scholarly journals Transient adverse events after REGN-CoV2 administration for mild COVID-19 patients and their potential predictive factors: a single center analysis

2021 ◽  
Author(s):  
Gen Kano ◽  
Kyoko Taniguchi ◽  
Yukiko Oue
Keyword(s):  
Adverse Events ◽  
Oxygen Saturation ◽  
Odds Ratio ◽  
Severity Of Illness ◽  
Additional Treatment ◽  
Exact Probability ◽  
Exact Test ◽  
Oxygen Administration ◽  
Moderate Disease ◽  
Significant Difference

Background The efficacy of REGN-COV2 in preventing severe COVID-19 has been proven, and its use in outpatient and home settings is expanding. Adverse events such as fever and decreased oxygen saturation, which are often seen after REGN-COV2 administration, are generally transient, but predicting these events is useful in developing a monitoring plan for patients. Methods We performed a retrospective analysis of 76 patients who received REGN-CoV2 between August and September 2021. The clinical course of the patients' fever and oxygen administration was collected from their medical records, and the patients were divided into two groups based on the presence or absence of these adverse events, and the underlying pathology and blood sampling data were compared. Parameters that showed significant differences were further examined by Fisher's exact probability test to see if the use of appropriate thresholds would significantly correlate with the occurrence of adverse events. Findings Of the 76 patients, 47 had fever of 38.5°C or higher within 24 hours after administration, and 27 of these patients had a body temperature of 37.5°C or lower before administration. Oxygen was required in 14 cases, 5 of which required oxygen more than 24 hours after administration of REGN-COV2, and additional treatment such as dexamethasone was given as a transition to moderate disease. Among the parameters analyzed, except for fever before administration, lymphocyte count and IFNλ3 showed significant differences between the fever and non-fever groups. There was also a significant difference in ferritin and CRP between the oxygen required and non-required groups. This was also the case in the comparison excluding patients who had fever before administration. In addition to IFNλ3, ferritin, and CRP, there was a significant difference in LDH between the group that required additional treatment and the group that did not. Fisher's exact test was used to examine the prediction threshold for fever and non-fever groups. The sensitivity and specificity were 55% and 79%, respectively with odds ratio 4.746 (95% CI: 1.666 to 14.12) when lymphocytes counts <950/μL was used (p=0.004). Similarly, when IFNλ3>5.0 was used as the cutoff, sensitivity 72%, specificity 76%, odds ratio 8.220 (2.857 to 22.22; p<0.0001). Interpretations Fever and decreased oxygen saturation after administration of REGN-Cov2 were found to correlate with the severity factors of COVID-19 itself. Evaluation of these items at the time of administration is useful not only for predicting the severity of illness but also for the development of adverse events in patients.

scholarly journals The yield of colorectal cancer among fast track patients with normocytic and microcytic anaemia

2014 ◽  
Vol 96 (4) ◽  
pp. 289-293 ◽  
Author(s):  
IG Panagiotopoulou ◽  
D Fitzrol ◽  
RA Parker ◽  
J Kuzhively ◽  
N Luscombe ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Logistic Regression ◽  
Odds Ratio ◽  
Fast Track ◽  
Microcytic Anaemia ◽  
Exact Test ◽  
Fisher's Exact Test ◽  
Significant Difference ◽  
Fisher’S Exact Test ◽  
Normocytic Anaemia

Introduction We receive fast track referrals on the basis of iron deficiency anaemia (IDA) for patients with normocytic anaemia or for patients with no iron studies. This study examined the yield of colorectal cancer (CRC) among fast track patients to ascertain whether awaiting confirmation of IDA is necessary prior to performing bowel investigations. Methods A review was undertaken of 321 and 930 consecutive fast track referrals from Centre A and Centre B respectively. Contingency tables were analysed using Fisher’s exact test. Logistic regression analyses were performed to investigate significant predictors of CRC. Results Overall, 229 patients were included from Centre A and 689 from Centre B. The odds ratio for microcytic anaemia versus normocytic anaemia in the outcome of CRC was 1.3 (95% confidence interval [CI]: 0.5–3.9) for Centre A and 1.6 (95% CI: 0.8–3.3) for Centre B. In a logistic regression analysis (Centre B only), no significant difference in CRC rates was seen between microcytic and normocytic anaemia (adjusted odds ratio: 1.9, 95% CI: 0.9–3.9). There was no statistically significant difference in the yield of CRC between microcytic and normocytic anaemia (p=0.515, Fisher’s exact test) in patients with anaemia only and no colorectal symptoms. Finally, CRC cases were seen in both microcytic and normocytic groups with or without low ferritin. Conclusions There is no significant difference in the yield of CRC between fast track patients with microcytic and normocytic anaemia. This study provides insufficient evidence to support awaiting confirmation of IDA in fast track patients with normocytic anaemia prior to requesting bowel investigations.

scholarly journals Influence of Cytochrome P450 (CYP) 2C8 polymorphisms on the efficacy and tolerability of artesunate-amodiaquine treatment of uncomplicated Plasmodium falciparum malaria in Zanzibar

2021 ◽  
Author(s):  
Leyre Pernaute-Lau ◽  
Ulrika Morris ◽  
Mwinyi Msellem ◽  
Andreas Mårtensson ◽  
Anders Björkman ◽  
...  
Keyword(s):  
Plasmodium Falciparum ◽  
Cytochrome P450 ◽  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Plasmodium Falciparum Malaria ◽  
Serious Adverse Events ◽  
Exact Test ◽  
Genotype Frequencies ◽  
Significant Difference ◽  
Minor Alleles

Abstract BackgroundThe antimalarial drug amodiaquine, a commonly used long acting partner drug in artemisinin-based combination therapy, is metabolized to active desethyl-amodiaquine (DEAQ) by cytochrome P450 2C8 (CYP2C8). The CYP2C8 gene carries several polymorphisms including the more frequent minor alleles CYP2C8*2 and CYP2C8*3. These minor alleles have been associated with decreased enzymatic activity, slowing the amodiaquine biotransformation towards DEAQ. This study aimed to assess the influence of these CYP2C8 polymorphisms on the efficacy and tolerability of artesunate-amodiaquine treatment for uncomplicated Plasmodium falciparum malaria in Zanzibar.MethodsWe analysed data from 618 children under 5 years of age with uncomplicated P. falciparum malaria enrolled in two randomized clinical trials comparing artesunate-amodiaquine and artemether-lumefantrine in 2002-2005 in Zanzibar. CYP2C8*2 and CYP2C8*3 genotype frequencies were determined by PCR-restriction fragment length polymorphism. Statistical associations between CYP2C8*2 and/or CYP2C8*3 allele carriers and treatment outcome or occurrence of adverse events were assessed by Fisher’s Exact test.ResultsThe allele frequencies of CYP2C8*2 and CYP2C8*3 were 17.5% (95% CI 15.4-19.7%) and 2.7% (95% CI 1.8-3.7%), respectively. There was no significant difference in the proportion of subjects carrying either CYP2C8*2 or CYP2C8*3 alleles amongst those with reinfections (44.1%; 95% CI 33.8-54.8) or those with recrudescent infections (48.3%; 95% CI 29.4-67.5), compared to those with an adequate clinical and parasitological response (36.7%; 95% CI 30.0-43.9) (P = 0.25 and P = 0.31, respectively). However, patients carrying either the CYP2C8*2 or CYP2C8*3 alleles were significantly associated with an increased occurrence of non-serious adverse events, when compared with CYP2C8 *1/*1 wildtype homozygotes (44.9%; 95% CI 36.1-54.0 versus 28.1%; 95% CI 21.9-35.0, respectively; P = 0.003). ConclusionsCYP2C8 genotypes did not influence treatment efficacy directly, but the tolerability to AS-AQ may be reduced in subjects carrying the CYP2C8*2 and CYP2C8*3 alleles. The importance of this non-negligible association with regards to amodiaquine-based malaria chemotherapy warrants further investigation.

scholarly journals Prevalence, characteristics, and predictors of Long COVID among diagnosed cases of COVID-19

2022 ◽  
Author(s):  
Arjun M C ◽  
Arvind Kumar Singh ◽  
Debkumar Pal ◽  
Kajal Das ◽  
Alekhya Gajjala ◽  
...  
Keyword(s):  
Odds Ratio ◽  
Severity Of Illness ◽  
Clinical History ◽  
Considerable Proportion ◽  
Outpatient Basis ◽  
Moderate Disease ◽  
Vaccination History

Background: Long COVID or long-term complication after COVID-19 has the ability to affect health and quality of life. Knowledge about the burden and predictors could aid in their prevention and management. Most of the studies are from high-income countries and focus on severe cases. We did this study to estimate the prevalence and identify the characteristics and predictors of Long COVID among our patients. Methodology: We recruited adult (≥18 years) patients who were diagnosed as Reverse Transcription Polymerase Chain Reaction (RTPCR) confirmed SARS-COV-2 infection and were either hospitalized or tested on outpatient basis. Eligible participants were followed up telephonically after four weeks of diagnosis of SARS-COV-2 infection to collect data on sociodemographic, clinical history, vaccination history, Cycle threshold (Ct) values during diagnosis and other variables. Characteristic of Long COVID were elicited, and multivariable logistic regression was done to find the predictors of Long COVID. Results: We have analyzed 487 individual data with a median follow-up of 44 days (Inter quartile range (IQR): 39,47). Overall, Long COVID was reported by 29.2% (95% Confidence interval (CI): 25.3%,33.4%) participants. Prevalence of Long COVID among patients with mild/moderate disease (n = 415) was 23.4% (95% CI: 19.5%,27.7%) as compared to 62.5% (95% CI: 50.7%,73%) in severe/critical cases(n=72). The most common Long COVID symptom was fatigue (64.8%) followed by cough (32.4%). Statistically significant predictors of Long COVID were - Pre-existing medical conditions (Adjusted Odds ratio (aOR)=2.00, 95% CI: 1.16,3.44), having a more significant number of symptoms during acute phase of COVID-19 disease (aOR=11.24, 95% CI: 4.00,31.51), two doses of COVID-19 vaccination (aOR=2.32, 95% CI: 1.17,4.58), the severity of illness (aOR=5.71, 95% CI: 3.00,10.89) and being admitted to hospital (Odds ratio (OR)=3.89, 95% CI: 2.49,6.08). Conclusion: A considerable proportion of COVID-19 cases reported Long COVID symptoms. More research is needed in Long COVID to objectively assess the symptoms and find the biological and radiological markers.

scholarly journals Clinical efficacy and safety in patients treated with teicoplanin with a target trough concentration of 20 μg/mL using a regimen of 12 mg/kg for five doses within the initial 3 days

2020 ◽  
Author(s):  
Takashi Ueda ◽  
Yoshio Takesue ◽  
Kazuhiko Nakajima ◽  
Kaoru Ichiki ◽  
Kaori Ishikawa ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Response ◽  
Clinical Efficacy ◽  
Trough Concentration ◽  
Treatment Efficacy ◽  
Odds Ratio ◽  
Efficacy And Safety ◽  
Conventional Regimen ◽  
Significant Difference ◽  
Clinical Responses

Abstract Background: A trough concentration (Cmin) ≥20 μg/mL of teicoplanin is recommended for the treatment of serious methicillin-resistant Staphylococcus aureus (MRSA) infections. However available data are limited because it is difficult to attain this target Cmin.Methods: Pharmacokinetics and adverse events were evaluated in all eligible patients. For clinical efficacy, patients who had bacteremia/complicated MRSA infections were analyzed. The primary endpoint for clinical efficacy was an early clinical response at 72–96 h after the start of therapy. Five dosed of 12 mg/kg or 10 mg/kg was administered as an enhanced or conventional high loading dose regimen, respectively. The Cmin was obtained at 72 h after the first dose.Results: Overall, 512 patients were eligible, and 76 patients were analyzed for treatment efficacy. The proportion of patients achieving the target Cmin range (20–40 μg/mL) by the enhanced regimen was significantly higher than for the conventional regimen (75.2% versus 41.0%, p < 0.001). In multivariate analysis, Cmin ≥20 μg/mL was an independent factor for an early clinical response (odds ratio 3.95, 95% confidence interval 1.25–12.53). There was no significant difference in the occurrence of adverse events between patients who did or did not achieve a Cmin ≥20 μg/mL.Conclusion: A target Cmin ≥20 μg/mL might improve early clinical responses during the treatment of difficult MRSA infections using 12 mg/kg teicoplanin for five doses within the initial 3 days.

Retrospective cohort study on the risk factors of admission due to serious adverse events during S-1 (tegaful, gimeracil, oteracil potassium) containing chemotherapy for gastric cancer.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 141-141
Author(s):  
Yasuyuki Kawamoto ◽  
Satoshi Yuki ◽  
Yoshimitsu Kobayashi ◽  
Koji Oba ◽  
Hideyuki Hayashi ◽  
...  
Keyword(s):  
Risk Factors ◽  
Gastric Cancer ◽  
Adverse Events ◽  
Odds Ratio ◽  
Univariate Analysis ◽  
Multivariate Logistic Regression Model ◽  
First Line ◽  
Serious Adverse Events ◽  
Exact Test ◽  
Line Chemotherapy

141 Background: S-1 (tegaful, gimeracil, oteracil potassium) containing regimens are widely used as first line chemotherapy for metastatic or unresectable gastric cancer in Japan. Because patients often need admission due to serious adverse events (SAE) during chemotherapy, it is important to predict admission. We retrospectively investigated the risk factors of admission due to SAE during first line chemotherapy which contained S-1. Methods: We retrospectively analyzed the patients who began to receive S-1 containing chemotherapy for the first line chemotherapy at our institution from January 2005 to December 2010 by medical records. Association between baseline characteristics and admission due to SAE were evaluated by Fisher’s exact test, t-test or Mann-Whitney test. Age, sex, S-1 dose (mg/m2) and other factors which significantly associated in the univariate analysis were evaluated in the multivariate logistic regression model. Results: One hundred nine patients were assessed. Admission due to SAE were observed in 24 patients (34 times), and tended to occur before 2nd cycle had ended. Multivariate analysis suggested that hypoalbuminemia was a risk factor of admission due to all SAE (Odds ratio 0.15, 95% C.I. 0.05 - 0.44, P = 0.0005). It is suggested that S-1 dose was a risk for admission due to FU-induced colitis (Odds ratio 1.30, 95% C.I. 1.12 - 1.50, P=0.0004). Conclusions: Hypoalbuminemia might constitute a marker of admission due to SAE. FU-induced colitis occurred in S-1 dose-related fashion, and the patients had lost their weight before appropriate course. It is suggested that clinicians should pay attention to patients’ weight loss during chemotherapy, notably time of initiation of chemotherapy.

scholarly journals Tinzaparin vs. Nadroparin Safety and Efficacy in Neurosurgery

2021 ◽  
Vol 13 (2) ◽  
pp. 202-206
Author(s):  
Florian Wilhelmy ◽  
Annika Hantsche ◽  
Michael Gaier ◽  
Johannes Kasper ◽  
Michael Karl Fehrenbach ◽  
...  
Keyword(s):  
Adverse Events ◽  
African Swine Fever ◽  
University Hospital ◽  
Thromboembolic Events ◽  
Safe Alternative ◽  
Exact Test ◽  
Vein Thrombosis ◽  
Neurosurgical Patients ◽  
Significant Difference ◽  
Prophylactic Anticoagulation

Background. An outbreak of African swine fever (ASF) in China in 2020 has led to an unprecedented shortage of nadroparin. Most patients, especially those kept in hospital for surgery, are currently treated with prophylactic anticoagulation (AC). In search of alternatives for nadroparin (fraxiparine), we found no sufficient data on alternatives for neurosurgical patients, such as tinzaparin of European origin. We compared nadroparin and tinzaparin concerning adverse events (bleeding versus thromboembolic events) in neurosurgical patients. Methods. Between 2012 and 2018, 517 neurosurgical patients with benign and malignant brain tumors as well as 297 patients with subarachnoid hemorrhage (SAH) were treated in the Department of Neurosurgery, University Hospital Leipzig, receiving prophylactic anticoagulation within 48 h. In 2015, prophylactic anticoagulation was switched from nadroparin to tinzaparin throughout the university hospital. In a retrospective manner, the frequency and occurrence of adverse events (rebleeding and thromboembolic events) in connection with the substance used were analyzed. Statistical analysis was performed using Fisher’s exact test and the chi-squared test. Results. Rebleeding rates were similar in both nadroparin and tinzaparin cohorts in patients being treated for meningioma, glioma, and SAH combined (8.8% vs. 10.3%). Accordingly, the rates of overall thromboembolic events were not significantly different (5.5% vs. 4.3%). The severity of rebleeding did not vary. There was no significant difference among subgroups when compared for deep vein thrombosis (DVT) or pulmonary embolism (PE). Conclusion. In this retrospective study, tinzaparin seems to be a safe alternative to nadroparin for AC in patients undergoing brain tumor surgery or suffering from SAH.

scholarly journals Homeopathy and the COVID-19 pandemic: quasi-experimental observational study

2021 ◽  
Vol 20 (1) ◽  
pp. 09-10
Author(s):  
Carla Holandino ◽  
Adriana Passos Oliveira ◽  
Edgard Costa Vilhena ◽  
Twoany Rebecca Pedroza Sanches ◽  
Fábio de Almeida Bolognani ◽  
...  
Keyword(s):  
Severity Of Illness ◽  
Categorical Variables ◽  
Fisher Exact Test ◽  
Significance Level ◽  
Exact Test ◽  
Health Authorities ◽  
Significant Difference ◽  
High Death ◽  
Quasi Experimental ◽  
Observational Cohort

Background: the number of cases of Covid-19 reached more than 11 million people in Brazil, but mostly in Caxias city (Rio de Janeiro) high death rates are very worrysome. In this scenario, homeopathy therapy, along with sanitary and therapeutic measures, should be recommended by health authorities. Aims: to evaluate the use of homeopathic complex (Bryonia alba, China officinalis and Metallum album 30cH), concerning the severity of the illness, during the coronavirus pandemic. Methodology: the complex was administrated at multiple families from Caxias, with (FW) and without (FWO) symptoms similar to COVID-19’s, therefore qualifying the project as a quasi-experimental longitudinal observational cohort study (applied in 51 families or 128 people). With this, the influence of homeopathic intervention in sick (FW) and health (FWO) groups was estimated. All volunteers used three drops of the medicine, once a day, per 60 days. The medicine was prepared accordingly to the Brazilian Homeopathic Pharmacopoeia1. The follow-up was carried out within seven days, which resulted in a total of 8 weeks, since the first interview. The data was organized and statistically analyzed with a 5% significance level, for categorical variables, by Fisher Exact test, in Excel sheet and SPSS 17.0 platform. The ethical committee approved this project under the code: CAAE 31601020.3.0000.5243. Results and Discussion: the preliminary results showed the absence of deaths in both groups (FW and FWO), without any statistically significant difference related to the severity of illness. Most of the families (98.03%) were thrilled to contribute in this particular homeopathic research and reported to have had general health symptoms’ improvements (84.31%). Despite the previous comorbidities presented in 52.9% of the families and considering that Covid-19 infected 0.020% of them, only 0.098% looked for medical assistance and none needed hospitalization. Conclusion: no differences between previous sick and health groups were detected after homeopathy intervention.

Effectiveness and Tolerability of Escitalopram in the Treatment of Depression with or Without Mental and/or Somatic Comorbidities

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
A. Yfantis ◽  
D. Giailoglou ◽  
E. Chourdaki ◽  
K. Sotiriadou ◽  
N. Laggis ◽  
...  
Keyword(s):  
Adverse Events ◽  
Severity Of Illness ◽  
Open Label ◽  
Significant Difference ◽  
Somatic Comorbidity ◽  
Naturalistic Setting ◽  
Somatic Comorbidities ◽  
Physical Disorders ◽  
Efficacy Assessment ◽  
Intent To Treat

Purpose:To evaluate the effectiveness and tolerability of escitalopram in patients suffering from depression with or without comorbid mental and/or physical disorders in a naturalistic setting.Methods:Open-label 3-month study, conducted in 186 investigational sites in Greece. Efficacy assessment was based on CGI-S, MADRS and CGI-I scales. Tolerability was evaluated by spontaneously reported adverse events and treatment discontinuation rates. Statistical analysis was based on a modified intent-to-treat dataset (at least one valid post-baseline CGI-S measurement) and the per protocol dataset (valid CGI-S measurements at all 3 visits).Results:The analysis dataset of the study included 3,931 patients (mean age 45.5±10.8, 65.8% women, 37.4% with any comorbidity, and baseline mean MADRS 26.7±8.4). Patients with comorbid mental disorders were more severely ill at baseline (p< 0.001, both MADRS and CGI-S). Patients showed significant improvement (p< 0.001) during the treatment period based on both MADRS and CGI-S scores. There was no significant difference between the four groups (no comorbidity, comorbid mental disorder, comorbid physical disorders, comorbid mental and physical disorders). However, for both scales, the change from baseline increased with the severity of illness. Patients in the comorbidity groups had slightly higher overall discontinuation rates (8.2% to 10%) than patients without comorbidity (6.9%), with a total of 7.8% (n=308) Discontinuation due to adverse events was 2.3% (n=92).Conclusion:Escitalopram was comparably effective and well tolerated in depressed patients with and without mental and/or somatic comorbidity.

scholarly journals Tinzaparin vs. Fraxiparin Safety and Efficacy in Neurosurgery

2021 ◽  
Author(s):  
Florian Wilhelmy ◽  
Annika Hantsche ◽  
Michael Gaier ◽  
Johannes Kasper ◽  
Michael Karl Fehrenbach ◽  
...  
Keyword(s):  
Adverse Events ◽  
African Swine Fever ◽  
University Hospital ◽  
Thromboembolic Events ◽  
Safe Alternative ◽  
Exact Test ◽  
Vein Thrombosis ◽  
Neurosurgical Patients ◽  
Significant Difference ◽  
Prophylactic Anticoagulation

Background An outbreak of African swine fever (ASF) in China in 2020 has led to an unprecedented shortage of fraxiparin. Most patients, especially those kept in hospital for surgery, are currently treated with prophylactic anticoagulation (AC). In search of alternatives for fraxiparin, we found no sufficient data on alternatives for neurosurgical patients, such as tinzaparin of European origin. We compared fraxiparin and tinzaparin concerning adverse events (bleeding versus thromboembolic events) in neurosurgical patients. Methods Between 2012 and 2018, 517 neurosurgical patients with benign and malignant brain tumors as well as 297 patients with subarachnoid hemorrhage (SAH) were treated in the Department of Neurosurgery, University Hospital Leipzig receiving prophylactic anticoagulation within 48 hours. In 2015, prophylactic anticoagulation was switched from fraxiparin to tinzaparin throughout the university hospital. In a retrospective manner, the frequency and occurrence of adverse events (rebleeding and thromboembolic events) in connection with the substance used was analyzed. Statistical analysis was performed using Fisher’s exact test and the chi-squared test. Results Rebleeding rates were similar in both fraxiparin and tinzaparin cohorts in patients being treated for meningioma, glioma, and SAH combined (8.8 vs 10.3%). Accordingly, the rates of overall thromboembolic events were not significantly different (5.5% vs 4.3%). The severity of rebleeding did not vary. There was no significant difference among subgroups when compared for deep vein thrombosis (DVT) or pulmonary embolism (PE). Conclusion In this retrospective study, tinzaparin seems to be a safe alternative to fraxiparin for AC in patients undergoing brain tumor surgery or suffering from SAH.

Does Patient-Specific Instrumentation Have a Higher Rate of Early Osteolysis Than Standard Referencing Techniques in Total Ankle Arthroplasty? A Radiographic Analysis

2019 ◽  
Vol 13 (1) ◽  
pp. 32-42
Author(s):  
Mario I. Escudero ◽  
Michael Symes ◽  
Thomas Bradford Bemenderfer ◽  
Maximiliano Barahona ◽  
Robert Anderson ◽  
...  
Keyword(s):  
Odds Ratio ◽  
Total Ankle Arthroplasty ◽  
Patient Specific ◽  
Fisher Exact Test ◽  
Therapeutic Level ◽  
Exact Test ◽  
Ankle Arthroplasty ◽  
Patient Specific Instrumentation ◽  
Soft Tissue Dissection ◽  
Significant Difference

Introduction: Patient-specific instrumentation (PSI) has been developed for total ankle arthroplasty (TAA), with proven benefits. One concern regarding PSI is the need for more soft tissue dissection in order to accurately position the PSI guides, which has the theoretical disadvantage of increased osteolysis. The purpose of our study is to compare the incidence and magnitude of osteolysis for the INFINITY Total Ankle System between PSI and standard referencing (SR) techniques. Methods: Sixty-seven patients who underwent primary TAA using Prophecy (PSI) or SR technique between 2013 and 2015 were reviewed in a retrospective observational study. Osteolysis was assessed on radiographs at 2 years. The incidence was calculated by binomial distribution. The number of zones compromised and the magnitude of osteolysis was calculated using the median as a summary statistic and interquartile range as dispersion statistic. Fisher exact test was used to compare both groups, then a regression model was estimated to calculate the odds ratio for osteolysis. Results: Of the 67 TAAs, 51 were in the PSI group and 16 in the SR group. In the PSI group the incidence, number of compromised zones (CZ), and magnitude was 41% (25%-59%), 1 [1-2], and 2 [2-3], respectively. In the SR group these were 36% (13%-65%), 3 [2-3], and 3 [2-4], respectively. No significant differences were found ( P = .46, P = .12, P = .33). A slightly higher risk of osteolysis was found in the PSI group (odds ratio = 1.33 [0.36-4.83]) ( P = .46). The majority of lesions were in 1 zone with size of 2 to 5 mm (63% for all cohort, 64% PSI, 60% SR). Two cases underwent revision for aseptic loosening, 1 in the SR group and 1 in the PSI group. Conclusion: According to our data, there is no significant difference between PSI and SR in terms of risk, incidence, size and magnitude of osteolysis in the INFINITY Total Ankle System at 2 years. Levels of Evidence: Therapeutic, Level III, Retrospective cohort study

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