Paclitaxel-coated stents to prevent hyperplastic proliferation of ureteral tissue: from in vitro to in vivo.

Ureteric stents have become an indispensable tool in the armamentarium of every urologist. However, they carry their own morbidity resulting mostly from infectious or abacterial fouling and biofilm formation, and/or urothelial hyperplastic reaction. All of these may interact and lead to clinical complications. Many different stent designs and coatings have been proposed. In this study, we focused on the effect of paclitaxel-coated stents on hyperplastic proliferation of ureteral tissue, using as example anastomotic strictures after ureteroureterostomy in a rat model. Human urothelial cells (SV-HUC-1) were used to determine paclitaxel dosages in vitro. Polyurethane stents were coated with a paclitaxel containing biodegradable polymer and studied in a ureteroureterostomy rat model. 48 male 9-week-old Sprague-Dawley rats underwent either sham surgery (n = 16) or ureteroureterostomy with sutured anastomosis, and consecutive stenting with either a paclitaxel-coated or an uncoated stent (16 per group), respectively. The animals received daily intraperitoneal injections of 5-bromo-2-deoxyuridine (20 mg/ml, 100 mg/kg body weight) during the first eight postoperative days, and were sacrificed on day 28. Healing of the ureteral anastomosis and proliferation of urothelial cells was examined histologically and immunohistochemically. In vitro, a concentration of 10 ng/mm2 paclitaxel can be considered as non-toxic, while still exerting an anti-proliferative effect on urothelial cells. Histologically, typical wound healing processes were seen at the site of the ureteral anastomosis in vivo. Proliferation of urothelial cells was significantly lower in animals with paclitaxel-coated stents compared to those with uncoated stents (LI 41.27 vs. 51.58, p < 0.001). Our results indicate that stenting of ureteral anastomoses with paclitaxel-coated stents can reduce hyperplastic proliferation of ureteral tissue. Paclitaxel-coated stents thus might be able to prevent not only scar-induced postoperative stenosis after reconstructive surgery, but also hyperplastic urothelial reaction in non-anastomotic stent patients as part of their inflammatory response to the foreign material.

[What Makes Happy Doctors? Job Satisfaction of General Practitioners in Mecklenburg-Western Pomerania - a Representative Cross-sectional Study]. / Was macht Ärzte glücklich? Berufszufriedenheit von Hausärzten in Mecklenburg-Vorpommern - eine repräsentative Querschnittsstudie.

AIM: Studies provide evidence for the importance of general practitioners (GPs) job satisfaction for a secure and high quality health care provision. This study focuses on job satisfaction of GPs in Mecklenburg-Western Pomerania (MV), a rural area threatened by a lack of GPs. We investigate how satisfied GPs are with their job and which factors influence their job satisfaction. METHODS: All 1 133 GPs working in MV in December 2011 were asked to complete a 57-item-questionnaire. The response rate reached 50.1%. RESULTS: The sample is representative for GPs in MV. Levels of job satisfaction are high and correlate with age and sex: females and GPs below 50 years of age are more satisfied. Factors contributing to high job satisfaction include a good doctor-patient relationship, fair pay, and the variety of reasons for doctor-patient consultations in primary care. Although all GPs were dissatisfied with bureaucracy, this factor has little impact on GPs' overall job satisfaction. CONCLUSION: In light of the imminent lack of GPs, in future it will be important to improve factors that have been demonstrated to increase job satisfaction.

[Visual analysis for an early detection of diabetic neuropathy]. / Visuelle Analyse zur Früherkennung einer diabetischen Neuropathie.

Diabetic neuropathy is the most common long-term complication of diabetes mellitus. It comes along with significant nerve dysfunction, which is not reversible. Hence, it is essential to detect nerve fibre abnormalities as early as possible. In this paper, we investigate markers describing degradation of corneal nerves. We apply statistical computations and visual analysis to identify those variables of two clinical studies that separate DN patients from a control group. In this way, the diagnosis of DN patients is supported. The visual analysis is based on different representations visualizing both the statistical results and the gathered multi-variate data. The user can interactively manipulate the views, or select data that will be shown by further displays. In this way, the understanding of the data and its classification is supported. Ambiguous categorisations can be identified and grouped into a so-called "fuzzy group". For this group, further investigations are needed to decide about diabetic neuropathy.

Influence of local hemostatic and antiplatelet agents on the incidence of bleeding complications in carotid endarterectomies.

BACKGROUND: For the reduction of cardio- and cerebrovascular events in carotid endarterectomies continuation of antiplatelet medication is recommended perioperatively. As a result, this patient population is at increased risk for postoperative bleeding complications. Intraoperative application of local hemostatic agents might reduce the incidence of bleeding complications. MATERIAL AND METHODS: All 565 patients undergoing carotid endarterectomy between January 2005 and January 2011 were analysed retrospectively. Most patients in the earlier cohort years of the study had no perioperative antiplatelet medication. In contrast antiplatelet medication was usually continued perioperatively in the later cohort years. To reduce the risk of perioperative bleeding local hemostatic agents were applied increasingly. RESULTS: Revision surgery, due to postoperative bleeding or massive hematoma, was necessary in 20 cases (3.5 %). Overall, 383 carotid endarterectomies (67.8 %) were performed with perioperative antiplatelet medication. Local hemostatic agents were applied in 259 cases (45.8 %) intraoperatively. Initially, operations performed in patients taking antiplatelet medication resulted in an increased need for surgical revision. Following an accelerated practice of using local hemostatic agents, the need for revision surgeries fell. Nevertheless, when patients from all years were analysed together there was no significant benefit from the application of local hemostatic agents. CONCLUSION: Application of local hemostatic agents might have contributed to a reduction of bleeding complications in carotid endarterectomies. However, this could not be shown of statistical significance. Other confounding factors such as different operative techniques or forms of anesthesia might also have influenced this decline.

Pneumocystis jirovecii colonisation in HIV-positive and HIV-negative subjects in Cameroon.

OBJECTIVE: To determine the prevalence of Pneumocystis pneumonia (PCP), a major opportunistic infection in AIDS patients in Europe and the USA, in Cameroon. MATERIALS AND METHODS: Induced sputum samples from 237 patients without pulmonary symptoms (126 HIV-positive and 111 HIV-negative outpatients) treated at a regional hospital in Cameroon were examined for the prevalence of Pneumocystis jirovecii by specific nested polymerase chain reaction (nPCR) and staining methods. CD4 counts and the history of antiretroviral therapy of the subjects were obtained through the ESOPE database system. RESULTS AND CONCLUSION: Seventy-five of 237 study participants (31.6%) were colonised with Pneumocystis, but none showed active PCP. The Pneumocystis colonisation rate in HIV-positive subjects was more than double that of HIV-negative subjects (42.9% vs. 18.9%, P < 0.001). In the HIV-positive group, the colonisation rate corresponds to the reduction in the CD4 lymphocyte counts. Subjects with CD4 counts >500 cells/µl were colonised at a rate of 20.0%, subjects with CD4 counts between 200 and 500 cells/µl of 42.5%, and subjects with CD4 counts <200 cells/µl of 57.1%. Colonisation with Pneumocystis in Cameroon seems to be comparable to rates found in Western Europe. Prophylactic and therapeutic measures against Pneumocystis should be taken into account in HIV care in western Africa.

Accompanying DCIS in breast cancer patients with invasive ductal carcinoma is predictive of improved local recurrence-free survival.

BACKGROUND: Ductal carcinoma in situ (DCIS) often accompanies invasive ductal carcinoma (IDC). The presence of co-existing DCIS is postulated to present as a less aggressive phenotype than IDC alone. PATIENTS AND METHODS: Patients diagnosed with hormone receptor-positive breast cancer receiving mastectomy were evaluated. Only patients without adjuvant radio- and chemotherapy were included to decrease treatment bias on local recurrence (LR). RESULTS: Of 2239 breast cancer patients, 198 fulfilled the inclusion criteria. The overall LR rate was 11.6%. Tumor stage (p = 0.002), nodal status (pN2 vs. pN0, p = 0.023) and pure IDC compared with IDC-DCIS (p = 0.029) were multivariate independent factors for increased LR risk. Patients with IDC-DCIS were significantly younger (p < 0.001), had smaller tumors (p = 0.001), less lymph node involvement (p = 0.012). The LR rate was significantly increased in patients with pure IDC (p = 0.012). The time to distant metastases was decreased in patients with pure IDC compared with that observed in patients with IDC-DCIS (log rank = 0.030). CONCLUSION: Invasive ductal carcinoma accompanied by DCIS is associated with lower LR. The prognostic value of co-existing DCIS in the adjuvant decision-making process may be considered a new independent prognostic marker. This finding needs further studies to evaluate its usefulness in premenopausal women.

Dental implants and immediate loading: multivariate analysis of success factors.

OBJECTIVES: The authors had for aim to examine factors potentially influencing the success of immediate implant placement and loading. MATERIALS AND METHODS: One hundred and ninety-five consecutive patients (16.5 to 80.4 years of age) were provided with 310 prostheses supported by 896 immediately loaded implants. The mean follow-up was 27.5 months. Univariate and multivariate Cox regression was performed to analyze potential modifiers of implant success. RESULTS: The overall implant success rate was 96.7%. The statistically significant modifiers of success on multivariate analysis (P<0.05) were duration of functional use (P<0.001), type of superstructure (P<0.001), implant-abutment connection (P<0.001), and maxilla versus mandible (P=0.026). None of the other investigated factors (age, gender, implant location/design/length) were statistically significant modifiers of success. DISCUSSION: Our study results demonstrate high success rates for immediately loaded implants whatever types and superstructure used. Prosthetic designs and their implementation have a significant effect on the success rate of implant-supported restoration, with adjusted hazard ratios of up to 51. Maxilla versus mandible was the only significant non-external modifier when using an adjusted hazard ratio of 2.75.

Differentiating between malignant and benign breast masses: factors limiting sonoelastographic strain ratio.

PURPOSE: We compared strain ratio vs. qualitative elastography for the further differentiation of focal breast lesions, with special focus on limiting factors. MATERIALS AND METHODS: 215 patients with 224 histologically proven breast masses (116 malignant, 108 benign) were prospectively examined using a high-end ultrasound system (Philips iU22) with serial elastography function. B-mode scans and available mammograms were reviewed according to the BIRADS classification, raw elastogram data was analyzed qualitatively using the Tsukuba score and semiquantitatively by calculating the strain ratio (fat to lesion ratio). For diagnostic performance, Receiver Operating Characteristic (ROC) curve analysis was obtained. A sub-group analysis regarding breast density, lesion size, lesion depth and histological subtypes was performed. RESULTS: Mean strain ratio values were 3.04 ± 0.9 for malignant and 1.91 ± 0.75 for benign lesions (p < 0,001). The areas under the ROC curve values were 0.832 (95 % CI 0.777; 0.888) for strain ratio, 0.869 (95 % CI 0.822; 0.917) for Tsukuba score, 0.822 (95 % CI 0.768; 0.876) for B-mode ultrasound and 0.853 (95 % CI 0.799; 0.907) for mammography. Sensitivity, specificity, positive predictive value and negative predictive value of the strain ratio were 90.7 %, 58.2 %, 70.3 % and 85.1 %, when a cutoff point of 2.0 was used. Only lesion depth ≤ 4 mm was associated with diagnostic failure in the multivariate analysis of factors influencing accuracy, whereas no significant correlation between breast density and lesion size and the accuracy of the strain ratio could be found. CONCLUSION: The addition of strain ratio to B-mode ultrasound increases specificity without loss of sensitivity in differentiating between malignant and benign breast tumors. Strain ratio measurements should not be carried out on tumors with a lesion depth ≤ 4 mm.

Radiograph-based study of gender-specific vertebral area gain in healthy children and adolescents as a function of age, height, and weight.

This study reports gender-specific vertebral area gain data from children and adolescents. Vertebral area was measured on lateral and anteroposterior thoracic and lumbar spine radiographs from 100 female and 100 male subjects aged 7-28 yr. T9, T11, T12, L1, and L2 X-ray area calculation was based on calculation of the area of the geometric figure of a trapezoid whose 2 nonparallel sides were equal in length, taking account of the waisted shape of the vertebrae. Both the boys and girls of our study population showed statistically significant dependence (p<0.001) of vertebral area gain on chronologic age, height, and weight right through the end of puberty, and especially so up to age 15 yr. However, height and weight were clearly better predictors of lateral and anteroposterior vertebral area gain than was chronologic age. Once vertebral growth is complete by age 18 yr or so, the lateral vertebral areas of the male subjects-regardless of body weight and height-are, on average, 25% larger, and the anteroposterior areas up to 30% larger than those of their female counterparts. After adjusting for chronologic age, height, and weight however we did not find significant differences, between gender, in vertebral area of male and female subjects, neither among children younger than 11 yr nor adolescents ages of 12-14 yr and young adults older than 18 yr.

Pharmacoeconomical consequences of postoperative CSF leaks after intracranial surgery--a prospective analysis.

Cerebrospinal fluid (CSF) leaks are well-known and frequent complications of intracranial procedures with their clinical aspects covered by numerous studies. Little, however, is known about the pharmacoeconomical aspects of this specific complication. 545 patients with a variety of intracranial procedures (elective and trauma) were recruited for a multicenter, prospective, observational study over a 13-month period. A specific pharmacoeconomic analysis was performed in 168 of these patients from the institution of the first author covering all clinical and pharmaco-economical aspects of this specific complication. Of all patients, 5.36% developed a postoperative CSF leak. Treatment of the leak required numerous diagnostic and therapeutic procedures such as reoperations (n = 6), lumbar punctures (n = 11) or lumbar drainages (n = 4). Costs for these procedures and prolonged hospital stays nearly doubled the costs per case (€14079/case without a fistula vs. €25499/case with a fistula). Reimbursement for the hospital covered these extra costs, but net earnings per case were diminished by €565 in cases with a CSF leak. The authors conclude that the presence of a CSF leak after an intracranial operation - although not influencing outcome in general - results in additional diagnostic and therapeutic procedures for the patient, an enormous increase in costs for the community, and a financial loss for the hospital. Strategies to lower this complication rate should therefore urgently be developed both from a clinical and a pharmacoeconomical point of view.

Surface and intracardiac ECG for discriminating conduction disorders after CoreValve implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been developed to minimize operative morbidity and mortality in high-risk symptomatic patients unfit for open surgery. With the proximity of the aortic valve annulus to the conduction system there is, however, an unknown risk of conduction disturbances necessitating monitoring and often cardiac pacing. MATERIALS AND METHODS: We enrolled 50 consecutive patients from January 2007 to 2008 in our prospective evaluation of conduction disturbances measured by surface and intracardiac ECG recordings. Baseline parameters, procedural characteristics as well as twelve-lead surface ECG and intracardiac conduction times were revealed pre-interventionally, after TAVI and at 7-day follow-up. RESULTS: TAVI was performed successfully in all patients. During 7 days of follow-up the rate for first-degree AV block raised from 14% at baseline to 44% at day 7 (p < 0.001), while rates for type II second- and third-degree were 0 versus 8% (p < 0.001) and 0 versus 12% (p < 0.001), respectively. Similarly, the prevalence of new left bundle branch block (LBBB) rose from 2 to 54% (p < 0.001). Intracardiac measurements revealed a prolongation of both AH and HV interval from 123.7 ± 41.6 to 136.6 ± 40.5 ms (p < 0.001) and from 54.8 ± 11.7 to 71.4 ± 20.0 ms (p < 0.001), respectively. Pacemaker implantation at a mean follow-up of 4.8 ± 1.2 days was subsequently performed in 23 patients (46%) due to complete AV block (12%) and type II second-degree AV block (8%) while another 13 patients (26%) received a pacemaker for the combination of new LBBB with marked HV prolongation. The high rate of first-degree AV block was primarily driven by an increase in HV interval. CONCLUSION: Cardiac conduction disturbances were common in the early experience with CoreValve implantation necessitating close surveillance for at least 1 week.

Evaluation of imbalance in stratified blocked randomization: some remarks on the range of validity of the model by Hallstrom and Davis.

OBJECTIVES: If in a clinical trial prognostic factors are known in advance, it is often recommended that randomization of patients should be stratified. The best-known method is permuted-block randomization within strata. But it suffers from the disadvantage that imbalance still occurs in the trial as a whole if there are a large number of strata, or/and the block sizes are too large for the number of patients. The results of Hallstrom and Davis are appropriate for evaluating the risk of such a troubled situation by using two special cases of their general variance formula. But it is merely generally argued for whichever practical situations these special cases are valid. Consequently, additional investigations are required to reveal the conditions for correct application. METHODS: We investigated the range of validity of special cases by performing computer simulations, varying a number of trial characteristics, and discuss the application of results for practical situations. RESULTS: The validity of special cases is not given in each situation. Depending on block size, a binomial distribution model is valid for a permitted average maximum number of patients per stratum between 36% and 57% of considered block sizes, whereas the uniform distribution model works adequately from at least 70%. In an intermediate range of invalidity, implementation of a simulation study is necessary to compute the probability distribution of differences. CONCLUSIONS: Our results are important if choosing the stratified permuted-block randomization to estimate the risk for an intolerable overall imbalance when planning a trial.

Immunohistochemical expression of retinoblastoma protein and p16 in renal cell carcinoma.

INTRODUCTION: The regulation proteins retinoblastoma protein (pRb) and p16 play an important role in the cell cycle as tumor suppressors. pRb is the main substrate for the function of cyclin-dependent kinases during the cell cycle in the transition from G(1) to S phase. In this study, the immunohistochemical expression of pRb and p16 in renal cell carcinoma (RCC) were examined. METHODS: Paraffin-embedded specimens from 94 patients with RCC were examined immunohistologically, using primary antibodies for p16 and pRb (Novocastra) and a biotin-conjugated anti-mouse IgG secondary antibody. Microscopically, the expression of p16 and pRb was evaluated by examination of the staining intensity of 100 cells of each specimen, and compared with epidemiological parameters (tumor size, TNM, nuclear grade and follow-up). Statistical analyses were conducted by SPSS, version 15.0 (SPSS® Inc., Chicago, Ill., USA), the χ(2) test (Fisher's exact test), the Kaplan-Meier method and Mantel's log rank test. RESULTS: All 94 tumors showed a positive reaction for pRb (weakly positive in 67.0%; strongly positive in 33.0%). p16 was expressed in only 52.1% (weakly positive in 48.9%; intermediately positive in 3.2%; no strongly positive expression). The expression of p16-positive tumors was significantly associated with the expression of pRb (p = 0.040). Tumor size, grading, lymph node and distant metastases did not correlate with p16/pRb expression. CONCLUSION: pRb and p16 control the cell cycle as tumor suppressors. Therefore, in many tumors they are dysregulated. There are distinct differences in expression in various individual RCC. However, in a limited number of cases there was no significant correlation with clinical parameters.

[Knowledge of school pupils about the HIV/AIDS topic at selected schools in Mecklenburg-Western Pomerania]. / Der Wissensstand von Schülern über das Thema HIV/AIDS an ausgewählten Schulen in Mecklenburg-Vorpommern.

AIM OF THE STUDY: The increasing numbers of new HIV diagnoses in Germany generate a need to measure the level of knowledge of the young generation about the issue of HIV/AIDS. METHODOLOGY: A survey was conducted of 769 pupils of different age groups and from different schools in Mecklenburg-Western Pomerania. Data analysis was performed using SPSS; statistically significant differences (p<0.05) were tested between the groups using the chi-square test. RESULTS: The level of knowledge within the sample differs: more precise knowledge is demonstrated by pupils following an awareness event (60%) and by pupils interested in HIV (69%) than by those who have attended no awareness event (40%) and those who have little interest in the issue (31%). Moreover, it was noted that grammar school pupils generally achieve better results than pupils from comprehensive and intermediate secondary schools. Furthermore, there are significant differences between the genders: girls give correct answers more frequently than boys and more often show an interest in the HIV/AIDS issue. In addition, age-specific differences are also identifiable: from the age of 14, there is a considerable increase in knowledge, which then remains static at the age of 16. AIDS education in biology lessons is common among pupils and 93% are familiar with this. Over 70% of pupils are unfamiliar with local AIDS awareness teams. CONCLUSIONS: There are significant gaps in the level of knowledge about methods of infection, particularly with respect to questions about the no risk areas, which should thus be particularly dealt with in awareness events. As to knowledge transfer, the pupils' interest should be aroused while taking the type of school, gender and age of the pupils into consideration. In the course of the school career, every pupil should take part in at least one awareness event since our survey showed that only 60% attended such an event. Local AIDS awareness teams should be more frequently active in the schools since 73% stated to be unfamiliar with them in our survey.

[Total knee replacement with ceramic femoral components: a national prospective multicenter study of clinical and radiological outcomes]. / Knieendoprothetik mit keramischen Femurkomponenten: Nationale prospektive Multicenterstudie zum klinischen und radiologischen Outcome.

BACKGROUND: The purpose of this prospective multicenter study was to evaluate the clinical and radiological outcomes of an unconstrained bicondylar total knee prosthesis with a new ceramic femoral component made of BIOLOX® delta. MATERIAL AND METHODS: Fifty patients underwent cemented total knee arthroplasty in three hospitals/centers. Clinical and radiological evaluations were undertaken preoperatively and at 3 as well as 12 months postoperatively using the HSS, WOMAC, and SF-36 scores. RESULTS: During 12 months follow-up three patients had to undergo revision surgery due to non-implant-related reasons (infection, periprosthetic fracture, and retropatellar replacement). The mean preoperative HSS score amounted to 56.2±11.0 points. At 3 and 12 months follow-up the mean HSS score was 75.5±11.5 and 83.6±10.9 points, respectively. Therefore, HSS and WOMAC scores improved significantly from preoperative values at both postoperative evaluations. The first significant improvement of SF-36 score was seen after 12 months. Radiolucent lines around the femoral ceramic components were found in one case. CONCLUSION: Subsequent long-term studies must be carried out in order to clarify the potential benefits of ceramic femoral components and confirm the good early clinical result. Moreover, the specific material properties of ceramic implants must be considered during implantation.

Different bone sesitivity to malformations induced by procarbazine in fetal rats.

The study aimed at to induce cleft-lip-alveolus-palate (CLAP) applying procarbazine in rat fetuses at the 14(th) day of pregnancy, to supply thiocyanate and/or folic acid sufficient for preventive treatment and subsequently to investigate cleft extent in the palatal area as well as bone maturity. In this animal model, female primiparous inbred rats (LEW.1A) were used. The gravid animals were separated into treatment groups: group K (control), group P (procarbazine), group TP (thiocyanate and procarbazine) and group FTP (folic acid, thiocyanate, procarbazine). The results reveal that procarbazine may induce clefts in the palate area. Clefts occurred most frequently in group TP and mainly comprised subtotal clefts of the posterior secondary palate. As for palatal length, group FTP displayed the longest palate which was significantly different only from group K. A different picture was shown for the secondary palate with group TP displaying the shortest values which were significantly different from those in groups K, P, and FTP. Thus, group TP showed the most marked negative changes both for cleft frequency and palatal length as compared to group K and the other groups. The preventive application of either thiocyanate (TP) or thiocaynate and folic acid combined (group FTP) failed to completely prevent cleft formation in the palate area. In conclusion, a preventive effect on palatal clefts and growth inhibition could not be proved for the vitaminoid thiocyanate.

[Which factors are predictive for long-term complaints after mild traumatic brain injuries?]. / Lassen sich Langzeitfolgen eines leichten Schädelhirntraumas anhand von Labor- und bildgebender Diagnostik vorhersagen?

Each year 330 of every 100,000 inhabitants in Germany suffer a mild traumatic brain injury. About 25% suffer persisting post-concussion syndrome (headache, dizziness). Although many studies have been carried out to make a prognosis of the long-term outcome of these patients, there are still no relevant tests for a valuable statement. The aim of our study was to identify parameters to predict post-traumatic complaints. Therefore we conducted a prospective study of 74 patients who were admitted with a mild traumatic brain injury in our hospital from March 2004 till October 2006. We were able to show a significant correlation between complaints and a pathological CT-scan and biochemical markers during the first two weeks. For long-term complaints only the SKT (Syndromkurztest) we used for a neuropsychological assesment was able to show a significant correlation.

[Bicondylar knee arthroplasty - influence of preoperative functional restriction on early functional postoperative outcome]. / Bikondylärer Oberflächenersatz - Einfluss präoperativer Funktionseinschränkungen auf das frühfunktionelle postoperative Outcome.

AIM: The point of time for total knee arthroplasty has a significant importance due to limited implant survival rate. To what extent the preoperative stage of physical and psychological function limitation, which is increasing with the progression of the osteoarthritis, has an influence on the early functional outcome after total knee arthroplasty should be clarified in a clinical evaluation. PATIENTS AND METHOD: 47 Patients were treated with the same bicondylar knee endoprosthesis system (Type Genia, ESKA Implants, Lübeck). A clinical evaluation was undertaken preoperatively and at 3 and 6 months postoperatively using HSS score, WOMAC index and SF-36 score. In relation to the preoperative HSS score the patients were allocated into three groups depending upon whether their level of function was "good", "average" or "poor". Additionally, all patients were assigned to three body mass index (BMI) groups (< 30, 30 - 35, > 35) which were descriptively analysed. RESULTS: The preoperative differences in HSS score and SF-36 score in all three groups show a high reduction after 3 and 6 months. Postoperatively there were no significant differences in all three groups at both timepoints. Patients with "poor" preoperative function achieved on average a lower score niveau than patients with preoperative "good" function, but have the benefit of the best function improvement. The early postoperative period (3 months) showed the highest decrease in physical and psychological function derogation. The BMI had no significant influence on the early functional outcome. CONCLUSION: Therefore, older people should receive early total knee arthroplasty to gain a high postoperative score niveau. In younger patients the indication for implant should be considered essentially because of the limited survival rate. Even in progressive osteoarthritis and extreme functional limitation the bicondylar surface replacement gives the possibility of a good early functional postoperative outcome. Total knee arthroplasty of obese patients is under attention of the perioperative internistic risks, a safe procedure with good functional results and can increase patient's mobility.

Impact of comorbidity and age on the outcome of patients with inoperable NSCLC treated with concurrent chemoradiotherapy.

BACKGROUND: The value of concurrent chemoradiotherapy (CRT) for treatment of locally advanced non-small cell lung cancer (NSCLC) in elderly and multimorbid patients is generally disputed due to the assumed lack of toxicity compensation or the limited prognosis of the accompanying morbidity. AIM: We investigated correlation between impaired organ function, age, tumor-associated symptoms, social factors and acute toxicity as well as survival following CRT. PATIENTS AND METHODS: Retrospective data collection and analysis were performed on the variables age, functional parameters: FEV1, VC, DLCO, LVEF, creatinine clearance, age, several categories of comorbidities, WHO performance status, alcohol and nicotine habits, toxicity according CTC-criteria and survival of all patients (n=66) with inoperable NSCLC suffering substantial comorbidities or advanced age (>70 years) treated with an CRT consisting of two cycles cisplatin or carboplatin plus vinorelbine and a conventionally fractionated radiotherapy up to 63Gy. RESULTS: Median survival of all patients was 13 months (10.6-15.4 months, 95% confidence interval). Univariate analyses showed significantly poorer survival (12 months vs. 15 months) in patients with LVEF<50% compared with LVEF> or = 50% (P=0.022, in log-rank test). All other variables did not exhibit any significant correlation to survival. Multivariate analyses revealed significantly inferior survival in patients suffering from cardiac or pulmonary dysfunction (P=0.039, hazard ratio [HR]: 2.18; 95% CI of HR [1.04-4.59]). Elderly patients (>70 years) had a higher prevalence of hematotoxicity of higher degree than younger patients (< or = 70 years), but without significant impact on the feasibility of both treatment modalities. CONCLUSION: Our results suggest that cardiac and pulmonary dysfunction may be associated with a reduced survival in elderly or poor-risk patients with inoperable NSCLC after CRT.

A new proposal for setting parameter values in restricted randomization methods.

OBJECTIVES: Complete randomization could result in an undesirable imbalance in the number of patients assigned to each treatment, especially in small trials. Therefore, a variety of restricted randomization procedures has been developed. By varying parameters it is possible to appropriately modify the balancing characteristics of these designs. However, there is little information on what are sensible choices for the parameters. Therefore, we suggest a new method for suitable determination of parameter values of restricted randomization rules. METHODS: For restriction to be effective, it need not yield exact equality. As the reliability of a test is not very sensitive to slight deviations from equal sample sizes we define that a given maximum tolerable imbalance d can be achieved or exceeded with a given probability p(*). By using this condition, parameter values of restricted procedures are determinable. RESULTS: For permuted-block, biased-coin, urn, and big-stick randomization we investigated the impact of parameters on balancing properties. For different extents of restriction and by using the submitted condition, the values of parameters to be chosen are determined. CONCLUSIONS: Up to now choice of parameter values has often occurred at random. Now it is possible to determine values of parameters by specifying the tolerable degree of imbalance and the risk to be worse. As a consequence restriction will, as much as possible, not be imposed and not imposed more than necessary in order to preserve the intrinsic quality of randomization.