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The article presents a study which compares the effectiveness of oral and intravenous antibiotic therapy for treatment of bone and joint infection. The study administered oral or intravenous antibiotics to bone or joint infection patients for 6 weeks and evaluated them for treatment failure within a year. Result shows that treatment failure was higher for intravenous group compared to the oral group, suggesting that the latter therapy was noninferior to intravenous antibiotic therapy.

Background: Orthopaedic infections, such as osteomyelitis, diabetic foot infection and prosthetic joint infection, are most commonly treated by a combination of surgical debridement and a prolonged course of systemic antibiotics, usually for at least 4-6 weeks. Use of local antibiotics, implanted directly into the site of infection at the time of surgery, may improve antibiotic delivery and allow us to shorten the duration of systemic antibiotic therapy, thereby limiting the frequency of side effects, cost and selection pressure for antimicrobial resistance., Methods: SOLARIO is a multicentre open-label randomised controlled non-inferiority trial comparing short and long systemic antibiotic therapy alongside local antibiotic therapy. Adult patients with orthopaedic infection, who have given informed consent, will be eligible to participate in the study provided that no micro-organisms identified from deep tissue samples are resistant to locally implanted antibiotics. Participants will be randomised in a 1:1 ratio to receive either a short course (≤ 7 days) or currently recommended long course (≥ 4 weeks) of systemic antibiotics. The primary outcome will be treatment failure by 12 months after surgery, as ascertained by an independent Endpoint Committee blinded to treatment allocation. An absolute non-inferiority margin of 10% will be used for both per-protocol and intention-to-treat populations. Secondary outcomes will include probable and definite treatment failure, serious adverse events, treatment side effects, quality of life scores and cost analysis., Discussion: This study aims to assess a treatment strategy that may enable the reduction of systemic antibiotic use for patients with orthopaedic infection. If this strategy is non-inferior, this will be to the advantage of patients and contribute to antimicrobial stewardship., Trial Registration: Clinicaltrials.gov, NCT03806166. Registered on 11 November 2019.

Background: Management of bone and joint infection commonly includes 4-6 weeks of intravenous (IV) antibiotics, but there is little evidence to suggest that oral (PO) therapy results in worse outcomes., Objective: To determine whether or not PO antibiotics are non-inferior to IV antibiotics in treating bone and joint infection., Design: Parallel-group, randomised (1 : 1), open-label, non-inferiority trial. The non-inferiority margin was 7.5%., Setting: Twenty-six NHS hospitals., Participants: Adults with a clinical diagnosis of bone, joint or orthopaedic metalware-associated infection who would ordinarily receive at least 6 weeks of antibiotics, and who had received ≤ 7 days of IV therapy from definitive surgery (or start of planned curative treatment in patients managed non-operatively)., Interventions: Participants were centrally computer-randomised to PO or IV antibiotics to complete the first 6 weeks of therapy. Follow-on PO therapy was permitted in either arm., Main Outcome Measure: The primary outcome was the proportion of participants experiencing treatment failure within 1 year. An associated cost-effectiveness evaluation assessed health resource use and quality-of-life data., Results: Out of 1054 participants (527 in each arm), end-point data were available for 1015 (96.30%) participants. Treatment failure was identified in 141 out of 1015 (13.89%) participants: 74 out of 506 (14.62%) and 67 out of 509 (13.16%) of those participants randomised to IV and PO therapy, respectively. In the intention-to-treat analysis, using multiple imputation to include all participants, the imputed risk difference between PO and IV therapy for definitive treatment failure was -1.38% (90% confidence interval -4.94% to 2.19%), thus meeting the non-inferiority criterion. A complete-case analysis, a per-protocol analysis and sensitivity analyses for missing data each confirmed this result. With the exception of IV catheter complications [49/523 (9.37%) in the IV arm vs. 5/523 (0.96%) in the PO arm)], there was no significant difference between the two arms in the incidence of serious adverse events. PO therapy was highly cost-effective, yielding a saving of £2740 per patient without any significant difference in quality-adjusted life-years between the two arms of the trial., Limitations: The OVIVA (Oral Versus IntraVenous Antibiotics) trial was an open-label trial, but bias was limited by assessing all potential end points by a blinded adjudication committee. The population was heterogenous, which facilitated generalisability but limited the statistical power of subgroup analyses. Participants were only followed up for 1 year so differences in late recurrence cannot be excluded., Conclusions: PO antibiotic therapy is non-inferior to IV therapy when used during the first 6 weeks in the treatment for bone and joint infection, as assessed by definitive treatment failure within 1 year of randomisation. These findings challenge the current standard of care and provide an opportunity to realise significant benefits for patients, antimicrobial stewardship and the health economy., Future Work: Further work is required to define the optimal total duration of therapy for bone and joint infection in the context of specific surgical interventions. Currently, wide variation in clinical practice suggests significant redundancy that likely contributes to the excess and unnecessary use of antibiotics., Trial Registration: Current Controlled Trials ISRCTN91566927., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 23, No. 38. See the NIHR Journals Library website for further project information., Competing Interests: Adrian Taylor reports personal fees from Zimmer Inc., Corin Group and DePuy Synthes Companies outside the submitted work. Martin McNally reports personal fees from Bonesupport AB outside the submitted work. R Andrew Seaton reports personal fees from previous consultancy and funding for speaking at educational meetings (Novartis Pharma) and consultancy for Merck Sharp & Dohme Corp. (MSD) outside the submitted work. Harriet Hughes reports other competing interests from Gilead Sciences Inc., MSD, Biocomposites, and personal fees from Biocomposites and Cubist Pharmaceuticals outside the submitted work. Jennifer Bostock was a member of the Health Services and Delivery Research Commissioned Panel Members during this project.

Background: Approximately 70,000 to 75,000 proximal femoral fracture repairs take place in the UK each year. Hemiarthroplasty is the preferred treatment for adults aged over 60 years. Postoperative infection affects up to 3% of patients and is the single most common reason for early return to theatre. Ultraclean ventilation was introduced to help mitigate the risk of infection, but it may also contribute to inadvertent perioperative hypothermia, which itself is a risk for postoperative infection. To counter this, active intraoperative warming is used for all procedures that take 30 min or more. Forced air warming (FAW) and resistive fabric warming (RFW) are the two principal techniques used for this purpose; they are equally effective in prevention of inadvertent perioperative hypothermia, but it is not known which is associated with the lowest infection rates. Deep surgical site infection doubles operative costs, triples investigation costs and quadruples ward costs. The Reducing Implant Infection in Orthopaedics (RIIiO) study seeks to compare infection rates with FAW versus RFW after hemiarthroplasty for hip fracture. A cost-neutral intervention capable of reducing postoperative infection rates would likely lead to a change in practice, yield significant savings for the health economy, reduce overall exposure to antibiotics and improve outcomes following hip fracture in the elderly. The findings may be transferable to other orthopaedic implant procedures and to non-orthopaedic surgical specialties., Methods: RIIiO is a parallel group, open label study randomising hip fracture patients over 60 years of age who are undergoing hemiarthroplasty to RFW or FAW. Participants are followed up for 3 months. Definitive deep surgical site infection within 90 days of surgery, the primary endpoint, is determined by a blinded endpoint committee., Discussion: Hemiarthroplasty carries a risk of deep surgical site infection of approximately 3%. In order to provide 90% power to demonstrate an absolute risk reduction of 1%, using a 5% significance level, a full trial would need to recruit approximately 8630 participants. A pilot study is being conducted in the first instance to demonstrate that recruitment and data management strategies are appropriate and robust before embarking on a large multi-centre trial., Trial Registration: ISRCTN, ISRCTN74612906 . Registered on 27 February 2017.

Introduction: It has been shown previously that a history of low back pain often begins in childhood or adulthood. Indeed, the prevalence of severe back symptoms among schoolchildren is not insignificant. Possibilities for the primary prevention of intervertebral disc degeneration-related conditions are poorly reported in the literature despite the assumed socio-economical impact of the prevention of these conditions., Methods: In this review, the authors have collated published data on the prevalence and risk factors of childhood low back pain as well as the structure and results of published primary prevention programs., Results: The prevalence of self-reported low back pain is 7-65% among children and it increases with age. Several lifestyle factors have been reported as significant risk factors for back pain, many of which are related to the schools. Current educational primary prevention programs in schools show no clear or long-term stable effect., Conclusion: Considering the growing evidence about the importance of normal and bad posture, an exercise-based posture correction program is suggested as a school-based primary prevention of disc degeneration-related symptoms. Further, prospective randomized studies with more than 20 years follow-up, however, are strongly required to confirm it.

Purpose: Patient-reported outcome measurements (PROMs) are widely used in spine care. The development of reliable and valid National versions of spine-related disability questionnaires is strongly recommended from both the clinical and scientific points-of-view. The aims of this study were to adapt and validate the Oswestry Disability Index (ODI) and the Quebec back pain disability scale (QDS) for use with the Hungarian language., Methods: After translating and culturally adapting the ODI and QDS, 133 patients with lumbar degenerative spinal disorder filled in the questionnaire booklet twice within 2 weeks. Subjects completed the Hungarian versions of the two PROMs as well as the WHOQoL-BREF validated as a general life quality questionnaire and Visual Analogue Scale of pain. Internal consistency, reliability and construct validity of the questionnaires were determined, as were the standard error of measurement (SEM) and minimal detectable change (MDC) scores., Results: The Hungarian ODI consisted of one factor that showed good internal consistency (Cronbach-α 0.890). The QDS showed a four-factor structure with Cronbach-α values between 0.788 and 0.917. No significant floor or ceiling effects were observed. The test-retest analysis showed excellent reliability of the Hungarian ODI and QDS. The intraclass correlation coefficients (ICC) were 0.927 and 0.923, respectively. SEM values of 4.8 and 5.2 resulted in a MDC of 13 and 14 points in the Hungarian ODI and QDS, respectively. The correlation coefficient (r) between pain and ODI was 0.680 (p < 0.001) and the correlation between the ODI and the physical subscale of WHOQoL was also very good (r = -0.705, p < 0.001). The QDS total score and its four subscales correlated significantly with pain and with the physical subscale of WHOQoL (r > 0.4, p < 0.001). The level of disability measured by the Hungarian ODI and QDS was significantly higher in the surgical subgroup than in non-surgically treated patients (p < 0.001)., Conclusions: Translation and cultural adaptation of the ODI and QDS were successful. Hungarian versions of the ODI and QDS proved to be reliable, valid PROMs confirming that they can be used in future clinical and scientific work with Hungarian-speaking spine patients.

The separation and detection of small oligopeptides in CE with contactless conductivity detection were demonstrated. A strongly acidic separation buffer (0.5 M acetic acid) was employed in order to render the species cationic. Separation of the stereoisomers was achieved in typically 10-15 min by using either dimethyl-beta-CD (DM-beta-CD), (+)-(18-crown-6)-2,3,11,12-tetracarboxylic acid (18C(6)H(4)), a combination of the two substances, or of histidine, as buffer additives. Calibration curves were determined for isomers of Gly-Asp and H-Pro-Asp-NH(2), in the range of 0.05-0.5 mM and 0.1-1 mM, respectively, and were found to be linear. LODs were determined to be in the order of 1.0 microM. The determination of isomeric impurities down to about 1% was found possible. Species showing good separation could also be successfully determined on an electrophoretic lab-on-chip device, with analysis times of a few minutes.