Publications by authors named "Peter Simon"

175 Publications

Comparing patient-reported outcome measures and physical examination for internal rotation in patients undergoing reverse shoulder arthroplasty: does surgery alter patients' perception of function?

J Shoulder Elbow Surg 2021 Feb 16. Epub 2021 Feb 16.

Shoulder Service, Florida Orthopaedic Institute, Tampa, FL, USA; Department of Orthopedics and Sports Medicine, Morsani College of Medicine, University of South Florida, Tampa, FL, USA. Electronic address:

Background: The purpose of this study was to evaluate how patients treated with reverse shoulder arthroplasty (RSA) achieve internal rotation (IR) using video assessment and to compare this to patient-reported outcome measures (PROMs).

Methods: We reviewed 215 preoperative and 657 postoperative videos (3-78 months) for 215 patients who underwent primary RSA, performing IR using the modified vertebral level method. Their functional motion pattern was then grouped into 3 types: type I, could not reach behind their back; type II, able to reach to at least waist level, with assistance; and type III, able to reach to a minimum of waist level in an uninterrupted fashion. Patients completed functional questions (put on a coat, wash back, tuck in a shirt, and manage toileting) and a diagram of perceived IR. Patients' functional motion types were compared to PROM answers. Pre- and postoperative scores were also compared to assess the effect of surgery on patients' perception of IR function.

Results: Patients undergoing RSA will achieve IR in 3 distinct motion patterns. Analysis of self-reported IR indicated statistically significant difference between the 3 functional types of IR (P < .001). Patient-perceived IR was not significantly different between the 3 studied IR functional types (P = .076) in the analysis of preoperative measures but was significantly different in the postoperative setting (P < .001).

Conclusion: Patients attempt IR in 3 distinct functional motion patterns. The improvement of IR after RSA is measured better by patient questionnaires than by physical examination.
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http://dx.doi.org/10.1016/j.jse.2021.01.020DOI Listing
February 2021

Influence of preoperative factors on timing for bilateral shoulder arthroplasty.

J Shoulder Elbow Surg 2021 Feb 8. Epub 2021 Feb 8.

Shoulder Service, Florida Orthopaedic Institute, Tampa, FL, USA. Electronic address:

Introduction: In bilateral shoulder arthroplasty patients, it is unclear what features are responsible for the timing of their contralateral shoulder arthroplasty. This study hypothesized that patient factors (age, gender, and hand dominance), disease factors (diagnosis and radiographic severity of contralateral shoulder), and surgical factors (type of arthroplasty) impact the timing to contralateral surgery.

Methods: A retrospective review of 332 patients treated with bilateral anatomic (TSA) or reverse (RSA) shoulder arthroplasty (172 TSA/TSA, 107 RSA/RSA, or 53 TSA/RSA) were divided into groups depending on the interval timing between arthroplasty surgeries: group 1, n = 142 (≤1 year); group 2, n = 62 (1-2 years); and group 3, n = 128 (≥2 years). Preoperative factors were analyzed to determine associations between different time groups, including age, gender, hand dominance, diagnosis, radiographic severity of contralateral shoulder, and type of surgery. Bilateral diagnoses included 211 osteoarthritis (OA), 36 cuff tear arthropathy (CTA), 13 inflammatory arthritis, 12 massive cuff tears without OA, and 4 avascular necrosis.

Results: OA patients had their contralateral shoulder arthroplasty sooner than CTA patients (P = .035). OA patients with arthritic changes on contralateral radiographs before the first arthroplasty had their contralateral arthroplasty sooner than those without contralateral radiographs (P < .0001). Patients who had TSA first had their contralateral arthroplasty sooner than patients who had RSA first (P = .037).

Discussion: This study confirmed our hypothesis identifying preoperative variables associated with different time intervals between arthroplasties. The preoperative factors associated with the highest likelihood of having contralateral shoulder arthroplasty within 1 year included OA, radiographic bilateral shoulder disease, and TSA for the first surgery.
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http://dx.doi.org/10.1016/j.jse.2020.12.023DOI Listing
February 2021

Room Temperature Synthesis and Characterization of Novel Bi(III) Complex with 2-Amino-3- Carbomethoxy-4,5,6,7-Tetrahydrobenzo[B]Thiophene as Potential Antimicrobial Agent.

Acta Chim Slov 2020 Mar;67(1):203-211

A novel bismuth(III) complex with 2-amino-3-carbomethoxy-4,5,6,7-tetrahydrobenzo[b]thiophene (ACTT) as a ligand have been synthesized. The novel complex was characterized on the basis of its IR, NMR, elemental analysis and MS spectral data. It was found that the ligand behaves as a monodentate chelating agent and bonds to the metal ion through the nitrogen atom of the amino group to form the [BiIII(ACTT)6]Cl3 complex. The new complex compound displayed significant antimicrobial activity (MIC = 8-32 µg/mL) against Bacillus subtilis, Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Shigella flexneri, Candida albicans, Candida tropicalis and Cryptococcus neoformans.
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March 2020

Microfluidic In Vitro Platform for (Nano)Safety and (Nano)Drug Efficiency Screening.

Small 2021 Apr 18;17(15):e2006012. Epub 2021 Jan 18.

Fraunhofer Institute for Biomedical Engineering IBMT, Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V., Joseph-von-Fraunhofer-Weg 1, Sulzbach, 66280, Germany.

Microfluidic technology is a valuable tool for realizing more in vitro models capturing cellular and organ level responses for rapid and animal-free risk assessment of new chemicals and drugs. Microfluidic cell-based devices allow high-throughput screening and flexible automation while lowering costs and reagent consumption due to their miniaturization. There is a growing need for faster and animal-free approaches for drug development and safety assessment of chemicals (Registration, Evaluation, Authorisation and Restriction of Chemical Substances, REACH). The work presented describes a microfluidic platform for in vivo-like in vitro cell cultivation. It is equipped with a wafer-based silicon chip including integrated electrodes and a microcavity. A proof-of-concept using different relevant cell models shows its suitability for label-free assessment of cytotoxic effects. A miniaturized microscope within each module monitors cell morphology and proliferation. Electrodes integrated in the microfluidic channels allow the noninvasive monitoring of barrier integrity followed by a label-free assessment of cytotoxic effects. Each microfluidic cell cultivation module can be operated individually or be interconnected in a flexible way. The interconnection of the different modules aims at simulation of the whole-body exposure and response and can contribute to the replacement of animal testing in risk assessment studies in compliance with the 3Rs to replace, reduce, and refine animal experiments.
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http://dx.doi.org/10.1002/smll.202006012DOI Listing
April 2021

Formation of Periodic Nanoridge Patterns by Ultrashort Single Pulse UV Laser Irradiation of Gold.

Nanomaterials (Basel) 2020 Oct 10;10(10). Epub 2020 Oct 10.

Physics Department, University of Kassel, Heinrich-Plett-Str. 40, 34132 Kassel, Germany.

A direct comparison of simulation and experimental results of UV laser-induced surface nanostructuring of gold is presented. Theoretical simulations and experiments are performed on an identical spatial scale. The experimental results have been obtained by using a laser wavelength of 248 nm and a pulse length of 1.6 ps. A mask projection setup is applied to generate a spatially periodic intensity profile on a gold surface with a sinusoidal shape and periods of 270 nm, 350 nm, and 500 nm. The formation of structures at the surface upon single pulse irradiation is analyzed by scanning and transmission electron microscopy (SEM and TEM). For the simulations, a hybrid atomistic-continuum model capable of capturing the essential mechanisms responsible for the nanostructuring process is used to model the interaction of the laser pulse with the gold target and the subsequent time evolution of the system. The formation of narrow ridges composed of two colliding side walls is found in the simulation as well as in the experiment and the structures generated as a result of the material processing are categorized depending on the range of applied fluencies and periodicities.
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http://dx.doi.org/10.3390/nano10101998DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7600624PMC
October 2020

Trace element concentrations and their potential ecological risk in the reef sediments of coral islands, Vembar group of islands, Gulf of Mannar, India.

Mar Pollut Bull 2020 Nov 5;160:111607. Epub 2020 Sep 5.

Department of Geology, University of Madras, Guindy Campus, Chennai 600 025, Tamil Nadu, India.

The present work was undertaken to assess the impact of trace element concentration and the status of potential ecological risk in the reef sediments of the Vembar group of islands, Gulf of Mannar Marine National Park, India. Totally, 114 reef sediments (surface) were collected from the Vembar group of islands (Nallathanni Island - 36 samples; Upputhanni Island - 48 samples; Puluvinichalli Island-30 samples). The reef sediments are enriched with sand-sized calcareous particles. The calcium carbonate percentage (CaCO) was primarily controlled by the distribution of coral colonies and available lithogenic grains. The pollution load index (PLI) reveals that the majority of the sediments fall under the unpolluted category. Moreover, the potential ecological risk (PERI) and sediment pollution index (SPI) reveals that the Vembar group of islands fall under the low ecological risk category.
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http://dx.doi.org/10.1016/j.marpolbul.2020.111607DOI Listing
November 2020

Perceptions of genetic testing in patients with hereditary chronic pancreatitis and their families: a qualitative triangulation.

Eur J Hum Genet 2021 Jan 12;29(1):29-38. Epub 2020 Aug 12.

Institute of History, Ethics and Philosophy of Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.

Hereditary chronic pancreatitis (HCP) is a genetically determined condition characterized by intermittent acute episodes of pancreatitis and long-term impairment of the exocrine and endocrine pancreatic functions. Genetic test results can have substantial psychological and social consequences for the individuals tested and their families. Nevertheless, little is known so far about the subjective experience of individuals genetically tested for HCP. This qualitative study examines the viewpoints of HCP patients and their relatives in order to identify the psychosocial and ethical implications related to genetic testing within families. Semi-structured qualitative individual interviews and a focus group with HCP patients and their family members were conducted. Data were audio-recorded, transcribed verbatim and analysed using qualitative content analysis. A total of 28 individuals were enrolled in the study: 24 individuals (17 patients, 7 relatives) were interviewed in semi-structured one-on-one interviews and 4 individuals (2 patients, 2 life partners) participated in the focus group. Emerging topics covered (1) genetic testing in childhood, (2) genetic testing within the family and (3) family planning. The study reveals that genetic testing for HCP has a wide influence in familial contexts and is accompanied by normative issues, such as autonomy, reproductive decisions and sharing of information within the family. The results raise the awareness of the complexity of family contexts: familial relationships and dynamics can have great influence on the individual decisions related to genetic testing. Increased understanding of these relational contexts can help health professionals, for example, in counselling, to discuss genetic testing better with patients and families.
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http://dx.doi.org/10.1038/s41431-020-00705-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7852527PMC
January 2021

Laser Ablated Periodic Nanostructures on Titanium and Steel Implants Influence Adhesion and Osteogenic Differentiation of Mesenchymal Stem Cells.

Materials (Basel) 2020 Aug 10;13(16). Epub 2020 Aug 10.

Department for Trauma Surgery, Orthopaedics and Plastic Surgery, University Medical Center Goettingen, Robert Koch Straße 40, 37075 Göttingen, Germany.

Metal implants used in trauma surgeries are sometimes difficult to remove after the completion of the healing process due to the strong integration with the bone tissue. Periodic surface micro- and nanostructures can directly influence cell adhesion and differentiation on metallic implant materials. However, the fabrication of such structures with classical lithographic methods is too slow and cost-intensive to be of practical relevance. Therefore, we used laser beam interference ablation structuring to systematically generate periodic nanostructures on titanium and steel plates. The newly developed laser process uses a special grating interferometer in combination with an industrial laser scanner and ultrashort pulse laser source, allowing for fast, precise, and cost-effective modification of metal surfaces in a single step process. A total of 30 different periodic topologies reaching from linear over crossed to complex crossed nanostructures with varying depths were generated on steel and titanium plates and tested in bone cell culture. Reduced cell adhesion was found for four different structure types, while cell morphology was influenced by two different structures. Furthermore, we observed impaired osteogenic differentiation for three structures, indicating reduced bone formation around the implant. This efficient way of surface structuring in combination with new insights about its influence on bone cells could lead to newly designed implant surfaces for trauma surgeries with reduced adhesion, resulting in faster removal times, reduced operation times, and reduced complication rates.
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http://dx.doi.org/10.3390/ma13163526DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7475978PMC
August 2020

A cohort comparison of humeral implant designs in reverse shoulder arthroplasty: does implant design lead to lower rates of complications and revision?

J Shoulder Elbow Surg 2021 Apr 6;30(4):850-857. Epub 2020 Aug 6.

Florida Orthopaedic Institute, Tampa, FL, USA; Department of Orthopaedics and Sports Medicine, University of South Florida Morsani College of Medicine, Tampa, FL, USA. Electronic address:

Introduction: The purpose of this study was to evaluate the outcomes, revisions, and complications between a first-generation cemented modular humeral implant and a second-generation monolithic, primarily uncemented humeral implant in reverse total shoulder arthroplasty with 135° neck-shaft angle and varying degrees of metallic glenosphere offsets.

Methods: We retrospectively evaluated patients undergoing reverse total shoulder arthroplasty from 2004 to 2014 with a first-generation cemented modular humeral implant (400 patients) or second-generation monolithic humeral stem (231 patients), who had at minimum 2-year clinical and radiographic follow-up.

Results: Both groups of patients had similar improvement of clinical outcomes (American Shoulder and Elbow Surgeons +30 points vs. +34 points, respectively) with improvements in all planes of motion (forward flexion +70° vs. +75°, abduction +61° vs. +71°, external rotation +23° vs. +22°, and internal rotation +1.6 vs. +1.5 level improvement, respectively). The incidence of humeral loosening for the cemented group was 3.6%, whereas in the uncemented group it was 0.4% (P = .01). A total of 28 shoulders treated with the cementing technique (4.0%) and 6 patients treated with the press-fit technique (1.5%) were revised (P = .028). The rate of postoperative acromial fractures within the first year was 3.4% in the cemented group and 1.8% in the uncemented group (P = .177).

Conclusions: Both the first-generation cemented modular humeral stem implant and the second-generation monolithic humeral stem implant had equivalent clinical outcomes. In addition, with the monolithic stem primarily using press-fit fixation, there was a significant reduction in the incidence of radiographic loosening and the need for revision compared with a cemented stem.
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http://dx.doi.org/10.1016/j.jse.2020.07.031DOI Listing
April 2021

The effect of glenoid bone loss and rotator cuff status in failed anatomic shoulder arthroplasty after revision to reverse shoulder arthroplasty.

J Shoulder Elbow Surg 2021 Apr 1;30(4):844-849. Epub 2020 Aug 1.

Florida Orthopaedic Institute, Tampa, FL, USA. Electronic address:

Hypothesis: We evaluated outcomes and the risk of re-revision in patients with a failed anatomic total shoulder arthroplasty (TSA) revised to a reverse shoulder arthroplasty (RSA) based on rotator cuff deficiency and glenoid bone loss.

Methods: From 2004 to 2017, 123 patients with failed TSAs underwent revision to RSAs with minimum 2-year follow-up. Preoperative radiographs were evaluated to determine whether the glenoid component was fixed or loose. The rotator cuff was assessed intraoperatively and as intact or deficient. Patient outcomes including shoulder motion and American Shoulder and Elbow Surgeons (ASES) scores were obtained preoperatively and postoperatively. Patient outcomes were compared based on glenoid fixation and rotator cuff status. There were 18 TSAs revised to RSAs that underwent subsequent revision.

Results: The mean preoperative ASES score was 31 (95% confidence interval [CI], 29-33) with no difference in preoperative ASES scores based on glenoid status (P = .412) or rotator cuff status (P = .89). No difference in postoperative ASES score was found based on glenoid component status or rotator cuff status. However, improvement in the ASES score was greater with an intact rotator cuff (mean postoperative score, 67 [95% CI, 57-76] vs. 55 [95% CI, 50-60]; P = .025). The overall re-revision rate was 11.4%, with a mean time to re-revision of 22 months (range, 0-89 months). The odds ratio was 1.786 for subsequent revision in patients with glenoid loosening compared with those without loose glenoids on preoperative radiographs.

Conclusion: There was an overall improvement in patient outcomes for failed TSAs revised to RSAs; however, patients with an intact cuff had a greater improvement in ASES scores.
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http://dx.doi.org/10.1016/j.jse.2020.07.024DOI Listing
April 2021

Randomized prospective evaluation of the use of tranexamic acid and effects on blood loss for proximal humeral fracture surgery.

J Shoulder Elbow Surg 2020 Aug 9;29(8):1627-1632. Epub 2020 Jun 9.

Foundation for Orthopaedic Research and Education, Tampa, FL, USA.

Background: Tranexamic acid (TXA) is an antifibrinolytic agent that has been used to reduce blood loss in orthopedic surgery. It has been shown to decrease blood loss in upper- and lower-extremity arthroplasty, as well as lower-extremity fracture surgery. The use of TXA for proximal humeral fracture surgery has yet to be evaluated. The purpose of this study was to examine the effects of TXA on blood loss in patients undergoing open reduction-internal fixation (ORIF) or arthroplasty for the treatment of proximal humeral fractures.

Materials And Methods: A total of 101 patients were randomized to receive either a single preoperative dose of intravenous TXA (53 patients) or a control dose of saline solution (48 patients) at the time of proximal humeral fracture surgery. On the basis of patient age and fracture pattern, ORIF was performed in 57 patients (30 TXA and 27 control patients) and reverse shoulder arthroplasty (RSA) was performed in the other 44 patients (23 TXA and 21 control patients). Intraoperative blood loss plus 24-hour drain output was used to calculate total blood loss for each procedure. The preoperative-to-postoperative change in hemoglobin level was also evaluated for each patient. Further stratification of blood loss and change in hemoglobin level based on procedure (ORIF or RSA) was performed as well.

Results: Compared with the control group, the TXA group had less average intraoperative blood loss (178 mL vs. 129 mL, P < .0001), less postoperative drain output (103 mL vs. 62 mL, P < .0001), and less total blood loss (280 mL vs. 188 mL, P < .0001). Compared with the control group, the TXA group had a smaller average preoperative-to-postoperative change in hemoglobin level (-2.6 g/dL vs. -1.5 g/dL, P < .0001). Further stratification based on procedure showed that among patients undergoing ORIF and patients undergoing RSA, those receiving TXA had less average total blood loss and a smaller decrease in hemoglobin level than the control group. No identifiable intraoperative or postoperative complications associated with the use of TXA occurred in any patient.

Conclusion: TXA was effective in reducing total blood loss and led to a smaller preoperative-to-postoperative decrease in hemoglobin level compared with control in patients undergoing surgery for proximal humeral fractures. This effect was consistent in patients treated with either ORIF or arthroplasty as the surgical procedure. TXA can be used to decrease blood loss in the surgical treatment of proximal humeral fractures.
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http://dx.doi.org/10.1016/j.jse.2020.04.016DOI Listing
August 2020

Optimizing humeral stem fixation in revision reverse shoulder arthroplasty with the cement-within-cement technique.

J Shoulder Elbow Surg 2020 Jul 29;29(7S):S9-S16. Epub 2020 Apr 29.

Florida Orthopaedic Institute, Tampa, FL, USA. Electronic address:

Background: The purpose of this study was to report on the clinical outcomes of patients undergoing revision reverse shoulder arthroplasty (RSA) by the cement-within-cement technique, as well as to identify whether surgical technique can affect subsequent humeral loosening.

Methods: In 98 patients, cemented humeral components that were revised to RSA using the cement-within-cement technique were identified and included in this study. We compared 8 patients in whom humeral stem loosening developed with 90 patients whose stem remained fixed. Preoperative and postoperative radiographs of each patient were downloaded in DICOM (Digital Imaging and Communications in Medicine) format and analyzed in Mimics. The total area of the cement mantle (in square millimeters) and of the stem (in square millimeters), as visualized on 2-dimensional plain films, was measured in each subject on both preoperative and postoperative radiographs. Outcomes at a minimum of 2 years of follow-up were analyzed.

Results: Clinical outcomes were available in 57 patients, with a mean follow-up period of 54 months (range, 21-156 months). Patients demonstrated significantly improved functional outcome scores and shoulder range of motion. In the group without loosening, the mean increase in the cement mantle area was 4380 ± 12701 mm (P < .0001). In the group with loosening, the mean increase in the cement mantle area was only 811 ± 4014 mm (P = .484).

Conclusions: Use of the cement-within-cement technique for fixation of the humeral component in revision RSA is effective in improving functional outcome scores and shoulder range of motion. Furthermore, these findings suggest that efforts to maximize the cement volume during reimplantation may lessen the chance of humeral stem loosening requiring additional revision.
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http://dx.doi.org/10.1016/j.jse.2020.01.094DOI Listing
July 2020

Relativistic-intensity near-single-cycle light waveforms at kHz repetition rate.

Light Sci Appl 2020 23;9:47. Epub 2020 Mar 23.

Laboratoire d'Optique Appliquée, CNRS, Ecole Polytechnique, ENSTA Paris, Institut Polytechnique de Paris, 181 chemin de la Hunière et des Joncherettes, 91120 Palaiseau, France.

The development of ultra-intense and ultra-short light sources is currently a subject of intense research driven by the discovery of novel phenomena in the realm of relativistic optics, such as the production of ultrafast energetic particle and radiation beams for applications. It has been a long-standing challenge to unite two hitherto distinct classes of light sources: those achieving relativistic intensity and those with pulse durations approaching a single light cycle. While the former class traditionally involves large-scale amplification chains, the latter class places high demand on the spatiotemporal control of the electromagnetic laser field. Here, we present a light source producing waveform-controlled 1.5-cycle pulses with a 719 nm central wavelength that can be focused to relativistic intensity at a 1 kHz repetition rate based on nonlinear post-compression in a long hollow-core fiber. The unique capabilities of this source allow us to observe the first experimental indications of light waveform effects in laser wakefield acceleration of relativistic energy electrons.
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http://dx.doi.org/10.1038/s41377-020-0280-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7089946PMC
March 2020

Involving Patient Groups in Drug Research: A Systematic Review of Reasons.

Patient Prefer Adherence 2020 12;14:587-597. Epub 2020 Mar 12.

Institute of Ethics and History of Medicine, University Medicine Greifswald, Greifswald, Germany.

Background: Patients have evolved from mere objects of study to active contributors to drug research in recent decades. Since individual patient's influence to change research processes effectively is limited, patient groups play an important role in the planning and conducting of pharmaceutical studies. Patient group engagement in drug research is usually seen as being beneficial from an ethical viewpoint as well as from the perspective of research practice, while potential disadvantages and risks have been discussed considerably less.

Purpose: A systematic review of reasons was conducted to allow for an overview of the reasons for and against involving patient groups in drug research.

Methods: The literature search was conducted in PubMed and Web of Science. Reasons concerning the influence of patient groups on drug research were extracted and synthesized using qualitative content analysis. The review's main limitation arises from a lack of critical appraisal regarding the quality of the reasons.

Results: A total of 2271 references were retrieved, of which 97 were included in the analysis. Data extraction revealed 91 (73.4%) reasons for and 30 (24.2%) reasons against involving patient organizations in drug research, and 3 (2.4%) ambivalent reasons; amounting to 124 reasons. The main groups of reasons were clustered around the categories: quality of research, acquisition and allocation of resources, and the patient role in research.

Conclusion: This is the first systematic review of reasons concerning the influence of patient groups on drug research. It provides a basis for a continuing debate about the value as well as the limits of involving patient groups. Due to the diversity of research projects there can be no general recommendation for or against patient group involvement. More research is necessary to assess potential advantages and disadvantages of patient groups' influence on other types of research (eg genetics).
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http://dx.doi.org/10.2147/PPA.S232499DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7075437PMC
March 2020

Acute surgical management of proximal humerus fractures: ORIF vs. hemiarthroplasty vs. reverse shoulder arthroplasty.

J Shoulder Elbow Surg 2020 Jul 13;29(7S):S32-S40. Epub 2020 Jan 13.

Shoulder & Elbow Service, Florida Orthopaedic Institute, Tampa, FL, USA. Electronic address:

Background: Proximal humerus fracture treatment varies by surgeon preference and patient factors. This study compares patient and fracture characteristics, with outcomes between current surgical treatment options.

Methods: Between 1999 and 2018, 425 proximal humerus fractures underwent acute surgical management: open reduction internal fixation (ORIF, n = 211), hemiarthroplasty (HA, n = 108), or reverse shoulder arthroplasty (RSA, n = 106). Patient and fracture characteristics included age, American Society of Anesthesiologists physical status classification (ASA), and fracture classification. Postoperative motion at 3, 6, and minimum 12 months (avg 20 ± 21 months), radiographic outcomes, and postoperative falls were analyzed.

Results: Average age for treatment groups was 65 ± 13 years (range: 18-93 years). Fractures were classified as 2- (11%), 3- (41%), or 4-part (48%). Age, ASA, and fracture classification were associated with selected surgical management (P < .0001, =.001, <.0001, respectively). Outcomes showed a significant improvement in forward flexion from 3 months to 6 months in all groups (P < .0001). No difference in final motion was seen between groups. Radiographic union was higher in ORIF (89%), and similar between HA (79%) and RSA (77%, P = .005). Rate of reoperation was RSA 6.6%, ORIF 17.5%, and hemiarthroplasty 15.7% (P = .029). Postoperatively, 23% patients had at least 1 fall, of which 73% resulted in fractures.

Conclusion: Older patients with high ASA were treated with arthroplasty, and younger patients with lower ASA were treated with ORIF. All groups showed improvements in motion. At minimum 1 year of follow-up, there was no difference in motion between groups. ORIF and HA showed significantly more reoperations compared with RSA. Patients should be counseled about reoperation, fall risk, and prevention.
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http://dx.doi.org/10.1016/j.jse.2019.10.012DOI Listing
July 2020

Comparability of size measurements of the pancreas in magnetic resonance imaging and transabdominal ultrasound.

Clin Anat 2020 Apr 7;33(3):431-439. Epub 2020 Jan 7.

Department of Medicine A, University Medicine Greifswald, Greifswald, Germany.

Introduction: Transabdominal ultrasound (US) and magnetic resonance imaging (MRI) are commonly used for the examination of the pancreas in clinical routine. We therefore were interested in the concordance of these two imaging methods for the size measurement of the pancreas and how age, gender, and body mass index (BMI) affect the organ size.

Methods: A total of 342 participants from the Study of Health in Pomerania underwent whole-body MRI and transabdominal US on the same day, and the diameter of the pancreatic head, body, and tail were measured. The agreement between US and MRI measurements was assessed by Bland and Altman plots. Intraclass correlation coefficients were used to compare observers. A multivariable regression model was applied using the independent variables age, gender, and body mass index.

Results: Compared to MRI, abdominal US returned smaller values for each segment of the pancreas, with a high level of inconsistency between these two methods. The mean difference was 0.39, 0.18, and 0.54 cm for the head, body, and tail, respectively. A high interobserver variability was detected for US. Multivariable analysis showed that pancreatic size in all three segments increased with BMI in both genders whereas pancreatic head and tail size decreased with age, an effect more marked in women.

Conclusions: Agreement of pancreatic size measurements is poor between US and MRI. These limitations should be considered when evaluating morphologic features for pathologic conditions or setting limits of normal size. Adjustments for BMI, gender, and age may also be warranted.
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http://dx.doi.org/10.1002/ca.23551DOI Listing
April 2020

Lumbar facet joint subchondral bone density in low back pain and asymptomatic subjects.

Skeletal Radiol 2020 Apr 30;49(4):571-576. Epub 2019 Oct 30.

Department of Orthopedic Surgery, Rush University Medical Center, 1611 W Harrison Street, Suite 201 Orthopedic Building, Chicago, IL, 60612, USA.

Objective: To report in vivo measurements of lumbar facet joint subchondral bone mineral density used in the description of facet joint loading patterns and to interrogate if low back pain is associated with changes in subchondral bone mineral density.

Materials And Methods: In vivo measurements of lumbar facet joint subchondral bone mineral density (L1/2 to L5/S1) in Hounsfield units were performed on 89 volunteers (56 controls and 33 with low back pain) by computed tomography osteoabsorptiometry at subchondral regions between 1.5 mm and 2.5 mm below the joint surface. The facet surface was divided into five topographic zones: cranial, lateral, caudal, medial, and central.

Results: We analyzed 1780 facet joint surfaces. Facets were denser (p < 0.0001) both in superior facets and in low back pain subjects (p < 0.0001). For the entire cohort, the facet center zone subchondral bone mineral density was higher (p < 0.0001) than that of the peripheral zones. The analyses indicate that subchondral bone mineral density is highest in patients with low back pain, the superior facets, and the center zone of the facets.

Conclusions: Subchondral bone mineral density is thought to reflect cumulative, long-term distribution of stress acting on a joint. This work shows that higher subchondral bone mineral density values in the center zone indicate predominant stress transmission through the center of the facet joints. Finally, the greater subchondral bone mineral density in patients with low back pain may reflect both increased load bearing by the facets secondary to disc degeneration and misdistribution of loading within the joint.
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http://dx.doi.org/10.1007/s00256-019-03314-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7024659PMC
April 2020

Do preoperative radiographs help predict intraoperative challenges in revision surgery after previous shoulder hemiarthroplasty?

J Shoulder Elbow Surg 2019 Jun;28(6S):S161-S167

Florida Orthopaedic Institute, Tampa, FL, USA. Electronic address:

Background: This study compares preoperative radiographic evaluation with intraoperative video and explant data in patients undergoing revision of a hemiarthroplasty.

Methods: From 2004 to 2017, 182 shoulder hemiarthroplasties underwent revision to reverse shoulder arthroplasty for symptomatic failure. Preoperative radiographs were evaluated for stem fixation, stability, and glenohumeral registry. Intraoperative videos (n = 48) were evaluated for humeral component stability and bone loss after humeral stem extraction. All explants (n = 83) were reviewed for humeral head wear patterns and extraction artifacts (EAs).

Results: A well-fixed stem was reliably identified on radiographs as well fixed (true-negative rate, 95%). Of cemented implants, 94% (97 of 103) were radiographically stable and 90% (18 of 20) were stable on intraoperative video. Significant proximal humeral bone loss was identified after cemented stem extraction in 83% of cases, and severe EAs were noted in 28% (14 of 50). Of uncemented implants, 95% (75 of 79) were radiographically stable and 96% (24 of 25) were operatively stable. Significant proximal humeral bone loss was identified after extraction in 36% of cases (9 of 25) (P = .001). Severe EAs were seen in 13% of explanted stems (3 of 23). Eccentrically worn humeral head explants were associated with eccentric glenohumeral registry in 84% of cases (P = .0075).

Conclusion: Preoperative radiographs for revision of a failed hemiarthroplasty help identify well-fixed stems and predict humeral bone loss during extraction. Cemented stems will have more EAs and result in greater bone loss than uncemented stems. Glenohumeral registry can help to predict humeral head wear. Eccentric registry leads to eccentric humeral head wear in 84% of cases.
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http://dx.doi.org/10.1016/j.jse.2019.04.013DOI Listing
June 2019

Is there a relationship between preoperative diagnosis and clinical outcomes in reverse shoulder arthroplasty? An experience in 699 shoulders.

J Shoulder Elbow Surg 2019 Jun;28(6S):S110-S117

Florida Orthopaedic Institute, Tampa, FL, USA. Electronic address:

Background: The influence of diagnosis on outcomes after reverse shoulder arthroplasty (RSA) is not completely understood. The purpose of this study was to compare clinical outcomes of different pathologies.

Methods: A total of 699 RSAs were performed for the following diagnoses: (1) rotator cuff tear arthropathy (RCA), (2) massive cuff tear (MCT) with osteoarthritis (OA), (3) MCT without OA, (4) OA, (5) acute proximal humeral fracture, (6) malunion, (7) nonunion, and (8) inflammatory arthropathy. All patients had minimum 2-year clinical follow-up (mean, 47 months; range, 24-155 months). Range of motion, Simple Shoulder Test scores, American Shoulder and Elbow Surgeons scores, visual analog scale scores for function, and health-related quality-of-life measures were obtained preoperatively and postoperatively.

Results: The RCA, MCT-with-OA, MCT-without-OA, and OA groups all exhibited significant improvements in all outcome scores and in all planes of motion from preoperatively until a minimum of 2 years postoperatively. The malunion, nonunion, and inflammatory arthropathy groups showed improvements in American Shoulder and Elbow Surgeons scores, Simple Shoulder Test scores, forward flexion, and abduction. The average changes for all other outcomes and planes of motions were also positive but did not reach statistical significance. After adjustment for age and compared with RCA, female patients with malunion had significantly poorer forward flexion (P < .05), those with OA had significantly better abduction (P < .05), and those with fractures had significantly worse patient satisfaction (P < .05). Among male patients, those with MCTs without OA had significantly worse satisfaction (P < .05).

Conclusion: RSA reliably provides improvement regardless of preoperative diagnosis. Although subtle differences exist between male and female patients, improvements in clinical outcome scores were apparent after RSA.
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http://dx.doi.org/10.1016/j.jse.2019.04.007DOI Listing
June 2019

Improving preoperative planning of revision surgery after previous anatomic total shoulder arthroplasty.

J Shoulder Elbow Surg 2019 Jun 21;28(6S):S168-S174. Epub 2019 May 21.

Florida Orthopaedic Institute, Tampa, FL, USA. Electronic address:

Background: The purpose of this study was to compare preoperative radiographic evaluation with intraoperative video and explant analysis in patients undergoing revision of a previous anatomic total shoulder arthroplasty (TSA).

Methods: We evaluated the preoperative radiographs of 165 revisions of failed TSAs for component loosening and glenohumeral registry (ie, the spatial relationship of the glenoid component and the prosthetic humeral head). Seventy-nine intraoperative videos were evaluated for component stability, rotator cuff (RC) integrity, synovitis, and glenoid bone loss. Eighty-seven explants were reviewed to assess wear patterns and presence of backside cement.

Results: Of 79 glenoid components, 47 were radiographically loose, but only 30 of 79 were loose intraoperatively. Thirty-two were radiographically fixed, but only 26 of 32 were fixed intraoperatively. If radiographically loose, 53% had severe glenoid bone loss. If radiographically fixed, 77% had mild to moderate bone loss (P = .008). Synovitis was associated with glenoid fixation: mild with a loose glenoid (6%) and severe with a fixed glenoid (30%, P = .012). Superior registry comprised 46%. RC deficiency was associated with posterior and anterior registry (88% and 79%, respectively). Explant examination revealed an eccentric wear pattern was predominant.

Conclusion: Radiographic evaluation of glenoid loosening in patients undergoing revision of TSAs will often differ from intraoperative findings (40% false-positive rate and 17% false-negative rate). Assessment of glenohumeral registry can help anticipate RC deficiency, with posterior and anterior registry associated with RC deficiency. Patients with a loose glenoid are more likely to have severe synovitis and more severe glenoid bone deficiencies. Failed TSAs are more likely to have asymmetrical wear of the glenoid component, suggesting altered pathomechanics that may have led to failure.
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http://dx.doi.org/10.1016/j.jse.2019.04.005DOI Listing
June 2019

Epidemic threshold in pairwise models for clustered networks: closures and fast correlations.

J Math Biol 2019 08 11;79(3):823-860. Epub 2019 May 11.

Department of Mathematics, School of Mathematical and Physical Sciences, University of Sussex, Falmer, Brighton, BN1 9QH, UK.

The epidemic threshold is probably the most studied quantity in the modelling of epidemics on networks. For a large class of networks and dynamics, it is well studied and understood. However, it is less so for clustered networks where theoretical results are mostly limited to idealised networks. In this paper we focus on a class of models known as pairwise models where, to our knowledge, no analytical result for the epidemic threshold exists. We show that by exploiting the presence of fast variables and using some standard techniques from perturbation theory we are able to obtain the epidemic threshold analytically. We validate this new threshold by comparing it to the threshold based on the numerical solution of the full system. The agreement is found to be excellent over a wide range of values of the clustering coefficient, transmission rate and average degree of the network. Interestingly, we find that the analytical form of the threshold depends on the choice of closure, highlighting the importance of model selection when dealing with real-world epidemics. Nevertheless, we expect that our method will extend to other systems in which fast variables are present.
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http://dx.doi.org/10.1007/s00285-019-01380-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6667428PMC
August 2019

Over-the-Scope Clip Closure of Pancreatico-Colonic Fistula Secondary to Acute or Chronic Pancreatitis: A Case Series.

J Laparoendosc Adv Surg Tech A 2019 Aug 9;29(8):1000-1004. Epub 2019 May 9.

1Department of General Surgery, Visceral, Thoracic and Vascular Surgery, Division of Interdisciplinary Endoscopy, Universitätsmedizin Greifswald, Greifswald, Germany.

Pancreatico-colonic fistula (PCF) is a rare adverse effect secondary to severe acute or chronic pancreatitis and potentially life-threatening because of abdominal sepsis. Over-the-scope clip (OTSC) system is a recently developed endoscopic device and has been successfully used for bleeding and perforations of the gastrointestinal tract. We hereby report a series of patients with PCFs in whom OTSC was used. From January 2011 to December 2018, we retrospectively collected data on cases of PCFs with endoscopic treatment using the OTSC system. After conservative management, the endoscopic intervention was carried out on patients in deep sedation by single skilled operators. A total of 9 patients were enrolled and patients were treated with 14/6 -type OTSC. PCF occurred secondary to chronic ( = 5) and acute pancreatitis ( = 4). There were no adverse effects related to the endoscopic procedure itself. Further endoscopic evaluation was performed 8 weeks later and revealed a successful fistula closure in 4 patients with chronic pancreatitis (80%) and in 2 patients with acute pancreatitis (50%). An insufficient fistula closure was observed in 3 cases because of dislocation of the OTSC and an additional surgical procedure was required. The OTSC system seems to be safe and effective in short-term management of PCFs because of acute or chronic pancreatitis in addition to the already established nonsurgical therapy. However, the OTSC closure of PCFs in patients with acute pancreatitis seems to be associated with a higher failure rate. To sum up, more evidence and long-term studies are needed to determine the criteria for the use of OTSC in closure of PCFs owing to acute or chronic pancreatitis.
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http://dx.doi.org/10.1089/lap.2019.0166DOI Listing
August 2019

Use of a modified Outerbridge-Kashiwagi procedure for the treatment of posttraumatic elbow sequelae.

J Shoulder Elbow Surg 2019 Jul 13;28(7):1387-1394. Epub 2019 Apr 13.

Florida Orthopaedic Institute, Tampa, FL, USA. Electronic address:

Background: To review our 10-year experience treating posttraumatic sequelae of the elbow using a modified Outerbridge-Kashiwagi (O-K) procedure.

Methods: Twenty-one patients with posttraumatic sequelae of the elbow treated using the technique were evaluated clinically using the Mayo Elbow Performance Score, range of motion testing, and pain level. We noted the presence of preoperative and postoperative ulnar nerve symptoms, complications, and reoperations. Open contracture release was selected to address either removal of hardware or ulnar nerve pathology.

Results: At a mean of 39 months (range, 12-116 months), the Mayo Elbow Performance Score improved from 52 to 84 (P < .0001) and the mean arc of motion improved from 44° to 98° (P < .0001). At the final follow-up, 90% of patients reported no pain or mild pain, and 81% of patients had a satisfactory objective result. In 15 of 21 cases (71%), it was necessary to mobilize the ulnar nerve. After contracture release, 1 patient developed new onset ulnar nerve symptoms. Three patients underwent reoperation: 2 for recalcitrant contracture and 1 for new onset ulnar nerve symptoms.

Conclusions: The mini-open O-K procedure is safe and effective in restoring function in patients with retained hardware and posttraumatic contracture. Posttraumatic arthritic patients often require both removal of hardware and neurolysis of the ulnar nerve. The mini-open O-K procedure allows complete access to the elbow joint, which facilitates release for both intrinsic and extrinsic contracture.
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http://dx.doi.org/10.1016/j.jse.2019.02.002DOI Listing
July 2019

Role of endoplasmic reticulum stress and protein misfolding in disorders of the liver and pancreas.

Adv Med Sci 2019 Sep 9;64(2):315-323. Epub 2019 Apr 9.

Department of Medicine A, University Medicine Greifswald, Greifswald, Germany.

The endoplasmic reticulum (ER) is the site of synthesis and folding of membrane and secretory proteins. The fraction of protein passing through the ER represents a large proportion of the total protein in the cell. Protein folding, glycosylation, sorting and transport are essential tasks of the ER and a compromised ER folding network has been recognized to be a key component in the disease pathogenicity of common neurodegenerative, metabolic and malignant diseases. On the other hand, the ER protein folding machinery also holds significant potential for therapeutic interventions. Many causes can lead to ER stress. A disturbed calcium homeostasis, the generation of reactive oxygen species (ROS) and a persistent overload of misfolded proteins within the ER can drive the course of adisease. In this review the role of ER-stress in diseases of the liver and pancreas will be examined using pancreatitis and Wilson´s disease as examples. Potential therapeutic targets in ER-stress pathways will also be discussed.
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http://dx.doi.org/10.1016/j.advms.2019.03.004DOI Listing
September 2019

Endoscopic management of complications of acute pancreatitis: an update on the field.

Expert Rev Gastroenterol Hepatol 2018 Dec 25;12(12):1207-1218. Epub 2018 Oct 25.

a Department of Medicine A , University Medicine Greifswald , Greifswald , Germany.

Introduction: Acute pancreatitis is a frequent, nonmalignant gastrointestinal disorder leading to hospital admission. For its severe form and subsequent complications, minimally invasive and endoscopic procedures are being used increasingly, and are subject to rapid technical advances. Areas covered: Based on a systematic literature search in PubMed, medline, and Web-of-Science, we discuss the currently available treatment strategies for endoscopic therapy of pancreatic pseudocysts, walled-off pancreatic necrosis (WON), and disconnected pancreatic duct syndrome (DPDS), and compare the efficacy and safety of plastic and metal stents. A special focus is placed on studies directly comparing different stent types, including lumen-apposing metal stents (LAMS) and clinical outcomes when draining pseudocysts or WONs. The clinical significance and endoscopic treatment options for DPDS are also discussed. Expert commentary: Endoscopic therapy has become the treatment of choice for different types of pancreatic and peripancreatic collections, the majority of which, however, require no intervention. The use of LAMS has facilitated drainage and necrosectomy in patients with WON or pseudocysts. Serious complications remain a problem in spite of high technical and clinical success rates. DPDS is an increasingly recognized problem in the presence of pseudocysts or WONs but evidence for endoscopic stent placement in this situation remains insufficient.
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http://dx.doi.org/10.1080/17474124.2018.1537781DOI Listing
December 2018

Clinical outcomes following reverse shoulder arthroplasty-allograft composite for revision of failed arthroplasty associated with proximal humeral bone deficiency: 2- to 15-year follow-up.

J Shoulder Elbow Surg 2019 May 25;28(5):900-907. Epub 2019 Jan 25.

Florida Orthopaedic Institute, Tampa, FL, USA. Electronic address:

Background: Patients with pain and disability due to a prior failed shoulder arthroplasty with associated proximal humeral bone loss have limited reconstruction options. Our purpose was to report the results of a large cohort of patients treated with a reverse shoulder allograft-prosthetic composite (APC).

Methods: Between 2002 and 2012, a total of 73 patients were treated with a reverse shoulder APC and had adequate follow-up. Clinical outcome scores, range of motion, and radiographic evidence of failure were assessed. The minimum follow-up period was 2 years, with an average of 67.9 months (range, 21-157 months). Of the patients, 43 had more than 5 years' follow-up and 12 had more than 10 years' follow-up.

Results: The total American Shoulder and Elbow Surgeons score improved from 33.8 to 51.4 (P < .0001), and the Simple Shoulder Test score improved from 1.3 to 3.5 (P < .0001). Good to excellent results were reported in 42 of 60 patients (70%), 10 patients (17%) reported satisfactory results, and 8 patients (13%) were unsatisfied. Range of motion improved in forward flexion (49° to 75°, P < .001) and abduction (45° to 72°, P < .001). Revision was required in 14 patients (19%) for periprosthetic fracture (n = 6), instability (n = 2), glenosphere dissociation (n = 2), humeral loosening (n = 2), and infection (n = 2) at a mean of 38 months postoperatively. The reoperation-free survival rate of all reconstructions was 88% (30 of 34) at 5 years, 78% (21 of 27) at 10 years, and 67% (8 of 12) beyond 10 years. Ten patients had radiographic evidence of humeral loosening at final follow-up, and 2 required revision.

Conclusions: The use of a reverse total shoulder APC provides reliable pain relief and improved range of motion, with an acceptable rate of complications. Although ultimate function achieved is limited, patient satisfaction remains high.
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http://dx.doi.org/10.1016/j.jse.2018.10.023DOI Listing
May 2019

Quantitative videographic analysis of intraoperative total shoulder arthroplasty is predictive of radiographic implant loosening.

JSES Open Access 2018 Mar 13;2(1):18-22. Epub 2018 Mar 13.

Department of Orthopaedics and Sport Medicine, University of South Florida, Tampa, FL, USA.

Background: It is believed that both patient and surgeon factors contribute to premature implant loosening. This video study was designed to answer the following questions: Can orthopedic surgeons reliably differentiate between procedures done well and those that will lead to early glenoid failure? Do the difficulty of the operation and the surgeon's performance predict a patient's outcome? Does the presence of a Walch B2 glenoid result in surgery that is evidently more difficult and performed in such a way to suggest early glenoid component failure?

Methods: Eleven upper extremity surgeons blindly graded a set of intraoperative videos of 15 total shoulder arthroplasty patients (grouped by outcome at 2 years). Evaluation questionnaires consisted of questions about the perceived difficulty and the surgeon's performance. Total and partial patient scores were calculated for each video. Higher calculated score would indicate worse postsurgical outcome.

Results: The loosening group had a significantly higher total score ( = .0057). Also, patients with B2 glenoids scored significantly higher than patients with other wear type. The analysis of overall procedure performance indicated difference between outcome groups ( = .0063).

Conclusion: Our results indicate that surgeons could review surgical videos and differentiate the cases that were difficult or those that were more likely to lead to loosening of the glenoid component. The presence of a B2 glenoid was predictive of difficult surgery. The results of this study should serve as a starting point for surgeons interested in critically evaluating performance and also for those interested in finding ways to maximize patient outcomes after total shoulder arthroplasty.
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http://dx.doi.org/10.1016/j.jses.2017.11.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6334877PMC
March 2018

Massive Rotator Cuff Tears in Patients Older Than Sixty-five: Indications for Cuff Repair versus Reverse Total Shoulder Arthroplasty.

Am J Orthop (Belle Mead NJ) 2018 Dec;47(12)

University of South Florida, Department of Orthopaedic Surgery, 5 Tampa General Circle, HMT 710, Tampa, FL 33606, USA. Email:

The decision to perform rotator cuff repair (RCR) versus reverse total shoulder arthroplasty (rTSA) for massive rotator cuff tear (MCT) without arthritis can be difficult. Our aim was to identify preoperative variables that are influential in a surgeon's decision to choose one of the two procedures and evaluate outcomes. We retrospectively reviewed 181 patients older than 65 who underwent RCR or rTSA for MCT without arthritis. Clinical and radiographic data were collected and used to evaluate the preoperative variables in each of these two patient populations and assess outcomes. Ninety-five shoulders underwent RCR and 92 underwent rTSA with an average followup of 44 and 47 months, respectively. Patients selected for RCR had greater preoperative flexion (113 vs 57), abduction (97 vs 53), and external rotation (42 vs 32), higher SST (3.1 vs 1.9) and ASES scores (43.8 vs 38.6), and were less likely to have had previous cuff surgery (6.3% vs 35.9%). Patients selected for rTSA had a smaller acromiohumeral interval (4.8 vs 8.7) and more superior subluxation (50.6% vs 14.1%). Similar preoperative characteristics included pain, comorbidities, and BMI. Patients were satisfied in both groups and had significant improvement in motion and function postoperatively. Both RCR and rTSA can result in significant functional improvement and patient satisfaction in the setting of MCT without arthritis in patients older than 65. At our institution, patients who underwent rTSA had less pre-operative motion, lower function, more evidence of superior migration, and were more likely to have had previous rotator cuff surgery.
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http://dx.doi.org/10.12788/ajo.2018.0109DOI Listing
December 2018

Beta-glucan and arabinogalactan-based xerogels for abuse-deterrent opioid formulations.

Eur J Pharm Sci 2019 Mar 6;129:132-139. Epub 2019 Jan 6.

Faculty of Chemical and Food Technology, Slovak University of Technology, 812 37 Bratislava, Slovakia.

Novel polysaccharide hydrogels based on Methocel and beta-glucan or arabinogalactan and corresponding xerogels were prepared and described. Phase stability of hydrogels was confirmed over multiple freeze-thaw cycles. Binary beta-glucan:Methocel hydrogels showed the highest freeze-thaw stability in terms of their syneresis. The viscosity of binary hydrogels was further increased by adding water-soluble resin. Freeze drying of polysaccharide gels yields xerogels suitable as abuse-deterrent vehicles for opioid delivery. The xerogels were characterized by infrared spectroscopy, X-ray diffraction, differential scanning calorimetry, scanning electron microscopy and by their swelling behavior. As a model opioid, tramadol hydrochloride formulations were prepared with various xerogel matrices and dissolution-release profiles were determined. The xerogel matrix acts as a functional excipient that forms a viscous gel barrier with decreased rate of tramadol release. Moreover, slower drug release with no dose dumping is observed in the presence of ethanol. The release kinetics demonstrated that hydrophilic gels with beta-glucan or arabinogalactan are effective for controlling and prolonging the drug release for 12 h which could reduce the required number of administrations.
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http://dx.doi.org/10.1016/j.ejps.2019.01.003DOI Listing
March 2019

Vitamins D and K as Factors Associated with Osteopathy in Chronic Pancreatitis: A Prospective Multicentre Study (P-BONE Study).

Clin Transl Gastroenterol 2018 10 15;9(10):197. Epub 2018 Oct 15.

Digestive & Liver Disease Unit, Sant'Andrea Hospital, "La Sapienza", Rome, Italy.

Background: Osteopathy is common in patients with chronic pancreatitis (CP), but previous studies carry several limitations. Vitamin K is essential for bone metabolism, but its role in this setting has never been investigated. Our aim is to assess the prevalence of osteoporosis and osteopenia in CP patients, and to investigate the association between osteopathy and CP features and nutritional parameters, especially vitamin D and K levels.

Methods: Multicentre cross-sectional study on CP patients diagnosed according to M-ANNHEIM criteria. Bone density was evaluated by dual-energy X-ray absorptiometry and pancreatic function by faecal elastase. Nutritional evaluation included vitamin D and vitamin K. Differences between patients with or without osteopathy were evaluated. The association between investigated variables and bone density were analysed with logistic regression analysis.

Results: In total, 211 CP patients were enrolled at eight Centres (67% men; mean age 60). In total, 18% had advanced-marked CP, 56% suffered from pancreatic exocrine insufficiency and disease aetiology was alcoholic in 43%. Vitamin D and K were deficient in 56% and 32%, respectively. Osteopenia was diagnosed in 42% and osteoporosis in 22%. In the multivariate analysis, female sex (OR 2.78), age (OR 1.07 per year) and higher BMI (OR 0.84) were associated with the presence of osteoporosis. In male patients, the only factor associated with osteoporosis was vitamin K deficiency (OR 4.23).

Conclusion: The present data confirm a high rate of osteopathy in CP patients and highlight the relevance of vitamin K deficiency as only factor associated with osteoporosis in male patients for the first time.
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http://dx.doi.org/10.1038/s41424-018-0066-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6189068PMC
October 2018