 mg twice daily for 11 to 14 days following TKA. The primary endpoint was the incidence of VTE, a composite of symptomatic deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE), and asymptomatic DVT. Treatment comparisons were performed using the chi-square test, and the 95 % confidence intervals were calculated. RESULTS: Among patients receiving edoxaban, the incidence of VTE was 3.8 and 5.8 % for patients with and without GCS, respectively. For patients receiving enoxaparin, VTE incidence was 8.4 and 20.8 % among those with and without GCS, respectively. Overall, VTE incidence was 6.0 and 13.0 % for anticoagulated patients with and without GCS mechanical prophylaxis, respectively. No deaths or symptomatic PE were reported during this study. CONCLUSIONS: Although the incidence of VTE was >2-fold lower among patients receiving anticoagulation plus GCS compared with those receiving anticoagulation alone, statistical significance was not achieved. Further studies are required to confirm the findings of this preliminary analysis. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01181102.

Preoperative retrolisthesis as a risk factor of postdecompression lumbar disc herniation.

OBJECT: In this study, the authors aimed to identify specific risk factors for postdecompression lumbar disc herniation (PDLDH) in patients who have not undergone discectomy and/or fusion. METHODS: Between 2007 and 2012, 493 patients with lumbar spinal stenosis underwent bilateral partial laminectomy without discectomy and/or fusion in a single hospital. Eighteen patients (herniation group [H group]: 15 men, 3 women; mean age 65.1 years) developed acute sciatica as a result of PDLDH within 2 years after surgery. Ninety patients who did not develop postoperative acute sciatica were selected as a control group (C group: 75 men, 15 women; mean age 65.4 years). Patients in the C group were age and sex matched with those in the H group. The patients in the groups were also matched for decompression level, number of decompression levels, and surgery date. The radiographic variables measured included percentage of slippage, intervertebral angle, range of motion, lumbar lordosis, disc height, facet angle, extent of facet removal, facet degeneration, disc degeneration, and vertebral endplate degeneration. The threshold for PDLDH risk factors was evaluated using a continuous numerical variable and receiver operating characteristic curve analysis. The area under the curve was used to determine the diagnostic performance, and values greater than 0.75 were considered to represent good performance. RESULTS: Multivariate analysis revealed that preoperative retrolisthesis during extension was the sole significant independent risk factor for PDLDH. The area under the curve for preoperative retrolisthesis during extension was 0.849; the cutoff value was estimated to be a retrolisthesis of 7.2% during extension. CONCLUSIONS: The authors observed that bilateral partial laminectomy, performed along with the removal of the posterior support ligament, may not be suitable for lumbar spinal stenosis patients with preoperative retrolisthesis greater than 7.2% during extension.

Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J-V.

BACKGROUND: In the absence of thromboprophylaxis, patients undergoing total hip arthroplasty (THA) are at increased risk for venous thromboembolism (VTE). The objective of this study was to compare the efficacy and safety of edoxaban with enoxaparin for the prevention of VTE after THA in Japan. METHODS: This was a phase 3, double-blind, double-dummy, noninferiority study. Patients undergoing elective, unilateral primary THA were randomized to receive edoxaban 30 mg once daily (n = 307) or enoxaparin 2000 IU (equivalent to 20 mg) twice daily (n = 303) for 11 to 14 days. The primary efficacy endpoint was the incidence of VTE. Safety endpoints included the incidence of major or clinically relevant nonmajor (CRNM) bleeding. RESULTS: The incidence of VTE, based on venography and clinical surveillance, was 2.4 % in the edoxaban group and 6.9 % in the enoxaparin group (P <0.001). The absolute difference in the incidence of VTE was -4.5 % (95 % confidence interval [CI]: -8.6, -0.9), which was within the noninferiority margin set at 8 % for the difference and established the noninferiority of edoxaban to enoxaparin. Since the upper limit of the 95 % CI of the absolute difference was less than 0 %, the superiority of edoxaban over enoxaparin was demonstrated. The incidence of major or CRNM bleeding was 2.6 % in the edoxaban group and 3.7 % in the enoxaparin group (P = 0.475). CONCLUSIONS: Oral edoxaban 30 mg once daily was superior to subcutaneous enoxaparin 2000 IU twice daily in the prevention of VTE following THA without increasing the risk for major or CRNM bleeding.