J Shoulder Elbow Surg
March 2023
Background: The US Food and Drug Administration (FDA) oversees medical device regulation and oversight in the United States, and the majority of shoulder arthroplasty devices are cleared via the 510(k) pathway, in which a device demonstrates "substantial equivalence" to a previously cleared predicate. The purpose of this study was to determine an interconnected ancestral network of shoulder arthroplasty devices and determine equivalency ties to devices subsequently recalled by the FDA for design-related issues.
Methods: The FDA 510(k) database was used to identify all legally marketed shoulder arthroplasty devices from May 28, 1976, to July 1, 2021.
Background: Dynamic anterior shoulder stabilization (DAS) with Bankart repair is a recently described stabilization technique thought to be more robust than an isolated Bankart repair while avoiding many coracoid transfer-related complications and technical demands. DAS involves transfer of the long head biceps through a subscapularis split to the anterior glenoid to create a sling effect. We hypothesize that DAS with Bankart repair will restore anterior stability in a human-cadaveric model with subcritical (15%) glenoid bone loss.
View Article and Find Full Text PDFPurpose: Despite the relative surgical ease and reduced donor-site morbidity of distraction osteogenesis (DO) in comparison with free tissue transfer, DO is currently precluded as a reconstructive option for head and neck cancer (HNC) patients because of the destructive effects of radiotherapy (XRT). This study investigates the ability of a novel combined therapy (CT) of radioprotective amifostine (AMF) and angiogenic deferoxamine (DFO) to mitigate XRT-induced bone injury in a murine model of DO.
Materials And Methods: Thirty male Sprague-Dawley rats were divided into 5 groups: DO (primary control), XRT (secondary control), AMF, DFO, and CT.
Objective: To compare faculty-to-student feedback rates from 2 different data sets: direct observation cards (direct evidence) and end-of-clerkship questionnaires (ECQs, secondary student reporting). We as authors hypothesized that direct evidence from observation cards would yield higher rates of feedback, compared with student-reported ECQs.
Design: Data were gathered from 2 consecutive medical classes of the third-year surgical clerkship.
Inattention to differences between animal strains is a potential cause of irreproducibility of basic science investigations. Accordingly, the authors' laboratory sought to ensure that cross-comparisons of results generated from studies of mandibular physiology utilizing the Sprague Dawley and Lewis rat strains are valid. The authors specifically investigated baseline histomorphometrics, bone mineral density, and biomechanical strength of the unaltered endogenous mandibles of the inbred, isogenic Lewis rat, and the outbred, nonisogenic Sprague Dawley rat to determine if they are indeed equal.
View Article and Find Full Text PDFPurpose: The vascularity, bone mineral density distribution, and histomorphometric data between the inbred, isogenic Lewis rat and the outbred, nonisogenic Sprague Dawley rat within mandibular distraction osteogenesis (MDO) were evaluated to allow future researchers to compare the results generated from these 2 animals. We hypothesized that little difference would be found between the 2 strains within these metrics.
Materials And Methods: We implemented a comparative study between the Lewis and Sprague Dawley rat strains within MDO.