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Background: Intervertebral disc degeneration is emphasized as an important cause of low back pain. Current surgical treatment provides relief to the accompanying pain and disability but does not restore the biological function of the intervertebral disc. NOVOCART™ Disc plus, an autologous cell compound for autologous disc chondrocyte transplantation, was developed to reduce the degenerative sequelae after lumbar disc surgery or to prophylactically avoid degeneration in adjacent discs.Methods/design: This is a multicenter, randomized, controlled, clinical phase I/II combination study. A total of 120 adult patients are allocated in a ratio of 2:1:1. Sample size and power calculations were performed to detect the minimal clinically important difference of 10 units, with an expected standard deviation of 12 in the Oswestry Disability Index, which is the primary outcome parameter. Secondary outcome parameters include the visual analog scale and the EQ-5D questionnaire. Changes in physical and mental health are evaluated using the Short Form-12 (SF-12). Moreover, radiological and functional outcomes are evaluated. The major inclusion criterion is a single lumbar disc herniation that requires sequestrectomy. Transplantation is performed 90 days thereafter. Study data generation (study sites) and data storage, processing, and statistical analysis are clearly separated.Discussion: In this phase-I/II study, NDplus is being investigated for its clinical applicability, safety, and efficacy in the repair of herniated, nucleotomized discs, and of adjacent degenerated discs, if present. To date, autologous disc chondrocytes have not been transplanted into degenerative discs without previous disc herniation. As such, this is the first study to investigate a therapeutic as well as a prophylactic approach to treat degenerative discs of the lumbar spine.Trial Registration: EudraCT No: 2010-023830-22, ID NCT01640457 , 8 November 2010. [ABSTRACT FROM AUTHOR]

• The investigated hospital uses 531g of plastic consumables/patient/day. • The most important consumables are PPE, accounting for 52% of the polymers. • The most relevant polymers are PP and latex. • Plastic packaging accounts for an additional 3% of the weight of consumables. • The studied consumables account for 20% of the hospital's mixed waste. Plastics have become omnipresent in healthcare but quantitative data on mass flows are scarce. This study, therefore, performed a material flow analysis of single-use medical plastics and their packaging in a surgical hospital in Germany. We quantified the flows of eight different polymers across six product categories of medical consumables, based on the evaluation of the consumption data for 2018 and 2019. A total of 619 g of medical consumables were used per patient per day, of which 86% were polymers (531 g/patient/day). Plastic packaging contributed an additional 16 g/patient/day. The major product categories were personal protective equipment (49%) and incontinence products (22%). Polypropylene with 45 % and latex with 25% were the major polymers, both of which are tied to the use of personal protective equipment. The detailed analysis of the material and waste flows may serve to highlight potential steps for the plastic reduction in hospitals. [Display omitted] [ABSTRACT FROM AUTHOR]

Study Design: A multicenter, population based, case-control study.Objective: The aim of the present analysis is to clarify potential differences in the "occupational risk profiles" of structural lumbar disc diseases on the one hand, and low back pain (LBP) on the other hand.Summary Of Background Data: Physical workplace factors seem to play an important etiological role.Methods: We recruited 901 patients with structural lumbar disc diseases (disc herniation or severe disc space narrowing) and 233 control subjects with "low-back-pain." Both groups were compared with 422 "low-back pain free" control subjects. Case history, pain data, neurological deficits, and movement restrictions were documented. LBP was recorded by the Nordic questionnaire on musculoskeletal symptoms. All magnetic resonance imaging, computed tomography, and X-rays were inspected by an independent study radiologist. The calculation of cumulative physical workload was based on a computer-assisted interview and a biomechanical analysis by 3-D-dynamic simulation tool. Occupational exposures were documented for the whole working life.Results: We found a positive dose-response relationship between cumulative lumbar load and LBP among men, but not among women. Physical occupational risks for structural lumbar disc diseases [odds ratio (OR) 3.7; 95% confidence interval (95% CI) 2.3-6.0] are higher than for LBP (OR 1.9; 95% CI 1.0-3.5).Conclusion: Our finding points to potentially different etiological pathways in the heterogeneous disease group of LBP. Results suggest that not all of the structural disc damage arising from physical workload leads to LBP.Level Of Evidence: 4. [ABSTRACT FROM AUTHOR]

Objectives: Since 2000/2001, no large-scale prospective studies addressing traumatic brain injury (TBI) epidemiology in Germany have been published. Our aim was to look for a possible shift in TBI epidemiology described in other European countries, to look for possible changes in TBI management and to identify predictors of 1-year outcome especially in patients with mild TBI., Design: Observational cohort study., Setting: All patients suffering from a TBI of any degree between 1 October 2014 and 30 September 2015, and who arrived in one of the seven participating BG hospitals within 24 hours after trauma, were included., Participants: In total, 3514 patients were included., Outcome Measures: Initial care, acute hospital care and rehabilitation were documented using standardised documentation forms. A standardised telephone interview was conducted 3 and 12 months after TBI in order to obtain information on outcome., Results: Peaks were identified in males in the early 20s and mid-50s, and in both sexes in the late 70s, with 25% of all patients aged 75 or older. A fall was the most frequent cause of TBI, followed by traffic accidents (especially bicyclists). The number of head CT scans increased, and the number of conventional X-rays of the skull decreased compared with 2000/2001. Besides, more patients were offered rehabilitation than before. Though most TBI were classified as mild, one-third of the patients participating in the telephone interview after 12 months still reported troubles attributed to TBI. Negative predictors in mild TBI were female gender, intracranial bleeding and Glasgow Coma Scale (GCS) 13/14., Conclusion: The observed epidemiologic shift in TBI (ie, elderly patients, more falls, more bicyclists) calls for targeted preventive measures. The heterogeneity behind the diagnosis 'mild TBI' emphasises the need for defining subgroups not only based on GCS., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)