Cooled radiofrequency ablation versus cryoneurolysis of the genicular nerves for the symptomatic pain management in knee osteoarthritis: a study protocol of a prospective, randomized, single-blinded clinical trial.

BACKGROUND: Cooled radiofrequency ablation (CRFA) and cryoneurolysis (CRYO) are two novel methods of genicular neurolysis to relief pain in symptomatic knee osteoarthritis (KOA). In this study, the two methods will be compared, giving us the opportunity to investigate their efficacy, safety and complications. METHODS: In this prospective randomized trial 70 patients with KOA will be recruited using a diagnostic block of four genicular nerves. Two groups will be created through software randomization: a CRFA group (35 patients) and a CRYO group (35 patients). The target of the interventions will be four genicular nerves; the superior medial, superior lateral, inferior medial, as well as the medial (retinacular) genicular branch from vastus intermedius. The primary outcome of this clinical trial will be the efficacy of CRFA or CRYO at 2-, 4-, 12-and 24-weeks post-intervention using the Numerical Rating Pain Scale (NRPS). The secondary outcomes are the safety of the two techniques, as well as the clinical evaluation using the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Oxford Knee Score (OKS), and the 7-point scale of Patient Global Impression of Change (PGIC). DISCUSSION: These two novel techniques can block pain transmission through genicular nerves in different ways. In contrast to cryoneurolysis, the CRFA method has been well documented in the past. This is the first clinical trial to compare CRFA vs CRYO and draw conclusions about their safety and efficacy. TRIAL REGISTRATION: ISRCTN87455770 [ https://doi.org/10.1186/ISRCTN87455770 ]. Registered 29/3/2022, first patient recruited 31/8/2022.

Prenatal antibiotic exposure increases the risk of infant atopic dermatitis: data from a Greek cohort.

Summary: Background. The human microbiome is important due to the impact it has on host immunologic development and allergy-associated diseases. This study aimed to investigate the impact of prenatal exposure to antibiotics on the incidence of atopic dermatitis (AD) in children at 18 months of age. Methods. Mothers were interviewed at baseline, in the maternity ward and by phone questionnaire after 18 months. Demographic data, mode of delivery, yoghurt consumption, antibiotic and other drug use during pregnancy, atopic history, diagnosis of AD and history of infections in the offspring were noted. Results. 385 mothers were interviewed at baseline. 231 (60%) mothers with 236 children responded at follow up. Cesarean section was reported in 116 (50.2%) deliveries while antibiotic use during pregnancy in 55/231 (23.8%) women. 43/236 (18.22%) infants were diagnosed with AD. Intravenous antibiotic use was associated with a 7.7 increased risk of AD diagnosis in the offspring (95%CI 1.23-48.27, p = 0.029). An increased odd for AD was recorded for mothers 30-40 years of age (OR 4.50, 95%CI 1.08-18.7, p = 0.039). No significant association between cesarean section and AD (p = 0.70) was recorded. In multivariate analysis, reported food allergy (OR 8.03, 95%CI 2.30-27.97, p = 0.001) and otitis media episodes in children (OR 3.76, 95%CI 1.60-8.83, p = 0.002) were significantly associated with AD diagnosis. Conclusions. An increased risk of AD was recorded only when antibiotics were given prenatally by intravenous route and in women between 30-40 years of age. Children with food allergy had an increased risk for AD. The relatively high percentage of cesarean sections was not a risk factor for AD.

Optimizing fixation methods for stable and unstable intertrochanteric hip fractures treated with sliding hip screw or cephalomedullary nailing: A comparative biomechanical and finite element analysis study.

BACKGROUND: Despite recent advances in implants and surgical techniques, catastrophic and clinical failures in the treatment of intertrochanteric fractures continue to occur, with dire consequences in an overall frail population subset. The aim of the current study is to evaluate the effect of the factors under the surgeons' control, namely fracture reduction and implant selection, on the biomechanical behavior of fracture fixation constructs. MATERIAL-METHODS: An experimental protocol was conducted with the use of instrumented sawbones, in order to validate the finite element models. The implants used were the Gamma3®and DHS systems. Subsequently, a series of scenaria were considered, including various reduction and implant angle combinations. Data were retrieved concerning the peak cancellous bone stresses around the hip screw and the volume of cancellous bone in the femoral head stressed at critical levels, as well as implant stresses and stresses on the cortical bone of the distal fragment. RESULTS: All stable fracture models displayed significantly decreased cancellous bone stresses and implant stresses compared to their unstable counterparts, regardless of implant used. The effect of increasing implant angle led to a decrease in implant stresses in all models studied, but had a beneficial effect on the stresses in the cancellous bone of the proximal fragment only in the subgroups of stable fractures with both implants and unstable fractures treated with a cephalomedullary nail (CMN). In unstable fractures anatomically reduced, the use of CMN led to significantly lower peak stresses in the cancellous bone and a smaller volume of bone stressed at critical levels. Increasing the reduction angle by 5 ° led to a significant decrease in both peak stresses and volume of bone stressed at critical levels, more prominent in the sliding hip screw (SHS) models. Decreasing the reduction angle into varus by 5 or 10 ° led to a significant increase in bone and implant stresses regardless of implant used. CONCLUSIONS: In stable two-part (AO31.A2) fractures the use of the SHS appears to be biomechanically equivalent to CMN. In unstable, anatomically reduced fractures, the use of CMN leads to significantly reduced cancellous bone stresses and decreased rotation of the proximal fragment during loading. A reduction in varus should be avoided at all costs. In unstable fractures treated with SHS a reduction in slight valgus appears to be biomechanically beneficial. The highest implant angle that allows for proper screw position and trajectory in the femoral head should be used for stable fractures with both implants and unstable fractures treated with Gamma3®.

Short-term clinical and radiological results of two different design metaphyseal fitting femoral stems in total hip arthroplasty: a prospective, randomized trial.

BACKGROUND: There is great design variability on short femoral stems available on the market. This study aims to evaluate the short-term clinical and radiological results of two different design short femoral stems, both classified as shortened tapered stems. METHODS: From March 2016 to March 2018, a prospective, randomized, parallel-group design study was conducted to compare functional and radiological outcomes of 45 patients underwent THA using the Tri-Lock Bone Preservation Stem and 45 patients underwent THA with the Minima S stem at a minimum 2 years of follow-up. Patients were assessed clinically and radiographically prior to surgery as well as at 3, 6, 12, and 24 months postoperatively. Primary outcomes were the change in health-related quality of life assessed with Western Ontario and McMaster Universities Osteoarthritis Index and 36-Item Short Form Health Survey and also the incidence of all hip-related complications. Secondary aims included hip function evaluated with the Harris hip score, rates of patient satisfaction, and the outcomes of a detailed radiological analysis. RESULTS: There were no significant differences between the 2 study groups in terms of patient-reported outcomes measurements, satisfaction scores, and complication rates at any of the measurement times. In both groups, stable fixation and radiographic osseointegration were achieved. However, analysis of the calcar region showed that 57.8% and 28.9% of patients had grade 1 or 2 stress shielding, in Tri-Lock and Minima S implantation group, respectively (p=0.015). Regarding coronal alignment, stems were placed in slight varus, valgus, and neutral position in 51.1%, 13.3%, and 35.6% of patients, respectively, in Tri-Lock BPS group. The Minima S stem was implanted at slight varus and valgus in 60% and 40% of patients, respectively, and neither stem in the exact neutral position. CONCLUSIONS: Both different design short femoral stems demonstrated excellent clinical performance at short-term follow up. Nevertheless, concerns were raised regarding the incidence of stress shielding phenomenon and mild discrepancies in coronal stem alignment during implantation. The clinical impact of these observations should be further evaluated through larger cohorts and longer follow-up. TRIAL REGISTRATION: ISRCTN registry, ISRCTN10096716 . Registered on May 8, 2018-Retrospectively registered.

OCT-Angiography for monitoring and managing neovascular age-related macular degeneration.

PURPOSE: To evaluate the combined use of optical coherence tomography and angiography (OCT-A) for imaging choroidal neovascularization (CNV) secondary to neovascular age-related macular degeneration (nAMD). MATERIALS AND METHODS: This prospective observational study was conducted from May 2015 to April 2017. Included in the study were 54 patients (n = 63 eyes), all of whom had CNV secondary to nAMD and all of whom had been examined by OCT-A. Angioscans (3x3 and 6 × 6) and conventional B-scan OCT scans were obtained for all patients at baseline and at various times during the 24-month follow-up period. For diagnostic confirmation, conventional imaging methods fluorescein angiography (FA) and indocyanine green angiography (ICGA) were performed at baseline. A total of 13 patients (n = 15 eyes) underwent serial imaging during 34 follow-up visits. The main outcomes included (i) determination of OCT-A sensitivity for the detection of CNV (classic and occult) and (ii) the correlation between B-scan OCT and OCT-A vis-à-vis consecutive follow-up changes. RESULTS: At baseline, the detection rate (i.e., overall sensitivity) of OCT-A for detecting CNV was 64.4% (75.7 and 48.0% for classic and occult CNV, respectively), independent of prior treatment status. In terms of quality, 6 × 6 angioscans were superior to 3 × 3. Moreover, specific CNV morphologic patterns by B-scan OCT did not correlate with lesion composition. Correspondence between OCT-A and B-scan OCT was observed in only 53% of the cases. CONCLUSIONS: OCT-A may prove to be a valuable adjunctive diagnostic tool for the interpretation of CNV, as it not only reduces the need for invasive angiographic procedures but also facilitates the follow-up process.

Clinical significance of cytotoxin-associated gene A status of Helicobacter pylori among non-steroidal anti-inflammatory drug users with peptic ulcer bleeding: a multicenter case-control study.

BACKGROUND: The role of Helicobacter pylori infection and especially of the cytotoxin-associated gene A (CagA) product strain in peptic ulcer bleeding among non-steroidal anti-inflammatory drugs (NSAIDs) users remains controversial. METHODS: A case-control study was carried out including 191 consecutive chronic NSAIDs users admitted to hospital because of peptic ulcer bleeding. Peptic ulcer was verified by endoscopy. Controls comprised 196 chronic NSAIDs users without signs of bleeding of similar age and gender to cases. Multivariate regression analysis was performed for further evaluation of the relationship between H. pylori, CagA status and other risk factors. RESULTS: H. pylori infection was present in 121 (63.4%) cases compared with 119 (60.7%) controls (odds ratio (OR) = 1.14, 95% CI, 0.76-1.72). CagA-positive strains were found to be significantly more frequent in cases than in controls (65/106 versus 41/99 P = 0.008). Current smoking (OR = 2.65; 95% CI, 1.14-6.15; P= 0.02), CagA status (OR = 2.28; 95% CI, 1.24-4.19; P = 0.008), dyspepsia (OR = 6.89; 95% CI, 1.84-25.76; P = 0.004) and past history of peptic ulcer disease (OR=3.15; 95% CI, 1.43-6.92; P=0.004) were associated significantly with increased risk of bleeding peptic ulcer. CONCLUSIONS: The results suggest that CagA-positive H. pylori infection is associated with a more than 2-fold increased risk of bleeding peptic ulcer among chronic NSAIDs users.

Evaluation of serial QT dispersion in patients with first non-Q-wave myocardial infarction: relation to the severity of underlying coronary artery disease.

BACKGROUND: Increased QT dispersion (QTD) has been correlated with ventricular arrhythmias. Recent reports suggest that it may serve as a marker of the severity of underlying coronary artery disease (CAD). HYPOTHESIS: The aim of this study was to examine in-hospital changes of QTD and their possible correlation with the severity of underlying CAD in patients with first non-Q-wave myocardial infarction. METHODS: In 62 patients we estimated QTD, precordial QTD, as well as their values corrected for heart rate on Days 3 and 7 after admission. The severity of underlying ischemic burden was estimated by means of the number of diseased vessels as well as by the jeopardy score. RESULTS: On Day 3, patients with jeopardy score > or = 6 exhibited greater QTD, corrected QTD, precordial QTD, and corrected precordial QTD (p = 0.001, p = 0.003, p = 0.02, p = 0.036, respectively); patients with multivessel disease had greater QTD (p = 0.007). On Day 7, patients with jeopardy score > or = 6 and multivessel disease exhibited greater QTD, corrected QTD, precordial QTD, and corrected precordial QTD (p < 0.001 for all). Multiple regression analysis revealed a jeopardy score of > or = 6 as the most significant independent predictor for QTD variables. From Days 3 to 7, only patients with none or one diseased vessel orjeopardy score < 6 had shortened QTD (p = 0.01 and p = 0.015, respectively) and corrected QTD (p < 0.001 for both). CONCLUSIONS: In patients with first non-Q-wave myocardial infarction, QTD variables and their in-hospital changes reflect the severity of underlying CAD.

Comparative efficacy of primary angioplasty with stent implantation and thrombolysis in restoring basal coronary artery flow in acute ST segment elevation myocardial infarction: quantitative assessment using the corrected TIMI frame count.

Following thrombolysis and primary percutaneous transluminal coronary angioplasty (PTCA) for acute ST segment elevation myocardial infarction, basal flow in the culprit artery is known to influence prognosis. The purpose of this study was to determine if differences exist in basal flow in culprit and nonculprit coronary arteries in patients with acute ST segment elevation myocardial infarction who were treated with thrombolysis or primary PTCA with stent implantation. Twenty patients were randomized to thrombolysis (with recombinant tissue plasminogen activator) and 24 to primary PTCA with stent implantation within 3 hours of onset of acute ST segment elevation myocardial infarction. Coronary angiography was performed 90-120 minutes after thrombolysis or immediately after PTCA with stent implantation and again at 18-36 hours after intervention in both groups. Patients who failed to achieve thrombolysis in myocardial infarction (TIMI) grade 2 or 3 flow were excluded. The corrected TIMI frame count was used as the index of basal coronary artery flow. Early after intervention the mean corrected TIMI frame count in the culprit coronary artery was significantly lower in the primary PTCA with stent group (27.4 +/- 7.7 frames) than in the thrombolysis group (39.8 +/- 10 frames, p < 0.001). Eight thrombolysis patients (40%) and 20 primary PTCA patients (83%, p < 0.01) achieved TIMI grade 3 flow early after intervention. By 18-36 hours after intervention there were no significant differences in the mean correct TIMI frame count between the thrombolysis and primary PTCA with stent groups. There were no significant differences in the mean corrected TIMI frame count between these two groups in the nonculprit coronary artery, either early after intervention or at 18-36 hours. In successfully reperfused coronary arteries following acute ST segment elevation myocardial infarction, primary angioplasty with stent implantation reestablished TIMI grade 2 or 3 flow faster and more effectively than thrombolysis did.