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PubMed2026

Perioperative analgesic efficacy of ultrasound-guided erector spinae plane block and posterior transversus abdominis plane block in paediatric patients undergoing open pyeloplasty: A prospective randomised trial.

PURPOSE: Open pyeloplasty in the paediatric population involves extensive tissue dissection and manipulation, resulting in significant postoperative pain. Ultrasound-guided fascial plane blocks have emerged as an important component of multimodal analgesia in abdominal surgeries. This study compared the analgesic efficacy of ultrasound-guided Erector spinae plane block (ESP) and posterior transversus abdominis plane (pTAP) block in children undergoing open pyeloplasty. METHODS: It is a prospective, randomised, double-blind study conducted at a single paediatric centre in a tertiary care hospital in Asia from January 2022 to June 2023. 40 ASA I-II children were randomised to receive either the ESP block (Group E) or the pTAP block (Group T). Both groups received 0.4 ml/kg, 0.2% ropivacaine with 1 mcg/kg dexmedetomidine. Children with an allergy to local anaesthetics, cardiac, renal or hepatic dysfunction and local site infection were excluded. The primary outcome was cumulative 24 h postoperative acetaminophen consumption. Secondary outcomes included the effects on intraoperative hemodynamics, perioperative opioid consumption, FLACC and Watcha scores, time to first rescue analgesia, and any block-related complications. RESULTS: Weight-normalised 24 h postoperative acetaminophen consumption was significantly lower in the ESP group (13.5 ± 4.7 mg/kg) compared to the pTAP group (25.4 ± 8.3 mg/kg), with a mean difference of -12 mg/kg (p < 0.001, 95%CI -16 to -7.6). The median time to first rescue analgesia was significantly longer in the ESP group (18 h [95% CI, 18-24]) than in the TAP group (9 h [95% CI, 6-12]), p < 0.001. Although FLACC scores were significantly lower in the ESP group at 30 min and 12 h postoperatively, the overall longitudinal analysis using a linear mixed-effects model showed no significant difference in the trend of FLACC scores over time between the two groups. There were no block-related complications. CONCLUSION: Ultrasound-guided ESPB provides better, longer-lasting analgesia than posterior TAP block in children undergoing open pyeloplasty. Hence, it may serve as an effective component of multimodal pain management in paediatric open pyeloplasty. CTRI REGISTRATION (CTRI/2022/04/041876) DATED 13/04/2022): https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=67747&EncHid=42257.14515&modid=1&compid=19.

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PubMed2026

Sacral Neuromodulation in the Management of Refractory Pediatric Lower Urinary Tract Dysfunction.

INTRODUCTION: Sacral neuromodulation is currently used in the pediatric patient population for refractory lower urinary tract dysfunction (LUTD). Evidence, however, is currently limited for institutional experiences of long-term outcomes for sacral neuromodulation in the pediatric patient population. OBJECTIVE: The objective of this study is to perform a retrospective review of a large multi-institutional cohort of pediatric patients that underwent sacral neuromodulation (SNM) for refractory LUTD, focused on rates of symptom improvement, quality of life, and bowel-bladder dysfunction measures following device implantation. Secondary objectives included assessing device complication rates and device removals due to failure or successful resolution of symptoms. METHODS: We performed a retrospective cohort study of pediatric patients at three children's hospitals that underwent SNM device implantation for refractory LUTD. Patients 4-18 years of age who were diagnosed with refractory LUTD and managed at a participating institution with follow-up were included. Outcomes were evaluated at baseline and post-operatively after two-stage device implantation at initial follow-up and annually until device removal or final follow-up. RESULTS: From 2010 to 2022, a total of 205 children underwent SNM procedures at three pediatric hospital centers. 204 patients completed the two-stage procedure for permanent device implantation with a median follow-up of 3.4 years (1.3, 4.9). One hundred seventy-eight patients reported partial (25%) or complete (54%) device response/symptom improvement by final follow-up. Comparison of patient-reported validated questionnaires completed at baseline and by final follow-up visit revealed significant improvement in median Pediatric Quality of Life Inventory (PedsQL) (p = 0.004) and Vancouver Nonneurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome bowel-bladder dysfunction (BBD) scores (p < 0.001). Of those with any device complication (n = 43;21%), 19 patients required device revision, and 20 required complete device removal. Separately, twenty-eight patients (13%) underwent device removal due to resolution of symptoms or treatment success at a median period of 5 years (4,7). CONCLUSION: SNM use demonstrated a majority of patients reporting at least partial subjective symptom improvement following device implantation across multiple institutions by final follow-up. SNM is a viable treatment option for refractory LUTD in the pediatric patient if willing to undergo an invasive procedure and in which thorough counseling of risks and benefits has occurred.

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PubMed2026

How I do it: 3-Suture robotic pyeloplasty: Step-by-step technique.

Robot-assisted pyeloplasty is now a gold standard in the treatment of pediatric ureteropelvic junction obstruction. We describe a standardized "3-suture" technique designed to facilitate the pyelo-ureteral anastomosis. We used this technique in 65 paediatric patients aged 3-17 years. Early major complications (Clavien-Dindo grade III) occurred in 3 patients (4.6%). The median operative time was 150 min. Surgical success was achieved in 96% of cases at a median follow-up of 9.5 months. This 3-suture approach offers a highly reproducible method for robotic pyeloplasty, facilitating accurate anatomical reconstruction with excellent surgical outcomes.

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PubMed2026

Prostate morcellation devices: a systematic review and meta-analysis of clinical outcomes and efficiency.

OBJECTIVE: To systematically evaluate the efficiency and safety of different prostate morcellators used during prostate enucleation for benign prostatic hyperplasia (BPH). METHODS: A systematic review was performed according to the Preferred Reporting Items for Systematic Review and Meta-analyses guidelines. PubMed/Medline, Scopus, and Web of Science were searched for studies published between October 2012 and May 2025. Studies reporting clinical outcomes of morcellators used during prostate enucleation were included. Primary outcome was morcellation efficiency (g/min). Secondary outcomes included intraoperative complications, device malfunction, and cost when available. Risk of bias (RoB) was assessed using the Risk Of Bias In Non-randomised Studies of Interventions (ROBINS-I), RoB 2 tool, and European Association of Urology case-series criteria. Random-effects meta-analyses and multilevel meta-regression adjusted for prostate volume were conducted. RESULTS: A total of 22 studies comprising 5980 patients were included, most undergoing holmium laser enucleation of the prostate. The most frequently evaluated devices were the Piranha™ (Richard Wolf GmbH, Knittlingen, Germany) and Lumenis VersaCut™ (Lumenis Ltd., Yokneam, Israel; 12 and 13 studies, respectively), followed by DrillCut™ (Karl Storz SE & Co. KG, Tuttlingen, Germany), MultiCut™ (Asclepion Laser Technologies GmbH, Jena, Germany), and Cyber Blade™ (Quanta System SpA, Milan, Italy) systems. Unadjusted weighted mean morcellation efficiency was 7.80 g/min (95% confidence interval [CI] 6.26-9.34 g/min) for Piranha, 4.70 g/min (95% CI 3.61-5.79 g/min) for VersaCut, 5.90 g/min (95% CI 3.16-8.64 g/min) for DrillCut, and 9.59 g/min (95% CI 4.78-14.39 g/min) for MultiCut. In volume-adjusted meta-regression using Piranha as reference, VersaCut remained significantly less efficient (-2.75 g/min; 95% CI -4.58 to -0.92 g/min; P = 0.003), with an even greater difference in prostates >70 mL (-4.34 g/min). Bladder mucosal injury was the most frequently reported complication; however, relatively rare across all devices. Meta-analysis demonstrated a significantly higher risk with VersaCut compared to Piranha (risk ratio 3.22, 95% CI 1.81-5.71), with low heterogeneity. CONCLUSION: This systematic review provides a contemporary clinical benchmark of the efficiency and safety of currently available prostate morcellators. Oscillating blade systems, particularly the Piranha morcellator, demonstrated higher morcellation efficiency and a more favourable safety profile than reciprocating blade devices, with the largest performance differences observed in patients with larger prostates.

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PubMed2026

Editorial Commentary: Stiff Patients After Rotator Cuff Repair: How Many Had Underrecognized Preoperative Adhesive Capsulitis?

Stiffness after rotator cuff repair is one of the most common sources of disability and one of the most common complications. Smoking, diabetes, Workers' compensation status, and traumatic tears are among the strongest risk factors. This is important information in setting appropriate expectations for both the patient and the surgeon preoperatively. Some of these factors are also associated with preoperative stiffness, so surgeons should maintain a high index of suspicion for concomitant adhesive capsulitis in patients presenting with limited motion, particularly in diabetic and non-English speaking populations. In cases where both a rotator cuff tear and adhesive capsulitis coexist, performing a concurrent capsular release or manipulation during the index procedure may improve functional outcomes and reduce the necessity for secondary surgical intervention.

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PubMed2026

Robotic-assisted transbronchial biopsy versus computed tomography-guided transthoracic needle biopsy for peripheral pulmonary lesions: a systematic review and meta-analysis of direct comparative studies.

Robotic-assisted bronchoscopy (RAB) and computed tomography-guided transthoracic biopsy (CTTB) are competing strategies for sampling peripheral pulmonary lesions (PPLs). Whether they differ in yield or safety is uncertain. To our knowledge, this is the first systematic review restricted to direct comparisons. We searched MEDLINE, Europe PMC, Scopus, Web of Science and ClinicalTrials.gov from inception to 7 July 2026 for studies directly comparing RAB with CTTB in adults with PPLs. The primary outcome was strict 2024 American Thoracic Society/American College of Chest Physicians diagnostic yield. Risk of bias was assessed with ROBINS-I and certainty with GRADE. A cohort-genealogy step identified, per outcome, the largest set of cohorts sharing no patients; only that set was pooled, with Hartung-Knapp and Mantel-Haenszel sensitivity analyses. Five retrospective studies from one US health system were eligible. Four share patients; at most three cohorts are mutually independent. Across those three, diagnostic yield was comparable (risk ratio [RR] 0.99, 95% confidence interval [CI] 0.93-1.06; I²=24%; Hartung-Knapp 0.87-1.13), with an identical relative effect under strict and intermediate definitions although absolute yields fell from 88% to 74-84% under strict criteria. Pneumothorax requiring a chest tube and/or admission was about three-quarters less frequent with RAB across all three cohorts (RR 0.25, 95% CI 0.14-0.46; I²=0%; Hartung-Knapp 0.07-0.96). Strict yield (RR 0.99) and any pneumothorax (RR 0.06) were reported by two cohorts each and neither survives the few-studies correction. RAB took about 50 min longer than CTTB where same-session staging endobronchial ultrasound was counted in the robotic time, but only about 8 min longer than CTTB where it was not. Only one cohort reported yield by lesion size category and none reported yield by bronchus sign or lung zone, so lesion-level subgroups could not be pooled. Certainty was low for pleural complications and very low elsewhere. Low-certainty evidence indicates that RAB is associated with fewer pleural complications, with no statistically detectable difference in diagnostic yield; equivalence was not formally established. Because all evidence is retrospective, confined to one health system, and almost never stratified by lesion size or accessibility, these findings are hypothesis-generating and require a multicenter randomized trial.

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PubMed2026

Aquablation/AquaBeam Waterjet Therapy for Benign Prostatic Hyperplasia: Three-Year Functional and Ejaculatory Outcomes in a Multicenter Real-World Italian Cohort.

OBJECTIVE: To evaluate the 3-year functional outcomes of Aquablation/AquaBeam waterjet therapy for bladder outlet obstruction secondary to benign prostatic hyperplasia (BPH), with particular attention to urinary symptoms, quality of life, continence, ejaculatory function, and complications. METHODS: We performed a retrospective analysis of a prospectively maintained multicenter database including 218 consecutive men who underwent Aquablation/AquaBeam for symptomatic BPH between January 2019 and January 2022 at three referral centers. Functional outcomes assessed preoperatively and during follow-up included International Prostate Symptom Score (IPSS), IPSS quality-of-life item (IPSS-QoL), maximum urinary flow rate (Qmax), post-void residual urine (PVR), continence, and ejaculatory function. Median follow-up was 36 months. Ejaculatory preservation was evaluated only in patients with preserved antegrade ejaculation at baseline. RESULTS: Median age was 61 years (IQR 57-66), median prostate-specific antigen (PSA) was 2.52 ng/mL (IQR 0.40-21.60), and median prostate volume was 55 mL (IQR 40-73). Median operative time was 56 min, while median catheterization time and length of hospital stay were both 48 h. Functional improvements were evident from the 3-month follow-up and remained stable through 36 months. At 36 months, median IPSS improved to 5 and median Qmax to 18 mL/s. Median PSA changed modestly from 2.52 ng/mL at baseline to 2.75 ng/mL at 36 months. No cases of de novo urinary incontinence were observed throughout follow-up. Among patients with preserved antegrade ejaculation at baseline, 87% maintained antegrade ejaculation at 36 months. Most postoperative complications were minor (Clavien-Dindo grade I-II, 20.2%). One grade III rectal injury occurred (0.5%). Median hemoglobin decreased from 15.2 g/dL preoperatively to 14.0 g/dL before hospital discharge, and two patients required blood transfusion. During the 36-month follow-up, no surgical retreatment was required, whereas 11 patients (5.0%) received temporary medical retreatment. CONCLUSION: In this multicenter real-world cohort, Aquablation/AquaBeam was safe and effective over 3 years, providing durable improvement in lower urinary tract symptoms and quality of life while preserving continence and antegrade ejaculation in most patients. These findings support Aquablation/AquaBeam as a valuable minimally invasive surgical option for selected men with BPH, particularly those who prioritize preservation of ejaculatory function. Longer-term and comparative studies are warranted. TRIAL REGISTRATION: 48281.

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PubMed2026

The transverse preputial onlay island flap: A reliable option for repair of small-glans hypospadias.

BACKGROUND: The Transverse Preputial Onlay Island Flap (TPOIF) technique is frequently used in cases with mild chordee and small glans. This study's objective was to evaluate the surgical outcomes of this technique at our center. MATERIALS AND METHODS: This study consisted of hypospadias patients diagnosed with small glans (diameter <14 mm) and mild chordee (<30°), underwent TPOIF urethroplasty. RESULTS: A total of 64 cases were included in this study. The mean glans diameter was 10.6 mm. The complication rate was 9.4 %. CONCLUSIONS: The TPOIF technique provides encouraging results for treating hypospadias with small glans, though larger studies are needed.

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PubMed2026

Hip Arthroscopy-Assisted Management of Pipkin Types I and II Femoral Head Fracture-Dislocations: Mid-Term Clinical and Radiographic Outcomes.

OBJECTIVES: Hip arthroscopy-assisted surgery has been proposed as a minimally invasive option for femoral head fractures; however, evidence with mid-term follow-up remains limited. This study aimed to evaluate the clinical and radiographic outcomes of arthroscopy-assisted management for Pipkin Types I and II femoral head fracture-dislocations with a minimum follow-up of 5 years. METHODS: This retrospective study included 23 consecutive adults (19 Pipkin I and 4 Pipkin II) treated with hip arthroscopy-assisted fragment excision or internal fixation between March 2013 and January 2020. Preoperative computed tomography was used for surgical planning, and fixation was placed with arthroscopic headless screws. Clinical outcomes were assessed using the Harris Hip Score (HHS) and Thompson-Epstein (T-E) criteria. Radiographic evaluation included avascular necrosis (AVN), heterotopic ossification (HO; Brooker), osteoarthritis (OA; Tönnis), and fracture reduction quality (Matta's criteria). Group comparisons were evaluated using independent samples t-tests, Mann-Whitney U tests, and Fisher's exact test. The mean follow-up was 86.2 ± 21.2 months. RESULTS: The cohort consisted of 19 males and 4 females with a mean age of 28.7 ± 9.9 years. Fifteen patients underwent fixation and eight underwent excision. The final mean HHS was 98.3 ± 1.9, with 21 patients (91%) achieving excellent and 2 (9%) good T-E criteria. There were no significant differences between the fixation and excision groups in demographic characteristics, operative time, or functional outcomes (all p > 0.05); however, hospital stay was significantly shorter in the excision group (2.9 ± 0.6 vs. 5.5 ± 4.6 days, p = 0.028). In the fixation group, mean maximal displacement improved from 7.6 mm preoperatively to 2.6 mm postoperatively, with anatomic reduction achieved in 6 cases (40%), imperfect in 6 (40%), and poor in 3 (20%). Patients with Pipkin Type I fractures had significantly higher HHS than those with Type II fractures (98.7 ± 1.7 vs. 96.0 ± 0.8, p = 0.018). Complications were rare, with one case of Brooker Grade I HO and one case of mild OA. No AVN or total hip arthroplasty occurred during the follow-up. CONCLUSIONS: Hip arthroscopy-assisted management of selected Pipkin Type I and II femoral head fractures yields excellent mid-term clinical outcomes with acceptable radiographic reduction and a low complication rate. This minimally invasive technique represents a viable alternative in appropriately selected patients when fragment characteristics and surgical expertise permit.

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PubMed2026

Bipolar circumcision with mucocutaneous plane separation: A safe, precise, blood-sparing, dressing-free approach.

Conventional circumcision techniques may result in bleeding, limited control of the mucosal collar, and the need for dressings. We describe a modified bipolar technique enabling near-bloodless dissection with precise mucosal trimming. Following bipolar division of the preputial skin, the inner mucosa is separated using two forceps and retracted proximally, creating a protective plane for safe skin adjustment. The mucosal collar is trimmed with scissors. The wound is closed with sutures and 2-octyl cyanoacrylate, avoiding dressings. This technique has been performed in 55 consecutive cases (median age: 2 years and 2 months; range: 0 days-17 years and 5 months) with no reported complications over a median follow-up of 2 years and 7 months (range: 3 months-4 years and 1 month).

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PubMed2026

S-layer-phage interaction in Clostridioides difficile.

Successful infection by a bacteriophage requires the injection of the phage genome into the cytoplasm of the host bacterium. To achieve this, an infecting phage must traverse the layers of the host cell envelope, including the membrane(s) and the cell wall. This process is further complicated in bacterial species that produce a proteinaceous S-layer on the outermost surface of the cell. Surprisingly little is known about the mechanistic basis of these early stages in the phage lifecycle, and even less is known about infection of S-layer producing bacteria. Recent advances in structural biology, particularly in cryoEM, have dramatically improved our understanding of the structures of both bacterial S-layers and phage virions separately, but we still lack a molecular view combining both phage and S-layer in the process of infection. Here, we review our current understanding of phage-S-layer interactions, using the human pathogen Clostridioides difficile as an example host.

Clostridioides difficile↗

PubMed2026

Chronic postsurgical pain: risk assessment and mitigation.

PURPOSE OF THE REVIEW: Chronic postsurgical pain (CPSP) and persistent postoperative opioid use (PPOU) are two of the most common complications of a number of surgical interventions, which can cause significant personal and economic negative consequences. This review outlines known and potential risk factors for CPSP and PPOU and approaches to reduce these risk factors. RECENT FINDINGS: Modifiable risk factors for developing CPSP include psychological distress, preoperative pain intensity, and perioperative opioid exposure. Although less studied, psychological comorbidities are also risk factors for PPOU. Evidence-based mitigation strategies include psychological interventions and perioperative opioid sparing. SUMMARY: A number of perioperative risk factors for developing CPSP and PPOU have been identified, and anesthesiologists should be cognizant of these risk factors and potential risk mitigation strategies. Additional prospective studies are needed to further develop easily adoptable, evidence-based interventions to reduce the incidence of CPSP and PPOU.

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PubMed2026

Crinecerfont: emerging role in the management of congenital adrenal hyperplasia.

INTRODUCTION: Congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency is a rare genetic endocrine disorder characterized by impaired cortisol synthesis, excessive adrenal androgen production, and elevated adrenocorticotropic hormone (ACTH) concentrations. The current standard of care involves supraphysiologic doses of glucocorticoids to suppress ACTH and manage androgen excess, often leading to long-term complications. AREAS COVERED: A literature search of PubMed was conducted. This review critically examines the pharmacology, clinical efficacy, and potential role of crinecerfont in redefining CAH management. EXPERT OPINION: Crinecerfont, a selective corticotropin-releasing factor type 1 receptor (CRF1) antagonist, offers a novel therapeutic approach by targeting ACTH secretion at its hypothalamic origin. Recent Phase 2 and Phase 3 trials have demonstrated promising efficacy and safety across adult, adolescent, and pediatric populations. Crinecerfont may represent a promising adjunctive therapy in CAH management, addressing both biochemical control as well as quality of life and potentially long-term outcomes.

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PubMed2026

New World screwworm: a re-emerging parasitic threat.

PURPOSE OF REVIEW: New World screwworm (NWS) is an emerging parasitic threat in Central America and Mexico, which is spreading northward into the southern United States. Here we highlight the changing epidemiology, lifecycle of the NWS fly, clinical presentation, identification, treatment, and potential complications of NWS myiasis. RECENT FINDINGS: Despite decades of successfully containing NWS flies south of the Darien Gap in southern Panama, NWS flies reemerged in the Central America region in 2023 and have continued to spread northward ever since. On 3 June 2026, United States Department of Agriculture (USDA) confirmed the identification of an NWS infestation in a young calf in southern Texas. In addition to describing the current epidemiology of the NWS outbreak, we present information about clinical presentation and management of NWS myiasis in patients and include representative cases of patients who experienced NWS myiasis. SUMMARY: This review provides important epidemiologic and clinical updates to an emerging parasitic threat so clinicians can understand the risks and clinical management for patients with suspected NWS myiasis.

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PubMed2026

Analysis of deep learning techniques in computer-aided diagnosis for meniscus injuries: a systematic literature review.

Meniscus informatics is a growing subject of study in the healthcare industry. One of the major hindrances to the healthcare system's transformation is obtaining knowledge and meaningful information from complicated, high-dimensional and diverse sources. Modern biomedical research, for instance, has seen an increase in the use of complex, dissimilar, poorly documented, and generally unstructured electronic health records, imaging, sensor data and text, even after many current techniques have been used to extract more robust and useful elements from the data for analysis. New efficient standards for building end-to-end learning models from complex data are therefore needed. Therefore, the current study aims to examine the most recent research on the use of deep learning techniques for diagnosing meniscus tears and recommend creating comprehensive and meaningful interpretable structures that might benefit the healthcare industry. We also draw attention to shortcomings and the need for better technique development, and we provide new perspectives about this exciting new development in the field.

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PubMed2026

Breaking the Debilitating Cycle: Pathophysiology, Assessment, and Multimodal Intervention of Secondary Debilitation After Hip Fracture in Older Adults-A Narrative Review.

Hip fractures pose a serious threat to the quality of life among older adults and impose a heavy burden on both society and families. Although current surgical techniques for hip fractures have become increasingly refined, postoperative quality of life and overall function in older adult populations often steeply decline. This decline is marked by "secondary debilitation," characterized by exacerbated sarcopenia, functional impairment, and physiological reserve depletion-a process that becomes a risk factor for recurrent fractures, creating a "vicious cycle" with hip fractures. This article provides a comprehensive overview of the pathophysiological mechanisms underlying "secondary debilitation," discusses the clinical application of risk assessment tools, and presents a phased, stepwise intervention strategy aimed at interrupting the "vicious cycle." The strategy includes early rapid rehabilitation, nutritional support, and prevention of complications; a mid-phase multimodal approach involving multidisciplinary management, comanaged wards, fracture liaison services, and systematic rehabilitation; and, finally, late-phase exploration of emerging pharmacotherapies and treatment methods. This review seeks to offer an evidence-based foundation for optimizing clinical risk assessment and developing precise interventional strategies.

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PubMed2026

Wedge tarsectomy using patient specific instrumentation for complex multiplanar foot deformity Reconstruction: A prospective case series.

BACKGROUND: Bony correction in complex cavovarus deformities is often multiplanar. We examine our results following wedge tarsectomy (WT) using patient-specific instrumentation (PSI). METHODS: This single-centre, prospective case series evaluated noncorrectable cavovarus feet undergoing PSI-guided WT. Accuracy of PSI guides/plans, operative duration, and adjunctive procedures were recorded. Weightbearing CT (WBCT) measurements and PROM scores were recorded preoperatively and postoperatively, with 1 year follow-up. Data was then statistically analysed. RESULTS: Eleven patients were included. Planned correction was achieved (two required minor intraoperative adjustments to the initial osteotomy and nine required adjunctive procedures). Mean operative time was 135 min. Postoperative improvements were significant radiologically and in MOxFW walking distance. All fused by 3 months, with no significant complications. CONCLUSION: PSI-guided wedge tarsectomy safely achieves predictable multiplanar corrections. Our unit's experience has been excellent, with improvement in patients' walking, particularly with larger deformity corrections. LEVEL OF EVIDENCE: Level IV, prospective case series.

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PubMed2026

Determinants of Nonspecific Response to Treatment in Randomized Controlled Trials of Major Depressive Disorder: A Narrative Review.

The design, conduct, and interpretation of double-blind randomized placebo-controlled clinical trials in major depressive disorder (MDD) are complicated by determinants of nonspecific response to treatment (NSRT). This narrative review provides a comprehensive overview of the determinants of NSRT in randomized controlled trials (RCTs) for MDD, including the placebo effect, factors related to measurement of the primary endpoint, the inclusion of misdiagnosed patients, the relapsing-remitting course of MDD, and factors related to functional unblinding. Potential strategies to reduce the impact of the determinants of NSRT and to improve the interpretation of RCT outcomes in MDD are also summarized. These strategies include use of centralized rating and standardized rater training, independent diagnostic confirmation, optimized site selection, minimizing financial incentives, exclusion of subjects participating in multiple clinical trials, exclusion of patients with unstable major depressive episode trajectories, and use of active placebo and alternative trial designs. Uniformity among experts in the definitions of determinants of NSRT and related concepts, as well as in strategies to address them, may facilitate progress in the development of novel treatments for MDD.

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