scholarly journals Bent or broken: analysis of set screw fracture in the TFNa implant

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Matthew Klima
Keyword(s):  
The United States ◽  
Rotational Instability ◽  
Level Of Evidence ◽  
Screw Insertion ◽  
Lag Screw ◽  
Femoral Shortening ◽  
United States Food ◽  
User Facility ◽  
Helical Blade ◽  
Proximal Screw

Abstract Objectives To evaluate set screw fracture in the Trochanteric Femoral Nail Advanced implant (TFNa, Synthes, West Chester, PA) and to identify additional mechanisms of set screw failure in the TFNa. Materials and methods Patients who had experienced failure after open reduction and internal fixation (ORIF) with the TFNa were identified. TFNa implants were explanted and inspected following revision surgery. Medical device reports (MDRs) and manufacturer’s inspection reports describing similar failures for the TFNa in the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database were also reviewed. Results Four set screw fractures that occurred at a level II trauma center were observed. Sixty-seven reported failures were identified in the MAUDE database for review. Twenty-eight failed implants were returned to the manufacturer for inspection with a published inspection report available for analysis. Set screw fractures can occur in the TFNa when the set screw is deployed prematurely into the proximal screw aperture prior to blade/screw insertion. The set screw can also bend and deform if it is advanced against a helical blade/lag screw that is not fully seated into position, thereby potentially compromising its function. Conclusion The TFNa set screw allows for potential fracture during implant insertion leading to uncontrolled collapse, early excessive proximal femoral shortening, and rotational instability of the helical blade/lag screw. Similar failures in the TFNa can be prevented by having the surgeon inspect the proximal screw aperture after attachment of the proximal aiming aim to ensure the set screw has not been deployed prematurely. Level of evidence Therapeutic Level III.

scholarly journals Adverse events related to total ankle replacement devices: an analysis of reports to the United States Food and Drug Administration

2021 ◽  
Author(s):  
Karim Mahmoud ◽  
Sreenivasulu Metikala ◽  
Kathryn M. O’Connor ◽  
Daniel C. Farber
Keyword(s):  
The United States ◽  
Control Device ◽  
Mandatory Reporting ◽  
Total Ankle Replacement ◽  
Published Data ◽  
Safety Database ◽  
Ankle Replacement ◽  
United States Food ◽  
User Facility ◽  
Reporting Mechanism

Abstract Background The published outcomes of total ankle replacement (TAR) implants came from limited institutions creating observational bias. For broader perspective, we queried the Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) voluntary database to explore complications reported outside published literature. Methods The database was reviewed retrospectively between November 2011 and April 2019 using two product codes assigned to six TAR devices. Results Among 648 relevant reports available in the database, common complications were aseptic loosening (19.3%), infection (18.2%), and alignment/mechanical issues (16.5%). Others included instrument/instrumentation complications, impingement, polyethylene problems, fractures, avascular necrosis of talus (AVN), and packaging issues. Conclusion MAUDE database revealed various patterns of device-related malfunctions that have been under-reported in published data. Despite inconsistency in the available reports, it provided opportunities for improvements in quality control, device design, and ultimately patient safety. Database would be further strengthened by more robust reporting mechanism or mandatory reporting of device-related complications.

Delirium Secondary to Lamotrigine Toxicity

2020 ◽  
Vol 15 (2) ◽  
pp. 156-159 ◽  
Author(s):  
Deborah L. Sanchez ◽  
Adam J. Fusick ◽  
Steven R. Gunther ◽  
Michael J. Hernandez ◽  
Gregory A. Sullivan ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Valproic Acid ◽  
Mental Status ◽  
The United States ◽  
Clinical Correlation ◽  
Medication Regimen ◽  
Medication Effects ◽  
United States Food ◽  
States Food ◽  
Rule Out

Background: Lamotrigine is a phenyltriazine medication that has been approved by the United States Food and Drug Administration as monotherapy and as an adjunctive agent for the treatment of seizure disorder. It was later approved by the FDA for the treatment of bipolar disorder. Lamotrigine is generally well tolerated by patients, but some serious symptoms can occur during treatment. These severe side effects include rashes and multi-organ failure. Lamotrigine has also been associated with the development of mental status changes, frequently when used concurrently with other medications that may impact the metabolism of lamotrigine. Objective: To present the case of a 65-year-old man being treated with lamotrigine and valproic acid who developed mental status changes after the addition of sertraline to his medication regimen, and to compare this case to existing cases reported in the literature. Discussion: Our case adds to the existing literature by demonstrating that patients may experience adverse medication effects despite lamotrigine levels that are normally considered to be in the therapeutic range, highlighting the importance of clinical correlation when obtaining medication levels. Conclusion: Clinicians should use caution interpreting lamotrigine levels when working up delirium, as normal levels may not rule out the development of lamotrigine toxicity.

Epidemiology of Acute Extensor Mechanism Injuries in Collegiate-Level Athletes in the United States

2021 ◽  
pp. 194173812110129
Author(s):  
Kevin K. Chen ◽  
Jimmy J. Chan ◽  
William Ranson ◽  
Nicholas Debellis ◽  
Hsin-Hui Huang ◽  
...  
Keyword(s):  
Large Scale ◽  
Injury Rate ◽  
Collegiate Athletes ◽  
The United States ◽  
Extensor Mechanism ◽  
Surveillance Program ◽  
Level Of Evidence ◽  
Severe Injuries ◽  
Male Athletes ◽  
Collegiate Level

Background: Extensor mechanism injuries involving the quadriceps tendon, patella, or patellar tendon can be a devastating setback for athletes. Despite the potential severity and relative frequency with which these injuries occur, large-scale epidemiological data on collegiate-level athletes are lacking. Study Design: Descriptive epidemiology study. Level of Evidence: Level 4. Methods: Knee extensor mechanism injuries across 16 sports among National Collegiate Athletic Association (NCAA) men and women during the 2004-2005 to 2013-2014 academic years were analyzed using the NCAA Injury Surveillance Program (NCAA-ISP). Extensor mechanism injuries per 100,000 athlete-exposures (AEs), operative rate, annual injury and reinjury rates, in-season status (pre-/regular/postseason), and time lost were compiled and calculated. Results: A total of 11,778,265 AEs were identified and included in the study. Overall, 1,748 extensor mechanism injuries were identified, with an injury rate (IR) of 14.84 (per 100,000 AEs). N = 114 (6.5%) injuries were classified as severe injuries with a relatively higher median time loss (44 days) and operative risk (18.42%). Male athletes had higher risk of season-ending injuries in both all (3.20% vs 0.89%, P < 0.01) and severe (41.54% vs 16.33%, P < 0.01) extensor mechanism injuries. Similarly, contact injuries were more frequently season-ending injuries (4.44% vs 1.69%, P = 0.01). Women’s soccer (IR = 2.59), women’s field hockey (IR = 2.15), and women’s cross country (IR = 2.14) were the sports with the highest rate of severe extensor mechanism injuries. Conclusion: Extensor mechanism injuries in collegiate athletes represent a significant set of injuries both in terms of volume and potentially to their athletic careers. Male athletes and contact injuries appear to have a greater risk of severe injuries. Injuries defined as severe had a higher risk of operative intervention and greater amount of missed playing time. Clinical Relevance: Knowledge of the epidemiology of extensor mechanism injuries may help clinicians guide their athlete patients in sports-related injury prevention and management.

scholarly journals The Efficacy of Convalescent Plasma Use in Critically Ill COVID-19 Patients

Medicina ◽  
2021 ◽  
Vol 57 (3) ◽  
pp. 257
Author(s):  
Livius Tirnea ◽  
Felix Bratosin ◽  
Iulia Vidican ◽  
Bianca Cerbu ◽  
Mirela Turaiche ◽  
...  
Keyword(s):  
Pilot Study ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Therapeutic Option ◽  
White Blood Cells ◽  
The United States ◽  
Plasma Therapy ◽  
Reactive Protein ◽  
United States Food ◽  
States Food

Background and Objectives: On 24 March 2020, the United States Food and Drug Administration (FDA) announced the approval of convalescent plasma therapy for critically ill patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as an emergency investigational new drug. This pilot study from Romania aimed to determine if convalescent plasma transfusion can be beneficial in the treatment of selected critically ill patients diagnosed with a SARS-CoV-2 infection. Materials and Methods: Donor and receiver eligibility for critically ill coronavirus disease 2019 (COVID-19) patients was based on Romanian guidelines issued at the time of the study. Here, we describe the evolution of a total of five eligible patients diagnosed with COVID-19 who received convalescent plasma (CP) in Romania. Results: In spite of our efforts and convalescent plasma administration, three of the five patients did not survive, while the other two recovered completely. Over the course of our five-day laboratory record, the surviving patients had significantly lower values for C-reactive protein, interleukin-6, and white blood cells. Conclusions: This pilot study provides insufficient evidence to determine the efficacy of convalescent plasma use as a therapeutic option for critically ill COVID-19 patients.

scholarly journals Enabling patient-reported outcome measures in clinical trials, exemplified by cardiovascular trials

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Theresa M. Coles ◽  
Adrian F. Hernandez ◽  
Bryce B. Reeve ◽  
Karon Cook ◽  
Michael C. Edwards ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Outcome Measures ◽  
Contextual Factors ◽  
The United States ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Think Tank ◽  
Level Of Evidence ◽  
Patient Reported ◽  
Evidentiary Standards

Abstract Objectives There has been limited success in achieving integration of patient-reported outcomes (PROs) in clinical trials. We describe how stakeholders envision a solution to this challenge. Methods Stakeholders from academia, industry, non-profits, insurers, clinicians, and the Food and Drug Administration convened at a Think Tank meeting funded by the Duke Clinical Research Institute to discuss the challenges of incorporating PROs into clinical trials and how to address those challenges. Using examples from cardiovascular trials, this article describes a potential path forward with a focus on applications in the United States. Results Think Tank members identified one key challenge: a common understanding of the level of evidence that is necessary to support patient-reported outcome measures (PROMs) in trials. Think Tank participants discussed the possibility of creating general evidentiary standards depending upon contextual factors, but such guidelines could not be feasibly developed because many contextual factors are at play. The attendees posited that a more informative approach to PROM evidentiary standards would be to develop validity arguments akin to courtroom briefs, which would emphasize a compelling rationale (interpretation/use argument) to support a PROM within a specific context. Participants envisioned a future in which validity arguments would be publicly available via a repository, which would be indexed by contextual factors, clinical populations, and types of claims. Conclusions A publicly available repository would help stakeholders better understand what a community believes constitutes compelling support for a specific PROM in a trial. Our proposed strategy is expected to facilitate the incorporation of PROMs into cardiovascular clinical trials and trials in general.

scholarly journals Review of COVID-19 mRNA Vaccines: BNT162b2 and mRNA-1273

2021 ◽  
pp. 089719002110096
Author(s):  
Shyh Poh Teo
Keyword(s):  
Vaccine Development ◽  
Safety Data ◽  
The United States ◽  
Virus Infections ◽  
Phase 3 ◽  
Vaccination Programs ◽  
Safety Surveillance ◽  
Mass Immunization ◽  
United States Food ◽  
States Food

The United States Food and Drug Administration recently issued emergency use authorization for 2 mRNA vaccines for preventing COVID-19 disease caused by SARS-CoV-2 virus infections. BNT162b2 from Pfizer-BioNTech and mRNA-1273 by Moderna are planned for use in mass-immunization programs to curb the pandemic. A brief overview of COVID-19 mRNA vaccines is provided, describing the SARS-CoV-2 RNA, how mRNA vaccines work and the advantages of mRNA over other vaccine platforms. The Pfizer-BioNTech collaboration journey to short-list mRNA vaccine candidates and finally selecting BNT162b2 based on safety data is outlined, followed by the Phase 3 study of BNT162b2 demonstrating 95% efficacy in preventing COVID-19 infections. Studies regarding mRNA-1273 (Moderna) are described, including extended immunogenicity data up to 119 days. The Phase 3 COVE study of mRNA-1273 eventually showed vaccine efficacy of 94.5%. Recommendations for future mRNA vaccine development are provided, including ongoing safety surveillance, evaluation in under-represented groups in previous studies and improving mRNA vaccine thermostability. Finally, further logistical considerations are required for manufacturing, storing, distribution and implementing mass vaccination programs to curb the pandemic.

scholarly journals New Insights into the Pathogenesis of Systemic Mastocytosis

2021 ◽  
Vol 22 (9) ◽  
pp. 4900
Author(s):  
Zhixiong Li
Keyword(s):  
Molecular Mechanisms ◽  
Kinase Inhibitor ◽  
Systemic Mastocytosis ◽  
Treatment Strategies ◽  
The United States ◽  
European Medicines Agency ◽  
Myeloid Neoplasm ◽  
Organ Systems ◽  
United States Food ◽  
Kit D816v

Mastocytosis is a type of myeloid neoplasm characterized by the clonal, neoplastic proliferation of morphologically and immunophenotypically abnormal mast cells that infiltrate one or more organ systems. Systemic mastocytosis (SM) is a more aggressive variant of mastocytosis with extracutaneous involvement, which might be associated with multi-organ dysfunction or failure and shortened survival. Over 80% of patients with SM carry the KIT D816V mutation. However, the KIT D816V mutation serves as a weak oncogene and appears to be a late event in the pathogenesis of mastocytosis. The management of SM is highly individualized and was largely palliative for patients without a targeted form of therapy in past decades. Targeted therapy with midostaurin, a multiple kinase inhibitor that inhibits KIT, has demonstrated efficacy in patients with advanced SM. This led to the recent approval of midostaurin by the United States Food and Drug Administration and European Medicines Agency. However, the overall survival of patients treated with midostaurin remains unsatisfactory. The identification of genetic and epigenetic alterations and understanding their interactions and the molecular mechanisms involved in mastocytosis is necessary to develop rationally targeted therapeutic strategies. This review briefly summarizes recent developments in the understanding of SM pathogenesis and potential treatment strategies for patients with SM.

scholarly journals Botulinum toxin in the management of chronic migraine: clinical evidence and experience

2016 ◽  
Vol 10 (2) ◽  
pp. 127-135 ◽  
Author(s):  
Claus M Escher ◽  
Lejla Paracka ◽  
Dirk Dressler ◽  
Katja Kollewe
Keyword(s):  
Chronic Migraine ◽  
Botulinum Neurotoxin ◽  
Prophylactic Treatment ◽  
Clinical Evidence ◽  
The United States ◽  
Headache Frequency ◽  
United States Food ◽  
History Of ◽  
States Food ◽  
Review Reports

Chronic migraine (CM) is a severely disabling neurological condition characterized by episodes of pulsating unilateral or bilateral headache. The United States Food and Drug Administration (FDA) approved onabotulinumtoxinA (Botox®) for the prophylactic treatment of CM in 2010. It has been shown that onabotulinumtoxinA is effective in the reduction of headache frequency and severity in patients with CM. Treatment is well tolerated by the patients. This review reports on the history of botulinum neurotoxin (BoNT) in CM and presents the current clinical evidence for the use of onabotulinumtoxinA in the treatment of CM.

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