Early Outcomes of Pelvic Trauma Patients - Complications, ICU Stay and Treatment Concepts in Two ATLS Compliant Trauma Centers: Germany and Qatar.

PURPOSE OF THE STUDY Pelvic trauma causes severe threats especially to polytraumatized patients. Not only it is in itself a possible cause for significant bleeding, but it also indicates a high risk for intra-abdominal injuries. The initial treatment of patients with pelvic trauma follows the ATLS principles of priority-oriented treatment. To examine the value of this highly standardized concept and to evaluate the effect of different patient collectives on early outcome parameters, two large collectives from Germany and Qatar were analyzed regarding injury parameters and early outcomes. MATERIAL AND METHODS Patients were recruited in Hamad General Hospital, Doha, Qatar (HGH) and BG Trauma Center Ludwigshafen, Germany (BG). All patients that were treated with a pelvic fracture between 2013 and 2016 were included in this retrospective analysis. Demographic parameters were collected as well as type of injury and the frequency of complication parameters as pneumonia, acute kidney failure, ARDS, sepsis and amount of blood transfusion. 1436 patients with pelvic fracture (645 from BG and 791 from HGH) were recruited. The mean age was 57.4 years in the BG and 33.6 years in the HGH group (p<0.000). The mean ISS was 17.81 in the BG and 15.88 in the HGH group (p=0.009). The mean pelvic AIS was 2.65 in the BG and 2.25 in the HGH group (p<0.000). RESULTS The mean frequency of complications was 9.3% in the BG and 9.9% in the HGH group (p=0.128). The mean frequency of ARDS was significantly higher in the BG group than in the HGH group (5.6% vs. 1.8%, p<0.000). The mean frequency of blood transfusion was significantly lower in the BG group than in the HGH group (28.8% vs. 39.2%, p<0.000). CONCLUSIONS Despite significant differences in the two collectives, this analysis shows comparable results regarding early outcome parameters in patients with pelvic injuries. In total, pelvic injuries are accompanied by a relatively high complication risk and need to be evaluated and treated according to priority-based algorithms. Key words: ATLS®, pelvic injury, complications, polytrauma.

Commentary - A comprehensive safety understanding of granulocyte-colony stimulating factor biosimilars and Intended Copy Biologics in treating chemotherapy associated febrile neutropenia.

Filgrastim, human white cell growth factor, Granulocyte colony-stimulating factor (G-CSF), is a core medicine in the WHO list of Essential Medicines. For this reason, recent reporting of statistically significant safety and efficacy differences between reference and Biosimilar brands of filgrastim by Rastogi and the Indian Pharmacopoeia Commission in Toxicology and Applied Pharmacology in 2020 is of great concern [Shruti Rastogi et al. Towards a comprehensive safety understanding of granulocyte-colony stimulating factor biosimilars in treating chemotherapy associated febrile neutropenia: Trends from decades of data. Toxicology and Applied Pharmacology Volume 395, 15 May 2020, 114,976. https://doi.org/10.1016/j.taap.2020.114976]. This commentary shows that the alarming report is a result of incorrect statistical tests misapplied to inappropriate data sets compounded by a further problem relating to the strict regulatory definition of a Biosimilar Medicine as opposed that of an Intended Copy Biologic. In contrast, the body of evidence from more than seven and a half thousand participants in Confirmatory Clinical Studies and Post Approval Clinical Studies as well as the Periodic Safety Update Reports confirms that European approved filgrastim Biosimilars show no meaningful difference in quality, safety or efficacy compared to the reference brand.

Gender influence on the outcome of an unisex total knee arthroplasty system.

BACKGROUND: Controversy exists on whether gender-specific anatomic differences in the human knee have to be taken into account by gender-specific design in total knee replacement (TKR). We evaluated total knees that were implanted in both genders. OBJECTIVE: This paper will describe the influence of gender on the outcome after a unisex total knee arthroplasty. METHODS: 52 total knee prostheses (mobile bearing Brehm Precision Knee®, BPK) were implanted in 48 patients (16 male, 32 female, 4 bilateral). Median follow-up was 15 months. HSS score, KSS score, ROM, VAS, and radiologic axis were used as outcome measures. We also obtained preoperative scores of these parameters, creating difference parameters respectively. All surgeries were performed by a single surgeon. RESULTS: No significant difference could be determined between genders for postoperative parameters and difference between preoperative and postoperative parameters between both groups. Women scored higher on HSS score preoperatively and postoperatively with 50.0 and 91.0 points versus 47.0 and 88.0 points in the male group. On KSS score, the female group scored higher preoperatively and postoperatively as well, with 79.0 and 174.0 points versus the male group with 74.0 and 168.0. CONCLUSION: As the results obtained with this unisex prosthesis system were not statistically significant when compared for gender, we conclude the BPK currently addresses gender-specific anatomic differences sufficiently.

[Locking, multidimensional plate osteosynthesis of midshaft clavicle fracture]. / Winkelstabile, mehrdimensionale Plattenosteosynthese der Klavikulaschaftfraktur.

BACKGROUND: The goal of this consecutive, retrospective clinical follow-up study was to analyse the quality of treatment with a multidimensional, anatomical locking plate osteosynthesis after comminuted clavicle shaft fracture (Robinson 2B). PATIENTS AND METHODS: Of 38 operated patients, 35 were examined after locking plate osteosynthesis, with a median follow-up of 32 months (11-65). Four patients had suffered a 2B1 Robinson fracture and 31 patients a 2B2 Robinson fracture. The clinical and functional results were determined based on the standard clinical examination of the shoulder, the Constant and DASH scores, an analogue visual scale and a patient survey. RESULTS: The clinical examination yielded a mean DASH score of 1.25, a mean Constant score of 98 and a mean VAS score on the visual analogue scale of 0.4 (with a range of 0-6). Neither nonunion nor implant failure was observed. We did, however, have one case of infection of the soft tissue. CONCLUSION: The treatment of comminuted shaft fractures of the clavicle by means of a multidimensional locking plate is a safe treatment option that includes early functional postoperative care with free range of motion.

Does ATLS trauma training fit into Western countries: evaluation of the first 8 years of ATLS in Germany.

BACKGROUND: With over 2 million certified physicians worldwide, the Advanced Trauma Life Support (ATLS) program is one of the most successful international medical education programs. Germany joined the ATLS program in 2003. Before implementation of the program, there was a controversial discussion as to whether a country like Germany with a long history of trauma care needed ATLS at all. 197 courses with nearly 3,000 providers were performed until December 2010. AIM: We assessed the course evaluations since the implementation of ATLS in Germany using the participants' systematic feedback. METHOD: During the course, each participant evaluated each presentation, skill station, and simulation on a rating scale from 1 to 4 (1 being the best, 4 being the worst). The participants completed the evaluation forms during the course and before they received their results. The course coordinator made sure that all forms were returned. The feedback forms were collected anonymously and were entered into a database. Statistical analysis was performed using frequencies and mean values. RESULTS: The cumulative evaluation of all courses revealed an average performance score of 1.39 (1.06-1.86; n = 197). The lectures, skill stations, and simulations were individually evaluated as follows: lectures 1.61 (1.00-2.81; n = 197), skill stations 1.40 (1.00-2.40; n = 197), and surgical skill stations 1.35 (1.00-2.38; n = 197). Practical skills simulation (case scenarios) received the highest grade of 1.24 (1.00-1.57; n = 197). There were no significant changes during the time concerning the results of the evaluation. CONCLUSION: The overall assessment showed constantly good and excellent evaluations by the participants over the years. In general, skill stations and simulations performed better than lectures. According to these results, the course format is well accepted by the participants and, therefore, can be recommended to all physicians treating trauma patients. Our results also underline the value of such a course format in an industrial country with an already established trauma system.

Development of a new G-CSF product based on biosimilarity assessment.

BACKGROUND: Zarzio, a new recombinant human granulocyte colony-stimulating factor (filgrastim), was evaluated in healthy volunteers and neutropenic patients in phase I and III studies. PATIENTS AND METHODS: Healthy volunteers in randomized, two-period crossover studies received single- and multiple-dose s.c. injections of 1 microg/kg (n = 24), 2.5 microg/kg (n = 28), 5 microg/kg (n = 28), or 10 microg/kg (n = 40), as well as single-dose i.v. infusions of 5 microg/kg (n = 26), of Zarzio or the reference product (Neupogen). Filgrastim serum levels were monitored; pharmacodynamic parameters were absolute neutrophil count (all studies) and CD34(+) cells (multiple-dose studies). Supportive efficacy and safety data were obtained from an open phase III study in 170 breast cancer patients undergoing four cycles of doxorubicin and docetaxel (Taxotere) chemotherapy, receiving Zarzio (300 or 480 microg) as primary prophylaxis of severe neutropenia. RESULTS: The results of the studies in healthy volunteers confirm the comparability of the test and reference products with respect to their pharmacodynamics and pharmacokinetics. Confidence intervals were within the predefined equivalence boundaries. In the phase III study in breast cancer patients, the administration of Zarzio was efficacious and safe, triggering no immunogenicity. CONCLUSION: The results of these studies demonstrate the biosimilarity of Zarzio with its reference product Neupogen.