A multicentre, retrospective and observational study to evaluate safety and functional outcomes of arthroscopic shoulder ligament repair using Sironix suture anchor

Background: Arthroscopic shoulder ligament repair is one of the most performed procedures in the orthopaedic specialty. Suture anchor devices are used in arthroscopic surgeries to reattach ligaments or other soft tissues to bone. The goal of this study was to evaluate the safety and functional outcomes after shoulder ligament repair. Methods: This is a multicentric, retrospective, observational study conducted on patients who underwent primary arthroscopic shoulder ligament tear repair between April 2018 to July 2022, using Sironix suture anchors at Kumaran Hospital and Rela Institute, Chennai, Tamil Nadu, India, and DNV Ortho Care Hospital, Dharmapuri, Tamil Nadu, India. A total of 75 patients were included. Post-surgery measurements of functional outcomes were performed using the PENN shoulder score, simple shoulder test questionnaire, shoulder pain and disability index, and single assessment numerical evaluation. Adverse events were recorded. Results: At post-surgery follow-up visits, there was a significant improvement in the functional outcomes of all the patients. The PENN shoulder score had a mean (SD) pain score of 92.04 (7.50), a satisfaction score of 91.87 (8.00), and a function score of 93.18 (6.16), respectively. The mean (SD) SST score and SPADI score was 88.9 (9.7), and 2.8 (2.79) respectively. The SANE mean (SD) values of the operated joint and opposite joint were 91.0 (7.31) and 98.1 (4.26) respectively with a p value of 0.0001. Conclusions: Based on the study results, arthroscopic shoulder ligament repair with Sironix suture anchor resulted in good and desirable functional outcomes with no major adverse events and improved quality of life

Evaluation of safety and functional outcomes after rotator cuff repair using Sironix suture anchor

Background: Arthroscopic rotator cuff repair procedures are performed to maximize clinical and functional outcomes. The surgical sector is experiencing a surge in repair surgeries involving arthroscopic repair of torn tendons using surgical implants. The study aimed to evaluate the safety and functional outcomes of rotator cuff tear repair using Sironix suture anchors. Methods: Patients with a mean age of 53.8 years who underwent arthroscopic rotator cuff repair using a Sironix suture anchor between January 2019 and June 2022 were included in this retrospective observational study. Postoperatively, patients were assessed using the American shoulder and elbow surgeons score (ASES), level of activity using the simple shoulder test questionnaire (SST), quality of life using the shoulder pain and disability index scale (SPADI), the single assessment numerical evaluation score (SANE), and adverse events associated with study devices. Results: Significant and clinically relevant ASES, SST, SPADI, and SANE scores were observed in all patients. The mean (SD) values of total ASES, SST, and SPADI scores were 91.6 (6.21), 94.1 (10.74), and 1.3 (2.48), respectively. The mean (SD) value of total SANE score in the affected joint was 95.8 (7.70), and the opposite side was 99.0 (3.04). No serious adverse events were reported. Conclusions: Sironix suture anchors (CEPTRE® knotted UHMWPE suture PEEK anchor, CEPTRE® knotted UHMWPE suture PLDLA-βTCP anchor, VIPLOK® knotless PEEK anchor with titanium tip and VIPLOK® knotless PLDLA-βTCP anchor with titanium tip) have proven to be both safe and effective in repairing rotator cuff tears, enhancing shoulder function without any serious adverse effects

Prucalopride: novel drug for chronic idiopathic constipation

Chronic Idiopathic Constipation (CIC), defined as constipation in which the underlying cause is unknown, is a common medical illness with a profound negative impact on health-related quality of life and increased propensity for life threatening complications. Current treatment for CIC includes lifestyle modifications, over-the-counter medications, and prescription medications. Presently, the only approved, prescription products for CIC in the US are prosecretory agents. However, the current knowledge that serotonin plays an important role in colonic motility has opened new horizons in the treatment of CIC promoting use of prokinetic agents with a different mechanism of action. Prucalopride is a highly selective 5-hydroxytryptamine type 4 (5-HT4) receptor agonist that enhances propulsive motor patterns in the large intestine due to a high affinity for 5-HT4 receptors in gastrointestinal (GI) tissues.  The onset of action of Prucalopride is fast, shows rapid absorption, oral bioavailability of 93% and linear pharmacokinetics. Most common adverse reactions seen are headache, nausea, diarrhea, and abdominal pain. Clinical trials for Prucalopride have been positive, and results suggest that the drug may be a new safe and effective option for CIC treatment, especially for patient’s refractory to prosecretory agents. As a prescription drug for the management of constipation and given the virtual demise of other prokinetic agents for this indication, prucalopride competes primarily with another class of agents: those that stimulate secretion. With Shire Pharmaceuticals having already received US FDA approval in Dec 2018, Prucalopride may soon be a new addition to the mounting armoury of drugs against CIC

Application of evidence-based methods to construct mechanism-driven chemical assessment frameworks

The workshop titled “Application of evidence-based methods to construct mechanism-driven chemical assessment frameworks” was co-organized by the Evidence-based Toxicology Collaboration and the European Food Safety Authority (EFSA) and hosted by EFSA at its headquarters in Parma, Italy on October 2 and 3, 2019. The goal was to explore integration of systematic review with mechanistic evidence evaluation. Participants were invited to work on concrete products to advance the exploration of how evidence-based approaches can support the development and application of adverse outcome pathways (AOP) in chemical risk assessment. The workshop discussions were centered around three related themes: 1) assessing certainty in AOPs, 2) literature-based AOP development, and 3) integrating certainty in AOPs and non-animal evidence into decision frameworks. Several challenges, mostly related to methodology, were identified and largely determined the workshop recommendations. The workshop recommendations included the comparison and potential alignment of processes used to develop AOP and systematic review methodology, including the translation of vocabulary of evidence-based methods to AOP and vice versa, the development and improvement of evidence mapping and text mining methods and tools, as well as a call for a fundamental change in chemical risk and uncertainty assessment methodology if to be conducted based on AOPs and new approach methodologies (NAM). The usefulness of evidence-based approaches for mechanism-based chemical risk assessments was stressed, particularly the potential contribution of the rigor and transparency inherent to such approaches in building stakeholders’ trust for implementation of NAM evidence and AOPs into chemical risk assessment

Applying evidence-based methods to the development and use of adverse outcome pathways

The workshop “Application of evidence-based methods to construct mechanistic frameworks for the development and use of non-animal toxicity tests” was organized by the Evidence-based Toxicology Collaboration and hosted by the Grading of Recommendations Assessment, Development and Evaluation Working Group on June 12, 2019. The purpose of the workshop was to bring together international regulatory bodies, risk assessors, academic scientists, and industry to explore how systematic review methods and the adverse outcome pathway framework could be combined to develop and use mechanistic test methods for predicting the toxicity of chemical substances in an evidence-based manner. The meeting covered the history of biological frameworks, the way adverse outcome pathways are currently developed, the basic principles of systematic methodology, including systematic reviews and evidence maps, and assessment of certainty in models, and adverse outcome pathways in particular. Specific topics were discussed via case studies in small break-out groups. The group concluded that adverse outcome pathways provide an important framework to support mechanism-based assessment in environmental health. The process of their development has a few challenges that could be addressed with systematic methods and automation tools. Addressing these challenges will increase the transparency of the evidence behind adverse outcome pathways and the consistency with which they are defined; this in turn will increase their value for supporting public health decisions. It was suggested to explore the details of applying systematic methods to adverse outcome pathway development in a series of case studies and workshops

Seasonal culture of dormant reproductive buds of Salix tetrasperma: analysis of the flowering process

The flowering process in a female tree of Salix tetrasperma was analysed by culturing its reproductive buds at different developmental stages during the dormant period on a chemically defined medium and examining the nature of sprouts produced by them. Buds at the upper eight nodes of the actively growing shoots developing in an acropetal sequence were cultured in separate lots. While all the buds collected from the 1st and 2nd nodes of the branches from the top downwards were vegetative and produced shoots, a considerable number of those collected from the 3rd and 4th nodes were reproductively determined and produced catkins. All the buds obtained from the 5th node and below were reproductive. Reproductive buds were cultured at regular time intervals during the dormant period. Freshly formed buds cultured in March during the spring growth flush produced catkins and were therefore reproductively determined. However, such a determination was not tantamount to flowering, as the floral meristems present in the axils of catkin bracts remained quiescent. Floral meristems of the buds cultured during April to August developed into small vegetative shoots. This was followed by the crucial period during September to December when the hitherto vegetative sprouts of the floral meristems showed a gradual transition into ovaries (female flowers) resulting in fertile catkins. Catkins produced from buds cultured in January and February produced well-developed ovaries