Abstract Background context Anterior decompression and fusion (ADF) for ossification of the posterior longitudinal ligament (OPLL) is technically demanding and associated with complications. Although ...various factors affecting clinical outcome have been investigated in posterior decompression, prognostic factors of ADF remain unclear. Purpose The purpose of the study was to identify surgical outcome and prognostic factors of ADF for cervical myelopathy due to OPLL. Study design This was a retrospective case study. Patient sample Between 2005 and 2012, 913 patients underwent decompression surgery for cervical OPLL at our institution. Among them, 131 who underwent ADF and 221 who underwent laminoplasty were enrolled. Inclusion criteria were (1) diagnosis of OPLL; (2) cervical compressive myelopathy; and (3) no trauma, infection, tumor, or previous surgery. We excluded 60 patients with ADF and 157 patients with laminoplasty owing to inadequate follow-up or absence of preoperative myelopathy. Finally, 71 patients with ADF and 64 patients with laminoplasty were enrolled in this study (mean follow-up, 48 vs 41 months). Outcome measures Neurologic assessment was conducted using the Japanese Orthopedic Association (JOA) scoring system for cervical myelopathy. Rate of neurologic improvement was calculated by comparing preoperative and postoperative JOA scores. Methods We investigated the effects of such variables as age, gender, body mass index (BMI), presence of diabetes mellitus (DM), smoking history, type of OPLL, shape of the ossified lesion, occupying ratio of OPLL, presence of intramedullary increased signal intensity (ISI) on magnetic resonance imaging (MRI), and sagittal alignment of the cervical spine on surgical outcome. Severity of ISI was classified into three groups based on T2-weighted sagittal MRI as follows: Grade 0, none; Grade 1, ISI limited to one disc level; or Grade 2, ISI beyond one disc level. This work was supported by the 2013 Korea Health Technology R&D Project of the Ministry of Health and Welfare of the Republic of Korea (A120254). Results In patients with an occupying ratio ≥60% or with presence of ISI on MRI, ADF yielded better surgical outcome than laminoplasty. A higher ISI grade (B=−28.5, p=.000) and a higher occupying ratio (B=0.88, p=.04) were significantly associated with a lower recovery rate (R=0.56, p=.006). Older age also was associated with a lower recovery rate. Gender, BMI, presence of DM, smoking history, type of OPLL, shape of the ossified lesion, and cervical alignment were not associated with recovery rate. Conclusion Anterior decompression and fusion has favorable outcome in patients with an occupying ratio ≥60% or with presence of ISI on MRI. Presence of higher ISI grade, higher occupying ratio, and older age were associated with a poor long-term surgical prognosis. Therefore, evaluating ISI and occupying ratio on preoperative MRI is important for selecting the appropriate surgical approach and for predicting clinical outcome after surgery for cervical compressive myelopathy due to OPLL.
Abstract Objectives The fusion rate in spinal surgery may vary in relation to the technique, and it remains unknown which surgical technique provides the best fusion rate and surgical outcomes. We ...aimed to compare radiological and surgical results between three surgical techniques used for lumbar inter-body fusion. Methods Seventy-seven patients diagnosed with degenerative spinal stenosis including spondylolytic spondylolisthesis. Patients were divided into three groups according to the surgical technique: anterior lumbar inter-body fusion (ALIF, n = 26), transforaminal lumbar inter-body fusion (TLIF, n = 21), and posterior lumbar inter-body fusion (PLIF, n = 30). Various radiological parameters were measured including fusion rates. Results Significant changes after surgery were observed in the ALIF group for the percentage of vertebral body slippage, anterior disc height, posterior disc height, segmental, and segmental ROM. The fusion rate on CT scan at the final follow-up was 69.2% in the ALIF, 72.7% in the TLIF, and 64.3 % in the PLIF. The cage subsidence rate 2 years after surgery was 15.4% in the ALIF, 38.1% in the TLIF, and 10% in the PLIF. Conclusions ALIF was associated with better restoration of segmental lordosis. The fusion rate on CT scan and with segmental ROM did not differ between the three groups. TLIF was associated with a better post op VAS. PLIF showed the lowest cage subsidence rate. Therefore, it looks difficult to tell which surgical technique is better between the three groups as well as all the surgical procedures being equivocal in terms of fusion rate and outcomes.
Background Soluble inflammatory mediators are known to exacerbate sepsis-induced acute kidney injury (AKI). Continuous renal replacement therapy (CRRT) has been suggested to play a part in ...immunomodulation by cytokine removal. However, the effect of continuous venovenous hemodiafiltration (CVVHDF) dose on inflammatory cytokine removal and its influence on patient outcomes are not yet clear. Study Design Prospective, randomized, controlled, open-label trial. Setting & Participants Septic patients with AKI receiving CVVHDF for AKI. Intervention Conventional (40 mL/kg/h) and high (80 mL/kg/h) doses of CVVHDF for the duration of CRRT. Outcomes Patient and kidney survival at 28 and 90 days, circulating cytokine levels. Results 212 patients were randomly assigned into 2 groups. Mean age was 62.1 years, and 138 (65.1%) were men. Mean intervention durations were 5.4 and 6.2 days for the conventional- and high-dose groups, respectively. There were no differences in 28-day mortality (HR, 1.02; 95% CI, 0.73-1.43; P = 0.9) or 28-day kidney survival (HR, 0.96; 95% CI, 0.48-1.93; P = 0.9) between groups. High-dose CVVHDF, but not the conventional dose, significantly reduced interleukin 6 (IL-6), IL-8, IL-1b, and IL-10 levels. There were no differences in the development of electrolyte disturbances between the conventional- and high-dose groups. Limitations Small sample size. Only the predilution CVVHDF method was used and initiation criteria were not controlled. Conclusions High CVVHDF dose did not improve patient outcomes despite its significant influence on inflammatory cytokine removal. CRRT-induced immunomodulation may not be sufficient to influence clinical end points.
Objectives The object of this study was to introduce the KORean Observational study Network for Arthritis (KORONA) registry with an emphasis on the design of the Korean rheumatoid arthritis (RA) ...national database, as well as to provide an overview of the RA patients who are currently registered in KORONA. Methods The KORONA was established in July 2009 by the Clinical Research Center for Rheumatoid Arthritis (CRCRA) in South Korea. KORONA is based on a prospective protocol and standard, defined data collection instruments. Demographic and clinical features, laboratory and radiologic data, health-related outcomes, treatment side effects, resource utilization, and health behaviors of the RA cohort patients are recorded in a database. Results A total of 23 institutions, which are about 38% of the rheumatologic departments at tertiary academic hospitals across South Korea, are part of KORONA. The quality control of data collection and management has been performed through annual monitoring and auditing, staff training, and providing standard operation protocol by the executive committee of CRCRA. As of 31 December 2010, 4721 patients with established RA were included in KORONA, because an annual survey had started to be performed in July 2010. Conclusions KORONA is the first nationwide Korean RA-specific cohort and it will provide valuable “real-world” information for Korean RA patients.
Abstract Background context Heterotopic ossification (HO) is defined as a formation of bone outside the skeletal system. The reported HO occurrence rate in cervical artificial disc replacement (ADR) ...is unexpectedly high and is known to vary. However, the predisposing factors for HO in cervical ADR have not yet been elucidated. Purpose Investigation of the predisposing factors of HO in cervical arthroplasty and the relationship between degeneration of the cervical spine and HO occurrence. Study design Retrospective study to discover predisposing factors of HO in cervical arthroplasty. Patient sample A total of 170 patients who underwent cervical ADR were enrolled including full follow-up clinical and radiologic data. Outcome measures Radiologic outcomes were assessed by identification of HOs according to McAfee's classifications. Methods This study enrolled a total of 170 patients who underwent cervical ADR. Pre-existing degenerative change included anterior or posterior osteophytes, ossification of the anterior longitudinal ligament, posterior longitudinal ligament, or ligamentum nuchae. The relationships between basic patient data, pre-existing degenerative change, and HO were investigated using linear logistic regression analysis. Results Among all 170 patients, HO was found in 69 patients (40.6%). Among the postulated predisposing factors, only male gender and artificial disc device type were shown to be statistically significant. Unexpectedly, preoperative degenerative changes in the cervical spine exerted no significant influence on the occurrence of HOs. The odds ratio of male gender compared with female gender was 2.117. With regard to device type, the odds ratios of Mobi-C (LDR medical, Troyes, France) and ProDisc-C (Synthes, Inc., West Chester, PA, USA) were 5.262 and 7.449, respectively, compared with the Bryan disc. Conclusions Definite differences in occurrence rate according to the gender of patients and the prosthesis type were identified in this study. Moreover, factors indefinably expected to influence HO in the past were not shown to be risk factors thereof, the results of which may be meaningful to future studies.
Although Asian people are believed to be more susceptible to bleeding on currently recommended dose of ticagrelor, there is limited evidence supporting low-dose ticagrelor. We prospectively ...randomized patients receiving dual antiplatelet therapy with aspirin and clopidogrel into 3 groups; aspirin plus clopidogrel 75 mg versus aspirin plus ticagrelor 90 mg once daily versus aspirin plus ticagrelor 45 mg twice daily. Platelet function assessments were conducted using VerifyNow P2Y12 assay at baseline and 28 days after randomization. No differences in baseline P2Y12 reaction unit (PRU) values were observed among the 3 groups. PRU values at the end of the treatment periods were significantly lower in low-dose ticagrelor (90 mg QD group, 98.6 ± 73.4 and 45 mg BID group, 65.5 ± 58.8) compared with clopidogrel (221.2 ± 50.1, both p <0.001). There was no significant difference in PRU values between 2 groups of low-dose ticagrelor (p = 0.208). The rates of high on-treatment platelet reactivity were significantly lower in low-dose ticagrelor compared with clopidogrel, whereas clopidogrel showed higher rate of optimal on-treatment platelet reactivity than ticagrelor 45 mg BID. However, similar rate of optimal on-treatment platelet reactivity was observed in clopidogrel and ticagrelor 90 mg QD. In conclusion, low-dose ticagrelor treatment, either with 90 mg QD or 45 mg BID, was associated with a more potent antiplatelet effect compared with clopidogrel treatment and once daily dose provided similar antiplatelet effect but favorable effect on optimal platelet inhibition compared with twice daily dose.
Abstract Background Context Laminoplasty is a major surgical method used to treat patients with cervical ossification of the posterior longitudinal ligament (OPLL). Sometimes, patients with cervical ...OPLL demonstrate postoperative kyphosis despite sufficient preoperative lordosis. Recently, the impact of T1 slope has emerged as a predictor of kyphotic alignment change after laminoplasty. However, the relationship between T1 slope and postoperative cervical alignment change is not yet fully established. Purpose The goals of the present study were to investigate the relationship between T1 slope and loss of cervical lordosis (LCL), and to identify the role of T1 slope as a predictor of postoperative kyphosis after laminoplasty in patients with OPLL. Study Design This is a retrospective case study. Patient Sample Between January 2011 and January 2012, 64 consecutive patients who underwent cervical laminoplasty for OPLL were enrolled (male:female ratio=47:17; mean age=55.9 years). Cervical spine lateral radiographs in neutral, flexion, and extension were taken before surgery and at 2-year follow-up. Outcome Measures The C2–C7 Cobb angle, cervical range of motion (ROM), T1 slope, neck tilt, and C2–C7 sagittal vertical axis (SVA) were measured from lateral radiographs of the cervical spine preoperatively and postoperatively at 2-year follow-up. Methods Patients were divided into two groups according to preoperative T1 slope, and the postoperative cervical alignment change was compared between the groups. Postoperative kyphosis and LCL incidence were also evaluated at 2-year follow-up. The relationships between postoperative cervical alignment change and preoperative variables, including age, T1 slope, cervical ROM, C2–C7 SVA, and T1 slope minus C2–C7 Cobb angle (T1S−CL), were investigated. Results Patients were divided into two groups above and below median preoperative T1 slope (23.2°). There were no differences in age, sex, type of OPLL, or operation level between the two groups. Patients with higher preoperative T1 slope demonstrated significantly more lordotic preoperative cervical alignment (p=.001). Patients with higher preoperative T1 slope were more likely to exhibit postoperative LCL (p=.03), and when it occurred the degree of LCL was greater (p=.06). In multiple linear regression analysis, higher T1 slope (B=0.414, p=.04) and lower T1S−CL (B=−0.412, p=.03) were significantly associated with more postoperative LCL. In spite of these results, postoperative kyphosis did not occur more frequently in patients with higher T1 slope (p=.64). Conclusions Patients with higher T1 slope had more lordotic curvature before surgery and demonstrated more LCL at 2-year follow-up. Cervical alignment was compromised after laminoplasty, and the degree of LCL was correlated with preoperative T1 slope. After laminoplasty for cervical OPLL, patients with higher T1 slope tended to exhibit a greater LCL yet did not drift into frank postoperative kyphosis.
Abstract Purpose The goal of this study was to evaluate the moxifloxacin-induced QT interval prolongation in healthy male and female Korean and Japanese volunteers to investigate interethnic ...differences. Methods This multicenter, randomized, double-blind, placebo-controlled, 2-way crossover study was conducted in healthy male and female Korean and Japanese volunteers. In each period, a single dose of moxifloxacin or placebo 400 mg was administered orally under fasting conditions. Triplicate 12-lead ECGs were recorded at defined time points before, up to 24 hours after dosing, and at corresponding time points during baseline. Serial blood sampling was conducted for pharmacokinetic analysis of moxifloxacin. The pharmacokinetic–pharmacodynamic data between the 2 ethnic groups were compared by using a typical analysis based on the intersection-union test and a nonlinear mixed effects method. Findings A total of 39 healthy subjects (Korean, male: 10, female: 10; Japanese, male: 10, female: 9) were included in the analysis. The concentration–effect analysis revealed that there was no change in slope (and confirmed that the difference was caused by a change in the pharmacokinetic model of moxifloxacin). A 2-compartment model with first-order absorption provided the best description of moxifloxacin’s pharmacokinetic parameters. Weight and sex were selected as significant covariates for central volume of distribution and intercompartmental clearance, respectively. An Emax model ( E C = E max ⋅ C / EC 50 + C ) described the QT interval data of this study well. However, ethnicity was not found to be a significant factor in a pharmacokinetic–pharmacodynamic link model. Implications The drug-induced QTc prolongations evaluated using moxifloxacin as the probe did not seem to be significantly different between these Korean and Japanese subjects. ClinicalTrials.gov identifier: NCT01876316.
Highlights • ‘Corrected’ group had significantly more angular and translational correction than ‘Not corrected’ group (CL : 19°, SVA : 16 mm, T1S – CL : 19.8°) • Patients with CP-CSM deformity who ...underwent cervical surgery had good clinical outcomes • Patients with CP-CSM deformity who underwent deformity correction had better clinical and functional outcomes than patients who did not undergo deformity correction.
Highlights AS patients had cervical spine fracture injuries after minor trauma, but OPLL patients mostly had spinal cord injuries without bony fractures. Improvement from neurologic deficit after ...proper surgical treatment showed better outcomes in AS and OPLL patients than in controls It is important to thoroughly examine patients with AS or OPLL after cervical trauma so as not to delay diagnosis.
