Primary Outcome Parameter Research Articles

On the Association between Dental Implants, Osteoporosis and Bone Modulating Therapy

Background: Osteoporosis affects bone metabolism and may result in fragility fractures. Medications include bone modulating therapy (BMT), which come with the risk of osteonecrosis of the jaws (ONJ). The literature is contradictory about the impact of osteoporosis and/or BMT on dental implant success and the incidence of ONJ. Purpose: The aim of the present study was to assess the effect of osteoporosis and BMT on early implant failure (EIF) and ONJ incidence (primary outcome parameters) following dental implant placement. Materials and Methods: Retrospective, cohort study based on dental records. Implant-supported prostheses (ISP) were delivered by experienced oral and maxillofacial surgeons and prosthodontists. Inclusion criteria: diagnosis of osteoporosis, delivery of ISP, consecutive individuals, and available data. Confounding variables included—age, gender, smoking status, BMT, bone grafting, and implant length/diameter. Results: There were a total of 72 osteoporosis patients, 46 using and 26 not using BMT. There were a total of 279 inserted implants, 154 in those using and 124 in those not using BMT. Univariate analysis of factors that may affect EIF showed no statistically significant differences between non-osteoporotic, osteoporotic using BMT, and osteoporotic patients not using BMT regarding EIF and ONJ incidence following dental implant delivery. Multivariate model using logistic regression demonstrated one factor associated with increased risk for EIF—bone augmentation. No cases of ONJ were reported up to one year post ISP delivery in any group. Conclusions: Within the limitations of the present study, it can be concluded that installing dental implants in osteoporotic patients, treated or not with BMT, is a safe procedure with EIF comparable to non-osteoporotic patients. The short-term risk for ONJ following dental implant insertion in osteoporotic (even when using BMT) patients is negligible.

Endoscopic therapy replaces surgery for clinical T1 oesophageal cancer in the Netherlands: a nationwide population-based study

BackgroundEndoscopic resection for early oesophageal cancer was introduced around 2000 in the Netherlands. The scientific question was how the treatment and survival of early oesophageal and gastro-oesophageal junction cancer has changed over time in the Netherlands.MethodsData were obtained from the nationwide population-based Netherlands Cancer Registry. All patients diagnosed with clinical in situ or T1 oesophageal or GOJ cancer without lymph node or distance metastasis during the study period (2000–2014) were extracted. Primary outcome parameters were the trends in treatment modalities over time and relative survival of each treatment regime.ResultsA total of 1020 patients were diagnosed with a clinical in situ or T1 oesophageal or gastro-oesophageal junction cancer without lymph node or distance metastasis. The proportion of patients who received endoscopic treatment increased from 2.5% in 2000 to 58.1% in 2014. During the same period the proportion of patients who received surgery decreased from 57.5 to 23.1%. Five-year relative survival of all patients was 69%. Five-year relative survival after endoscopic therapy was 83% and after surgery 80%. Relative excess risk analyses showed no significant difference in survival between patients in the endoscopic therapy group and patients in the surgery group after adjustment for age, sex, clinical TNM classification, morphology and tumour location (RER 1.15; CI 0.76–1.75; p 0.76).ConclusionOur results demonstrate an increase in endoscopic treatment and a decrease of surgical treatment for in situ and T1 oesophageal/GOJ cancer between 2000–2014 in the Netherlands. The relative 5-year survival after endoscopic treatment is high (83%) and comparable with surgery (80%).

Membrane oxygenator longevity was higher in argatroban-treated patients undergoing vvECMO.

In severe acute respiratory distress syndrome (ARDS), venovenous extracorporeal membrane oxygenation (vvECMO) can be a lifesaver. However, anticoagulation therapy is mandatory because the nonendothelial extracorporeal surface increases the risk of thromboembolic problems. Heparin is still the most common anticoagulant, but argatroban could be an alternative. This work investigates whether argatroban offers a therapeutic advantage over heparin during vvECMO. We performed a retrospective cohort study of patients who underwent vvECMO for severe ARDS and received heparin or argatroban as anticoagulation therapy. Demographic variables, intensivecareunit(ICU) treatment and outcome parameters were evaluated. The primary outcome parameter was the operating time of the membrane oxygenator normalized to the duration of vvECMO treatment. Secondary outcome parameters were transfusion requirements normalized to the duration of vvECMO therapy. Fifty seven patients from January 2019 to February 2021 underwent vvECMO and were included in this study. Thirty three patients received heparin and 24 patients argatroban as anticoagulatory therapy. The groups did not differ in demographics, ICU scoring systems, or comorbidities. Platelet counts and partial prothrombin time did not differ between the two groups during the first 6 days of vvECMO. The argatroban group had lower requirements for red blood cells, platelets and fresh frozen plasma. The mean runtime of the individual membrane oxygenator increased from 12.3 days (heparin group) to 16.6 days in the argatroban group. Our findings suggest that argatroban can be considered as anticoagulant during vvECMO.

Tocilizumab in Combination with Corticosteroids in COVID-19 Pneumonia: A Single-Centre Retrospective Controlled Study.

Introduction: Interleukin 6 receptor inhibition by tocilizumab (TCZ) has been effectively used worldwide for the treatment of multisystem inflammatory syndrome (MIS) associated with COVID-19. In this single centre study, we compared the outcome of COVID-19 pneumonia in TCZ-treated vs. untreated (control) patients. We wished to compare TCZ administration in the general ward vs. in the intensive care unit (ICU). We also studied the role of a consulting rheumatologist in the management of severe COVID-19 pneumonia. Patients and methods: In our patients, COVID-19 pneumonia was confirmed by SARS-CoV-2 PCR, chest X-ray, and CT. We compared patients selected for TCZ treatment with TCZ-untreated age- and sex-matched controls. All patients received corticosteroids. In the TCZ-treated group, patients received one or two doses of TCZ 8 mg/kg IV in combination with corticosteroids. We recorded age, sex, symptom duration, oxygen saturation (SaO2), partial arterial oxygen pressure (PaO2), total white blood cell (WBC), absolute neutrophil, absolute lymphocyte and platelet counts, CRP, ferritin, IL-6, LDH, procalcitonin (PCT), and D-dimer. The primary outcome parameters were the need for ICU, ventilation, death, and time of hospitalisation. Results: Altogether, 104 patients, 52 TCZ-treated and 52 TCZ-untreated, were included in this study. At baseline, the TCZ-treated patient group indeed had more pronounced COVID-19-related MIS compared to controls. Consultation with a rheumatologist was performed in 60% vs. 40% of cases. Nineteen patients (37%) received one, while 33 (63%) received two TCZ doses. TCZ was administered to 28 patients (54%) in the general ward and to 24 (46%) in the ICU. TCZ treatment was found to be safe in our COVID-19 pneumonia patients. TCZ treatment favourably influenced MIS biomarkers, and was associated with better clinical outcomes compared to controls. Patients receiving TCZ treatment in combination with corticosteroids already in the general ward exerted much better outcomes than those treated in the ICU. Consultation with a rheumatologist also improved outcome. Conclusions: We successfully used TCZ in combination with corticosteroids in Hungarian COVID-19 pneumonia patients. We pointed out the importance of early treatment already in the general ward, and the involvement of a rheumatologist in making treatment decisions.

The Outcomes of Flexor Tendon Injury Repair of the Hand: A Clinico-Epidemiological Study.

Background and objective The incidence of flexor tendon injury is estimated to be 7-14 per 100,000 population. In India, such injuries are common and about 5% of these injuries require repair of the flexor tendon. In the present study, we share our experience of hand flexor tendon repair at a tertiary care center in western India. Material and methods Over a period of three years, 45 patients were admitted for tendon repair. After performing a proper evaluation, patients were taken for tendon repair. Primary outcome and secondary outcome parameters were assessed at the end of three months. Physiotherapy was continued for a longer duration in patients with movement restrictions. Data were compiled at each stage. Results The mean age of the patients was 28.84 years (range: 13-68 years) with a majority of the cases belonging to the age group 15-60 years. The majority of hand injuries were accidental (caused by work-related accidents, machine injuries, or animal bites) amounting to 80% (n=36), followed by assault cases (11%, n=5) andself-inflicted injuries, i.e., attempted suicides (around 9%, n=4). Among all injuries, the majority were in zone V (60%, n=27) followed by 24.4% (n=11) of cases in zone II. A few cases were in zone I, III, and IV (2.2%, 11.2%, and 2.2% respectively). The Buck-Gramcko scoring for primary injury was excellent with a recovery rate of 57.78%. Conclusion Flexor tendon injuries should be repaired with the aim of recovering strength as well as mobility. Foroptimal outcomes, total active motion protocol should be commenced immediately after the surgical repair. However, long-term physiotherapy may be required for attaining desired benefits.

Comparison of efficacy of needle-free injection versus injection by needle for iron supplementation of piglets: a double blind randomized controlled trial

BackgroundIn pig husbandry, most piglets receive an intramuscular injection with iron around three days of age for the prevention of hypochromic, microcytic anaemia. In recent years an increased interest is noted for needle-free injections, because of efficiency and safety for man and animal. This study aims to support the evidence on efficacy to extent the registration of a commercial iron supplement with a needle-free administration application. To this aim the study has two objectives: 1) to determine the effect of needle-free injection of the iron supplement on the mean blood Haemoglobin level at weaning, as primary outcome, and mean Haematocrit and mean Body weight of pigs at weaning as secondary outcome compared to no treatment, as main determinant of iron deficiency anaemia in piglets at time of weaning; 2) to compare the effects of needle-free administration of the iron supplement with regular injection by needle, with regard to the course over time of Haemoglobin, Haematocrit, piglet growth and the differentiated haematological and serum iron parameters.MethodsA double blind randomized controlled trial was conducted with 72 piglets, 8 piglets per litter from 9 litters. At three days of age pigs were selected, based on body weight, and random allocated to three study groups: a) control non-treated group (2 pigs per litter, 18 in total), b) a group with regular iron injection by needle injection (3 pigs per litter, 27 in total), c) a group that received iron by needle-free injection (3 pigs per litter, 27 in total). At four points in time (day 3, 14, 26 and 40) piglets were weighed and bled to analyse the dynamics of red blood counts and haematological parameters as well as serum iron parameters. The primary outcome parameter was the Haemoglobin (Hb) level on day 26. Of secondary importance were Haematocrit (Ht) and body weight (BW) at weaning and parameters with tertiary importance were the course of Hb, Ht and differentiated red blood cell parameters, serum iron, iron binding capacity and iron saturation. In the statistical analyses, linear mixed effect regression modelling was used to account for repeated measures within litters and pigs.ResultsThe analyses showed that needle-free administration was as efficacious to prevent iron deficiency anaemia at day 26 as administration using regular needle injection, compared to the control group. The mean level of Hb and Ht of pigs in the needle and needle-free group did not differ significantly. No side effects were observed.ConclusionIt is concluded that needle-free iron administration of the tested product is as efficacious as regular administration by needle injection.

Treatment of unresectable stage III NSCLC: Real world cohort study and literature review

IntroductionUntil recently, the treatment for patients with locally advanced unresectable stage III non-small cell lung cancer (NSCLC) was combined chemoradiotherapy (CRT), delivered either concurrently (cCRT) or sequentially (sCRT). There is limited data on the outcomes and safety of CRT in a real-world setting. We conducted a real-world cohort analysis of our Leuven Lung Cancer Group (LLCG) experience with CRT for unresectable stage III NSCLC, prior to the era of consolidation treatment with immunotherapy. Patients and MethodsIn this observational, real-world monocentric cohort study, a total of 163 consecutive patients were included. They were diagnosed with unresectable stage III primary NSCLC and treated with CRT between January 1st, 2011, and December 31st, 2018. Patient and tumor characteristics, treatment patterns, toxicity, and primary outcome parameters such as PFS, OS and pattern of relapse were captured. ResultsCRT was concurrent in 108 patients, sequential in 55. Overall tolerability was good, with two thirds of patients without severe adverse events such as severe febrile neutropenia, ≥ grade 2 pneumonitis, or ≥ grade 3 esophagitis. All registered adverse events were more frequent in the cCRT group compared to the sCRT group. Median PFS was 13.2 months (95% CI 10.3–16.2), median OS was 23.3 months (95% CI 18.3–28.0), with a 47.5% survival rate at 2 years, and 29.4% at five years. Conclusions: This study provides a clinically relevant benchmark on the outcomes and toxicity of concurrent and sequential chemoradiotherapy in unresectable stage III NSCLC in a real-world setting in the pre-PACIFIC era.

Efficacy of Apnoeic Oxygenation by Nasal Prongs in Preventing Desaturation during Airway Management in Infants Undergoing General Anaesthesia: A Randomised Controlled Study

Introduction: Neonates and infants are more prone to desaturation during the apnoeic period of laryngoscopy and intubation. Various options exist to reduce this risk beyond conventional preoxygenation. Aim: To assess whether continuous apnoeic oxygenation via nasal prongs during intubation can extend the safe apnoea period compared to standard management with preoxygenation alone. Materials and Methods: A randomised controlled, two-group parallel clinical study was conducted at the Department of Anaesthesiology, Vijayanagar Institute of Medical Sciences, Ballari, Karnataka, India, from July 2019 to November 2020. The study involved 63 infants aged one day to six months undergoing elective or emergency surgeries under general anaesthesia. Preoxygenation via a mask was followed by sevoflurane induction and vecuronium-induced muscle relaxation. Conventional laryngoscopy and intubation were performed in 32 infants in Group-C (Control group), while 31 infants in Group-O (Apnoeic Oxygenation group) also received oxygen (O2 ) via nasal prongs at 4 L/min in addition to preoxygenation. The primary outcome parameter was the time taken for desaturation by 1%. The time taken to desaturate by 2%, 3%, 4%, and 5%, as well as their incidences, lowest observed saturation, safe apnoea period, and Heart Rate (HR) trends, were also noted. Data were analysed using Statistical Package for Social Sciences (SPSS) version 20.0 and OpenEpi version 3.01. Results: Demographic and clinical parameters were comparable between the groups. The mean time for 1% desaturation was 18.33±4.3 seconds in Group-C, while all Group-O cases maintained 100% saturation during the study period. No significant difference was found in the safe apnoea period between the groups (p=0.503). The average lowest O2 saturation observed in Group-C was 98.81±1.28%, while it was 100% in Group-O. Only one infant in Group-C showed desaturation down to 95%. Both groups exhibited similar HR trends. Conclusion: Apnoeic oxygenation by nasal prongs in healthy infants helps prolong the time to desaturation and can be beneficial for those at risk of desaturation and hypoxia.

PSMA-RLT in Patients with Metastatic Hormone-Sensitive Prostate Cancer: A Retrospective Study

Prostate-specific membrane antigen (PSMA)-directed radioligand therapy (RLT) is a novel treatment for patients with castration-resistant prostate cancer (CRPC). Given the mode of action, patients in an earlier disease stage, such as hormone-sensitive prostate cancer (HSPC), are also likely to benefit from [177Lu]Lu-PSMA- (177Lu-PSMA) or [225Ac]Ac-PSMA-radioligand treatment (225Ac-PSMA). In this retrospective study, we analyzed the safety and efficacy of PSMA-RLT in early-stage and hormone-sensitive metastatic prostate cancer patients. A retrospective study was performed in patients who received 177Lu-PSMA and/or 225Ac-PSMA with early-stage metastatic prostate cancer. The primary outcome parameter evaluated in this study was the progression-free survival (PFS) after PSMA-RLT and toxicity according to the Common Terminology Criteria for Adverse Events. Secondary outcome parameters were prostate-specific antigen (PSA) response and the date of onset of CRPC state. In total, 20 patients were included of which 18 patients received 177Lu-PSMA radioligand and two patients received tandem treatment with both 177Lu-PSMA and 225Ac-PSMA radioligands. Patients received a median of 2 treatment cycles (range 1-6) and a median activity of 6.2 GBq 177Lu-PSMA per cycle (interquartile range (IQR) 5.2-7.4 GBq). PSMA-RLT was overall well-tolerated. The most common grade 1-2 side effects were xerostomia (n = 6) and fatigue (n = 8), which were only temporarily reported. One patient that received 225Ac-PSMA developed grade 3-4 bone marrow toxicity. The median PFS was 12 months (95% confidence interval (CI), 4.09-19.9 months). Seventeen (85%) patients had a ≥50% PSA response following PSMA-RLT. One patient developed CRPC 9 months following PSMA-RLT. In this small cohort study, PSMA-RLT appeared safe and showed encouraging efficacy for (metastasized) early-stage and hormone-sensitive prostate cancer patients. Prospective studies are awaited and should include long-term follow-up.

A mobile-based aftercare intervention to increase self-esteem in inpatients diagnosed with depression: A randomized controlled trial

Objective In this randomized controlled trial, we investigated the effectiveness, side effects and user satisfaction of the self-help smartphone app “MCT & More” among inpatients with a diagnosis of depression after their discharge from a psychiatric hospital over a period of 4 weeks. Methods A total of 159 inpatients were recruited in four German psychiatric hospitals three days before hospital discharge (intervention group: n = 79; treatment as usual: n = 80). Based on the vulnerability model (low self-esteem contributes to depression), self-esteem represented the primary outcome, quality of life and depressive symptoms the secondary outcomes. Results Intention-to-treat analyzes showed no statistical significance for the primary and secondary outcome parameters, except for the subscale self-competence in favor of the intervention group (with a small effect size of d = 0.35), in the context of an exploratory approach (post hoc). The more positive the attitude toward mobile-based interventions and the more positive the treatment expectations, the more frequently the app was used (r = .35, p = .008; r = .34, p = .009). Conclusion Further symptom reduction could not be obtained. However, the results suggest that an effect on improvement in self-competence could be achieved by low-threshold aftercare programs. Future studies should include long-term assessments to examine the impact of mobile-based aftercare on relapse. Trial registration: DRKS00022559.

Noninvasive continuous hemoglobin monitoring of blood transfusion in obstetric procedures

ABSTRACT Background Non-invasive Hb (SpHb) may allow for a faster detection of clinically important blood loss, improve perioperative transfusion practices significantly and enable a faster evaluation of a patient’s condition and a better blood treatment and may even reduce needless transfusions. This study determined the accuracy of continuous SpHb monitoring as a guide for fluid and blood transfusion practice using Masimo pulse co-oximetry in comparison with invasive Hb during elective cesarean section (CS). Methods This prospective cohort study was carried out on 60 pregnant women candidates for elective CS under general anesthesia. Participants were multigravida, aged between 18 and 45 years and carry a singleton fetus with ASA I–II. All had antepartum hemorrhage and were candidates for blood transfusion. Pre-induction of anesthesia (basal), pre-transfusion and post-transfusion SpHb and invasive Hb were assessed. The primary outcome parameter was the correlation between SpHb and invasive hemoglobin (Hb). Results There was a significant positive correlation between SpHb and Invasive Hb in baseline, pretransfusion and posttransfusion (r = 0.946, 0.902 and 0.698, respectively). Bland–Altman analysis between SpHb and invasive Hb reported low bias with moderate limits of agreement at baseline, pre-transfusion and post-transfusion [mean bias (limits of agreement): 0.348 (−0.584 and 1.280) g/dl, 0.314 (−0.561 and 1.188) g/dl and 0.348 (−0.584 and 1.280) g/dl, respectively] Conclusions In patients undergoing CS with antepartum hemorrhage, continuous SpHb through Masimo pulse co–oximetry demonstrated clinically acceptable accuracy of Hb measurement compared with Invasive Hb, even at low hemoglobin levels.

Thoracic aortic vascular graft infection: outcome after conservative treatment without graft removal.

Surgical debridement with aortic graft removal is considered the preferred treatment for thoracic aortic vascular graft infection (VGI). Conservative treatment with antibiotics only is usually reserved for inoperable patients. Due to Outpatient Parenteral Antimicrobial Therapy (OPAT) and better understanding of the antibiotic impact on biofilms, long-term targeted antibiotic therapy without graft removal may be an alternative treatment option for selected thoracic aortic VGI patients. The aim of this case series was to evaluate the outcome in patients with thoracic aortic VGI who were treated without graft removal. This single-centre retrospective cohort study evaluated patients with a thoracic aortic VGI diagnosed between 2008 and 2021 and who were treated without graft removal. The primary outcome parameter was the 6-month mortality rate after VGI diagnosis. Secondary outcome parameters were cure rates and relapse of infection. Twenty-four patients with thoracic aortic VGI who were managed without graft removal were identified. The mortality rate 6 months after VGI diagnosis was 8% (2/24); one of these deaths was infection related. The median antibiotic treatment duration was 13 months (interquartile range 15). A total of 16 patients (67%) were cured. No relapses occurred after a median of 24-month (interquartile range 32) follow-up. Intensive antibiotic treatment, without graft removal, may be a non-inferior option in patients with a thoracic aortic VGI who are not considered for surgery.

Retrospective evaluation of radiological and clinical outcomes after surgical treatment of proximal femur fractures utilizing TFNA

IntroductionThe aim of this study was to evaluate the clinical and radiological outcomes of patients treated with the TFN-Advanced™ Proximal Femoral Nailing system (TFNA¸ DePuy Synthes, West Chester, PA) including intra- and postoperative complications.Materials and methodsAll patients with an acute proximal femur fracture consequently treated with a TFNA between September 2014 and December 2018 were evaluated. Clinical and radiological data were assessed for intra- and postoperative complications, including treatment failure. In addition, intra- and postoperative X-rays were used to determine the position of the implant, and any migration, via tip-apex-distance (TAD) and the caput-collum-diaphyseal angle (CCD). The accuracy of the fracture reduction was rated by both observers according to Baumgartners criteria.Results275 consecutive patients (mean age 77.5 ± 14.1; 70.2% female) were included. The predominant OTA/AO fracture classification was 31A2 (140 cases, 50.7%). The average surgical time was 69 min (± 39.8). The reduction quality was good in 253 cases (92.0%) and acceptable in 22 cases (8.0%). In 18 cases, a pre-defined primary outcome parameter (6.5%) was recorded after a mean of 8.2 ± 8.0 months. During the observational period, 19 patients (6.9%) required a total of 23 additional surgeries. Implant removal was not considered a failure in the absence of pain. Significant group differences were observed with younger age (p = 0.001), lower Charlson Comorbidity Index (CCI)-score (p = 0.041) and lower rate of osteoporosis (p = 0.015) in the failure group. There were no cases of cut-out or cut-through among the patients who underwent augmentation as part of osteosynthesis.ConclusionsProximal femur fractures treated with the TFNA show low complication rates and high levels of radiological healing. Implant-related complications might be more common in patients with younger age, a lower CCI-score and lower frequency of osteoporosis. Usage of cement augmentation could potentially be beneficial to reduce postoperative cut-through and cut-out.

Pupillometry pain index during day care anesthesia using remifentanil: comparison of perioperative analgesic consumption in a double blind RCT

Background: Communication is impossible in sedated patients. Nowadays there is no single best technology to measure nociception during anesthesia. Objectives: The primary outcome parameter was the postoperative pain intensity queried as pain intensity by numeric rating scale and the amount of pain killer usage. Our hypothesis was that patients with a good titrated remifentanil administration peroperative should have less pain and less need of pain medication. Secondary outcome parameters were the characteristics of the pupillometry introducing a pupillometry pain index chart to individual titrate remifentanil dosage. Tertiary outcome parameters were nausea and vomiting, length of stay at the post anesthesia care unit and health state index. Design and setting: In a single center double blind randomized controlled trial we evaluated if pupillometry controlled use of remifentanil is better than free choice administration of remifentanil by anesthesiologists. Fifty-five patients undergoing elective day care surgery were enrolled. A pupillometry pain index score chart was introduced for remifentanil administration guidance. Methods: After induction, a first pupillary reflex dilation (PRD) measurement was performed using pupillometry. A second identical evaluation was performed six minutes after remifentanil administration and adapted every 10 minutes. Remifentanil dosage was adjusted following the pupillometry pain index score (intervention group) or by the discretion of the anesthesiologist (control group). Results: No statistically significant difference was found in pain intensity and pain killer usage at postoperative day one. The pupillometry pain index chart was usable. Although both groups received 0.21 mcg kg-1 min-1 remifentanil. No Statistically significant difference in opioïd induced side effects, nor health state index was seen. Conclusion: This study showed no additional value for PRD assessment in response to remifentanil administration during daycare procedures with our protocol to titrate remifentanil. A pupillometry pain index score chart could be implemented. Further research to lower the remifentanil administration within this protocol is needed. (Ethics Committee EC17/28/319 of the University Hospital of Antwerp. Registration at clinicaltrials.gov NCT03248908.)

Silver-coated versus uncoated locking plates in subjects with fractures of the distal tibia: a randomized, subject and observer-blinded, multi-center non-inferiority study

BackgroundAntimicrobial coatings of implants are of interest to reduce infection rate in orthopedic surgery. Demonstration of clinical effectiveness of such coated implants to obtain market approval is challenging. The objective of this article is to define a design for a randomized controlled trial to evaluate the clinical performance of a silver-coating for locking plates for fracture treatment.MethodsThe study design has to respect different criteria, such as feasibility, focus on overall complications, such as functional impairment, fracture healing, and particularly on infection rates. Distal tibia fractures were chosen due to the high prevalence of infections in this type of injuries, which warrants a particular benefit of antimicrobial prophylaxis and thus might allow to see a statistical trend in favor of the coated product. The study design was defined as a randomized, controlled, subject and observer-blinded, multi-center study in subjects with fractures of the distal tibia with a total of 226 patients. A number of 113 patients are planned for each of the two treatment arms with treatment of the fracture with a silver-coated device (first arm) or with an uncoated device (second arm). Inclusion criteria are closed fractures of the distal tibia according to the Tscherne-Oestern classification or open fractures of the distal tibia according to the Gustilo-Anderson classification in subjects older than 18 years. Primary outcome parameter is the Anticipated Adverse Device Effects (AADE) including all typical complications of this type of injury, such as functional impairment of the affected limb, non-union, and infections based on a non-inferiority study design. Also, silver-typical complications, such as argyria, are included. Secondary parameters are infection rates and fracture healing. Follow-up of patients includes five visits with clinical and X-ray evaluations with a follow-up time of 12 months.DiscussionDemonstration of clinical effectiveness of antimicrobial coatings of fracture fixation devices remains a challenge. Definition of a prospective randomized pre-market trial design and recruitment of clinical sites for such a study is possible. A confirmative proof of the expected clinical benefit in terms of reduction of device-related infections will be addressed with a prospective post-market clinical follow-up study in a second step due to the large sample size required.Trial registrationClinicalTrials.gov NCT05260463. Registered on 02 March 2022.

Comparison of immediate changes of repolarization parameters after left bundle branch area pacing and traditional biventricular pacing in heart failure patients.

Comparison of immediate changes of repolarization parameters after left bundle branch area pacing and traditional biventricular pacing in heart failure patients.

Exploring experiences and health-related quality of life of caregivers of patients who start home dialysis: study protocol for a prospective, multicentre cohort study

IntroductionStarting dialysis not only has a major impact on the life of patients but also on their informal caregivers. Previous research shows greater burden and lower quality of life among...

Short-term outcomes of Ivor Lewis vs. McKeown esophagectomy: A meta-analysis

The objective of this article is to assess the rate of anastomotic leak and other perioperative outcomes in patients undergoing esophagectomy with either thoracic or cervical anastomosis. This meta-analysis was conducted by searching relevant literature studies in Web of Science, Cochrane Library, PubMed, and Embase databases. Articles that included patients undergoing esophagectomy and compared perioperative outcomes of McKeown with Ivor Lewis procedures were included. The primary outcome parameter was anastomotic leak, and secondary outcome parameters were grade ≥2 anastomotic leak, chylothorax, recurrent laryngeal nerve injury, hospital length of stay, intensive care unit (ICU) length of stay, postoperative mortality rate, operative time, blood loss, R0 resection rate, and lymph nodes examined. A total of eight studies, with 3,291 patients (1,857 Ivor Lewis procedure and 1,434 McKeown procedure) were eligible for analysis. Meta-analysis showed that Ivor Lewis procedure was associated with lower rate of anastomosis leak of all grades [risk ratio (RR), 0.67; 95% confidence interval (CI), 0.55-0.82; P = 0.0001], lower rate of recurrent laryngeal nerve injury (RR, 0.14; 95% CI, 0.08-0.25), and shorter length of hospital stay (weighted mean difference, 0.13; 95% CI, 0.04-0.22). Grade ≥2 anastomotic leak, chylothorax, ICU length of stay, postoperative mortality rate, operative time, blood loss, R0 resection rate, and lymph nodes examined were similar between the two groups. Although all grades of anastomotic leak and recurrent laryngeal nerve injury are higher in the McKeown procedure, this meta-analysis supports similar short-term outcomes and oncological efficacy between Ivor Lewis and McKeown esophagectomy.

Introduction of a modified Degan classification to specify treatment algorithms in fractures of the anterior process of the calcaneus

BackgroundFractures of the anterior process of the calcaneus are often missed, and their treatments and results receive little attention in the current literature. The aim of this study was to specify treatment algorithms through a modification of the Degan classification.MethodsBetween 2009 and 2019, patients with APC fractures were retrospectively analyzed. The Degan classification was used and modified. Type III fractures were further divided into subgroups A (not displaced) and B (displaced). The type of treatment and complications were recorded. Return to work and posttraumatic osteoarthritis were determined as primary and secondary outcome parameters, respectively.ResultsForty-one patients with 43 fractures were included. Follow-up averaged 35,5 months (range 1,5–152 months). Fractures were eight type I, six type II, 15 type IIIA and 14 type IIIB. The fracture was initially recognized in 29 (70,7%) patients, and missed in 12 (29,3%) patients, respectively. Overall, the delayed diagnosed fractures had a significantly higher complication rate (p < 0,000) than the initially diagnosed fractures and received surgical treatment significantly (p < 0,009) more often.After surgical treatment of 13 type IIIB, one nonunion occurred. Six missed type IIIA fractures were treated surgically after delayed diagnosis because of persistent symptoms. Two type I fractures required arthrodesis of the Chopart joint. Four patients did not return to work during the follow-up (3 missed type IIIA fractures, 1 type II fracture).ConclusionMissed APC type IIIA fractures are at risk to develop complications, which is why computed tomography diagnostics should be performed if there is any clinical suspicion.

CORRELATION BETWEEN RED BLOOD CELL DISTRIBUTION WIDTH-TO-PLATELET RATIO AND MORTALITY IN PATIENTS WITH ACUTE RESPIRATORY DISTRESS SYNDROME: A RETROSPECTIVE COHORT STUDY.

Background: This study aims to assess the prognostic value of red blood cell distribution width-to-platelet ratio (RPR) in acute respiratory distress syndrome (ARDS) patients. Methods: The data collected from 540 ARDS patients from 2001 to 2012 were obtained from the Medical Information Mart for Intensive Care III Database. The 28-day all-cause mortality risk was considered as the primary outcome parameter, and the secondary outcomes were 60- and 90-day all-cause mortality. The association between RPR (≥0.19 vs. <0.19) and mortality was assessed by Cox proportional hazards models, and potential nonlinear associations were assessed by restricted cubic spline regression analysis. Results: The 28-day all-cause mortality was 22.4%. Among the 121 deaths, 92 (20.0%) presented with an RPR <0.19, and 29 patients had RPR ≥0.19 ( P < 0.001). The 60- and 90-day all-cause mortality was 27% and 28.7%, respectively. After adjusting for the relevant factors in the multivariate model, RPR ≥0.19 was independently correlated with the 28-day all-cause mortality (hazard ratio, 2.74; 95% confidence interval, 1.46-5.15; P = 0.002). There was no nonlinear relationship between RPR and the risk of 28-day all-cause mortality ( P for overall association <0.001, P for nonlinear = 0.635). Similar results were observed for both the pneumonia and nonpneumonia subgroups and sensitivity analyses. Conclusions: The data promote the use of RPR as a valuable prognostic indicator for ARDS patients.