Therapy aspects of peri-implant femoral fractures-a retrospective analysis of 64 patients.

PURPOSE: The incidence of peri-implant femoral fractures (PIFF) is increasing. Information regarding outcomes, timing of surgery, risk factors, and a clinically applicable treatment algorithm are lacking. The aim of this study was to identify outcome-related risk factors and to derive a treatment algorithm. METHODS: Sixty-four PIFFs treated between 01.01.2006 and 31.12.2020 in a level I trauma centre were evaluated retrospectively for fracture pattern, surgical technique, risk factors, complications, and 1-year mortality. The study was approved by the ethics committee (No. 21-2714-104). RESULTS: One-year mortality was 24.1%. Surgical complications occurred in 4.7%, and general complications in 15.6% of the patients. General complications, low haemoglobin level at admission, elevated CHA2DS2-VASc, and Charlson score resulted in increased 1-year mortality. Time to surgery > 24 h did not increase complication or mortality rates. The three predominant fracture patterns were fractures close or distal to cephalomedullary nails, close or proximal to distal lateral plates, and close or distal to sliding hip screws. Recommendations for surgical treatment were derived: Osteosynthesis should enable as much weight-bearing as possible; the initial implant should only be removed, if this is essential for the new osteosynthesis; lateral locking plates should span the whole femur; antegrade nails should have a cephalomedullary component to avoid consecutive femoral neck fractures; implants should overlap to reduce the risk of consecutive inter-implant fractures. CONCLUSION: Risk factors for 1-year mortality in patients with PIFFs were identified. A treatment algorithm and general principles for surgery of PIFFs were developed.

Surgery Within 24 Hours Reduces Mortality and General Complication Rates in Patients Who Have Periprosthetic Femoral Fractures at the Hip.

BACKGROUND: In patients who have hip fractures, treatment within 24 hours reduces mortality and complication rates. A similar relationship can be assumed for patients who have hip periprosthetic femoral fractures (PPFs) owing to the similar baseline characteristics of the patient populations. This monocentric retrospective study aimed to compare the complication and mortality rates in patients who had hip PPF treated within and after 24 hours. METHODS: In total, 350 consecutive patients who had hip PPF in a maximum-care arthroplasty and trauma center between 2006 and 2020 were retrospectively evaluated. The cases were divided into 2 groups using a time to surgery (TTS) of 24 hours as the cutoff value. The primary outcome variables were operative and general complications as well as mortalities within 1 year. RESULTS: Overall, the mean TTS was 1.4 days, and the 1-year mortality was 14.6%. The TTS ≤ 24 hours (n = 166) and TTS > 24 hours (n = 184) groups were comparable in terms of baseline characteristics and comorbidities. Surgical complications were equally frequent in the 2 groups (16.3 versus 15.2%, P = .883). General complications occurred significantly more often in the late patient care group (11.4 versus 28.3%, P < .001). In addition, the 30-day mortality (0.6 versus 5.5%, P = .012), and 1-year mortality (8.3 versus 20.5%, P = .003) rates significantly increased in patients who had TTS > 24 hours. Cox regression analysis yielded a hazard ratio of 4.385 (P < .001) for the TTS > 24 hours group. CONCLUSIONS: Prompt treatment is required for patients who have hip PPF to reduce mortality and overall complications.

Host cell protein networks as a novel co-elution mechanism during protein A chromatography.

Host cell proteins (HCPs) are process-related impurities of therapeutic proteins produced in for example, Chinese hamster ovary (CHO) cells. Protein A affinity chromatography is the initial capture step to purify monoclonal antibodies or Fc-based proteins and is most effective for HCP removal. Previously proposed mechanisms that contribute to co-purification of HCPs with the therapeutic protein are either HCP-drug association or leaching from chromatin heteroaggregates. In this study, we analyzed protein A eluates of 23 Fc-based proteins by LC-MS/MS to determine their HCP content. The analysis revealed a high degree of heterogeneity in the number of HCPs identified in the different protein A eluates. Among all identified HCPs, the majority co-eluted with less than three Fc-based proteins indicating a drug-specific co-purification for most HCPs. Only ten HCPs co-purified with over 50% of the 23 Fc-based proteins. A correlation analysis of HCPs identified across multiple protein A eluates revealed their co-elution as HCP groups. Functional annotation and protein interaction analysis confirmed that some HCP groups are associated with protein-protein interaction networks. Here, we propose an additional mechanism for HCP co-elution involving protein-protein interactions within functional networks. Our findings may help to guide cell line development and to refine downstream purification strategies.

Effectiveness of wearable devices as a support strategy for maintaining physical activity after a structured exercise intervention for employees with metabolic syndrome: a randomized controlled trial.

BACKGROUND: Metabolic syndrome (MetS) is associated with an increased risk for cardiovascular events and high socioeconomic costs. Despite lifestyle interventions focusing on exercise are effective strategies to improve parameters of the above aspects, many programs fail to show sustained effects in the long-term. METHODS: At visit 2 (V2) 129 company employees with diagnosed MetS, who previously participated in a 6-month telemonitoring-supported exercise intervention, were randomized into three subgroups for a 6-month maintenance treatment phase. A wearable activity device was provided to subgroup A and B to assess and to track physical activity. Further subgroup A attended personal consultations with individual instructions for exercise activities. Subgroup C received neither technical nor personal support. 6 months later at visit (V3), changes in exercise capacity, MetS severity, work ability, health-related quality of life and anxiety and depression were compared between the subgroups with an analysis of variance with repeated measurements. RESULTS: The total physical activity (in MET*h/week) declined between visit 2 and visit 3 (subgroup A: V2: 48.0 ± 33.6, V3: 37.1 ± 23.0; subgroup B: V2: 52.6 ± 35.7, V3: 43.8 ± 40.7, subgroup C: V2: 51.5 ± 29.7, V3: 36.9 ± 22.8, for all p = 0.00) with no between-subgroup differences over time (p = 0.68). In all three subgroups the initial improvements in relative exercise capacity and MetS severity were maintained. Work ability declined significantly in subgroup C (V2: 40.3 ± 5.0, V3: 39.1 ± 5.7; p < 0.05), but remained stable in the other subgroups with no between-subgroup differences over time (p = 0.38). Health-related quality of life and anxiety and depression severity also showed no significant differences over time. CONCLUSIONS: Despite the maintenance of physical activity could not be achieved, most of the health related outcomes remained stable and above baseline value, with no difference regarding the support strategy during the maintenance treatment phase. Trial registration The study was completed as a cooperation project between the Volkswagen AG and the Hannover Medical School (ClinicalTrials.gov Identifier: NCT02029131).

Telemonitoring-Supported Exercise Training in Employees With Metabolic Syndrome Improves Liver Inflammation and Fibrosis.

INTRODUCTION: Metabolic syndrome (MetS) is a major health problem worldwide and the main risk factor for metabolic-associated fatty liver disease (MAFLD). Established treatment options are lifestyle interventions facilitating dietary change and increased physical activity. Here, we tested the effect of a telemonitoring-supported intervention on liver parameter of inflammation and fibrosis in individuals with MetS. METHODS: This was a prospective, randomized, parallel-group, and assessor-blind study performed in workers of the main Volkswagen factory (Wolfsburg, Germany). Volunteers with diagnosed MetS were randomly assigned (1:1) to a 6-month lifestyle intervention focusing on supervised, activity-tracker-guided exercise or to a waiting-list control group. This secondary analysis assessed the effect of the intervention on liver enzymes and MAFLD-related parameters. RESULTS: We screened 543 individuals between October 10, 2017, and February 27, 2018, of whom 314 were randomly assigned to the intervention group (n = 160) or control group (n = 154). Liver transaminases, alkaline phosphatase, and gamma-glutamyl transferase significantly decreased after 6 months in the intervention group compared with the CG. Furthermore, an aspartate aminotransferase-to-platelet ratio index score as a marker for liver fibrosis significantly decreased in the intervention group. These improvements were associated with changes in obesity and exercise capacity. DISCUSSION: A 6-month lifestyle intervention based on exercise training with individualized telemonitoring-based supervision led to improvements of liver inflammation and fibrosis in employees with MetS. Therefore, this intervention shows therapeutic potential for individuals at high risk of MAFLD (ClinicalTrials.gov Identifier: NCT03293264).

Interaction of heparin and protamine in presence of overdosage: in vitro study.

BACKGROUND: Heparin is used for anticoagulation during cardiopulmonary bypass. After weaning from bypass, protamine is administered to neutralize the effects of heparin and thus reestablish hemostasis. Rotational thrombelastometry has been shown to discriminate between heparin and other impairing effects on coagulation. We analyzed the interaction of heparin and protamine under different conditions of overdosage in an in-vitro trial. METHODS: Blood samples were taken from 17 healthy volunteers, separated, and spiked in vitro with heparin, protamine for heparin neutralization, an overdosage of protamine, and two dosages of re-heparinization to evaluate heparin effects under the condition of protamine overdosage. All samples were analyzed in a standard ROTEM rotational thromboelastometry device after intrinsic activation with and without addition of heparinase. Coagulation time, maximum clot firmness, and clot formation time were recorded. RESULTS: Heparin led to prolongation of coagulation and clot formation times in the test without heparinase. Adequate protamine addition normalized the test, and overdosage of protamine led to significant prolongation of both times. Addition of heparin in the presence of protamine overdosage normalized these parameters. CONCLUSION: We reconfirmed that the ROTEM device enables discrimination of the effects heparin and protamine on coagulation and detection of the coagulation-impairing effects of protamine overdosage. Furthermore, we were able to show a positive effect on coagulation times by heparin in the presence of protamine overdosage. Because this was an in-vitro study, these findings need to be confirmed in vivo, requiring further research.

Influence of Officially Ordered Restrictions During the First Wave of COVID-19 Pandemic on Physical Activity and Quality of Life in Patients after Kidney Transplantation in a Telemedicine Based Aftercare Program-A KTx360° Sub Study.

Guidelines recommend a healthy lifestyle and regularly physical activity (PA) after kidney transplantation (KTx). The KTx360° program is a multicenter, multisectoral, multimodal, telemedicine-based follow-up care program. Effects of the first COVID-19 wave restrictions on health-related quality of life and PA of supervised KTx360° patients were evaluated using an online questionnaire. Six hundred and fifty-two KTx360° patients were contacted via email and were asked to complete the Freiburg questionnaire of physical activity and the Short form 12 Health Survey (SF-12) online. Pre-pandemic and lockdown data were compared in 248 data sets. While sporting activity decreased during the COVID-19 pandemic, basic and leisure activity increased, resulting in increased overall activity. The physical component scale of the SF-12 was in the low normal range before as well as during the pandemic, with a small but significant increase during the pandemic. The mental component scale showed normal values before and during pandemic with a small but statistically significant decrease. Our study supports the effectiveness of a telemedicine based program for KTx patient care in maintaining PA and quality of life during the first peak of the COVID-19 pandemic. However, further research and observation during the ongoing pandemic are required.

Everyday Pedelec Use and Its Effect on Meeting Physical Activity Guidelines.

Pedelecs (e-bikes with electrical support up to 25 km·h-1) are important in active transportation. Yet, little is known about physiological responses during their everyday use. We compared daily pedelec (P) and bicycle (B) use to determine if pedelecs are a suitable tool to enhance physical activity. In 101 employees, cycling duration and intensity, heart rate (HR) during P and B were recorded via a smartphone app. Each recording period was a randomized crossover design and lasted two weeks. The ride quantity was higher in P compared to B (5.3 ± 4.3 vs. 3.2 ± 4.0 rides·wk-1; p < 0.001) resulting in a higher total cycling time per week for P (174 ± 146 min·wk-1) compared to B (99 ± 109 min·wk-1; p < 0.001). The mean HR during P was lower than B (109 ± 14 vs. 118 ± 17 bpm; p < 0.001). The perceived exertion was lower in P (11.7 ± 1.8 vs. 12.8 ± 2.1 in B; p < 0.001). The weekly energy expenditure was higher during P than B (717 ± 652 vs. 486 ± 557 metabolic equivalents of the task [MET]·min·wk-1; p < 0.01). Due to a sufficient HR increase in P, pedelecs offer a more active form of transportation to enhance physical activity.

Employers With Metabolic Syndrome and Increased Depression/Anxiety Severity Profit Most From Structured Exercise Intervention for Work Ability and Quality of Life.

BACKGROUND: Major depressive disorder and anxiety disorders are associated with less productivity, earlier retirement, and more sick-days at the workplace. These associations also exist for patients with metabolic syndrome. For both, exercise is a generally recommended part of multimodal treatments. However, for individuals with metabolic syndrome, in which depression and anxiety is more prevalent and severe, evidence for the efficacy of exercise interventions is limited. METHODS: Company employees with diagnosed metabolic syndrome (n=314, age: 48 ± 8 yrs) were randomized to a 6-month exercise intervention (150 min per week) or wait-list control. Participants received individual recommendations for exercise activities by personal meetings, telephone, or via a smartphone app. Physical activities were supervised and adapted using activity monitor data transferred to a central database. Work ability (work ability index), depression severity and anxiety severity [hospital anxiety and depression scale (HADS)], and health-related quality of live [short form 36 (SF-36)] were assessed. RESULTS: We included 314 subjects from which 287 finished the intervention. Total work ability, depression- and anxiety severity, and the mental component score of the SF-36 improved after 6 months exercise compared to controls. After baseline stratification for normal (HADS scores 0-7) and increased depression- and anxiety scores (HADS scores 8-21) individuals with increased severity scores had similar age, body composition, blood lipids, and cardiorespiratory fitness compared to those with normal scores, but lower total work ability and component sum scores of health-related quality of life. After 6 months total work ability increased in the exercise group compared to controls with the magnitude of the observed increase being significantly greater for subjects with increased depression- and anxiety severity at baseline compared to those with normal severity scores. CONCLUSIONS: A 6-month exercise intervention for company employees with metabolic syndrome showed strongest effects on self-perceived work ability in individuals with mild to severe depression- and anxiety severity. This suggests exercise programs offered to workers with metabolic syndrome not only reduces individual disease risk but may also reduce healthcare and employers costs arising from metabolic syndrome and mental disease conditions. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT03293264.

Effects of six month personalized endurance training on work ability in middle-aged sedentary women: a secondary analysis of a randomized controlled trial.

BACKGROUND: To test the effects of guided endurance training on work ability in middle-aged female hospital workers of various occupations. METHODS: We randomized 265 healthy, sedentary, middle-aged women (45-65 years) to an endurance training group (EG 210 min/week) or a wait-list control group (CG). At baseline and at 6-month follow-up, we assessed work ability (Work Ability Index [WAI]), physical activity (Freiburger activity questionnaire) and peak oxygen uptake (VO2peak) by cardiopulmonary exercise testing. To examine the influence of baseline work ability, participants were divided into poor-moderate (WAI 1, 7-36 points, n = 83), good (WAI 2, 37-43 points, n = 136) and excellent (WAI 3, 44-49 points, n = 46) WAI subgroups. RESULTS: Cardiorespiratory fitness improved significantly after 6 months in the EG but not in the CG. The WAI total score increased significantly in the EG (38.3 ± 5.0 to 39.8 ± 4.9 points) but not in the CG (39.4 ± 4.7 to 39.3 ± 4.9 points), with a significant difference between groups (p < 0.01). In the EG, only the poor-moderate subgroup (WAI 1, 33.0 ± 2.9 to 36.6 ± 4.8 points, p < 0.05) increased the WAI total score, with this increase being significantly higher compared to the good (WAI 2, 40.2 ± 2.1 to, 40.4 ± 3.7 points) and excellent (WAI 3, 45.6 ± 1.5 to 45.7 ± 1.8 points) subgroup. CONCLUSIONS: A 6-month guided exercise training intervention significantly increases cardiorespiratory fitness with concomitant improvements in work ability in middle-aged previously sedentary hospital employees. Women with low baseline work ability seem to particularly benefit from the intervention, which implies that similar interventions may be particularly beneficial for this group of individuals. TRIAL REGISTRATION: German Clinical Trails Register Identifier: DRKS00005159. Registered 25 September 2013.

Obesity After Kidney Transplantation-Results of a KTx360°Substudy.

OBJECTIVE: There is solid evidence that kidney transplant (KTx) patients are susceptible to weight gain after transplantation. Post-transplantation obesity [body mass index (BMI) ≥ 30 kg/m2] seems to be associated with higher risks of hypertension, dyslipidemia, diabetes mellitus, and cardiovascular events, while there are contradicting findings regarding the association between obesity and mortality, graft failure after transplantation as well as other variables. We aimed to evaluate the course of weight after KTx and to assess the prevalence of post-transplant obesity in a large sample of German KTx patients. Further, we focused on potential associations between weight gain, obesity, and BMI after transplantation with sociodemographic, medical, psychological [levels of anxiety and depression measured with the Hospital Anxiety and Depression Scale (HADS)], and donation-specific variables. METHODS: In a structured post-transplant care program 433 KTx patients were evaluated at Hannover Medical School. Information on the pre-transplant body weight/dry weight of dialysis patients was taken from the electronic patient charts. At post-transplant assessment body weight was measured in the transplant center. For statistical analyses, descriptive statistics, analyses of variance, tests for correlations, and regression analyses were used. RESULTS: Mean age was 51.3 years, 59% were male and 26.3% had ≥12 years of school attendance. Regarding somatic conditions 6.0% were suffering from type 2 diabetes mellitus, 6.9% were affected by new-onset diabetes after transplantation (NODAT), and the mean estimated glomerular filtration rate (eGFR) was 47.7 ml/min/1.73m2. The prevalence rates of obesity before and after kidney transplantation were 14.8 and 19.9%, respectively. This represents an increase of 34%. Obesity after transplantation was associated with higher rates of type 2 diabetes mellitus and of NODAT. Additionally, there was an association between increasing pre-transplant as well as post-transplant BMI and decreasing eGFR. Higher age and female sex were associated with higher rates of post-transplant obesity. CONCLUSIONS: Our results suggest that obesity represents a serious problem in KTx patients, especially regarding the association between increasing BMI and decreasing graft functioning (eGFR). However, this aspect is often overlooked and information on effective treatment options for these patients are scarce making further research on this topic necessary.

Coagulation monitoring and transfusion in major non-emergency orthopaedic surgery - An observational study.

OBJECTIVE: Perioperative coagulation monitoring and transfusions were evaluated. METHODS: 70 cases were included. Time points: before (PRE), after surgery (POST), day 1, day 3, day 7. Standard and patient near tests were assessed. Groups were: Transfused (TG); Control (CG). RESULTS: 23 patients were transfused (TG), 47 were not (CG). PRE haemoglobin was reduced, coagulation time (CT) was prolonged in TG. FIBTEM decrease was higher in TG. Leukocytes were elevated in TG. ASPI decreased, TRAP and ADP aggregability increased in both groups. CONCLUSION: CT, haemoglobin and fibrinogen were associated with transfusion. TRAP and ADP aggregability increased and could account for thromboembolism.

Highland games: A benchmarking exercise in predicting biophysical and drug properties of monoclonal antibodies from amino acid sequences.

Biopharmaceutical product and process development do not yet take advantage of predictive computational modeling to nearly the degree seen in industries based on smaller molecules. To assess and advance progress in this area, spirited coopetition (mutually beneficial collaboration between competitors) was successfully used to motivate industrial scientists to develop, share, and compare data and methods which would normally have remained confidential. The first "Highland Games" competition was held in conjunction with the October 2018 Recovery of Biological Products Conference in Ashville, NC, with the goal of benchmarking and assessment of the ability to predict development-related properties of six antibodies from their amino acid sequences alone. Predictions included purification-influencing properties such as isoelectric point and protein A elution pH, and biophysical properties such as stability and viscosity at very high concentrations. Essential contributions were made by a large variety of individuals, including companies which consented to provide antibody amino acid sequences and test materials, volunteers who undertook the preparation and experimental characterization of these materials, and prediction teams who attempted to predict antibody properties from sequence alone. Best practices were identified and shared, and areas in which the community excels at making predictions were identified, as well as areas presenting opportunities for considerable improvement. Predictions of isoelectric point and protein A elution pH were especially good with all-prediction average errors of 0.2 and 1.6 pH unit, respectively, while predictions of some other properties were notably less good. This manuscript presents the events, methods, and results of the competition, and can serve as a tutorial and as a reference for in-house benchmarking by others. Organizations vary in their policies concerning disclosure of methods, but most managements were very cooperative with the Highland Games exercise, and considerable insight into common and best practices is available from the contributed methods. The accumulated data set will serve as a benchmarking tool for further development of in silico prediction tools.

Systematic Investigation of Insulin Fibrillation on a Chip.

A microfluidic protein aggregation device (microPAD) that allows the user to perform a series of protein incubations with various concentrations of two reagents is demonstrated. The microfluidic device consists of 64 incubation chambers to perform individual incubations of the protein at 64 specific conditions. Parallel processes of metering reagents, stepwise concentration gradient generation, and mixing are achieved simultaneously by pneumatic valves. Fibrillation of bovine insulin was selected to test the device. The effect of insulin and sodium chloride (NaCl) concentration on the formation of fibrillar structures was studied by observing the growth rate of partially folded protein, using the fluorescent marker Thioflavin-T. Moreover, dual gradients of different NaCl and hydrochloric acid (HCl) concentrations were formed, to investigate their interactive roles in the formation of insulin fibrils and spherulites. The chip-system provides a bird's eye view on protein aggregation, including an overview of the factors that affect the process and their interactions. This microfluidic platform is potentially useful for rapid analysis of the fibrillation of proteins associated with many misfolding-based diseases, such as quantitative and qualitative studies on amyloid growth.

[Effectiveness of blood flow restriction training in competitive sports]. / Effektivität des "blood flow restriction training" im Leistungssport.

BACKGROUND: Training under conditions of blood flow restriction (BFR) has recently been advocated as an option for alternative training in athletes. OBJECTIVE: Does BFR make sense in athlete training? MATERIAL AND METHODS: An overview of the currently available literature is given. RESULTS: The use of BFR appears to be a possibility to achieve muscle hypertrophy and an increase in muscular strength and can also improve parameters of cardiocirculatory function. CONCLUSION: Various approaches for implementation of BFR in athletes can be found in the literature. These approaches differ in the frequency, force used, duration and finally type of implementation of BFR itself. Clear recommendations for training cannot be given to date and the individual weighing up of possibilities and supervised implementation of BFR in athlete training by the trainer are still necessary.

eHealth-supported case management for patients with panic disorder or depression in primary care: Study protocol for a cRCT (PREMA).

BACKGROUND: Panic disorder (PD), frequently occurring with agoraphobia (AG), and depression are common mental disorders in primary care and associated with considerable individual and societal costs. Early detection and effective treatment of depression and PD/AG are of major importance. Cognitive behavioural exposure exercises have been shown to be effective in reducing anxiety and depressive symptoms. Practice team-based case management can improve clinical outcomes for patients with chronic diseases in primary care. The present study aims at evaluating the effects and cost-effectiveness of a primary care team-based intervention using behavioural therapy elements and case management supported by eHealth components in patients with PD/AG or depression compared to treatment as usual. METHODS/DESIGN: This is a two-arm cluster-randomized, controlled trial (cRCT). General practices represent the units of randomisation. General practitioners recruit adult patients with depression and PD ± AG according to the International Classification of Diseases, version 10 (ICD-10). In the intervention group, patients receive cognitive behaviour therapy-oriented psychoeducation and instructions to self-managed exposure exercises in four manual-based appointments with the general practitioner. A trained health care assistant from the practice team delivers case management and is continuously monitoring symptoms and treatment progress in ten protocol-based telephone contacts with patients. Practice teams and patients are supported by eHealth components. In the control group, patients receive usual care from general practitioners. Outcomes are measured at baseline (T0), at follow-up after 6 months (T1), and at follow-up after 12 months (T2). The primary outcome is the mental health status of patients as measured by the Mental Health Index (MHI-5). Effect sizes of 0.2 standard deviation (SD) are regarded as relevant. Assuming a drop-out rate of 20% of practices and patients each, we aim at recruiting 1844 patients in 148 primary care practices. This corresponds to 12.5 patients on average per primary care practice. Secondary outcomes include depression and anxiety-related clinical parameters and health-economic costs. DISCUSSION: If the intervention is more effective than treatment as usual, the three-component (cognitive behaviour therapy, case-management, eHealth) primary care-based intervention for patients suffering from PD/AG or depression could be a valuable low-threshold option that benefits patients and primary care practice teams. TRIAL REGISTRATION: German clinical trials register, DRKS00016622. Registered on February 22nd, 2019.

Telemonitoring-supported exercise training, metabolic syndrome severity, and work ability in company employees: a randomised controlled trial.

BACKGROUND: Metabolic syndrome is a predisposing factor for cardiovascular and metabolic disease, but also has socioeconomic relevance by affecting the health and productivity of workers. We tested the effect of regular telemonitoring-supported physical activity on metabolic syndrome severity and work ability in company employees. METHODS: This was a prospective, randomised, parallel-group, and assessor-blind study done in workers in the main Volkswagen factory (Wolfsburg, Germany). Volunteers with diagnosed metabolic syndrome according to American Heart Association/National Heart, Lung, and Blood Institute criteria were randomly assigned (1:1) to a 6-month lifestyle intervention focusing on regular exercise (exercise group), or to a waiting-list control group, using a computer-based assignment list with variable block length. Participants in the exercise group received individual recommendations for exercise at face-to-face meetings and via a smartphone application, with the aim of doing 150 min physical activity per week. Activities were supervised and adapted using activity-monitor data, which were transferred to a central database. Participants in the control group continued their current lifestyle and were informed about the possibility to receive the supervised intervention after study completion. The primary outcome was the change in metabolic syndrome severity (metabolic syndrome Z score) after 6 months in the intention-to treat population. This trial is registered with ClinicalTrials.gov, number NCT03293264, and is closed to new participants. FINDINGS: 543 individuals were screened between Oct 10, 2017, and Feb 27, 2018, of whom 314 (mean age 48 years [SD 8]) were randomly assigned to receive the intervention (n=160; exercise group) or to a waiting list (n=154; control group). The mean metabolic syndrome Z score for the exercise group was significantly reduced after the 6-month intervention period (0·93 [SD 0·63] before and 0·63 [0·64] after the intervention) compared with the control group (0·95 [0·55] and 0·90 [0·61]; difference between groups -0·26 [95% CI -0·35 to -0·16], p<0·0001). We documented 11 adverse events in the exercise group, with only one event (a twisted ankle) regarded as directly caused by the intervention. INTERPRETATION: A 6-month exercise-focused intervention using telemonitoring systems reduced metabolic syndrome severity. This form of intervention shows significant potential to reduce disease risk, while also improving mental health, work ability, and productivity-related outcomes for employees at high risk for cardiovascular and metabolic disease. FUNDING: Audi BKK health insurance and the German Research Foundation through the Cluster of Excellence REBIRTH.

Long-term outcome after surgical treatment of intra-articular tibial plateau fractures in skiers.

INTRODUCTION: Tibial plateau fractures occur frequently during downhill skiing. There is a lack of information about the outcome and development of posttraumatic osteoarthritis after internal fixation of such fractures at long-term follow-up in skiers. MATERIALS AND METHODS: A population of 83 skiers was followed up in a case series after internal fixation of intra-articular tibial plateau fractures AO-OTA 41 B1-B3 and C1-C3. Functional outcomes Visual Analog Scale, Tegner Activity Scale, Modified Lysholm Score, Hospital for Special Surgery (HSS) Knee Score and X-ray images of the affected knees (preoperative, postoperative and at time of follow-up) were obtained. Radiological evaluation focused on severity of osteoarthritis according to the Kellgren and Lawrence score of the lateral, medial and retropatellar knee compartments separately. Subgroup analyses for fracture type and age were performed separately. RESULTS: Patients age was 49.8 ± 12.9 years (range 19-74 years) at the time of surgery, with a mean follow-up period of 10.3 ± 1.9 years (range 6-14 years). All tibial plateau fractures affected the lateral compartment, while the medial compartment was affected in addition as part of bicondylar fractures in two cases. Both the Tegener Activity Scale and Lysholm Score decreased significantly during the follow-up period and their median values dropped from 6 (range 3-7) to 5 (range 2-7) and from 100 (range 90-100) to 95 (range 58-100), respectively (both p < .01). The median clinical knee function at the time of follow-up revealed an HSS Knee Score of 96.5 points (range 74-100). Among the whole patient population, the radiological evaluation at follow-up revealed a significantly higher grade of osteoarthritis in all compartments of the knee joint compared to the time of the operation (p < .01). The grade of osteoarthritis in the lateral compartment was significantly higher than that in the medial and retropatellar compartments (p < .01). CONCLUSIONS: In addition to physiologic aging, progression of radiologic signs of osteoarthritis following internal fixation of intra-articular tibial plateau fractures in an athletic population of skiers is most severe in the lateral knee compartment corresponding to fracture location. However, the long-term functional outcomes seem to be very satisfactory.

The determination of the validity of an application-based knee-training device.

The goals of knee rehabilitation are to improve range of motion and muscle status. The aim of the study was to investigate accuracy and reproducibility of a newly designed knee-training device (KT) under standardized laboratory conditions.Two application-based software programs, one to measure maximum force and the other intended to improve users' coordination were developed to be used on a tablet during exercises, wirelessly connected to KT placed under the popliteal fossa.KT was loaded for 20 intervals of 15 seconds (s) ranging between 0-350 Newton (N) each. The interval of times was chosen to be enough to take right measurement for accurate results. In addition, a 300-s continuous measurement was undertaken. The pressure readings were developed through a servo-hydraulic system and used as reference values. KT results were compared with the reference values to assess its accuracy. In addition, KT was tested on a force-measuring platform in a close to reality measurement.Based on Bland-Altman plots, the mean difference between KT and material testing machine was -0.63 N (0.4%), between KT and force-measuring platform was -0.11 N (0.7%), which proves the accuracy of its result.Laboratory experiments confirm that KT delivers precise and reproducible values, which provide base for clinical trials.

[Isolated fracture of the coracoid process in a 14-year-old national water polo player : Case example]. / Isolierte Fraktur des Processus coracoideus bei einem 14-jährigen Wasserballnationalspieler : Fallbeispiel.

BACKGROUND: Isolated fractures of the coracoid process during sporting activities are very rare. There are a few case studies and retrospective studies with low numbers of cases. OBJECTIVE: Presentation of an initially neglected fracture and conservative treatment. METHODS: Case study of a 14-year-old national water polo player with a non-dislocated fracture of the coracoid process and conservative therapy using focused shockwave therapy. RESULT: Return to sports after conservative therapy was after 13 weeks and return to competitive sport after 14 weeks. CONCLUSION: In cases with therapy refractory shoulder pain after trauma and unremarkable native X­ray, extended 3D imaging by magnetic resonance imaging (MRI) or computed tomography (CT) should be done early. Conservative therapy of a non-dislocated fracture in this case showed a good outcome.