Primary Outcome Parameter Research Articles

Neurodegeneration is highly associated with comorbidity burden in HFrEF patients

Abstract Background Heart failure (HF) is associated with cognitive decline and risk for dementia. Blood levels of amyloid beta 40 and 42 (Aβ40, Aβ42), tau protein (tau), and neurofilament light chain (NfL) have been found to be altered in neurodegenerative disease. Previous research has established a clear association between these neuromarkers and the risk of developing cognitive dysfunction and mortality in the general population. Objective The aim of this study was to investigate the association between the respective neuromarkers and comorbidity burden, as well as to explore whether comorbidity burden impacts the relationship between neuromarkers and outcome in HF patients. Methods Plasma levels of Aβ40, Aβ42, tau, and NfL were quantified using a single-molecule array assay. The primary outcome parameter was all-cause mortality. Results A total of 470 HFrEF patients were enrolled in the study, with a median age of 62 years (IQR: 52–72); 77% were male. Median NT-proBNP concentration was 1812 pg/ml (IQR: 718–3881). Elevated levels of all biomarkers were closely associated with comorbidity burden (Figure 1). All neuromarkers showed increased levels in individuals with chronic kidney disease (CKD) and known carotid artery stenosis (CAS), except for Aβ40, which did not show significant elevation in CAS (NfL: p<0.001 for both; t-tau: p<0.001 and p=0.041; Aβ40: p<0.001 and p=0.050; Aβ42: p<0.001 and p=0.033, respectively). In patients with type 2 diabetes mellitus (T2DM) and coronary artery disease (CAD), only NfL levels were significantly elevated (p<0.001 for both), whereas atrial fibrillation (AF) was associated with higher levels of NfL and t-tau (p<0.001 for both). In individuals with iron deficiency, only Aβ42 levels were significantly higher (p=0.025). All biomarkers showed significant associations with all-cause mortality [crude HR for an increase in 1-log unit (95%CI): NfL 4.44 (3.02-6.53), t-tau 5.04 (2.97-8.58), Aβ40 3.90 (2.27-6.72), Aβ42 5.14 (2.84-9.32); p<0.001 for all] (Figure 2). These associations remained statistically significant after adjusting for comorbidity burden including AF, T2DM, CAD, CKD, CAS and ID [adjusted HR for an increase in 1-log unit (95%CI): NfL 3.28 (1.93-5.57), t-tau 3.96 (2.07-7.57), Aβ40 2.42 (1.34-4.38), Aβ42 3.05 (1.56-5.97); p<0.01 for all]. Conclusion The findings suggest a close connection between elevated levels of markers of neurodegeneration and increased comorbidity burden in HFrEF patients. While this association may indicate the cumulative risk leading to neuronal injury and HFrEF progression, a causal relationship cannot be excluded. The observed accelerated neurodegeneration in HFrEF underscores the need for further investigation into this complex interplay.Figure 1Figure 2

Angiotensin receptor-neprilysin inhibition and improved ventricular-arterial coupling in heart failure with reduced ejection fraction.

Sacubitril/valsartan improves outcome in chronic heart failure (HF) with reduced ejection fraction (EF). The underlying mechanisms on left ventricular (LV) myocardial function are incompletely understood. In this study, 117 patients with symptomatic HF and LV-EF ≤ 40% were enrolled prospectively. Non-invasive pressure-volume analysis was calculated from transthoracic echocardiography with simultaneous arm-cuff blood pressure measurements. Primary outcome parameters were LV end-systolic elastance (Ees; a measure of LV contractility), effective arterial elastance (Ea; a measure of afterload), and the ventricular-arterial coupling ratio (Ea/Ees). Mean age was 65±13 years, 30% were female, and 54.7% had ischemic heart disease. During six months of follow-up, eight patients died, three withdrew their consent, and four were lost to follow-up. 102 patients were included in pressure-volume analyses. After six months of sacubitril/valsartan treatment, Ees increased (0.66mmHg/ml [IQR 0.45-0.94] vs. 0.78mmHg/ml [IQR 0.57-1.10], p=0.001), Ea decreased (1.76mmHg/ml [IQR 1.48-2.13] vs. 1.62mmHg/ml [IQR 1.36-1.96], p=0.014), and the Ea/Ees ratio improved (2.52 [IQR 1.88-4.05] vs. 1.93 [IQR 1.50-2.63], p<0.001). LV end-diastolic pressure and LV volumes were reduced, and LVEF increased from 33% to 43% (both p<0.001). Clinical improvement occurred in NYHA functional class, NT-proBNP level, and 6-minute walking distance. Change in LVEF correlated with change in Ees (r=0.33, p=0.0008), while change in NT-proBNP was associated with change in LVEDP (r=0.42, p<0.0001). In conclusion, sacubitril/valsartan is associated with improved ventricular-arterial coupling by enhancing LV contractility and reducing afterload. Beyond LV reverse remodeling, optimized ventricular-arterial interaction may contribute to the favorable outcome of sacubitril/valsartan treatment in HF with reduced EF.

Accuracy of Zygomatic Implant Placement Using Task-Autonomous Robotic System or Dynamic Navigation: An InVitro Study.

To evaluate and compare the accuracy of task-autonomous robot-assisted implant surgery (RAIS) and dynamic computer-assisted implant surgery (dCAIS) for zygomatic implant placement. Ten atrophic edentulous maxilla models requiring zygomatic implant (ZI) placement were randomly divided into the RAIS and dCAIS groups. Osteotomies and implant placement were performed under the guidance of a task-autonomous robotic system or dynamic navigation system. A total of 20 ZIs were analyzed. The angular, coronal, lateral coronal, coronal depth, apical, lateral apical, and apical depth deviations were measured and analyzed between the two groups. The primary outcome parameters were the angular deviations between the planned and the placed ZIs. Data was subjected to descriptive and comparative statistical analysis. The significance of inter-group differences for continuous variables was assessed with Student's two-sample t-tests, Welch two-sample t-tests, and Mann-Whitney U tests according to the distribution normality and variance homogeneity. ZI placement deviations were compared between the RAIS and dCAIS groups, showing a mean angular deviation of 0.92 ± 0.40° versus 2.03 ± 0.53° (p < 0.001), a mean (±SD) coronal deviation of 0.48 ± 0.25 mm versus 1.29 ± 0.46 mm (p < 0.001), and a mean apical deviation of 0.88 ± 0.28 mm versus 1.96 ± 0.46 mm (p < 0.001). For computer-guided ZI placement, task-autonomous RAIS was superior to dCAIS in terms of accuracy.

Characteristics and outcomes of inpatients aged 85 and older with thoracolumbar vertebral fractures: impact on hospital stay and mortality.

There is a gap in evidence about medical outcomes in oldest-old patients (aged 85 and older) with vertebral fractures (VFs). The aim of this study was to evaluate the impact of patient and fracture characteristics on "short-term" hospital outcomes. All patients aged ≥ 85 presenting an acute or subsequent VF at our single level I spine center between 2019 and 2021 requiring hospital treatment were included. The data collection was conducted retrospectively. The primary parameters of interest were length of stay (LOS) and in-hospital mortality. Further outcome parameters were the occurrence of general (non-operative) complications and Intensive Care Unit (ICU) admission. For statistical analysis, linear and binary logistic regression modeling were performed. A total of 153 patients with an average age of 88.5 (range 85 to 99) met the inclusion criteria. Our patients were mostly female (68.6%) and moderately comorbid according to a Charlson Comorbidity Index (CCI) of 2.9. 58.8% had diagnosed osteoporosis. Fracture morphologies represented as "Osteoporotic Fracture" (OF) classification types were of central importance for undergoing operative treatment (OP) (p < 0.001), necessity for intensive care (p = 0.023), LOS (p = 0.014), and mortality (p = 0.018). 38.6% had OP. We recorded a complication rate of 59.5%, which highly influenced (p < 0.001) both primary outcome parameters. Overall, patients stayed 14.6 days with a mortality of 11.1%. VFs are a severe event in oldest-old patients with a crucial risk of poor medical outcomes during hospitalization. The fracture morphologies are of central importance. However, little is known about the hospital stay of oldest-old inpatients with VFs. Considering an aging population, further investigations would be recommended.

A Prospective Comparative study to assess the effect of modified del Nido versus standard del Nido on Myocardial protection in Adults

Objective. This comparative observational study aimed to assess the efficacy and safety of modified del Nido cardioplegia (MDN) prepared using Ringer Lactate [Group R] compared to the standard del Nido cardioplegia (SDN) with Plasmalyte–A [Group P] in adult patients undergoing cardiac surgery with cardioplegic arrest. Materials and Methods. A total of 88 patients were evaluated. The primary outcome of myocardial injury was measured by specific markers viz cardiac Troponin I (cTnI), Creatine Phosphokinase–MB (CPK–MB), and Coronary Sinus (CS) Lactate at various time points. Secondary outcomes were postoperative left ventricular ejection fraction, inotropic score, and duration of intensive care unit (ICU) stay. The differences in primary and secondary outcomes between the groups were measured and analysed. Results. Two primary outcome parameters showed significant differences between the two groups viz. the CS lactate levels measured immediately after the removal of the aortic cross–clamp (group–R 3.23 ± 1.07, group–P 2.58 ± 0.99, p–0.004) and troponin–I levels measured at 24 hours post–surgery (group–R 6.45 ± 4.89, group–P 4.64 ± 3.98, p–0.012). However other primary and secondary parameters did not exhibit significant differences between the two groups. Conclusion. Although there were no significant differences in the secondary outcome parameters, two of the primary outcome parameters associated with myocardial injury showed significant difference. Hence modified del Nido should be used with caution unless the safety is validated by large multi–centric RCTs.

Preoperative Embolization of Glomus Tumors: Role, Effectiveness, and Complications.

Purpose: Paragangliomas represent a surgical challenge due to their hypervascularization. The preoperative selective embolization of these tumors significantly decreases intraoperative blood loss. However, the literature on preoperative embolization in glomus tumors is limited. The aim of this study is to contribute additional evidence regarding the role of preoperative embolization, as well as to evaluate risks and complications in the treatment of glomus tumors. Methods: A retrospective evaluation of all the embolizations of glomus tumors from 2009 to 2023 was conducted. The primary outcome parameter was the rate of devascularization after embolization and the occurrence of significant perioperative hemorrhages. The secondary outcome was embolization-related complications. Results: Twenty-one embolizations in 20 patients were investigated in the study. In 43% of the cases more than 90% devascularization was achieved by embolization, while in the remaining cases, 80 to 90% devascularization was reached. In one case (5%), significant perioperative bleeding after embolization occurred. In one case (5%), a symptomatic complication occurred periinterventionally due to the brief dislocation of the coaxial and microcatheter into the internal carotid artery (ICA), which led to fresh punctate DWI lesions on the subsequent MRI. No patients developed nerve palsy following embolization. Conclusions: The preoperative embolization of glomus tumors can lead to significant tumor devascularization and a reduction in perioperative bleeding, with a low complication rate.

Simplifying the Orientation of S1 Iliosacral Screws for Placement in the Dysmorphic Sacrum.

Determining the proper iliosacral screw orientation in a dysmorphic S1 sacral segment using a C-arm is difficult, and pelvic computed tomography (CT) is often necessary for the preoperative planning. On the preoperative pelvic axial CT section, the intended screw trajectory can be delineated intraosseously along the axis of the oblique osseous corridor. An inherently accurate orientation would be determined by 2 factors: (1) the trajectory is in the pelvic transverse plane, and (2) it is oriented relative to the coronal plane at a patient-specific angle, which should be measured preoperatively. Based on the above reasoning, we aimed to simplify and verify the orientation. After establishing the starting point on the sacral lateral view, we tested a method of simplifying the guidewire orientation: placing the guidewire in the pelvic transverse plane and then manipulating it to be angled relative to the coronal plane at the preoperatively measured patient-specific angle. The guidewire orientation should then be reproducibly accurate on the pelvic outlet and inlet views. The feasibility and safety of our method were verified through computer-simulated virtual surgical procedures in 95 dysmorphic sacra and clinical surgical procedures in 12 patients. The primary outcome parameters were the guidewire orientation and screw placement accuracy. Using our method, the S1 guidewire orientation was reproducibly accurate on the pelvic outlet and inlet views in all of the virtual and clinical surgical procedures. Ninety-five virtual S1 screws (1 screw in each left hemipelvis) were placed intraosseously in the pelvic transverse plane. Fourteen unilateral S1 screws were placed intraosseously in the pelvic transverse plane in the 12 patients (2 patients had double screws) without iatrogenic injuries. The guidewire orientation can be simplified by placing the guidewire in the pelvic transverse plane and replicating the preoperatively measured patient-specific angle between the guidewire and the coronal plane. After establishing the starting point on the sacral lateral view, our simplified manipulation yields a reproducibly accurate orientation on the pelvic outlet and inlet views. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Prolonged Time to Diagnosis of Crohn’s Disease in Patients With Perianal Fistulas Negatively Affects Long-Term Outcomes

Abstract Background and Aim This study aims to evaluate the effect of time to Crohn’s disease (CD) diagnosis on perianal fistula (PAF) outcomes in patients with a fistula as the first manifesting sign. Methods In this multicenter, retrospective study, CD patients with a PAF preceding CD diagnosis between November 2015 and June 2022 were included. The primary outcome parameter was the time to CD diagnosis and its correlation with long-term outcomes. Results In total, 126 patients with a PAF prior to CD diagnosis were identified. The median time to CD diagnosis was 15.0 months (IQR 3.8-47.3). A total of 49 patients (38.9%) had a clinically closed fistula of which 21 patients (42.9%) achieved radiological healing. Twenty-five patients (19.8%) underwent defunctioning, of which 9 patients (36.0%) needed proctectomy. Median time to CD diagnosis was shortest in patients with radiological healing (4.0 months, IQR 2.0-16.5) or clinical closure without radiological healing (11.0 months, IQR 3.0-47.8). In patients without fistula closure (n = 51), the median time to CD diagnosis was significantly longer compared to patients with fistula closure, 18.0 months vs 8.0 months (p = 0.031). In patients who needed defunctioning, the median time to diagnosis was more than twice as long compared to patients without defunctioning, 30.0 months vs 12.0 months (p = 0.054). Conclusion A prolonged time to CD diagnosis in patients with a PAF as a manifesting sign is associated with worse long-term outcomes. Patients in whom radiological healing could be achieved had the shortest time to CD diagnosis, emphasizing the relevance of increased clinical awareness of underlying CD in fistula patients.

Flexible endoscopic treatment of Zenker's diverticulum-a retrospective, observational multicenter study.

The European Society of Gastroenterology and Endoscopy recommends a primarily flexible endoscopic approach for the treatment of Zenker's diverticulum. Due to the rarity of the disorder, evidence for its effectiveness and safety comes mainly from small, retrospective, single-center studies. In this retrospective, observational, multicenter cohort study, data from six German tertiary referral centers were analyzed. The primary outcome parameters were technical and clinical success; among the secondary outcomes, the rates of adverse events (AE) and re-admission with symptomatic recurrence and mortality were the most relevant. Between 2003 and 2024, 384 treatments were performed in 327 patients (61.8% male, mean age 74.70 (± 10.60)). Incision methods/techniques were 250 needle knives, 44 ESD knives, 64 stag beetle knives, 24 staplers, one APC-probe, and one Z-POEM. The Zenker's diverticulum overtube was used in 65.1%, prophylactic clipping in 30.2%, and antibiotic therapy in 25.3% of treatments. The rates of technical and clinical success were 99.2% and 97.4%, and the rates of AE and re-admission with symptomatic recurrence were 11.2% and 16.7%, respectively. Mortality was 0.3%. Comparative subgroup analyses of 312 diverticula without prior treatment versus 72 symptomatic recurrences and incision methods/techniques showed no significant differences in outcome parameters. The use of additional devices and prophylactic measures (clipping, antibiotic therapy) were not independent predictors of technical/clinical success or AE in uni-/multivariable regression analysis. Flexible endoscopic Zenker's diverticulotomy is a safe and effective minimally invasive treatment. Recurrences can be treated by flexible endoscopy with comparable results. None of the cutting methods, ancillary devices, or prophylactic measures showed superiority in effectiveness or safety.

WP1.2 - Does intraoperative urinary catheterisation decrease postoperative urinary retention after laparoscopic inguinal hernia repair? A systematic review and meta-analysis

Abstract Aims To evaluate comparative outcomes of laparoscopic inguinal hernia repair with and without use of intraoperative urinary catheterisation. Methods A systematic search of MEDLINE, CENTRAL and Web of Science and bibliographic reference lists were conducted. All comparative studies evaluating outcomes of laparoscopic inguinal hernia repair with and without use of intraoperative urinary catheterisation were included and their risk of bias were assessed using their risk of bias were assessed using ROBINS-I tool. Postoperative urinary retention was analysed as the primary outcome parameter and an odds ratio (OR) was determined using Random-effects modelling. Results We included 6 comparative studies reporting a total of 8,675 patients who underwent laparoscopic inguinal hernia repair with (n=3,318) and without (n=5,357) use of intraoperative urinary catheterisation. There was no significant difference in postoperative urinary retention between the two groups (4.3% versus 3.7%, OR 0.93; 95% CI 0.55-1.58, p=0.80). There was significant heterogeneity among the included studies (I2: 75%, p=0.001). Results of sensitivity analyses were consistent with the results of the main analysis. Conclusions Meta-analysis of best available evidence (level 2a) demonstrated that use of intraoperative urinary catheter has no advantage in prevention of postoperative urinary retention following laparoscopic inguinal hernia repair. Future randomised controlled trials are required to control for confounding factors that increases the risk of urinary retention.

Evaluation of a Video-Based Concept for Hand Hygiene Education of Parents in a Neonatal Intensive Care Unit.

Current clinical guidelines support family-centered care in Neonatal Intensive Care Units (NICUs). This implies parents should also be involved in the most critical patient safety measures. Hand hygiene is the single most important tool to prevent healthcare-associated infections and related long-term effects. Although often studied in healthcare workers, the hand hygiene compliance of parents is rarely assessed. The aim of this study was to evaluate the effectiveness of an educational video, available in ten different languages, in teaching parents hand hygiene techniques in a NICU, lowering the burden on the staff. Parents in the intervention group were educated through a video; the control group received personal instruction from healthcare workers. The primary outcome parameter was the predicted probability of passing a subsequent hand scan. The quality of hand hygiene among parents educated through the video was at least as good as that of those who received instruction from a healthcare worker, demonstrated by a higher predicted probability of passing the hand scan (43.8% vs. 57.1% in male and 67.9% vs. 75.9% in female participants). The feedback from the intervention group was predominantly positive, with most parents (62%) expressing a preference for video-based education. Implementing a video-based approach seems to be effective for educating parents about hand hygiene in a NICU and was well accepted by the parents. This method offers a consistent standard of hand hygiene education, helps to overcome language barriers, and can also be used as regular reminder of the importance and proper technique of hand hygiene.

Clinical and functional outcomes of locked plating vs. cerclage compression wiring for AO type C patellar fractures– a retrospective single-center cohort study

Abstract Purpose Although “tension-band wiring” is still commonly used to stabilize patellar fractures, the technique has recently been scrutinized due to biomechanical insufficiency. Consequently, the AO Foundation renamed the principle to compression cerclage wiring (CCW). Several studies propose favorable outcomes when utilizing locked plating (LP). This study aims to compare outcome of CCW and LP for complex patellar fractures. Methods A retrospective, single-center cohort study was performed on patients who underwent operative treatment for (AO 34 C-Type) patellar fractures between April 2013 and March 2023. Patients with a 12 month follow up were included. We grouped and compared patients based on the applied treatment strategy: group LP vs. group CCW. Primary outcome parameters included implant-related complications and revision surgeries. Secondary outcomes were length of stay, return to work and 12 months functional outcome (Lysholm score). Odd ratios for complications and revisions were calculated using the conditional Maximum Likelihood Estimate. The threshold for statistical significance was set at p &lt; 0.05. Results Of 145 patients, 63 could be included (group LP: n = 23 and group CCW: n = 40). Fractures in group LP were significantly more complex in regard to AO Classification (p &lt; 0.001), number of fragments (p &lt; 0.001) and degree of comminution (p &lt; 0.001), yet odds of complications were significantly lower in group LP (OR: 0.147; 95%CI: 0.015–0.742; p = 0.009). K-wire migration was the most common complication in group CCW (20%). Odds of revision surgery were significantly lower in group LP (OR: 0.000; 95%CI: 0.000-1.120; p = 0.041). The average Lysholm score at one year was favorable in both groups (89.8; SD: 11.9 in group LP and 90.6; SD: 9.3 in group CCW; n.s.). Conclusion In our study cohort, LP was routinely chosen for more complex fracture morphologies; nevertheless the data implies that LP may be considered as the superior fixation technique in regard to complications and revision operations. Especially, K-wire migration occurs frequently after CCW. The one year functional outcome was comparable between the groups, with both demonstrating good results. Prospective randomized studies are indicated to validate our findings.

Trends in sex differences of functional outcome after intravenous thrombolysis in patients with acute ischemic stroke.

Intravenous thrombolysis (IVT) is an approved treatment for patients with acute ischemic stroke irrespective of sex. However, the current literature on sex differences in functional outcomes following IVT is inconsistent. So far, a number of studies-including a previous analysis based on data from the Austrian Stroke Unit Registry (ASUR)-detected significant sex-related differences in functional outcome, while others did not report any differences between women and men. In addition, currently there is a lack of data on how sex-related differences evolve over time. To assess time trends of sex-related differences in functional outcome of ischemic stroke in a large nationwide cohort and to investigate associations of patient characteristics with functional outcome post thrombolysis in women and men. These data will offer crucial insights into whether sex differences in functional outcome persist despite the large advances in acute stroke treatment. We analyzed retrospective data of consecutive patients with acute ischemic stroke treated with IVT in 39 stroke centers contributing to the ASUR between 2006 and 2021. We included patients over 18 years of age diagnosed with an acute ischemic stroke who received IVT and with available data on functional outcome at 3 months after treatment. The primary outcome parameter was favorable functional outcome (modified Rankin Scale (mRS) of 0-2) at 3 months. Multivariable logistic regression analysis was performed in the overall population and stratified by sex to assess associations of baseline characteristics with functional outcome. Among 11,840 patients receiving IVT, 2489 of 5503 (45.4%) women achieved favorable functional outcome compared to 3787 of 6337 (59.8%) men. Overall, female sex was a statistically significant predictor of functional outcome after thrombolysis, but additional predictors of outcome differed between women and men. Female sex was independently associated with decreased chances of achieving functional independency (adjusted odds ratio (adjOR) = 0.87, 95% confidence interval (CI) = 0.79-0.96, p = 0.005) and we detected a statistically significant improvement in functional outcome over time only in men (year of treatment, adjOR (per year) = 1.04, 95% CI = 1.02-1.06, p < 0.001) but not in women (adjOR (per year) = 1.01, 95% CI = 0.99-1.03, p = 0.280). Hypertension, smoking, and longer or unknown onset-to-door times were statistically significant predictors of outcome only in male patients, whereas atrial fibrillation, prior myocardial infarction, and longer door-to-needle times were significantly associated with outcome only in women. Sex differences in functional outcome after IVT for acute ischemic stroke are persisting over the past years. Results of our analysis can increase awareness and a resulting focus on sex differences in predictors of outcome could be helpful in mitigating these differences in the future by supporting a more individualized patient care in clinical routine. Follow-up analyses are needed to assess this potential impact and its effect in the future. Data from the Austrian Stroke Unit Registry can only be accessed by the employed statistician (D.M.), access inquiries have to be addressed to the registry's academic review board.

Efficacy and outcomes of rescue screws in unstable pelvic ring injuries - A retrospective matched cohort study.

The emergency treatment of unstable pelvic ring injuries is still a challenge and requires surgical and anesthesiological resuscitation. Emergency fixation of the unstable pelvic ring with percutaneous sacroiliac (SI) screws, also known as "Rescue Screws", is an established treatment method. The aim of our study was to compare the outcome and complication rates of "Rescue Screws" with elective SI-screw fixations. A 1:1 ratio nearest-neighbor matched, retrospective cohort study of trauma patients with acute pelvic ring injuries at a level one trauma center was performed. Patients ≥ 15 years, treated with SI-screw fixation were included. pathologic fractures, missing consent and navigated procedures. The primary outcome parameters was defined as SI-screw revision operations. Patients were stratified according to treatment strategy (RS: Rescue Screws; EL: elective SI-screws). From 392 patients identified between 11/2014 and 08/2021, 186 met the inclusion criteria with 41 in the RS Group and 145 in the EL group. After matching, 41 patients were included in each group with similar baseline characteristics except persistent hemodynamic shock (RS: n = 22 (53.37%) vs. EL: n = 1 (4.3%), p < 0.001). Surgical characteristics were comparable in terms of instrumentation levels and insertion-sites. No significant differences were observed in the outcome parameters (revisions, reoperations, implant-associated complications, LOS and mortality) between both groups. Treatment of unstable pelvic ring fractures with Rescue Screws appears as a feasible treatment option for emergency stabilization. Rescue Screws are not associated with elevated revision rates and increased complications rates. This minimally invasive technique enables safe emergency stabilization of the posterior pelvic ring. Prospective or randomized clinical trials are required to directly compare Rescue Screws with other competing emergency stabilization techniques.

Efficacy of Real-Time Feedback Exercise Therapy in Patients Following Total Hip Arthroplasty: Protocol for a Pilot Cluster-Randomized Controlled Trial.

Osteoarthritis of the hip joint is an increasing functional and health-related problem. The most common surgical treatment is hip replacement to reduce pain and improve function. Rehabilitation after total hip arthroplasty (THA) is not regulated in Austria and mostly depends on the patient's own initiative and possibilities. Functional deficits, such as valgus thrust of the leg, functional Trendelenburg gait, or Duchenne limp, are characteristic symptoms before and, due to the performance learning effect prior to surgery, also after the operation. Addressing these deficits is possible through neuromuscular-focused exercise therapy. The efficacy of such therapy relies significantly on the quality of performance, the frequency of exercise, and the duration of engagement. Enhancing sustainability is achievable through increased motivation and real-time feedback (RTF) on exercise execution facilitated by digital feedback systems. This study will be performed to quantify the medium-term effectiveness of digital home exercise feedback systems on functional performance following THA. A clinical trial with a cluster-randomized, 2-arm, parallel-group design with an 8-week intervention phase and subsequent follow-ups at 3 and 6 months postsurgery will be conducted. Feedback during exercising will be provided through a blended-care program, combining a supervised group exercise program with a self-developed digital feedback system for home exercise. In total, 70 patients will be recruited for baseline. The primary outcome parameters will be the frontal knee range of motion, pelvic obliquity, and lateral trunk lean. Secondary outcomes will be the sum scores of patient-reported outcomes and relevant kinematic, kinetic, and spatiotemporal parameters. The trial started in January 2024, and the first results are anticipated to be published by June 2025. RTF-supported home exercise is expected to improve exercise execution quality and therapeutic adherence compared to using paper instructions for excise guidance. The anticipated findings of this study aim to offer new insights into the effect of a blended-care program incorporating digital RTF on exercise therapy after unilateral THA, in addition to knowledge on the functional status 3 and 6 months postsurgery, for further improvement in the development of rehabilitation guidelines following THA. ClinicalTrials.gov: NCT06161194; https://clinicaltrials.gov/study/NCT06161194. PRR1-10.2196/59755.

A Clinical Study of Anterior Abdominal Wall Hernias and Its Management: A Medical College Experience.

Objective We aim to evaluate the various risk factors contributing to the occurrence of anterior abdominal wall hernias and assess the various surgical modalities. Materials and methods This prospective observational research was conducted between 2022 and 2024 at a tertiary care health center, involving 100 participants with an anterior abdominal wall hernia diagnosis aged over 14 years. The study excluded patients under 14 years with bleeding diathesis, inherited coagulopathies, inguinal or femoral hernias, or recurrent ventral hernias. Participants underwent detailed clinical examinations and biochemical evaluationsand underwent a primary ultrasonography (USG)/contrast-enhanced computed tomography (CECT) to determine defect size. Risk factors were documented, including age, gender, occupation, body mass index (BMI), comorbidities, previous surgery history, multiparity, smoking, chronic straining due to constipation or benign prostatic hyperplasia (BPH), malnutrition, chronic steroid use, chronic renal failure, and chronic liver disease. The surgical procedure was determined by the same surgical team for all cases. Standard antibiotic prophylaxis and preoperative painting/draping protocols were followed in all cases. Intraoperatively, intraoperative time (in hours) was documented. Postoperative parameters included pain, hematoma formation, seroma formation, surgical site infections (SSIs), and early recurrence. These intra- and postoperative findingsconstituted the primary outcome parameters. Secondary outcome parameters included hospital stayduration and time taken to return to work. Data analysis was performed using Statistical Package for the Social Sciences (SPSS) version 16 (IBM SPSS Statistics, Armonk, NY) software. Results The study analyzed the occurrence of ventral hernias in 100 patients, with the fourth decade having the highest occurrence (n=42 (42%)). The majority of the participants were male (female: n=47 (47%), male: n=53 (53%)). The majority of the participants were laborers, and 24% (n=24) were office workers. The study found that hypertension, diabetes mellitus, and chronic obstructive pulmonary disease were risk factors for hernias. Other risk factors included obesity, previous history of surgery, multiparity, smoking, chronic straining, malnutrition, and chronic steroid use. The most common type of ventral hernia was umbilical hernia (n=33 (33%)), followed by paraumbilical hernias (n=30 (30%)), and incisional hernias (n=20 (20%)). Of the 100 patients, 74% underwent open hernia repair, with the mean operation time being minimal in cases managed with laparoscopic repair (2.5±0.67 hours). Postoperative painwas highest with the Rives-Stoppa (RS) repair with component separation group. The incidence of surgical site infection was the maximum among cases of open anatomical repair (41.7%), followed by RS repair (31.3%), while it was the minimum in laparoscopic repair (3.7%). Early recurrence was lower in the laparoscopic group (n=1 (3.7%)). Conclusion The study highlights risk factors for abdominal wall hernia and management approaches. Understanding these is crucial for identifying and preventing recurrence. Surgeons must choose the right surgical approach based on patient health and symptoms to achieve desired outcomes and minimize complications. In addition, surgical expertise, availability of resources, and knowledge of what works best for the surgeon constitute important determinants of surgical outcomes.

Results of medial patellofemoral ligament reconstruction with and without tibial tubercle osteotomy in patellar instability: a systematic review and single-arm meta-analysis

PurposeTo confirm which method provides lower rate of recurrent instability and superior clinical outcomes.MethodWe searched PubMed, Embase and Web of Science for the trials involving one intervention or both for patellar instability: medial patellofemoral ligament reconstruction (MPFLR) with and without tibial tubercle osteotomy (TTO). The postoperative Kujala score, Lysholm score, Tegner scores and the rate of recurrent instability (dislocation or subluxation) were analyzed as the primary clinical outcome parameters in a random or fixed effects meta-analysis.ResultsIn total, 43 articles met inclusion criteria after full-text review. A total of 2046 patients were analyzed. The overall mean age was 20.3 years (range, 9.5–60.0 years), with a mean follow-up time of 3.2 years (range, 1–8 years). The mean Kujala scores in MPFLR and MPFLR + TTO were 89.04 and 84.44, respectively. There was significant difference in Kujala scores between MPFLR and MPFLR + TTO (MD = 4.60, 95%CI: 1.07–8.13; P = 0.01). The mean Lysholm scores in MPFLR and MPFLR + TTO were 90.59 and 88.14, respectively. There was no significant difference in Lysholm scores between MPFLR and MPFLR + TTO (MD = 2.45, 95%CI: -3.20-8.10; P = 0.40). The mean Tegner scores in MPFLR and MPFLR + TTO were 5.30 and 4.88, respectively. There was no significant difference in Tegner scores between MPFLR and MPFLR + TTO (MD = 0.42, 95%CI: -0.39-1.23; P = 0.31). At final follow-up, the rates of recurrent instability in MPFLR and MPFLR + TTO were 3% and 4%, respectively. There was no significant difference in the rates between MPFLR and MPFLR + TTO (OR = 0.99, 95%CI: 0.96–1.02; P = 0.4848).ConclusionMPFLR and MPFLR + TTO are effective and reliable treatments in the setting of patellofemoral instability. MPFLR seems to show a better performance in functional outcomes than MPFLR + TTO. Moreover, their rates of recurrent instability are very low, and no significant difference exists.

Outcomes of Thoracolumbar Burst Fractures Treated With Open Versus Minimally Invasive Percutaneous Posterior Spinal Stabilization: A Retrospective Study at a Rural Teaching Hospital in South India.

Background Thoracolumbar spine fractures are the most prevalent type of axial skeleton fractures, with approximately two-thirds occurring between T11 and L2. Percutaneous pedicle screw fixation has been reported to be an effective treatment for thoracolumbar fractures. Minimally invasive percutaneous pedicle screw fixation yields outcomes comparable to those of the standard open procedure and has the advantages of less stress, bleeding, and pain, as well as rapid postoperative recovery. The main objective of this research was to compare the clinical and radiological outcomes of two surgical approaches (open and percutaneous posterior spinal stabilization), concentrating on nonosteoporotic AO Spine Type A3 thoracolumbar burst fractures between T11 and L2. Materials and methods We conducted a retrospective study in our hospital, where cases of thoracolumbar burst fractures meeting the inclusion criteria were chosen retrospectively from April 2022 to March2023. A total of 54 patients (aged 18-60 years) who underwent spinal stabilization were included in this investigation. The population was divided into two cohorts, with 27 patients in each: Group A underwent open posterior spinal stabilization, and Group B underwent percutaneous posterior spinal stabilization. Data retrieved from medical records were analyzed with at least a six-month follow-up, mainly assessing the demographic data, intraoperative parameters, duration of hospitalization, clinical outcomes (Visual Analog Scale, Oswestry Disability Index, and McGill Pain Questionnaire scores), and radiological outcomes (vertebral wedge angle and correction loss). Results Both groups had a male preponderance. There were statistically meaningful distinctions between both groups regarding intraoperative parameters (blood loss and surgical duration) and primary clinical outcome parameters (Visual Analog Scale, Oswestry Disability Index, and McGill Pain Questionnaire scores) in the early phase of the study. However, there were no statistically significant differences concerning radiological parameters (vertebral wedge angle and correction loss) or primary clinical outcome parameters at the last follow-up. Conclusion The treatment modalities (open and percutaneous posterior spinal stabilization surgery) were equally safe and effective. However, the percutaneous group demonstrated significant reductions in the length of the surgical procedure, blood loss during surgery, duration of hospital stay, and immediate postoperative pain scores, all of which could potentially benefit patients.

Correlation of Visual System Biomarkers With Motor Deficits in Experimental Autoimmune Encephalomyelitis-Optic Neuritis.

Experimental autoimmune encephalomyelitis (EAE) scoring, the most commonly used primary outcome metric for an in vivo model of multiple sclerosis (MS), is highly variable and subjective. Here we explored the use of visual biomarkers in EAE as more objective and clinically relevant primary outcomes. Motor impairment in myelin oligodendrocyte glycoprotein-immunized C57BL/6J mice was quantified using a five-point EAE grading scale. Pattern electroretinography (pERG) and retinal ganglion cell/inner plexiform layer (RGC/IPL) complex thickness were measured 60 days after induction. Optic nerve histopathology was analyzed at endpoint. EAE mice displayed motor impairments ranging from mild to severe. Significant correlations were seen between pERG amplitude and last EAE score, mean EAE score, and cumulative EAE score. Optical coherence tomography (OCT) analysis demonstrated a significant correlation between thinning of the RGC/IPL complex and both EAE score and pERG amplitude. Optic nerve histopathology showed significant correlations between demyelination and cumulative EAE score, pERG amplitude, and RGC/IPL complex thickness, as well as between immune cell infiltration and cumulative EAE score, pERG amplitude, and RGC/IPL complex thickness in EAE mice. Unlike EAE scoring, pERG and OCT show direct measurement of retinal structure and function. Therefore we conclude that visual outcomes are well suited as a direct assessment of optic nerve involvement in this EAE model of MS while also being indicative of motor impairment. Standardizing directly translatable measurements as primary outcome parameters in the murine EAE model could lead to more rapid and relevant testing of new therapeutic approaches for mitigating MS.

Design of a clinical study to demonstrate the therapeutic benefit of another wound treatment product

Due to new legal requirements, a patient-relevant benefit for other wound treatment products (sPW) must be demonstrated through clinical studies if reimbursement at the expense of the statutory health insurance is sought in the non-inpatient sector. An interdisciplinary group with expertise in clinical wound care has developed general recommendations for the design of suitable studies. In addition to regulatory documents, previous studies that have already been recognized as proof of benefit in other areas served as a basis. Randomized controlled trials that cover at least the most common types of chronic wounds (arterial, venous, diabetic or pressure sore) are recommended as the best method for gathering evidence. Despite the heterogeneous etiology of chronic wounds, the results should also be transferable to other wound types. The test intervention does not usually consist of the sPW alone, but of a combined wound treatment that follows a treatment plan that is as clearly defined as possible. In the comparison group, all wound treatment options (besides the sPW) must also be available and used according to a similar predefined treatment plan. Depending on the intended purpose and treatment goal, complete wound closure should, if possible, be recorded as the cardinal - although not always as the primary - endpoint. In justified cases, e.g. in the case of intermediate use as part of phase-appropriate wound therapy for chronic wounds, a significant reduction in the wound area can also be considered for benefit assessment. Quality of life (e.g. pain) can also justify a benefit and can therefore be recorded as a primary outcome parameter in clinical trials. The duration of the clinical trial should be adapted to the central endpoints, the medical or nursing goal of wound care and the intended purpose of the sPW. A benefit does not always arise from microbiological, physiological, laboratory or histological parameters or imaging findings.