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Background: Mortality of patients with a femoral neck fracture is high, especially within the first year after surgery, but also remains elevated thereafter. The aim of this study was to identify factors potentially associated with long-term mortality in patients homogeneously treated with hemiarthroplasty for femoral neck fracture. Methods: This retrospective cohort study was performed at a single level 1 national trauma center at the university hospital of Leipzig (Saxony, Germany). The study time-window was January 1, 2010 to December 31, 2020. Primary outcome measure was mortality depending on individual patient-related characteristics and perioperative risk factors. Inclusion criteria was a low-energy femoral neck fracture (Garden I-IV) in geriatric patients 60 years of age or older that were primarily treated with bipolar hemiarthroplasty. Date of death or actual residence of patients alive was obtained from the population register of the eastern German state of Saxony, Germany. The outcome was tested using the log-rank test and plotted using Kaplan-Meier curves. Unadjusted and adjusted for other risk factors such as sex and age, hazard ratios were calculated using Cox proportional hazards models and presented with 95% confidence intervals (CI). Results: The 458 included patients had a median age of 83 (IQR 77–89) years, 346 (75%) were female and 113 (25%) male patients. Mortality rates after 30 days, 1, 5 and 10 years were 13%, 25%, 60% and 80%, respectively. Multivariate regression analysis revealed age (HR = 1.1; p < 0.001), male gender (HR = 1.6; p < 0.001), ASA-Score 3–4 vs. 1–2 (HR = 1.3; p < 0.001), dementia (HR = 1.9; p < 0.001) and a history of malignancy (HR = 1.6; p = 0.002) as independent predictors for a higher long-term mortality risk. Perioperative factors such as preoperative waiting time, early surgical complications, or experience of the surgeon were not associated with a higher overall mortality. Conclusions: In the present study based on data from the population registry from Saxony, Germany the 10-year mortality of older patients above 60 years of age managed with hemiarthroplasty for femoral neck fracture was 80%. Independent risk factors for increased long-term mortality were higher patient age, male gender, severe comorbidity, a history of cancer and in particular dementia. Perioperative factors did not affect long-term mortality. [ABSTRACT FROM AUTHOR]

Background: Recombinant antibodies are essential reagents for research, diagnostics and therapy. The well established production host Escherichia coli relies on the secretion into the periplasmic space for antibody synthesis. Due to the outer membrane of Gram-negative bacteria, only a fraction of this material reaches the medium. Recently, the Gram-positive bacterium Bacillus megaterium was shown to efficiently secrete recombinant proteins into the growth medium. Here we evaluated B. megaterium for the recombinant production of antibody fragments. Results: The lysozyme specific single chain Fv (scFv) fragment D1.3 was succesfully produced using B. megaterium. The impact of culture medium composition, gene expression time and culture temperatures on the production of functional scFv protein was systematically analyzed. A production and secretion at 41°C for 24 h using TB medium was optimal for this individual scFv. Interestingly, these parameters were very different to the optimal conditions for the expression of other proteins in B. megaterium. Per L culture supernatant, more than 400 μg of recombinant His6-tagged antibody fragment were purified by one step affinity chromatography. The material produced by B. megaterium showed an increased specific activity compared to material produced in E. coli. Conclusion: High yields of functional scFv antibody fragments can be produced and secreted into the culture medium by B. megaterium, making this production system a reasonable alternative to E. coli. [ABSTRACT FROM AUTHOR]

Background: Improved oncological and surgical measures now enable curative treatment of malignant lower extremity tumors in majority of cases. Complication rates associated with surgical resection of lower extremity tumors and replacement with megaendoprostheses are high. The aim of this study was to identify risk factors that predispose to revision surgery following the use of megaimplants in curative treatment of malignant tumors of the lower extremities. Methods: this retrospective study included patients aged ≥ 18 years who underwent implantation of a megaendoprosthesis for tumors or metastatic lesions of the lower extremities between January 2010 and December 2020. Baseline characteristics and information on adjuvant treatment, hospitalization time, comorbidities, mobility, complications, and revision surgery were considered. Primary outcomes were revision surgery and reasons for revision. Secondary outcomes were in-hospital complications and the duration of hospitalization. Results: Fifty-four patients (48% female, age 63 years, SD 15) were available for final analysis. Surgeries were performed at hip level in 37 patients (68.5%) and at knee level in 17 patients (31.5%). Revision for wound-related causes was performed in 12 cases (22.2%), with microbiological proof of infection in 8 cases (14.8%). Revision for hip joint instability was carried out in 4 cases (7.4%) and for disconnection between components of the megaimplant in 2 cases (3.7%). Those patients requiring a wound-related revision had undergone a longer primary surgical intervention than those who required an implant-related revision (276 vs 134 min, p =.002). Wound drains after the primary implantation remained longer in situ in patients who later required revision surgery for wound-related complications (5 vs 3 days, p =.020). An ASA > 3 was associated with an increased likelihood for in-hospital complications in general (p =.041), and in-hospital death in particular (p =.012). Conclusions: The management of malignant tumors of the lower extremities with megaendoprostheses is associated with a high rate of wound-related complications. Swift surgical performance and early postoperative removal of wound drains minimize the risk of complications in general and the necessity of revision surgery in particular. Patients with more comorbidities were more likely to suffer in-hospital complications. [ABSTRACT FROM AUTHOR]

Background: Molecular identification of Mycobacterium species has two primary advantages when compared to phenotypic identification: rapid turn-around time and improved accuracy. The information content of the 5' end of the 16S ribosomal RNA gene (16S rDNA) is sufficient for identification of most bacterial species. However, reliable sequence-based identification is hampered by many faulty and some missing sequence entries in publicly accessible databases. Methods: In order to establish an improved 16S rDNA sequence database for the identification of clinical and environmental isolates, we sequenced both strands of the 5' end of 16S rDNA (Escherichia coli positions 54 to 510) from 199 mycobacterial culture collection isolates. All validly described species (n = 89; up to March 21, 2000) and nearly all published sequevar variants were included. If the 16S rDNA sequences were not discriminatory, the internal transcribed spacer (ITS) region sequences (n = 84) were also determined. Results: Using 5'-16S rDNA sequencing a total of 64 different mycobacterial species (71.9%) could be identified. With the additional input of the ITS sequence, a further 16 species or subspecies could be differentiated. Only Mycobacterium tuberculosis complex species, M. marinum / M. ulcerans and the M. avium subspecies could not be differentiated using 5'-16S rDNA or ITS sequencing. A total of 77 culture collection strain sequences, exhibiting an overlap of at least 80% and identical by strain number to the isolates used in this study, were found in the GenBank. Comparing these with our sequences revealed that an average of 4.31 nucleotide differences (SD ± 0.57) were present. Conclusions: The data from this analysis show that it is possible to differentiate most mycobacterial species by sequence analysis of partial 16S rDNA. The high-quality sequences reported here, together with ancillary information (e.g., taxonomic, medical), are available in a public database, which is currently being expanded in the RIDOM project http://www.ridom-rdna.de), for similarity searches. [ABSTRACT FROM AUTHOR]

Background: The design and internal layout of modern operating rooms (OR) are influencing the surgical team's collaboration and communication, ergonomics, as well as intraoperative hygiene substantially. Yet, there is no objective method for the assessment and design of operating room setups for different surgical disciplines and intervention types available. The aim of this work is to establish an improved OR setup for common procedures in arthroplasty.Methods: With the help of computer simulation, a method for the design and assessment of enhanced OR setups was developed. New OR setups were designed, analyzed in a computer simulation environment and evaluated in the actual intraoperative setting. Thereby, a 3D graphical simulation representation enabled the strong involvement of clinical stakeholders in all phases of the design and decision-making process of the new setup alternatives.Results: The implementation of improved OR setups reduces the instrument handover time between the surgeon and the scrub nurse, the travel paths of the OR team as well as shortens the procedure duration. Additionally, the ergonomics of the OR staff were improved.Conclusion: The developed simulation method was evaluated in the actual intraoperative setting and proved its benefit for the design and optimization of OR setups for different surgical intervention types. As a clinical result, enhanced setups for total knee arthroplasty and total hip arthroplasty surgeries were established in daily clinical routine and the OR efficiency was improved. [ABSTRACT FROM AUTHOR]

Background: The treatment aims of periprosthetic fractures (PPF) of the distal femur are a gentle stabilization, an early load-bearing capacity and a rapid postoperative mobilization of the affected patients. For the therapy planning of PPF a standardized classification is necessary which leads to a clear and safe therapy recommendation. Despite different established classifications, there is none that includes the types of prosthesis used in the assessment. For this purpose, the objective of this work is to create a new more extensive fracture and implant-related classification of periprosthetic fractures of the distal femur based on available classifications which allows distinct therapeutic recommendations.Methods: In a retrospective analysis all patients who were treated in the University Hospital Leipzig from 2010 to 2016 due to a distal femur fracture with total knee arthroplasty (TKA) were established. To create an implant-associated classification the cases were discussed in a panel of experienced orthopaedists and well-practiced traumatologists with a great knowledge in the field of endoprosthetics and fracture care. In this context, two experienced surgeons classified 55 consecutive fractures according to Su et al., Lewis and Rorabeck and by the new created classification. In this regard, the interobserver reliability was determined for two independent raters in terms of Cohen Kappa.Results: On the basis of the most widely recognized classifications of Su et al. as well as Lewis and Rorabeck, we established an implant-dependent classification for PPF of the distal femur. In accordance with the two stated classifications four fracture types were created and defined. Moreover, the four most frequent prosthesis types were integrated. Finally, a new classification with 16 subtypes was generated based on four types of fracture and four types of prosthesis. Considering all cases the presented implant-associated classification (κ = 0.74) showed a considerably higher interobserver reliability compared to the other classifications of Su et al. (κ = 0.39) as well as Lewis and Rorabeck (κ = 0.31). Excluding the cases which were only assessable by the new classification, it still shows a higher interobserver reliability (κ = 0.70) than the other ones (κ = 0.63 or κ = 0.45).Conclusions: The new classification system for PPF of the distal femur following TKA considers fracture location and implant type. It is easy to use, shows agood interobserver reliability and allows conclusions to be drawn on treatment recommendations. Moreover, further studies on the evaluation of the classification are necessary and planned. [ABSTRACT FROM AUTHOR]

Background: Hip and knee replacements in patients with bone defects after infection correlates with high rates of reinfection. In this vulnerable patient population, the prevention of reinfection is to be considered superordinate to the functionality and defect bridging. The use of silver coating of aseptic implants as an infection prophylaxis is already proven; however, the significance of these coatings in septic reimplantation of large implants is still not sufficiently investigated.Methods: In a retrospective analysis, 34 patients who have been treated with a modular mega-endoprosthesis after a cured bone infection of the lower limb (femur or tibia) have been evaluated. One group with 14 patients (NSCG: non silver- coated group) was supplied with the non silver- coated implants: MML München- Lübeck™ modular endoprosthesis system (AQ Implants, Ahrensburg, Germany) or MUTARS® Modular Universal Tumor And Revision System (Implantcast GmbH, Buxtehude, Germany). The other group with 20 patients (SCG: silver- coated group) was supplied with the silver- coated system of MUTARS®. In addition to the clinical findings and the patients' histories, specifically the reinfection rates, the patients' mobility was assessed using the New Mobility Score (NMS, by Parker and Palmer).Results: The median follow-up period was 72 months, ranging from 6 to 267 months. The dropout rate was 5.8%. The reinfection rate after healed reinfection in SCG was 40% (8/20), in NSCG 57% (8/14), p = 0.34; α =0.05. The time for reinfection was, on average, 14 months (1-72 months) in SCG and 8 months (1-48 months) in the NSCG (p = 0.61; α =0.05). The two groups showed no differences in the NMS.Conclusion: With this retrospective analysis, it can be determined that the rate of reinfection of modular mega-endoprostheses on the hip and knee joint after healed periprosthetic joint infection (PJI) can be reduced by the use of silver coated implants. The time until reinfection can also be delayed by utilizing silver coated implants. Due to the low number of cases of this highly specific patient population, no statistical significance could be determined. A positive effect, however, can be assumed through the use of silver coatings in mega-endoprostheses after an infectious situation. [ABSTRACT FROM AUTHOR]

Background: In spite of the improvement of many aspects around Total knee arthroplasty (TKA), there is still a group of 10% to 34% of patients who is not satisfied with the outcome. The therapy of chronic pain after TKA remains a medical challenge that requires an interdisciplinary therapy concept. The aim of this prospective pilot study was to evaluate the efficacy of a multimodal pain therapy in chronic complaints after TKA. Methods: In a prospective cohort pilot study, we included patients with chronic pain after TKA who obtained in-patient care, especially multimodal pain therapy (MMPT), for at least 10 days. Essential elements of this therapy concept were physiotherapy, pain medication therapy, topical application of ketamine, local infiltration and Traditional Chinese Medicine. Patients with varying causes of complaints were excluded in advance. Before the start of the study all test persons were informed and gave their written consent. Moreover, each patient was examined and questioned at hospital admission, discharge and at its first as well as second follow-up. Additionally, knee joint mobility and stability were investigated at all examination times. Results: From 03/07/2016 to 07/14/2016, 21 patients were included in the pilot study. 52% of the considered population were female (11 persons). The median age was 65 years (45-79 years) and the median stay in hospital amounted 9 days (8-14 days). The first follow-up was scheduled after six weeks (median: 38 days, 30-112 days) and the second one after six months (median: 8 months, 7-12 months). The number of patients of the first follow-up was 17 out of 21 (19% drop out). The drop out of the last follow-up accounted for 33%. All patients benefit from the presented applications and therapies with regard to pain, function and range of motion. Especially, during the period of in-patient treatment, nearly all patients have improved in all terms. However, during the first follow-up clear deteriorations occurred in all areas, which stagnated up to the second follow-up. The range of motion has even worsened slightly. Conclusions: With the presented pilot study on multimodal in-patient therapy of chronic complaints due to TKA, the improvement of pain, function and mobility could be verified, especially during the stationary stay. Even though the results deteriorate during the follow-up period, they did never relapse to their initial level. In order to ensure an effective treatment, a clear diagnostic algorithm is essential, by which treatable causes, such as low-grade infections or loosenings, are safely excluded. Further prospective studies are necessary to obtain precise statements on prospects of success of our therapy plan. [ABSTRACT FROM AUTHOR]

Background: Modular mega-endoprosthesis systems are used to bridge very large bone defects and have become a widespread method in orthopaedic surgery for the treatment of tumours and revision arthroplasty. However, the indications for the use of modular mega-endoprostheses must be carefully considered. Implanting modular endoprostheses requires major, complication-prone surgery in which the limited salvage procedures should always be borne in mind. The management of periprosthetic infection is particularly difficult and beset with problems. Given this, the present study was designed to gauge the significance of periprosthetic infections in connection with modular mega-implants in the lower extremities among our own patients. Methods: Patients who had been fitted with modular endoprosthesis on a lower extremity at our department between September 1994 and December 2011 were examined retrospectively. A total of 101 patients with 114 modular prostheses were identified. Comprising 30 men (29.7 %) and 71 women (70.3 %), their average age at the time of surgery was 67 years (18-92 years). Results: The average follow-up period was 27 months (5 months and 2 weeks to 14 years and 11 months) and the drop-out rate was about 8.8 %. Altogether, there were 19 (17.7 %) endoprosthesis infections: 3 early infections and 16 late or delayed infections. The pathogen spectrum was dominated by coagulase-negative staphylococci (36 %) and Staphylococcus aureus (16 %), including 26 % multi-resistant pathogens. Reinfection occurred in 37 % of cases of infection. Tumours were followed by significantly fewer infections than the other indications. Infections were twice as likely to occur after previous surgery. Conclusion: In our findings modular endoprostheses (18 %) are much more susceptible to infection than primary endoprostheses (0.5-2,5 %). Infection is the most common complication alongside the dislocation of proximal femur endoprostheses. Consistent, radical surgery is essential - although even with an adequate treatment strategy, the recurrence rate is very high. Unfortunately, the functional results are frequently unsatisfactory, with amputation often being the last resort. Therefore, the indication for implantation must be carefully considered and discussed in great detail, especially in the case of multimorbid patients with previous joint infections. [ABSTRACT FROM AUTHOR]

Background: Recent research has focused on identifying chemical modulators of osteogenesis. We present initial findings on the osteoinductive properties of prostaglandin Е1 (Vasaprostan), using a rabbit model.Methods: Data were collected on callus formation in 14 male rabbits. These were divided into two groups (control and treatment) with 7 animals in each group. In all animals, the right tibia was fractured using a standardized protocol and stabilized by an intramedullary nail. Treatment group received a 5 μg/kg subcutaneous injection of PGE1/day during 10 postoperative days. Visual and radiological evaluation of callus formation was prospectively collected. After 30 days, all animals were killed and the tibia specimens were examined histologically.Results: In all the treatment group animals, fractures were consolidated radiologically by day 30. No treatment group animals and two control group animals were excluded form the experiment. In the control group, 4 animals demonstrated slower callus formation than the main group. Two control group animals were excluded from the experiment on the 20th day due to wound infection; one developed a nonunion. The mean coefficient of bone callus thickening in the main group was 2.08 (±0, 16) and 1.77 (±0.05) (p < 0.05) in the control group. Calculation of mean quantity of neogenic vessels in 10 random visual fields of the bone callus revealed 78 (±9.82) in the main group and 40 (±4.68) in the control group (p < 0.05).Conclusions: Our study demonstrates an increased rate and amount of bone callus formation in the group treated with prostaglandin E1 compared to the control group. Prospective radiological analysis was corroborated by histologic evaluation. [ABSTRACT FROM AUTHOR]

Background: Elective knee and hip arthroplasty is followed by infections in currently about 0.5-2.0 % of cases - a figure which is on the increase due to the rise in primary implants. Correct diagnosis early on is essential so that appropriate therapy can be administered. This work presents a retrospective analysis of the diagnoses of patients suffering infections after total hip or knee arthroplasty. Methods: 320 patients with prosthetic joint infection (PJI) following knee or hip arthroplasty were identified. They comprised a) 172 patients with an infection after total hip arthroplasty (THA): 56 % females (n = 96) and 44 % males (n = 76) with a mean age of 70.9 (39-92) years; and 148 patients with an infection after total knee arthroplasty (TKA): 55 % females (n = 82) and 45 % males (n = 66) with a mean age of 70.7 (15-87) years. Results: Although significantly more TKA than THA patients reported pain, erythema, a burning sensation and swelling, no differences between the two groups were observed with respect to dysfunction, fever or fatigue. However, significant differences were noted in the diagnosis of loosening (THA 55 %, TKA 31 %, p < 0.001) and suspected infection using conventional X-rays (THA 61 %, TKA 29 %, p < 0.001). FDG-PET-CT produced very good results in nearly 95 % of cases. There were no differences between THA and TKA patients regarding levels of inflammation markers. Histological evaluation proved to be significantly better than microbiological analysis. Summary: The clinical picture may be non-specific and not show typical inflammatory symptoms for a long time, particularly in PJI of the hip. As imaging only provides reliable conclusions after the symptoms have persisted for a long time, morphological imaging is not suitable for the detection of early infections. FDG-PT-CT proved to be the most successful technique and is likely to be used more frequently in future. Nevertheless, there are currently no laboratory parameters which are suitable for the reliable primary diagnosis of PJI. Diagnosis requires arthrocentesis, and the fluid obtained should always be examined both microbiologically and histologically. [ABSTRACT FROM AUTHOR]