Combined Medial Collateral Ligament Reconstruction and Polyethylene Exchange for Valgus Instability Following Total Knee Arthroplasty.

Valgus instability can occur after total knee arthroplasty (TKA) due to traumatic medial collateral ligament (MCL) injury, component malpositioning, or progressive ligamentous laxity. Although revision TKA with exchange of the polyethylene to a varus-valgus-constrained liner can reduce laxity due to MCL insufficiency, isolated liner exchange in the setting of collateral ligament insufficiency may lead to greater strain at the cement-bone or implant-cement interface and possibly a greater rate of aseptic loosening. Anatomic MCL reconstruction can be performed in conjunction with liner exchange to restore stability and reduce strain compared with liner exchange alone. The purpose of this Technical Note is to describe a technique for MCL reconstruction and liner exchange for treatment of valgus instability after TKA.

Matrix-Induced Autologous Chondrocyte Implantation Versus Autologous Chondrocyte Implantation of the Knee A Retrospective Comparison.

OBJECTIVE: The purpose of this study was to compare the short-term clinical outcomes of matrix-induced autologous chondrocyte implantation (MACI) to those seen following traditional autologous chondrocyte implantation (ACI) in the management of symptomatic cartilage lesions of the knee. METHODS: This was a retrospective cohort study of patients who underwent either ACI or MACI from January 2011 to March 2018. Patients with a minimum postoperative follow-up of 18 months were contacted. Demographic information, intraoperative findings, and patient-reported functional outcomes scores were collected. Comparisons were made between the two cell-based cartilage repair techniques. RESULTS: Fifty-six patients were included in the study (39 ACI, 17 MACI). Visual analog scale (VAS) for pain scores improved significantly in both groups, with MACI patients demonstrating significantly lower postoperative pain scores compared to those treated with ACI. In the ACI group, there was a decrease in the Tegner Activity score compared to the preoperative baseline, while no significant difference was seen between pre- and postoperative activity levels in the MACI group. Patients were generally satisfied with the outcome of their procedures, and there was no significant difference in satisfaction between groups. No patients re-quired additional surgery during the follow-up period. CONCLUSION: Both ACI and MACI demonstrated good short-term postoperative clinical results with improved pain and activity levels compared to the preoperative baseline. Patients treated with the MACI technique demonstrated greater reductions in pain scores compared to ACI, and while ACI resulted in a decrease in levels of postoperative activity, activity levels for MACI remained stable.

Tissue Loss During Eye Bank Processing.

This comparative effectiveness research study assesses the rate of tissue loss in ultrathin descemet stripping automated endothelial keratoplasty grafts vs descemet membrane endothelial keratoplasty grafts during eye bank processing.

Trends in Elbow Ulnar Collateral Ligament Repairs and Reconstructions and an Analysis Between Low- and High-Volume Surgical Centers: A 10-Year Study in New York State.

Background: Elbow ulnar collateral ligament (UCL) reconstruction (UCLR) is the gold standard for operative treatment of UCL tears, with renewed interest in UCL repairs. Purpose: To (1) assess trends in rates of UCLR and UCL repair and (2) identify predictors of complications by demographic, socioeconomic, or surgical center volume factors. Study Design: Descriptive epidemiology study. Methods: Patients who underwent UCLR or UCL repair at New York State health care facilities between 2010 and 2019 were retrospectively identified; concomitant ulnar nerve procedures among the cohort were also identified. Surgical center volumes were classified as low (<99th percentile) or high (≥99th percentile). Patient information, neighborhood socioeconomic status quantified using the Area Deprivation Index, and complications within 90 days were recorded. Poisson regression analysis was used to compare trends in UCLR versus UCL repair. Multivariable regression was used to determine whether center volume, demographic, or socioeconomic variables were independent predictors of complications. Results: A total of 1448 UCL surgeries were performed, with 388 (26.8%) concomitant ulnar nerve procedures. UCLR (1084 procedures; 74.9%) was performed more commonly than UCL repair (364 procedures; 25.1%), with patients undergoing UCL repair more likely to be older, female, and not privately ensured and having undergone a concomitant ulnar nerve procedure (all P < .001). With each year, there was an increased incidence rate ratio for UCL repair versus UCLR (ß = 1.12 [95% CI, 1.02-1.23]; P = .022). The authors identified 2 high-volume centers (720 UCL procedures; 49.7%) and 131 low-volume centers (728 UCL procedures; 50.3%). Patients undergoing UCL procedures at high-volume centers were more likely to be younger and male and receive workers' compensation (all P < .001). UCL repair and ulnar nerve-related procedures were both more commonly performed at low-volume centers (P < .001). There were no significant differences in 3-month infection, ulnar neuritis, instability, arthrofibrosis, heterotopic ossification, or all-cause complication rates between low- and high-volume centers. The only significant predictor for all-cause complication was Medicaid insurance (OR, 2.91 [95% CI, 1.20-6.33]; P = .011). Conclusion: A rising incidence of UCL repair compared with UCLR was found in New York State, especially among female patients, older patients, and nonprivate payers. There were no differences in 3-month complication rates between high- and low-volume centers, and Medicaid insurance status was a predictor for overall complications within 90 days of operation.

Relative contribution of the nail and plate to a nail-plate construct for comminuted distal femoral fractures.

The purpose of this study was to assess the biomechanical contributions of the nail and the plate individually to a complete nail-plate construct in the setting of comminuted distal femur fractures. For this biomechanical study, comminuted extra-articular distal femur fractures were created in 24 synthetic osteoporotic femur models. These were then split into three groups: the nail-only group, the plate-only group, and the nail-plate group. After fixation, each specimen underwent sequential axial and torsional loading, and axial and torsional stiffness were calculated and compared. The addition of a nail to a plate-only construct increased axial stiffness by 19.7% and torsional stiffness by 59.4%. The plate-only group and nail-plate group both demonstrated significantly greater axial and torsional stiffness than the nail-only group at all levels of axial and torsional load. (p < 0.001) At 1000 and 2000 N of cyclic loading, the nail-plate group demonstrated significantly greater axial stiffness than the plate-only group (p ≤ 0.018). The nail-plate group demonstrated greater torsional stiffness than the plate-only groups at all levels of torsional loading (p < 0.001). In osteoporotic comminuted distal femur fracture models, most of the axial stiffness in a nail-plate construct comes from the plate. While the combination of the two constructs is not fully additive, the plate contributes the majority of the axial and torsional stiffness in a nail-plate construct. The supplementation of the plate with a nail primarily helps to increase resistance to rotational forces. Level of Evidence: III.

Hemodynamics of low-pressure cardiac tamponade: An illustrative case report.

A 55-year-old male with acute pericarditis presented with low-pressure cardiac tamponade (LPCT) unresponsive to volume infusion. Subsequent pericardiocentesis resulted in hemodynamic improvement and unmasking of pericardial constriction. This case provides illustrative hemodynamic tracings of LPCT. Additionally, the presence of concurrent pericardial constriction that may indicate a plausible underlying mechanism for the blunted responsiveness to fluid expansion in LPCT. The underlying physiologic processes and the associated hemodynamic tracings are discussed.

Total hip arthroplasty outcomes in Ehlers-Danlos patients: data from the Statewide Planning and Research Cooperative System.

INTRODUCTION: Ehlers-Danlos syndromes (EDS) are genetic connective tissue disorders affecting multiple organ systems that frequently result in connective tissue hyperlaxity and early osteoarthritis. Short- and long-term outcomes after primary total hip arthroplasty (THA) in this patient population remain poorly characterised. The primary purpose of this study is to compare postoperative outcomes and survivorship after primary THA in patients with and without EDS. METHODS: The New York Statewide Planning and Research Cooperative System (SPARCS) database was queried for all patients undergoing primary elective THA between September 2009 and December 2020. Patients with EDS were identified using ICD9 and ICD10 diagnosis codes. Given the relatively low incidence of EDS in this patient population, the cohort was propensity-matched 1:10 to patients without diagnosis of EDS based on demographics characteristics and medical comorbidities as measured by the Elixhauser Comorbidity Index. RESULTS: A total of 66 THA patients with and 660 without EDS were included in each group after 1:10 propensity-matching. There were no significant differences in baseline characteristics or THA indications. Early postoperative outcomes such as length of hospital stay and discharge disposition were similar. Emergency Room visits and inpatient readmission rates at 3 months postoperatively did not significantly differ between groups. Patients with EDS had a higher overall revision rate compared to those without (15.0% vs. 3.2%, p < 0.001). Revision free survival after primary THA in patients with EDS was significantly lower than those without EDS at 9-year follow-up. Cox proportional hazard regression demonstrated EDS patients had 7-times higher risk of revision (hazard ratio [HR] 7.43; 95% CI, 3.46-16.00; p < 0.001). Lastly, revision due to instability insignificantly trended higher in the EDS cohort (HR 2.29; 95% CI, 0.95-5.49; p = 0.063). CONCLUSIONS: EDS patients undergoing primary THA have increased rate of all cause revision and demonstrate decreased revision free survival compared to non-EDS THA patients.

A mitochondrial NADPH-cholesterol axis regulates extracellular vesicle biogenesis to support hematopoietic stem cell fate.

Mitochondrial fatty acid oxidation (FAO) is essential for hematopoietic stem cell (HSC) self-renewal; however, the mechanism by which mitochondrial metabolism controls HSC fate remains unknown. Here, we show that within the hematopoietic lineage, HSCs have the largest mitochondrial NADPH pools, which are required for proper HSC cell fate and homeostasis. Bioinformatic analysis of the HSC transcriptome, biochemical assays, and genetic inactivation of FAO all indicate that FAO-generated NADPH fuels cholesterol synthesis in HSCs. Interference with FAO disturbs the segregation of mitochondrial NADPH toward corresponding daughter cells upon single HSC division. Importantly, we have found that the FAO-NADPH-cholesterol axis drives extracellular vesicle (EV) biogenesis and release in HSCs, while inhibition of EV signaling impairs HSC self-renewal. These data reveal the existence of a mitochondrial NADPH-cholesterol axis for EV biogenesis that is required for hematopoietic homeostasis and highlight the non-stochastic nature of HSC fate determination.

Macrophages coordinate immune response to laser-induced injury via extracellular traps.

BACKGROUND: Retinal degeneration results from disruptions in retinal homeostasis due to injury, disease, or aging and triggers peripheral leukocyte infiltration. Effective immune responses rely on coordinated actions of resident microglia and recruited macrophages, critical for tissue remodeling and repair. However, these phagocytes also contribute to chronic inflammation in degenerated retinas, yet the precise coordination of immune response to retinal damage remains elusive. Recent investigations have demonstrated that phagocytic cells can produce extracellular traps (ETs), which are a source of self-antigens that alter the immune response, which can potentially lead to tissue injury. METHODS: Innovations in experimental systems facilitate real-time exploration of immune cell interactions and dynamic responses. We integrated in vivo imaging with ultrastructural analysis, transcriptomics, pharmacological treatments, and knockout mice to elucidate the role of phagocytes and their modulation of the local inflammatory response through extracellular traps (ETs). Deciphering these mechanisms is essential for developing novel and enhanced immunotherapeutic approaches that can redirect a specific maladaptive immune response towards favorable wound healing in the retina. RESULTS: Our findings underscore the pivotal role of innate immune cells, especially macrophages/monocytes, in regulating retinal repair and inflammation. The absence of neutrophil and macrophage infiltration aids parenchymal integrity restoration, while their depletion, particularly macrophages/monocytes, impedes vascular recovery. We demonstrate that macrophages/monocytes, when recruited in the retina, release chromatin and granular proteins, forming ETs. Furthermore, the pharmacological inhibition of ETosis support retinal and vascular repair, surpassing the effects of blocking innate immune cell recruitment. Simultaneously, the absence of ETosis reshapes the inflammatory response, causing neutrophils, helper, and cytotoxic T-cells to be restricted primarily in the superficial capillary plexus instead of reaching the damaged photoreceptor layer. CONCLUSIONS: Our data offer novel insights into innate immunity's role in responding to retinal damage and potentially help developing innovative immunotherapeutic approaches that can shift the immune response from maladaptive to beneficial for retinal regeneration.

Polyvinyl alcohol hydrogel implant for the treatment of hallux rigidus is associated with a high complication rate and moderate failure rate at short-term follow-up: a systematic review.

PURPOSE: Moderate-to-severe hallux rigidus is a debilitating pathology that is optimally treated with surgical intervention. Arthrodesis produces reliable clinical outcomes but is limited by restriction in 1st metatarsophalangeal joint range of motion. The advent of polyvinyl alcohol hydrogel (PVA) implants have produced early promise based on initial trials, but more recent studies have called into question the efficacy of this procedure. The purpose of this systematic review was to evaluate the clinical and radiological outcomes following the use of PVA for hallux rigidus. METHODS: The MEDLINE, EMBASE and Cochrane library databases were systematically reviewed using the preferred reporting items for systematic reviews and meta-analyses guidelines. 18 studies were included. RESULTS: In total, 1349 patients (1367 feet) underwent PVA at a weighted mean follow-up of 24.1 ± 11.1 months. There were 168 patients (169 feet) included in the cheilectomy cohort and 322 patients (322 feet) included in the arthrodesis cohort. All 3 cohorts produced comparable improvements in subjective clinical outcomes. Postoperative imaging findings in the PVA cohort included joint space narrowing, peri-implant fluid, peri-implant edema and erosion of the proximal phalanx. The complication rate in the PVA cohort, cheilectomy cohort and arthrodesis cohort was 27.9%, 11.8% and 24.1%, respectively. The failure rates in the PVA cohort, cheilectomy cohort and arthrodesis cohort was 14.8%, 0.3% and 9.0%, respectively. CONCLUSION: This systematic review demonstrated that PVA produced a high complication rate (27.9%) together with concerning postoperative imaging findings at short-term follow-up. In addition, a moderate failure rate (14.8%) and secondary surgical procedure rate (9.5%) was noted for the PVA cohort. The findings of this review calls into question the efficacy and safety of PVA for the treatment of hallux rigidus. LEVEL OF EVIDENCE: IV.

Do Patients With Insulin-Dependent and Non-Insulin-Dependent Diabetes Have Different Risks for Complications After Total Ankle Arthroplasty?

BACKGROUND: Patients with diabetes undergoing total ankle arthroplasty tend to be at greater risk for complications than those without diabetes. However, the effect of diabetes severity and how it impacts the risk for perioperative complications is less clear. The purpose of this study was to compare (1) complications, (2) length of hospital stay, and (3) readmissions within 30 days for total ankle arthroplasty (TAA) patients without diabetes, patients with non-insulin-dependent diabetes, and patients with insulin-dependent diabetes. METHODS: Using the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database, a total of 1803 patients undergoing TAA between 2007 and 2019 were collected. The relationship between diabetes status (no diabetes [n = 1,589], insulin-dependent [n = 169], and non-insulin-dependent [n = 45]) and outcomes were compared. Multivariate linear regression models were used to adjust for confounding variables such as age, sex, race, body mass index, smoking, steroid use, hypertension, chronic obstructive pulmonary disease, anesthesia type, dyspnea, and outpatient status. Statistical significance was set at P <.05. RESULTS: Insulin-dependent diabetes was an independent risk factor for increased odds of infection within 30 days (odds ratio 6.47, 95% CI 0.79-33.66; P = .043). Hospital length of stay was also increased in patients with non-insulin-dependent diabetes (ß = 0.21, 95% CI 0.02-0.40; P = .031) and insulin-dependent diabetes (ß = 0.40, 95% CI 0.04-0.76; P = .028). However, neither diabetic state demonstrated a statistically significant increase in readmissions or wound complications within 30 days. CONCLUSION: Patients with insulin-dependent diabetes included in this cohort were at increased risk of having an infection within 30 days after TAA. Additionally, patients with diabetes status had an increased hospital length of stay. These results can inform patients on their potential outcomes after total ankle arthroplasty based on their diabetes status. LEVEL OF EVIDENCE: Level III, retrospective comparative study.

Resilient anatomy and local plasticity of naive and stress haematopoiesis.

The bone marrow adjusts blood cell production to meet physiological demands in response to insults. The spatial organization of normal and stress responses are unknown owing to the lack of methods to visualize most steps of blood production. Here we develop strategies to image multipotent haematopoiesis, erythropoiesis and lymphopoiesis in mice. We combine these with imaging of myelopoiesis1 to define the anatomy of normal and stress haematopoiesis. In the steady state, across the skeleton, single stem cells and multipotent progenitors distribute through the marrow enriched near megakaryocytes. Lineage-committed progenitors are recruited to blood vessels, where they contribute to lineage-specific microanatomical structures composed of progenitors and immature cells, which function as the production sites for each major blood lineage. This overall anatomy is resilient to insults, as it was maintained after haemorrhage, systemic bacterial infection and granulocyte colony-stimulating factor (G-CSF) treatment, and during ageing. Production sites enable haematopoietic plasticity as they differentially and selectively modulate their numbers and output in response to insults. We found that stress responses are variable across the skeleton: the tibia and the sternum respond in opposite ways to G-CSF, and the skull does not increase erythropoiesis after haemorrhage. Our studies enable in situ analyses of haematopoiesis, define the anatomy of normal and stress responses, identify discrete microanatomical production sites that confer plasticity to haematopoiesis, and uncover unprecedented heterogeneity of stress responses across the skeleton.

Stereotactic ablative body radiotherapy for primary kidney cancer (TROG 15.03 FASTRACK II): a non-randomised phase 2 trial.

BACKGROUND: Stereotactic ablative body radiotherapy (SABR) is a novel non-invasive alternative for patients with primary renal cell cancer who do not undergo surgical resection. The FASTRACK II clinical trial investigated the efficacy of SABR for primary renal cell cancer in a phase 2 trial. METHODS: This international, non-randomised, phase 2 study was conducted in seven centres in Australia and one centre in the Netherlands. Eligible patients aged 18 years or older had biopsy-confirmed diagnosis of primary renal cell cancer, with only a single lesion; were medically inoperable, were at high risk of complications from surgery, or declined surgery; and had an Eastern Cooperative Oncology Group performance status of 0-2. A multidisciplinary decision that active treatment was warranted was required. Key exclusion criteria were a pre-treatment estimated glomerular filtration rate of less than 30 mL/min per 1·73 m2, previous systemic therapies for renal cell cancer, previous high-dose radiotherapy to an overlapping region, tumours larger than 10 cm, and direct contact of the renal cell cancer with the bowel. Patients received either a single fraction SABR of 26 Gy for tumours 4 cm or less in maximum diameter, or 42 Gy in three fractions for tumours more than 4 cm to 10 cm in maximum diameter. The primary endpoint was local control, defined as no progression of the primary renal cell cancer, as evaluated by the investigator per Response Evaluation Criteria in Solid Tumours (version 1.1). Assuming a 1-year local control of 90%, the null hypothesis of 80% or less was considered not to be worthy of proceeding to a future randomised controlled trial. All patients who commenced trial treatment were included in the primary outcome analysis. This trial is registered with ClinicalTrials.gov, NCT02613819, and has completed accrual. FINDINGS: Between July 28, 2016, and Feb 27, 2020, 70 patients were enrolled and initiated treatment. Median age was 77 years (IQR 70-82). Before enrolment, 49 (70%) of 70 patients had documented serial growth on initial surveillance imaging. 49 (70%) of 70 patients were male and 21 (30%) were female. Median tumour size was 4·6 cm (IQR 3·7-5·5). All patients enrolled had T1-T2a and N0-N1 disease. 23 patients received single-fraction SABR of 26 Gy and 47 received 42 Gy in three fractions. Median follow-up was 43 months (IQR 38-60). Local control at 12 months from treatment commencement was 100% (p<0·0001). Seven (10%) patients had grade 3 treatment-related adverse events, with no grade 4 adverse events observed. Grade 3 treatment-related adverse events were nausea and vomiting (three [4%] patients), abdominal, flank, or tumour pain (four [6%]), colonic obstruction (two [3%]), and diarrhoea (one [1%]). No treatment-related or cancer-related deaths occurred. INTERPRETATION: To our knowledge, this is the first multicentre prospective clinical trial of non-surgical definitive therapy in patients with primary renal cell cancer. In a cohort with predominantly T1b or larger disease, SABR was an effective treatment strategy with no observed local failures or cancer-related deaths. We observed an acceptable side-effect profile and renal function after SABR. These outcomes support the design of a future randomised trial of SABR versus surgery for primary renal cell cancer. FUNDING: Cancer Australia Priority-driven Collaborative Cancer Research Scheme.

The Role of Hyaluronan/Receptor for Hyaluronan-Mediated Motility Interactions in the Modulation of Macrophage Polarization and Cartilage Repair.

Hyaluronan (HA), a negatively charged linear glycosaminoglycan, is a key macromolecular component of the articular cartilage extracellular matrix. The differential effects of HA are determined by a spatially/temporally regulated display of HA receptors, such as CD44 and receptor for hyaluronan-mediated motility (RHAMM). HA signaling through CD44 with RHAMM has been shown to stimulate inflammation and fibrotic processes. This study shows an increased expression of RHAMM in proinflammatory macrophages. Interfering with HA/RHAMM interactions using a 15-mer RHAMM-mimetic, HA-binding peptide, together with high-molecular-weight (HMW) HA reduced the expression and release of inflammatory markers and increased the expression of anti-inflammatory markers in proinflammatory macrophages. HA/RHAMM interactions were interfered in vivo during the regeneration of a full-thickness cartilage defect after microfracture surgery in rabbits using three intra-articular injections of 15-mer RHAMM-mimetic. HA-binding peptide together with HMWHA reduced the number of proinflammatory macrophages and increased the number of anti-inflammatory macrophages in the injured knee joint and greatly improved the repair of the cartilage defect compared with intra-articular injections of HMWHA alone. These findings suggest that HA/RHAMM interactions play a key role in cartilage repair/regeneration via stimulating inflammatory and fibrotic events, including increasing the ratio of proinflammatory/anti-inflammatory macrophages. Interfering with these interactions reduced inflammation and greatly improved cartilage repair.

A narrative review of the Medtronic Hugo RAS and technical comparison with the Intuitive da Vinci robotic surgical system.

Medtronic launched the Hugo Robotic-Assisted Surgery (RAS) System in 2021, offering a modular alternative to the incumbent market leader in surgical robotics, the Intuitive da Vinci (dV) surgical system. A detailed technical review of the Hugo RAS was conducted to explore the strengths and weaknesses of this new robotic surgical system. Each component of the system-vision tower, arm cart, and surgeon console-was compared against the existing dV systems. The docking process, instrumentation, and external arm movement trajectories were analyzed. The modular Hugo RAS provides the possibility of operating using up to four arm carts. It has certain design features that are unique to itself, and others that have been implemented to address the shortcomings of the dV Si. While Medtronic's first-generation robot offers distinct advantages over the older Intuitive systems, the true test of its mettle will be its performance compared to the latest dV Xi.

Postoperative complications in rheumatic disease patients undergoing arthroscopy on immunosuppression.

BACKGROUND: There are currently no guidelines on peri-arthroscopic management of immunosuppressive (IS) treatment in rheumatic disease patients. PURPOSE: The purpose of this study is to characterize the rheumatic disease patient population undergoing arthroscopy, compare the incidence of postoperative complications among patients who either remained on IS perioperatively, held IS perioperatively or were not on IS at baseline, and compare the incidence of postoperative complications by rheumatic disease type, medication type, and procedure. METHODS: We conducted a retrospective review of all arthroscopic sports medicine surgeries in patients with a rheumatic disease diagnosis at our institution over an 11-year period. Patients on IS at baseline were grouped into those who remained on IS perioperatively or held all IS before the date of their surgery. These two groups were compared to patients who were not on IS at baseline. Incidence of postoperative complications was calculated for the three cohorts and by medication class, rheumatic disease type, and procedure risk. Analysis of variance (ANOVA), chi-squared, and Fisher's exact tests were used to determine the statistical significance of between-group differences in postoperative complication incidence. RESULTS: We identified 1,316 rheumatic disease patients undergoing arthroscopy, with 214 of them taking IS medications at baseline. In total, 8.4% (n = 110) remained on IS perioperatively, 7.9% (n = 104) held IS perioperatively, and 83.7% (n = 1102) were not on IS at baseline. In all cohorts, seven patients experienced postoperative complications; six of whom experienced infections. Two (1.82%) occurred in patients remaining on IS perioperatively, zero infections occured in patients who held all IS, and four (0.36%) occured in patients who were not on any IS at baseline. There was no statistically significant difference in postoperative infections or complication rates among the three cohorts or further subgroups. CONCLUSION: The risk of postoperative complications including infectious, major, and minor complications in patients on IS at the time of arthroscopy is low and acceptable.

Descemet Endothelial Thickness Comparison Trial 1 (DETECT 1): outcome masked, placebo-controlled trial comparing two types of corneal transplant surgeries and effect of rho kinase inhibitors on endothelial cell loss protocol.

BACKGROUND: It remains uncertain which endothelial keratoplasty (EK) technique yields the best outcomes while maintaining safety, particularly in eyes with coexisting ocular conditions. Moreover, the impact of endothelial cell loss (ECL) on long-term graft survival requires further investigation. Adjuvant ripasudil, a rho kinase inhibitor, may address the challenge of ECL in corneal transplantation. This paper presents the protocol for the Descemet Endothelial Thickness Comparison Trial 1 (DETECT 1), a multicentre, outcome-masked, randomised, placebo-controlled, four-arm clinical trial. METHODS: A total of 160 eligible patients with endothelial dysfunction will be enrolled from five participating sites in the USA. The patients will be randomly assigned in a 2×2 factorial design to one of the following treatment groups: group 1-ultrathin Descemet stripping endothelial keratoplasty (UT-DSAEK) plus topical ripasudil 0.4%; group 2-UT-DSAEK plus topical placebo; group 3-Descemet membrane endothelial keratoplasty (DMEK) plus topical ripasudil 0.4% and group 4-DMEK plus topical placebo. Primary outcomes include the best spectacle-corrected visual acuity at 12 months and ECL at 12 months. Secondary outcomes include visual acuity at different time points, vision-related quality of life, endothelial cell morphology and cost-effectiveness. RESULTS: The study outcomes will be analysed using mixed effects linear regression models, taking into account the treatment arms and relevant covariates. Adverse events, including rebubble procedures, graft failure and graft rejection, will be documented and analysed using appropriate statistical methods. CONCLUSION: DETECT I aims to provide evidence on the comparative effectiveness of UT-DSAEK and DMEK, as well as the potential benefits of adjuvant topical ripasudil in reducing ECL. The results of this trial will contribute to optimising corneal transplantation techniques and improving long-term graft survival, while also exploring the cost-effectiveness of these interventions. Dissemination of findings through peer-reviewed publications and national/international meetings will facilitate knowledge translation and guide clinical practice in the field of corneal transplantation. ETHICS AND DISSEMINATION: A data and safety monitoring committee (DSMC) has been empaneled by the NEI.All study protocols will be subject to review and approval by WCG IRB as the single IRB of record.This study will comply with the National Institute of Health (NIH) Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. Data from the trial will be made available on reasonable request.

Positive outcome reporting in orthopaedic literature.

Aims: Perthes' disease (PD) is a relatively rare syndrome of idiopathic osteonecrosis of the proximal femoral epiphysis. Treatment for Perthes' disease is controversial due to the many options available, with no clear superiority of one treatment over another. Despite having few evidence-based approaches, many patients with Perthes' disease are managed surgically. Positive outcome reporting, defined as reporting a study variable producing statistically significant positive (beneficial) results, is a phenomenon that can be considered a proxy for the strength of science. This study aims to conduct a systematic literature review with the hypothesis that positive outcome reporting is frequent in studies on the treatment of Perthes' disease. Methods: We conducted a systematic review of all available abstracts associated with manuscripts in English or with English translation between January 2000 and December 2021, dealing with the treatment of Perthes' disease. Data collection included various study characteristics, surgical versus non-surgical management, treatment modality, mean follow-up time, analysis methods, and clinical recommendations. Results: Our study included 130 manuscripts. Overall, 110 (85%) reported positive (beneficial) results, three (2%) reported negative results, and 17 (13%) reported no significant difference. Despite only 10/130 studies (8%) having a testable hypothesis, 71 (55%) recommended the use of their studied treatment methods for the patients, five (4%) made recommendations against the use of the studied treatment modality, and 54 (42%) did not make any recommendations. Conclusion: The overall rate for positive outcomes among included manuscripts regarding different treatment methods for Perthes' disease (85%) is higher than the 74% positive outcome rate found among studies for other surgically treated disorders and significantly higher than most scientific literature. Despite the lack of testable hypotheses, most manuscripts recommended their studied treatment method as a successful option for managing patients solely based on the reporting of retrospective data.

Trends in the treatment of proximal humerus fractures from 2010 to 2020.

BACKGROUND: The incidence of proximal humerus fractures (PHF) is continuing to rise due to shifts towards a more aged population as well as advancements in surgical treatment options. The purpose of this study is to examine and compare trends in the treatment of PHFs (nonoperative vs. operative; different surgical treatments) across different age groups over the last decade (2010-2020). METHODS: The New York Statewide Planning and Research Cooperative System (SPARCS) database was queried using International Classification of Diseases and Current Procedural Terminology codes to identify all patients presenting with or undergoing surgery for PHF between 2010 and 2020. Treatment trends, demographics, and insurance information were analyzed during the study period. Comparisons were made between operative and nonoperative trends with respect to the number and type of surgeries performed among 3 age groups: ≤49 years, 50-64 years, and ≥65 years. The rate of postoperative complications and reoperations was evaluated and compared among different surgical treatments for patients with a minimum 1-year postoperative follow-up. RESULTS: A total of 92,308 patients with a mean age of 67.8 ± 16.8 years were included. Over the last decade, there was no significant increase in the percentage of PHFs treated with surgery. A total of 15,523 PHFs (16.82%) were treated operatively, and these patients, compared with the nonoperative cohort, were younger (64.9 years vs. 68.4 years, P < .001), more likely to be White (80.2% vs. 74.7%, P < .001), and more likely to have private insurance (41.4% vs. 32.0%, P < .001). For patients ≤49 years old, trends in operative treatment have remained stable with internal fixation (IF) as the most used surgical modality. For patients 50-64 years old, we observed a gradual decline in the use of hemiarthroplasty (HA), with a corresponding increase in the use of reverse total shoulder arthroplasty (rTSA), but IF continued to be the most used operative modality. In patients over 65 years, a steep decline in the use of IF and HA was noted during the first half of the decade along with a significant exponential increase in the use of rTSA, which surpassed the use of IF in 2019. Despite the increase in the use of rTSA, no differences in rate of surgical complications were noted between rTSA and IF (χ2 = 0.245, P = .621) or reoperations (χ2 = 0.112, P = .730). CONCLUSION: Nonsurgical treatment remains the mainstay treatment of PHFs. Although there is no increase in the prevalence of operative treatment in patients ≥50 years in the last decade, there is an exponential increase in the use of rTSA with a corresponding decrease in HA and IF, a trend more substantial in patients ≥65 years compared with patients between 50 and 64 years.