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1.
J Am Acad Orthop Surg ; 32(16): e832-e838, 2024 Aug 15.
Article in English | MEDLINE | ID: mdl-39093461

ABSTRACT

INTRODUCTION: Postoperative fracture site infection can lead to notable patient morbidity, increase cost of care, and further contribute to healthcare disparities globally. Dogma suggests surgical blades as a vehicle for introducing bacteria into the surgical site; however, there is a paucity of literature to support this claim. This study uses advanced DNA sequencing to detect bacterial DNA on surgical blades used in upper extremity fracture surgeries. METHODS: This was a prospective study, conducted at a high-volume level 1 trauma center. All acute, closed upper extremity fractures requiring surgical stabilization were consecutively enrolled in a prospective fashion. The primary end point was the presence of bacterial DNA on the surgical blade using next-generation sequencing (NGS). At the time of surgery, two blades were sterilely opened. One blade served as the control while the other was used for the initial skin incision. Two negative control blades were opened directly into a sterile container. Two positive control blades were used for skin incision through known infections. All samples were sent for NGS analysis. RESULTS: Forty patients were enrolled in this study. The median age was 33.5 years, and 30% were female; the median body mass index was 26.52. Humerus fractures were the most common injury (N = 17, 42.5%), followed by clavicle fractures (13, 32.5%) and radius/ulna fractures (10, 25.0%). NGS analysis revealed no contamination of test blades used for skin incision. Three control blades tested positive for bacterial DNA. Negative control blades tested negative for bacterial DNA (0/2); the positive control blades resulted positive for bacterial DNA contamination (2/2). CONCLUSION: Surgical blades used for skin incision in the upper extremity are not contaminated with bacterial DNA as analyzed by NGS. This finding challenges previous surgical dogma regarding surgical blade contamination and supports that the same surgical blade can safely be used for deeper dissection. LEVEL OF EVIDENCE: Level II study: IRB approval-IRB#848938.


Subject(s)
High-Throughput Nucleotide Sequencing , Surgical Wound Infection , Humans , Prospective Studies , Surgical Wound Infection/prevention & control , Surgical Wound Infection/microbiology , Female , Male , Adult , Middle Aged , Fractures, Bone/surgery , DNA, Bacterial/analysis , Young Adult , Upper Extremity/surgery , Upper Extremity/injuries , Equipment Contamination , Cohort Studies , Humeral Fractures/surgery
2.
Article in English | MEDLINE | ID: mdl-39121795

ABSTRACT

INTRODUCTION: Geriatric hip fractures are associated with high rates of disability and mortality. Many of these patients require perioperative and postoperative allogeneic blood transfusions, which carry several noteworthy risks. A growing body of literature supports the efficacy of tranexamic acid (TXA) in geriatric hip fractures, without sufficient data examining which subgroups are likely to benefit the most. METHODS: In this study, we sought to evaluate whether TXA was associated with reduced blood loss and transfusions in a geriatric population undergoing hip fracture fixation at our institution during a 2-year period. The first year's data were collected in a retrospective fashion before the introduction of a quality control initiative encouraging TXA administration for all geriatric hip fractures. The second year's data were collected prospectively. A subgroup analysis was conducted for patients who underwent arthroplasties. RESULTS: Among the pooled cohort of patients undergoing surgery, TXA showed no benefit over control subjects for reducing blood loss or transfusion requirements. However, the subgroup of patients undergoing arthroplasty procedures showed a notable decrease in total blood loss and total units transfused during hospitalization. DISCUSSION: These results suggest that TXA may be most beneficial when targeted to arthroplasties performed for geriatric hip fractures.


Subject(s)
Antifibrinolytic Agents , Arthroplasty, Replacement, Hip , Blood Loss, Surgical , Blood Transfusion , Bone Nails , Hip Fractures , Tranexamic Acid , Humans , Tranexamic Acid/therapeutic use , Tranexamic Acid/administration & dosage , Antifibrinolytic Agents/therapeutic use , Hip Fractures/surgery , Female , Aged , Male , Aged, 80 and over , Retrospective Studies , Blood Loss, Surgical/prevention & control , Fracture Fixation, Intramedullary/methods , Treatment Outcome
3.
Health Technol Assess ; : 1-17, 2024 Jun 26.
Article in English | MEDLINE | ID: mdl-38970429

ABSTRACT

Research question: Is withholding anticoagulation for patients with isolated or incidental subsegmental pulmonary embolism clinically and cost-effective compared with full anticoagulation for 3 months? Background: There has been an increase in the diagnosis of subsegmental pulmonary embolism since the advent of computed tomography pulmonary angiogram to investigate patients with suspected pulmonary embolism. Subsegmental pulmonary embolism is not often detectable with older nuclear medicine-based diagnostic imaging for ventilation/perfusion mismatch. The case fatality of pulmonary embolism has reduced as subsegmental pulmonary embolism diagnoses from computed tomography pulmonary angiogram have increased. There is growing equipoise about the optimal treatment for patients with subsegmental pulmonary embolism, given that full anticoagulation has significant risks of bleeding and subsegmental pulmonary embolism was not often diagnosed previously with ventilation/perfusion scanning and therefore most likely left predominantly untreated prior to the introduction of computed tomography pulmonary angiogram scanning. Objectives: Determine whether withholding anticoagulation for isolated or incidental subsegmental pulmonary embolism (i.e. subsegmental pulmonary embolism with no coexisting deep-vein thrombosis) reduces the harms of recurrent thromboembolism and major bleeding compared with 3 months of full anticoagulation at 3, 6 and 12 months. Determine the rate of complications of anticoagulation therapy (predominantly bleeding) in patients with isolated subsegmental pulmonary embolism. Determine whether not treating isolated subsegmental pulmonary embolism is acceptable to clinicians and patients. Determine the reclassification rate of subsegmental pulmonary embolism diagnoses made by general reporting radiologists when reviewed by specialist respiratory radiologists and develop a set of rules to improve general radiologists' diagnoses of subsegmental pulmonary embolism. Assess cost-effectiveness of not treating patients with isolated subsegmental pulmonary embolism with anticoagulation, taking a health service perspective. Methods: Prospective individually randomised open controlled trial with blinded end-point committee assessment for outcomes, powered for non-inferiority for recurrent venous thromboembolism and for superiority for bleeding events. An internal pilot phase is included for feasibility and acceptability of no anticoagulation. We planned to recruit 1466 patients from at least 50 acute hospital sites. Allowing for a dropout rate of 15%, this would have given us 90% power to detect a reduction in major and clinically relevant non-major bleeding from 7.3% in the anticoagulation arm to 3% in the intervention arm. We were powered to determine that a strategy of no anticoagulation was non-inferior to anticoagulation with an upper margin of a 2.3% increase in recurrent venous thromboembolism from an expected rate of 2% in those who receive full anticoagulation. We also planned to undertake a study comparing acute reporting radiologists' diagnoses of subsegmental pulmonary embolism from all computed tomography pulmonary angiograms with specialist respiratory radiologists. This would have allowed us to determine safety in the pilot study (i.e. patients with pulmonary embolism that was in fact larger than subsegmental would have been identified) and develop guidance for subsegmental pulmonary embolism diagnosis for general radiologists. Patients with lived experience of thrombosis contributed to all aspects of the trial design and were part of the Trial Management Group. Progress of study: The STOPAPE trial was stopped prematurely due to a low recruitment rate in the wake of the COVID pandemic and prioritisation of recovery of the National Institute for Health and Care Research research portfolio. There are no outcome data available for this trial. Separate NIHR Library publications will detail the linked qualitative study examining the views of patients and clinicians around withholding anticoagulation for isolated subsegmental pulmonary embolism as well as presenting all collected data of recruited patients. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR128073. A plain language summary of this research article is available on the NIHR Journals Library Website https://doi.org/10.3310/HRCW7937.


Pulmonary embolism is a potentially serious condition, whereby blood clots cause a blockage of the blood supply to the lungs. The diagnosis of pulmonary embolism is made with a scan of the lungs, by showing areas where blood cannot get through the vessels easily due to blood clots. The treatment of pulmonary embolism includes anticoagulant medication ('blood thinners') that is taken over months and includes warfarin, an injectable form of heparin and directly acting oral anticoagulants. These medications work by preventing new clots from forming while the body's own mechanisms break down the clots. As the scanning technology for pulmonary embolism has become more sensitive, smaller clots are being diagnosed. However, small pulmonary embolisms may not cause any symptoms and may be found incidentally on scans performed for other reasons. In these situations, it is unclear whether treatment is required for the pulmonary embolism. These clots in smaller blood vessels away from the centre of the lungs (subsegmental pulmonary embolism) may be removed by the body's own mechanisms for dissolving clots without needing medications. Anticoagulant medication can cause side effects in some patients such as bleeding. For the anticoagulant medication to be appropriate in these smaller pulmonary embolisms, the benefits from preventing future blood clots (pulmonary embolism and deep-vein thrombosis) would need to outweigh the potential risks from the medication side effects. The STOPAPE study aimed to answer this question by testing whether we can safely withhold anticoagulation from patients diagnosed with subsegmental pulmonary embolism. Although we aimed to enrol 1466 patients in the trial with half getting usual care of anticoagulation and half getting no anticoagulation, we could not recruit patients quickly enough to the trial and, as a result, we could not continue with the STOPAPE study. This study protocol is published to help future research teams that wish to answer this research question.

4.
Injury ; 55(8): 111698, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38959675

ABSTRACT

INTRODUCTION: Case volumes of trauma centers and surgeons influence clinical outcomes following orthopaedic trauma surgery. This study quantifies surgical volume benchmarks for Orthopaedic Trauma Association (OTA)-accredited fellowship training in the United States. METHODS: This was a retrospective cross-sectional study of orthopaedic trauma fellows graduating between 2018 and 2019 to 2022-2023. Case volume percentiles were calculated across categories and variability defined as the fold-difference between 90th and 10th percentiles. Temporal trends were assessed with linear regression. RESULTS: 446 orthopaedic trauma fellows were included in this study. Mean reported case volume increased from 898 ± 245 in 2018-2019 to 974 ± 329 in 2022-2023 (P = 0.066). Mean case volume was 924 over the study period and mostly consisted of other (418 cases, 45 %), subtrochanteric/intertrochanteric femoral neck (84 cases, 9 %), open fracture debridement (72 cases, 8 %), pelvic ring disruption / fracture (55 cases, 6 %), acetabular fracture (41 cases, 4 %), tibial shaft fracture (39 cases, 4 %), and femoral shaft fracture (38 cases, 4 %) cases. Overall variability in total reported case volume was 2.0. Variability was greatest in distal radius fracture (14.8), amputation (9.5), fasciotomy (8.0), and proximal humerus repair (5.0). CONCLUSION: Graduates from OTA-accredited fellowship training perform 924 cases on average, which exceeds the current minimum requirement of 600 cases. Case volume benchmarks can assist trainees and faculty align training goals with fellowship program strengths. More research is needed to determine evidence-based case minimum requirements for core competency training in orthopaedic trauma surgery.


Subject(s)
Benchmarking , Clinical Competence , Fellowships and Scholarships , Orthopedics , Humans , Retrospective Studies , Cross-Sectional Studies , Orthopedics/education , Orthopedics/standards , United States , Clinical Competence/standards , Education, Medical, Graduate/standards , Male , Female , Orthopedic Procedures/education , Orthopedic Procedures/standards , Trauma Centers/standards , Traumatology/education , Traumatology/standards , Accreditation , Adult , Internship and Residency
5.
Article in English | MEDLINE | ID: mdl-39083504

ABSTRACT

INTRODUCTION: Matching into an orthopaedic surgery residency consistently reinforces a competitive landscape, challenging the applicants and programs. A group of orthopaedic surgery residency programs implemented video prompts asking applicants to respond to a standardized question by video recording. Assessing the impact of this video on the decision to offer an interview can help guide programs and applicants through the interview process. METHODS: Twenty residency applications to one institution requiring video prompts were randomly selected and deidentified. Thirteen experienced faculty from various orthopaedic surgery programs served as applicant reviewers. The reviewers evaluated the electronic residency application service (ERAS) application and determined whether they would grant the applicant an interview ("no," "maybe," or "yes") before and after watching the video prompt. The reviewer also scored the impact of the applicant's dress, facial presentation, and video background distractions on their evaluation of the video. Multivariable logistic regressions were conducted using a group of applicants where interview status was not impacted by the video compared with the group of applicants where the interview status changed after video review. An alpha value of 0.05 was used to define significance. RESULTS: The video prompt impacted the decision to offer an interview 29.3% of the time; 15.8% were switched from "yes" or "maybe" to "no" and 13.5% were switched from "no" or "maybe" to "yes." For the positively impacted applicants, facial presentation score was significantly higher (P = 0.005). No recorded variables were associated with decreased chance of interview. DISCUSSION: Video prompts impacted the decision to offer interviews to orthopaedic surgery applicants approximately one-third of the time, with a similar number of applicants being positively and negatively impacted. Facial presentation score was associated with increased chance of interview, and no variables were associated with decreased chance of interview. Thus, the answer to the videos presumably negatively impacted applicants.

6.
J Bone Joint Surg Am ; 106(12): 1054-1061, 2024 Jun 19.
Article in English | MEDLINE | ID: mdl-38900013

ABSTRACT

BACKGROUND: Periprosthetic fractures can be devastating complications after total joint arthroplasty (TJA). The management of periprosthetic fractures is complex, spanning expertise in arthroplasty and trauma. The purpose of this study was to examine and project trends in the operative treatment of periprosthetic fractures in the United States. METHODS: A large, public and private payer database was queried to capture all International Classification of Diseases, Tenth Revision (ICD-10) diagnosis codes for periprosthetic femoral and tibial fractures. Statistical models were created to assess trends in treatment for periprosthetic fractures and to predict future surgical rates. An alpha value of 0.05 was used to assess significance. A Bonferroni correction was applied where applicable to account for multiple comparisons. RESULTS: In this study, from 2016 to 2021, 121,298 patients underwent surgical treatment for periprosthetic fractures. There was a significant increase in the total number of periprosthetic fractures. The incidence of periprosthetic hip fractures rose by 38% and that for periprosthetic knee fractures rose by 73%. The number of periprosthetic fractures is predicted to rise 212% from 2016 to 2032. There was a relative increase in open reduction and internal fixation (ORIF) compared with revision arthroplasty for both periprosthetic hip fractures and periprosthetic knee fractures. CONCLUSIONS: Periprosthetic fractures are anticipated to impose a substantial health-care burden in the coming decades. Periprosthetic knee fractures are predominantly treated with ORIF rather than revision total knee arthroplasty (TKA), whereas periprosthetic hip fractures are predominantly treated with revision total hip arthroplasty (THA) rather than ORIF. Both periprosthetic knee fractures and periprosthetic hip fractures demonstrated increasing trends in this study. The proportion of periprosthetic hip fractures treated with ORIF relative to revision THA has been increasing. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.


Subject(s)
Periprosthetic Fractures , Reoperation , Humans , Periprosthetic Fractures/epidemiology , Periprosthetic Fractures/surgery , Periprosthetic Fractures/etiology , United States/epidemiology , Reoperation/statistics & numerical data , Female , Fracture Fixation, Internal/trends , Fracture Fixation, Internal/methods , Fracture Fixation, Internal/statistics & numerical data , Male , Arthroplasty, Replacement, Hip/adverse effects , Arthroplasty, Replacement, Hip/statistics & numerical data , Arthroplasty, Replacement, Hip/trends , Arthroplasty, Replacement, Knee/adverse effects , Arthroplasty, Replacement, Knee/statistics & numerical data , Aged , Incidence , Middle Aged , Femoral Fractures/surgery , Femoral Fractures/epidemiology , Femoral Fractures/etiology , Tibial Fractures/surgery , Tibial Fractures/epidemiology
7.
BMJ Open ; 14(6): e086587, 2024 Jun 10.
Article in English | MEDLINE | ID: mdl-38858149

ABSTRACT

INTRODUCTION: Aortic stenosis (AS) is common affecting >13% of adults over the age of 75 years. In people who develop symptoms, without valve replacement, prognosis is dismal with mortality as high as 50% at 1 year. In asymptomatic patients, the timing of valve intervention is less well defined and a strategy of watchful waiting is recommended. Many, however, may develop symptoms and attribute this to age related decline, rather than worsening AS. Timely intervention in asymptomatic severe AS is critical, since delayed intervention often results in poor outcomes. Proactive surveillance of symptoms, quality of life and functional capacity should enable timely identification of people who will benefit from aortic valve replacement. There are no data however, to support the clinical and cost effectiveness of such an approach in a healthcare setting in the UK. The aim of this pilot trial is to test the feasibility of a full-scale randomised controlled trial (RCT) to determine the utility of proactive surveillance in people with asymptomatic severe AS to guide the timing of intervention. METHODS AND ANALYSIS: APRAISE-AS is a multi-centre, non-blinded, two-arm, parallel group randomised controlled trial of up to 66 participants aged >18 years with asymptomatic severe AS. Participants will be randomised to either standard care or standard care supplemented with the APRAISE-AS intervention. Primary outcomes will capture; adherence to and participant acceptability of the intervention, recruitment and retention rates, and completeness of data collection. The findings will be used to inform the sample size and most appropriate outcome measure(s) for a full-scale RCT and health economic evaluation. ETHICS AND DISSEMINATION: Ethical approval was granted by the Black Country REC, reference: 22/WM/0214. Results will be submitted for publication in peer-reviewed journals and disseminated at local, regional and national meetings where appropriate. TRIAL REGISTRATION NUMBER: ISRCTN19413194 registered on 14.07.2023.


Subject(s)
Aortic Valve Stenosis , Humans , Aortic Valve Stenosis/surgery , Pilot Projects , United Kingdom , Quality of Life , Randomized Controlled Trials as Topic , Asymptomatic Diseases/therapy , Multicenter Studies as Topic , Aged , Tertiary Care Centers , Telemedicine , Heart Valve Prosthesis Implantation/methods , Watchful Waiting , Time-to-Treatment , Cost-Benefit Analysis
8.
Europace ; 26(7)2024 Jul 02.
Article in English | MEDLINE | ID: mdl-38940494

ABSTRACT

AIMS: The aim is to describe the rationale, design, delivery, and baseline characteristics of the Stroke prevention and rhythm control Treatment: Evaluation of an Educational programme of the European society of cardiology in a cluster-Randomized trial in patients with Atrial Fibrillation (STEEER-AF) trial. METHODS AND RESULTS: STEEER-AF is a pragmatic trial designed to objectively and robustly determine whether guidelines are adhered to in routine practice and evaluate a targeted educational programme for healthcare professionals. Seventy centres were randomized in six countries (France, Germany, Italy, Poland, Spain, and UK; 2022-23). The STEEER-AF centres recruited 1732 patients with a diagnosis of atrial fibrillation (AF), with a mean age of 68.9 years (SD 11.7), CHA2DS2-VASc score of 3.2 (SD 1.8), and 647 (37%) women. Eight hundred and forty-three patients (49%) were in AF at enrolment and 760 (44%) in sinus rhythm. Oral anticoagulant therapy was prescribed in 1543 patients (89%), with the majority receiving direct oral anticoagulants (1378; 89%). Previous cardioversion, antiarrhythmic drug therapy, or ablation was recorded in 836 patients (48.3%). Five hundred fifty-one patients (31.8%) were currently receiving an antiarrhythmic drug, and 446 (25.8%) were scheduled to receive a future cardioversion or ablation. The educational programme engaged 195 healthcare professionals across centres randomized to the intervention group, consisting of bespoke interactive online learning and reinforcement activities, supported by national expert trainers. CONCLUSION: The STEEER-AF trial was successfully deployed across six European countries to investigate guideline adherence in real-world practice and evaluate if a structured educational programme for healthcare professionals can improve patient-level care. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT04396418.


Subject(s)
Atrial Fibrillation , Guideline Adherence , Practice Guidelines as Topic , Humans , Atrial Fibrillation/therapy , Atrial Fibrillation/drug therapy , Atrial Fibrillation/diagnosis , Female , Male , Aged , Europe , Middle Aged , Stroke/prevention & control , Treatment Outcome , Research Design , Cardiology/standards , Cardiology/education , Anticoagulants/therapeutic use , Practice Patterns, Physicians'/standards , Anti-Arrhythmia Agents/therapeutic use
9.
Injury ; 55(7): 111584, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38762944

ABSTRACT

INTRODUCTION: Intensive care unit risk stratification models have been utilized in elective joint arthroplasty; however, hip fracture patients are fundamentally different in their clinical course. Having a critical care risk calculator utilizing pre-operative risk factors can improve resourcing for hip fracture patients in the peri­operative period. METHODS: A cohort of geriatric hip fracture patients at a single institution were reviewed over a three-year period. Non-operative patients, peri­implant fractures, additional procedures performed under the same anesthesia period, and patients admitted to the intensive care unit (ICU) prior to surgery were excluded. Pre-operative laboratory values, Revised Cardiac Risk Index (RCRI), and American Society of Anesthesiologists (ASA) scores were calculated. Pre-operative ambulatory status was determined. The primary outcome measure was ICU admission in the post-operative period. Outcomes were assessed with Fisher's exact test, Kruskal-Wallis test, logistic regression, and ROC curve. RESULTS: 315 patient charts were analyzed with 262 patients meeting inclusion criteria. Age ≥ 80 years, ASA ≥ 4, pre-operative hemoglobin < 10 g/dL, and a history of CVA/TIA were found to be significant factors and utilized within a "training" data set to create a 4-point scoring system after reverse stepwise elimination. The 4-point scoring system was then assessed within a separate "validation" data set to yield an ROC area under the curve (AUC) of 0.747. Score ≥ 3 was associated with 96.8 % specificity and 14.2 % sensitivity for predicting post-op ICU admission. Score ≥ 3 was associated with a 50 % positive predictive value and 83 % negative predictive value. CONCLUSION: A hip fracture risk stratification scoring system utilizing pre-operative patient specific values to stratify geriatric hip patients to the ICU post-operatively can improve the pre-operative decision-making of surgical and critical care teams. This has important implications for triaging vital hospital resources. LEVEL OF EVIDENCE: III (retrospective study).


Subject(s)
Critical Care , Geriatric Assessment , Hip Fractures , Intensive Care Units , Humans , Hip Fractures/surgery , Female , Male , Aged, 80 and over , Risk Assessment/methods , Aged , Geriatric Assessment/methods , Retrospective Studies , Risk Factors , Postoperative Care/methods
10.
PLoS One ; 19(2): e0290480, 2024.
Article in English | MEDLINE | ID: mdl-38422002

ABSTRACT

Idiopathic sudden sensorineural hearing loss (ISSNHL) is the rapid onset of reduced hearing due to loss of function of the inner ear or hearing nerve of unknown aetiology. Evidence supports improved hearing recovery with early steroid treatment, via oral, intravenous, intratympanic or a combination of routes. The STARFISH trial aims to identify the most clinically and cost-effective route of administration of steroids as first-line treatment for ISSNHL. STARFISH is a pragmatic, multicentre, assessor-blinded, three-arm intervention, superiority randomised controlled trial (1:1:1) with an internal pilot (ISRCTN10535105, IRAS 1004878). 525 participants with ISSNHL will be recruited from approximately 75 UK Ear, Nose and Throat units. STARFISH will recruit adults with sensorineural hearing loss averaging 30dBHL or greater across three contiguous frequencies (confirmed via pure tone audiogram), with onset over a ≤3-day period, within four weeks of randomisation. Participants will be randomised to 1) oral prednisolone 1mg/Kg/day up to 60mg/day for 7 days; 2) intratympanic dexamethasone: three intratympanic injections 3.3mg/ml or 3.8mg/ml spaced 7±2 days apart; or 3) combined oral and intratympanic steroids. The primary outcome will be absolute improvement in pure tone audiogram average at 12-weeks following randomisation (0.5, 1.0, 2.0 and 4.0kHz). Secondary outcomes at 6 and 12 weeks will include: Speech, Spatial and Qualities of hearing scale, high frequency pure tone average thresholds (4.0, 6.0 and 8.0kHz), Arthur Boothroyd speech test, Vestibular Rehabilitation Benefit Questionnaire, Tinnitus Functional Index, adverse events and optional weekly online speech and pure tone hearing tests. A health economic assessment will be performed, and presented in terms of incremental cost effectiveness ratios, and cost per quality-adjusted life-year. Primary analyses will be by intention-to-treat. Oral prednisolone will be the reference. For the primary outcome, the difference between group means and 97.5% confidence intervals at each time-point will be estimated via a repeated measures mixed-effects linear regression model.


Subject(s)
Ear, Inner , Hearing Loss, Sensorineural , Adult , Humans , Audiometry, Pure-Tone , Hearing , Hearing Loss, Sensorineural/drug therapy , Multicenter Studies as Topic , Prednisolone/therapeutic use , Randomized Controlled Trials as Topic
11.
N Engl J Med ; 390(5): 409-420, 2024 Feb 01.
Article in English | MEDLINE | ID: mdl-38294973

ABSTRACT

BACKGROUND: Studies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture). METHODS: In a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures. Every 2 months, the hospitals alternated interventions. Separate populations of patients with either open or closed fractures were enrolled and included in the analysis. The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for fracture-healing complications. RESULTS: A total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial. In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P = 0.049). In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd ratio, 0.86; 95% CI, 0.58 to 1.27; P = 0.45). The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events were similar in the two groups. CONCLUSIONS: Among patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.).


Subject(s)
Anti-Infective Agents, Local , Chlorhexidine , Fracture Fixation , Fractures, Bone , Iodine , Surgical Wound Infection , Humans , 2-Propanol/administration & dosage , 2-Propanol/adverse effects , 2-Propanol/therapeutic use , Anti-Infective Agents, Local/administration & dosage , Anti-Infective Agents, Local/adverse effects , Anti-Infective Agents, Local/therapeutic use , Antisepsis/methods , Canada , Chlorhexidine/administration & dosage , Chlorhexidine/adverse effects , Chlorhexidine/therapeutic use , Ethanol , Extremities/injuries , Extremities/microbiology , Extremities/surgery , Iodine/administration & dosage , Iodine/adverse effects , Iodine/therapeutic use , Preoperative Care/adverse effects , Preoperative Care/methods , Skin/microbiology , Surgical Wound Infection/etiology , Surgical Wound Infection/prevention & control , Fractures, Bone/surgery , Cross-Over Studies , United States
12.
Anesthesiology ; 140(3): 375-386, 2024 Mar 01.
Article in English | MEDLINE | ID: mdl-37831596

ABSTRACT

BACKGROUND: The effects of spinal versus general anesthesia on long-term outcomes have not been well studied. This study tested the hypothesis that spinal anesthesia is associated with better long-term survival and functional recovery than general anesthesia. METHODS: A prespecified analysis was conducted of long-term outcomes of a completed randomized superiority trial that compared spinal anesthesia versus general anesthesia for hip fracture repair. Participants included previously ambulatory patients 50 yr of age or older at 46 U.S. and Canadian hospitals. Patients were randomized 1:1 to spinal or general anesthesia, stratified by sex, fracture type, and study site. Outcome assessors and investigators involved in the data analysis were masked to the treatment arm. Outcomes included survival at up to 365 days after randomization (primary); recovery of ambulation among 365-day survivors; and composite endpoints for death or new inability to ambulate and death or new nursing home residence at 365 days. Patients were included in the analysis as randomized. RESULTS: A total of 1,600 patients were enrolled between February 12, 2016, and February 18, 2021; 795 were assigned to spinal anesthesia, and 805 were assigned to general anesthesia. Among 1,599 patients who underwent surgery, vital status information at or beyond the final study interview (conducted at approximately 365 days after randomization) was available for 1,427 (89.2%). Survival did not differ by treatment arm; at 365 days after randomization, there were 98 deaths in patients assigned to spinal anesthesia versus 92 deaths in patients assigned to general anesthesia (hazard ratio, 1.08; 95% CI, 0.81 to 1.44, P = 0.59). Recovery of ambulation among patients who survived a year did not differ by type of anesthesia (adjusted odds ratio for spinal vs. general, 0.87; 95% CI, 0.67 to 1.14; P = 0.31). Other outcomes did not differ by treatment arm. CONCLUSIONS: Long-term outcomes were similar with spinal versus general anesthesia.


Subject(s)
Anesthesia, Spinal , Hip Fractures , Humans , Anesthesia, General , Canada/epidemiology , Hip Fractures/surgery , Treatment Outcome , Male , Female , Middle Aged , Aged
13.
Kidney Int ; 105(1): 200-208, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37783444

ABSTRACT

In the STOP-ACEi trial, the outcome was similar whether or not renin-angiotensin system inhibitors (RASi) were discontinued. We now investigate whether the effect of withdrawing angiotensin converting enzyme inhibitors (ACEi) or angiotensin-receptor blockers (ARBs) differed. In this open label trial patients with estimated glomerular filtration rates (eGFR) under 30ml/min per 1.73 m2 and progressive chronic kidney disease (CKD) were randomized to stop or continue RASi. The primary outcome was eGFR at three years. The composite of kidney failure, over 50% fall in eGFR, or kidney replacement therapy (KRT) was also assessed. Of patients randomized, 99 stopped and 123 patients continued ACEi while 104 stopped and 77 continued ARB at baseline. At three years, the eGFR was similar whether or not patients were withdrawn from ACEi or from ARB. Kidney failure or initiation of KRT occurred in 65% of those stopping and 54% continuing ACEi (hazard ratio if stopped, 1.52; 95% Confidence Interval, 1.07 to 2.16) and in 60% on an ARB regardless of randomized group (hazard ratio if stopped, 1.23; 0.83 to 1.81). Kidney failure/Initiation of KRT with over 50% decline in eGFR occurred in 71% of those stopping and 59% continuing ACEi (relative risk if stopped, 1.19; 95% CI, 1.00 to 1.41) and in 65% stopping and 69% continuing ARB (relative risk if stopped, 0.96; 0.79 to 1.16). Thus, neither discontinuing ACEi nor ARB slowed the rate of decline in eGFR. Although discontinuation of ACEi appeared to have more unfavorable effects on kidney outcomes than stopping ARB, the trial was neither designed nor powered to show differences between agents.


Subject(s)
Angiotensin Receptor Antagonists , Renal Insufficiency, Chronic , Humans , Angiotensin Receptor Antagonists/adverse effects , Angiotensin-Converting Enzyme Inhibitors/adverse effects , Renal Insufficiency, Chronic/diagnosis , Renal Insufficiency, Chronic/drug therapy , Kidney , Antihypertensive Agents , Angiotensins
14.
Clin Biomech (Bristol, Avon) ; 111: 106151, 2024 01.
Article in English | MEDLINE | ID: mdl-37989063

ABSTRACT

BACKGROUND: Design freedom offered by additive manufacturing allows for the implementation of functional gradients - where mechanical stiffness is decreased along the length of the implant. It is unclear if such changes will influence failure mechanisms in the context of rib fracture repair. We hypothesized that our novel functionally graded rib implants would be less stiff than controls and decrease occurrence of secondary fracture at implant ends. METHODS: Five novel additively manufactured rib implants were tested along with a clinically used Control implant. Fracture reconstructions were modeled with custom synthetic rib bones with a transverse B1 fracture. Ribs were compressed in a cyclic two-point bend test for 360,000 cycles followed by a ramp to failure test. Differences in cyclic stiffness, 3D interfragmentary motions, ramp-to-failure stiffness, maximum load, and work to failure were determined. FINDINGS: The Control group had lower construct stiffness (0.76 ± 0.28 N/mm), compared to all novel implant designs (means: 1.35-1.61 N/mm, p < 0.05) and rotated significantly more about the bending axis (2.7° ± 1.3°) than the additively manufactured groups (means between 1.2° - 1.6°, p < 0.05). All constructs failed via bone fracture at the most posterior screw hole. Experimental implants were stiffer than Controls, and there were few significant differences between functional gradient groups. INTERPRETATION: Additively manufactured, functionally graded designs have the potential to change the form and function of trauma implants. Here, the impact of functional gradients was limited because implants had small cross-sectional areas.


Subject(s)
Rib Fractures , Humans , Rib Fractures/surgery , Bone Plates , Fracture Fixation , Bone Screws , Biomechanical Phenomena , Ribs , Printing, Three-Dimensional , Fracture Fixation, Internal
16.
Ann Med Surg (Lond) ; 85(11): 5795-5799, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37915634

ABSTRACT

Introduction and importance: This case report presents an intriguing instance of a 35-year-old nonsmoker female who exhibited a convergence of acute necrotizing pneumonia (ANP) and squamous cell carcinoma (SCC), two distinct pulmonary conditions. ANP involves severe lung infection and tissue necrosis, while SCC is a non-small cell lung carcinoma originating from the bronchial epithelium. Such a unique combination in a nonsmoker female patient emphasizes the intricate interplay of diverse pulmonary pathologies and the importance of comprehensive diagnostic evaluation and effective patient management strategies. Case presentation: The patient's symptoms include fever, pain, cough, and sporadic hemoptysis. Initial imaging suggested ANP due to a multilobulated necrotic lung mass. Despite empirical antibiotic therapy, no improvement occurred, prompting further investigation. Positron emission tomography and computed tomography revealed intense fluorodeoxyglucose avidity in the lesion. A computer tomography-guided Tru-cut biopsy confirmed non-small cell carcinoma with squamous differentiation in the necrotic mass. Clinical discussion: ANP is a severe manifestation of pneumonia, predominantly affecting young, healthy individuals, while SCC, commonly linked to smoking, presents as non-small cell lung carcinoma. Overlapping symptoms and radiological findings complicate diagnosis. Early diagnosis and appropriate management are crucial for both conditions to prevent progression and complications. Conclusion: This case highlights the significance of precise diagnosis and adaptable treatment approaches. The coexistence of ANP and SCC in a nonsmoker female patient underscores the necessity of meticulous diagnostic evaluation and personalized treatment strategies. The scarcity of such presentations emphasizes the need for further research to comprehend the mechanisms underlying these occurrences.

17.
Injury ; 54(12): 111137, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37919113

ABSTRACT

INTRODUCTION: The SARS-CoV-2 viral outbreak created unprecedented challenges in surgical education. Yet, its impact on reported case volume during orthopaedic trauma fellowship training remains poorly understood. We hypothesized that cases performed during orthopaedic trauma fellowship training would decrease by 8 %-17 % during the 2019-2020 academic year corresponding to the 1-2 month moratorium of non-essential cases during the initial SARS-CoV-2 outbreak in the United States. METHODS: We designed a retrospective cohort study of orthopaedic trauma fellows at Accreditation Council for Graduate Medical Education (ACGME)-accredited training programs (2018-2019 to 2021-2022). Mean case volumes were compared by case category across academic years. RESULTS: There was a -13 % year-over-year decrease in reported case volume during the 2019-2020 academic year (505 ± 126 vs 441 ± 94, P = 0.079, Fig. 1). Case categories with the greatest percentage declines were Treatment of Nonunion / Malunion (-31 %), Fasciotomy (-25 %), External Fixation (-21 %), Forearm / Wrist (-21 %), and Intra-articular Distal Humerus Fracture (-17 %). There was a 7 % year-over-year increase in case volume during the subsequent 2020-2021 academic year with near universal increases in case volume across case categories. CONCLUSION: There was a 13 % decrease in orthopaedic trauma case volume during the 2019-2020 academic year, corresponding to the SARS-CoV-2 outbreak. Certain trauma case categories experienced the greatest negative impact, which subsequently recovered during the next academic year. These results may help inform accrediting bodies and surgical educators on the impact of future viral outbreaks on orthopaedic trauma fellowship training.


Subject(s)
COVID-19 , Internship and Residency , Orthopedics , Humans , United States/epidemiology , Orthopedics/education , SARS-CoV-2 , Fellowships and Scholarships , Retrospective Studies , COVID-19/epidemiology , Education, Medical, Graduate , Accreditation
18.
Ann Med Surg (Lond) ; 85(10): 5123-5126, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37811036

ABSTRACT

Introduction: Mesothelioma is a rare and aggressive cancer that is primarily caused by asbestos exposure. However, cases of mesothelioma without asbestos exposure suggest the involvement of other risk factors. Sarcomatoid mesothelioma, which is characterized by spindle-shaped cells, is a particularly aggressive subtype with limited treatment options. Case presentation: The authors present a case of a 72-year-old man with no history of asbestos exposure who presented with abdominal pain, fatigue, and weight loss. Imaging revealed a large cystic mass in the liver. A Liver biopsy confirmed the diagnosis of sarcomatoid mesothelioma. Immunohistochemistry results further supported this diagnosis. Due to the advanced stage and tumor size, surgical resection was not feasible. Palliative chemotherapy was initiated, but the patient's condition deteriorated rapidly, leading to his demise. Conclusion: This case highlights the complexity of mesothelioma and the need for further research to identify the nonasbestos-related risk factors. Understanding alternative causative agents and mechanisms is crucial for the early detection, the development of targeted therapies, and improving patient outcomes. The presented case contributes to the existing literature and aligns with the Surgical CAse REport (SCARE) Criteria.

19.
Clin Case Rep ; 11(9): e7841, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37649902

ABSTRACT

Key Clinical Message: Cortical venous thrombosis is a rare but severe complication of TBM that requires a high index of suspicion for early diagnosis. The treatment of CVT in TBM is based on anticoagulant therapy, which is known to improve the outcomes of the patients. Abstract: The case report describes an 18-year-old male in India with symptoms of tubercular meningitis complicated by cortical venous thrombosis. Tubercular meningitis is a rare but severe form of meningitis caused by tuberculosis bacteria and is a significant public health concern in India. The patient presented to the emergency department with a history of fever, headache, and vomiting for the past month, with a positive Mycobacterium tuberculosis test. The patient was started on standard antitubercular therapy and was diagnosed with cortical venous thrombosis via an MRI scan. Treatment included antitubercular therapy, anticoagulation therapy, dexamethasone, and antiemetic drugs. The patient's symptoms improved over 2 weeks of therapy. The case highlights the importance of early detection, treatment, and prevention strategies, such as the National Tuberculosis elimination program, in controlling the spread of tuberculosis in India. It also emphasizes the importance of close monitoring for complications in patients with tubercular meningitis, such as cortical venous thrombosis, which can be life-threatening.

20.
Cureus ; 15(7): e41661, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37565095

ABSTRACT

The use of calcium sulfate beads (CSBs) as a carrier for local delivery of antibiotics is increasingly reported for the treatment of localized infections. They are used most commonly in bone and joint infections, post-trauma infections, diabetes-related foot wounds, and vascular grafts. Hypercalcemia is rarely reported with CSB use but is an important safety concern, and patients at higher risk should be identified prospectively and followed carefully postoperatively. This case report details an 85-year-old male who developed severe, symptomatic postoperative hypercalcemia after antibiotic bead placement in the right knee. He presented with confusion, weakness, and lethargy, and was subsequently treated with fluids, calcitonin, and alendronate. The patient quickly returned to normal mental status, and calcium levels normalized, leading to discharge. The case report and review of the literature describe an incident of severe hypercalcemia attributed to the use of antibiotic-eluting CSBs and describe the risk factors and time course that may be expected.

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