Preclinical evaluation of saroglitazar magnesium, a dual PPAR-α/γ agonist for treatment of dyslipidemia and metabolic disorders.

1. Saroglitazar, a novel peroxisome proliferator-activated receptor (PPAR) agonist, regulates lipid and glucose metabolism. The objective of this report is to provide a preclinical evaluation (in vitro/in vivo) of ADME properties of saroglitazar. In vitro studies included determination of permeability, metabolic stability, plasma protein binding, CYP reaction phenotyping and CYP inhibitory liability. In vivo studies included oral bioavailability and pharmacokinetic assessment in mouse, rat and dog. The excretion of saroglitazar was determined in rats. Exploratory metabolism of saroglitazar was evaluated using in vitro and in vivo samples. 2. Saroglitazar was metabolically more stable in human liver microsomes as compared to rat and dog liver microsomes, highly protein bound (98-99.6%) with high Caco2 permeability (104 nm/s) with <2 efflux ratio. In vitro metabolism in rat, dog and human liver microsomes revealed three putative metabolites corresponding to di-hydroxylation, mono-oxygenation and dehydrogenation moieties. 3. Oral bioavailability was 100%, 72% and 47% in mouse, rat and dog, respectively. The intravenous clearance and volume of distribution of saroglitazar were 3.6, 8.5 and 6.9 mL/min/kg and 1.3, 4.8 and 1.8 L/kg for mouse, rat and dog, respectively. The elimination half-life of saroglitazar ranged between 6 and 15 h. Saroglitazar appeared to be eliminated via hepatobiliary route with negligible renal excretion.

Summary of validation considerations with real-life examples using both qualitative and semiquantitative flow cytometry assays.

In the clinical laboratory, flow cytometry assays are critical to providing diagnostic and prognostic information to the treating clinicians. A validation or verification provides confidence that the assay will yield reliable results that can be trusted to make critical medical decisions. The following performance specifications should be included in a validation for laboratory developed tests as needed: accuracy (or trueness), precision (reproducibility and repeatability), detection capability, selectivity, reference range, and sample and reagent stability. We define these terms and present our approach to validation of several common flow cytometry assays, including examples of a leukemia/lymphoma assay and a paroxysmal nocturnal hemoglobinuria (PNH) assay.

Left Ventricular Non-compaction Cardiomyopathy: A Case Report and Literature Review.

Left Ventricular Non-Compaction Cardiomyopathy (LVNC) is a rare myocardial disorder characterized by abnormal myocardial tissue formation in which the left ventricular wall appears to be trabecular with prominent intertrabecular recesses. The diagnosis of LVNC is predominantly reliant on cardiac imaging, namely thoracic echocardiography, however, cardiac MRI is indicated in conditions in which echocardiography is inconclusive. Diagnostic criteria for both echocardiography and cardiac MRI differ, however, the general principle of diagnosis is a comparison of the thickness of non-compacted to compacted myocardial tissue. The management of LVNC is nearly identical to that of Heart Failure with reduced Ejection Fraction (HFrEF), however, anticoagulation is an additional measure of management to the thrombogenic nature of non-compacted myocardial tissue. Here, we discuss a case of LVNC and the current data on its management.

Clinical outcomes of MANTA vs suture-based vascular closure devices after transcatheter aortic valve replacement: An updated meta-analysis.

OBJECTIVE: A recently published randomized control trial showed different results with suture-based vascular closure device (VCD) than plug-based VCD in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). The learning curve for MANTA device is steep, while the learning curve for suture based VCD is shallow as the devices are quite different. In this meta-analysis, we have compared suture-based (ProGlide and Prostar XL) vs plug-based VCDs (MANTA). METHODS: We performed a meta-analysis of all published studies (using PubMed/Medline and Cochrane databases) reporting the clinical outcome of plug-based vs suture-based VCDs in transfemoral TAVR patients. RESULTS: We included nine studies with a total of 2865 patients (plug-based n = 1631, suture-based n = 1234). There was no significant difference in primary outcome of all bleeding when using plug-based as opposed to suture-based VCDs (RR 1.14 [0.62-2.06] I2 = 72%). There was no significant difference in the incidence of secondary outcomes between two groups including major life threatening bleeding (RR 1.16 [0.38-3.58] I2 = 65%), major vascular complications (RR 0.84 [0.35-2.00] I2 = 55%), minor vascular complications (RR 1.05 [0.56-1.95] I2 = 42%), pseudo aneurysm (RR 1.84 [0.11-29.98] I2 = 44%), stenosis-dissection (RR 0.98 [0.66-1.47] I2 = 0%), VCD failure (RR 1.71 [0.96-3.04] I2 = 0%), and blood transfusion (RR 1.01 [0.38-2.71], I2 = 61%). CONCLUSION: Large bore arteriotomy closure with plug-based VCD was not superior to suture-based VCDs in this transfemoral TAVR population. There was very frequent use of secondary VCDs in suture-based VCD group which is not practical when using MANTA. Additional high-powered studies are required to determine the safety and efficacy of MANTA device.

Giant-Cell Aortitis-Induced Acute Aortic Insufficiency: An Underestimated Etiology.

BACKGROUND Acute aortic insufficiency can be secondary to multiple conditions, including infective endocarditis, aortic root pathologies (eg, dissection, aortitis), or traumatic injury. Aortitis involves a broad spectrum of disorders characterized by inflammatory changes in the aortic wall. This pathology can be subsequently classified depending on its etiology into inflammatory and infectious causes. Large-vessel vasculitis (giant-cell arteritis, Takayasu arteritis, and IgG4-related vasculitis) is the most common non-infectious causes of aortitis. Giant-cell aortitis usually lacks the classic clinical findings of giant-cell arteritis such as headache, visual symptoms, or jaw claudication, which can be a diagnostic challenge. However, clinicians should have a high index of suspicion, since this pathology can evolve into potentially life-threatening conditions, including aortic aneurysm, aortic wall rupture, and aortic acute dissection. CASE REPORT We present a case of a 76-year-old woman who presented to the Emergency Department (ED) with shortness of breath associated with orthopnea, paroxysmal nocturnal dyspnea, and mild productive cough with white sputum. A transthoracic echocardiogram demonstrated reduced left ventricular ejection fraction, dilated left ventricle, and severe aortic insufficiency. Cardiac catheterization revealed mild non-obstructive coronary arteries and severe aortic regurgitation. The surgical pathology report of the portion of the aorta was consistent with giant-cell aortitis. CONCLUSIONS In this article, we present a case of giant-cell aortitis as an unusual etiology of acute aortic insufficiency, which is most probably under-detected in clinical practice. In addition to describing the case, we aim to highlight the importance of proper ascending aorta evaluation in patients presenting with new-onset aortic regurgitation and heart failure to prevent associated morbidity and mortality.

Peritumoral Immunoglobulin M Lambda Light Chain Amyloidosis in a Patient With Advanced Follicular Lymphoma.

Peritumoral light chain (AL) amyloidosis secondary to lymphoid malignancies is a rare but well-described entity. Peritumoral deposition of amyloid without systemic amyloidosis has been described in mucosa-associated lymphoid tissue (MALT) lymphomas; however, there are no reported cases of follicular lymphoma with localized peritumoral AL amyloidosis without systemic involvement of amyloidosis. We present a rare case of a patient with advanced follicular lymphoma with peritumoral lymph node IgM lambda light chain amyloidosis without an underlying monoclonal gammopathy or plasma cell dyscrasia.

Fatigue Failure of Outer Metal Dome of Bipolar Monoblock Shell in Hemiarthroplasty Hip: Case Report and Review of Literature.

Introduction: We report a rare case of transmural wear-through of the polyethylene inner liner leading to fatigue failure of polished outer metallic dome of bipolar monoblock shell in cemented hemiarthroplasty 5-years after the index surgery. Case Presentation: A 62-year-old active man reported with 6 months of worsening right hip pain. He had undergone cemented bipolar hemiarthroplasty for sub-capital fracture of the right femur 5 years back. Radiographs demonstrate significant full-thickness wear-through of the Cobalt-Chromium head through the polyethylene inner liner and outer metal dome into the acetabulum. Biomechanics study revealed inadequate thickness of outer metallic dome of monoblock shell. Revision Total hip arthroplasty was performed. At the 5-year follow-up, radiographs show stable components and no clinical abnormality. Conclusion: Albeit rare, this failure mode aimed to raised awareness, routine follow-up, and quality assurance.

Predictors of 90-Day All-Cause Morbidity, Mortality and Poor Functional Outcome Scores Following Elective Total Knee Arthroplasty in a High-Volume Setting: A Prospective Cohort Study.

Background: The primary objective was to ascertain the predictors of 90-day all-cause morbidity, mortality and poor functional outcome scores following primary total knee arthroplasty (TKA). Material and Method: The study population comprised 3645 patients who underwent elective primary unilateral TKA at our institution. Demographic variables, Body Mass Index (BMI), American Society of Anesthesiologists (ASA) grade and the Deyo-Charlson comorbidity scores were ascertained. The Functional outcomes, perioperative complications, mortality and readmission rates were monitored prospectively for 90 days and analysed. Patients were assessed twice: at baseline and at 90 days postoperatively. Odds ratio and the corresponding 95% confidence intervals were calculated to quantify the risk. A p < 0.05 for two-tailed tests were considered significant. Result: The 90-day mortality rate was 0.08% (all males) and 3.95% of the patients experienced one or the other complications. The majority of patients reported excellent-to-poor scores at 90-day follow-up VAS (8.85 ± 1.02 vs. 2.65 ± 1.15; p < 0.0001) and KSS scores (42.96 ± 5.90 vs. 80.52 ± 4.15; p < 0.0001). The early readmission rate was 0.96%. Infection was being the primary reason. Age > 70 years; Deyo-Charlson co-morbidity score ≥ 4, ASA grade-III, Diabetes Mellitus, BMI > 35, Cardiac Issues and Male gender were significant predictors of early morbidity and mortality. Female, Deyo-Charlson comorbidity score ≥ 4, ASA grade-III, BMI > 35, Age > 75 years and poor preoperative scores were significantly associated with poor functional outcome. Conclusion: The present study explicates the relative importance of predictors on morbidity, mortality and functional outcome. Efforts to minimize morbidity and mortality should concentrate more on elderly male patients, and those with high Deyo-Charlson comorbidity score, BMI and ASA grade.

Painless Presentation of a Deadly Disease: Type A Aortic Dissection Requiring the Bentall Procedure.

Aortic dissection is a relatively uncommon, although catastrophic, disease which requires early and accurate diagnosis and treatment for patient survival. Aortic dissection can be difficult to diagnose due to the diverse symptom presentation, which can lead to later diagnosis, resulting in a higher mortality rate. Here we present a case of type A aortic dissection with a varied symptom presentation, highlighting the importance of early detection and the Bentall procedure for management of such cases. A 50-year-old man with no known medical history presented with bilateral lower extremity swelling and fatigue for 2 weeks. The patient denied any chest pain or dyspnoea. Vital signs showed blood pressure of 160/76 mmHg, pulse of 103 bpm, respiratory rate of 18, and temperature of 36.7°C. Laboratory findings indicated a BNP of 1901 pg/ml and troponin of 0.5 ng/ml. An initial diagnosis of decompensated heart failure was made, and IV Lasix was started. Subsequently, an echocardiogram indicated an EF of 50-55% and ascending dissection of the aorta. A CT angiogram of the chest and abdomen confirmed this diagnosis. This patient presented with unusual symptoms of aortic dissection without the typical presentation of chest pain. It is important to consider aortic dissection in a cardiac-related case as prompt imaging can help confirm the diagnosis. We explore the risks and benefits of the Bentall procedure for the management and early detection of aortic dissection. LEARNING POINTS: The absence of chest pain does not rule out aortic dissection as 50% of patients are pain free.It is critical to diagnose aortic dissection early in the disease course as mortality increases by 1% per hour from symptom onset.The aim of this study is also to raise awareness among healthcare professionals about the Bentall procedure in patients with type A aortic dissection involving the aortic valve.

A Rare Case of Eustachian Valve Endocarditis in a Young Male With Poorly Controlled Type 1 Diabetes Mellitus.

The eustachian valve (EV) is a vestigial structure found at the junction of the inferior vena cava and the right atrium, a remnant of the embryological sinus venosus that may persist throughout life. Right-sided infective endocarditis of the eustachian valve remains a distinctly rare and under-diagnosed entity. Commonly known risk factors of eustachian valve endocarditis (EVE) are intravenous drug use, in-dwelling intracardiac devices, and central lines, although more recently immunocompromised states, e.g. uncontrolled diabetes mellitus and old age, have been recognized as risk factors for the disease. Although Staphylococcus aureus has been the most commonly implicated organism, cases of infections with gram-negative organisms are emerging. We present a 47-year-old male with uncontrolled type 1 DM who initially presented to the ED with complaints of low back pain and dysuria and was later found to have eustachian valve endocarditis ultimately treated with intravenous antibiotics.

Reduction of blood loss in primary hip arthroplasty with tranexamic acid or fibrin spray.

BACKGROUND AND PURPOSE: Previous studies have shown that either fibrin spray or tranexamic acid can reduce blood loss at total hip replacement, but the 2 treatments have not been directly compared. We therefore conducted a randomized, controlled trial. PATIENTS AND METHODS: In this randomized controlled trial we compared the effect of tranexamic acid and fibrin spray on blood loss in cemented total hip arthroplasty. 66 patients were randomized to 1 of 3 parallel groups receiving (1) a 10 mg/kg bolus of tranexamic acid prior to surgery, (2) 10 mL of fibrin spray during surgery, or (3) neither. All participants except the surgeon were blinded as to treatment group until data analysis was complete. Blood loss was calculated from preoperative and postoperative hematocrit. RESULTS: Neither active treatment was found to be superior to the other in terms of overall blood loss. Losses were lower than those in the control group, when using either tranexamic acid (22% lower, p = 0.02) or fibrin spray (32% lower, p = 0.02). INTERPRETATION: We found that the use of tranexamic acid at induction, or topical fibrin spray intraoperatively, reduced blood loss compared to the control group. Blood loss was similar in the fibrin spray group and in the tranexamic acid group. ClinicalTrials.gov identifier: NCT00378872. EudraCT identifier: 2006-001299-19. Regional Ethics Committee approval: 06/S0703/55, granted June 6, 2006.

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of a Nutritional Supplement (ImmuActiveTM) for COVID-19 Patients.

BACKGROUND: SARS-CoV-2 has emerged as a global threat due to its infectivity and rapid transmission. We evaluated the safety and efficacy of herbal and mineral formulation (ImmuActive) as an adjunct therapy in COVID-19 patients. METHODS: A randomized, double-blind, placebo-controlled study was conducted in 100 COVID-19 patients in three centers in Southern India, and 92 subjects completed the study. Subjects were followed up until they were discharged from the hospital or for a maximum of 28 days, whichever was earlier. The primary outcome parameters were the mean change and time required to change the ordinal scale of disease severity by one unit. The secondary outcomes were the time required to turn RT-PCR negative or get discharged from the hospital, change in modified Jackson's Symptom Severity score, and COVID-19 quality of life questionnaire. RESULTS: The ordinal scale at the end of the study was significantly lower in COVID-19 patients supplemented with ImmuActive (0.57) than placebo (1.0), with a p value of 0.0043. The ordinal scale decreased by one unit within 2.35 days in ImmuActive-supplemented patients, while it took 3.36 days in placebo-supplemented patients. Days of hospitalization and time required to turn RT-PCR negative were comparatively lower in the ImmuActive arm than the placebo arm. Change in modified Jackson's Symptom Severity Score and COVID-19 QOL were significant from screening to the end of the study in both ImmuActive and placebo arms. There were no adverse events observed during the study period. CONCLUSION: The study results suggest that ImmuActive could be a beneficial and safe adjunct treatment for effectively managing COVID-19 infection symptoms.

Acute-Hypoxemia-Induced Right-To-Left Shunting in the Presence of Patent Foramen Ovale.

Patent foramen ovale (PFO) is a common congenital abnormality of the heart. It results from incomplete closure of foramen ovale that persists in adulthood. Most individuals with PFO are asymptomatic and are discovered incidentally. The left atrial pressure is generally higher than the right atrial pressure, which prevents blood flow against the gradient; however, any medical condition that increases the pulmonary artery pressure can lead to reversal of blood flow from right to left by elevating right atrial pressure. We present a case of a 59-year-old female who presented with complaints of shortness of breath associated with bilateral lower-extremity edema and was found to have acute decompensated heart failure and atrial fibrillation. Transesophageal echocardiogram (TEE) with cardioversion was performed. Propofol was given for conscious sedation; however, the procedure was terminated as patient became hypoxemic and was noted to have moderately dilated right ventricle (RV) with hypokinesia and PFO with right-to-left shunting. It also demonstrated mild mitral regurgitation, mild left ventricular hypertrophy, and a left ventricular ejection fraction of 55-60%. In contrast to TEE findings, while the patient was having normal oxygen saturation, transthoracic echocardiogram showed left-to-right shunting instead of right-to-left and no RV hypokinesia was noted. In conclusion, this case draws attention to the relationship between acute hypoxemia and right-to-left shunting in a patient with PFO. This case illustrates and highlights the need for more prospective studies to establish a relationship between acute hypoxemia and right-to-left shunting in the presence of PFO.

COVID-19 pandemic and total knee arthroplasty: the concept of a containment sheet-a frugal innovation.

BACKGROUND: The primary purpose of the present study was to assess whether use of proposed containment sheet (so called "a frugal innovation") minimizes the aerosol and splatter dispersion during total knee arthroplasty (TKA). MATERIAL AND METHOD: A total of 32 patients with knee osteoarthritis who were scheduled to undergo primary and unilateral TKA reported during the COVID-19 pandemic were enrolled into this prospective single-institution cohort study. Demographic and epidemiological data, travel and contact history were collected. Eligible cohort was randomly assigned to a study (TKA using containment sheet) group and a control group (TKA without containment sheet). Radiological and functional outcomes before operation and at the final follow-up were assessed using Western Ontario and Mc-master Universities Osteoarthritis Index score (WOMAC) and the visual analog scale (VAS). The primary outcome was the postoperative effectiveness of containment sheet and face shield, defined as the numbers of countable macroscopic aerosols and/or splatters to naked eyes. The level of significance was set at p < 0.05 levels. RESULTS: Present cohort was comprised of 14 men (43.75%) and 18 women (56.25%) with an average age of 65.45 ± 4.07 years (range, 62-75 years). There were no statistically significant differences with regard to baseline parameters and perioperative demographics. Functional outcomes for knee function at the last follow-up showed significant improvement in both the groups (p < 0.05). Face shield showed significant number of aerosols/splatters in control group. Highest number/concentration of aerosols/splatters was contained within the sheet. CONCLUSION: The proposed containment sheet can minimize the dispersion of aerosols and splatters generated during TKA and provide a safe healthcare environment in a cost-effective manner.

Medial Soft-Tissue Release for Lateralising Calcaneal Osteotomy: A Cadaveric Study.

BACKGROUND: Lateralising calcaneal osteotomy for pes cavus is generally regarded to be harder to shift than a medialising calcaneal osteotomy for pes planus. The aim of our study was to determine the structures which restrain a lateral shift. METHODS: Lateralising calcaneal osteotomy was performed on four soft-embalmed cadavers via a standard lateral approach and the lateral calcaneal shift was measured before and after the release of flexor retinaculum. Further exploratory dissection around the osteotomy site revealed the abductor hallucis muscle to be the main restraint to the lateral shift of the calcaneus. Subsequently, lateralising calcaneal osteotomy was performed on another four cadavers and the abductor hallucis muscle fascia as well as the plantar fascia was released. The lateral shift was measured before and after the fascia release, and compared with the results achieved following the flexor retinaculum release in the first four cadavers. RESULTS: Lateralising calcaneal osteotomy alone resulted in an average of 4.5-mm lateral shift in the first four cadaveric specimens. Releasing the flexor retinaculum led to a further 3-mm increase of lateral shift on average. In the next four cadaveric specimens, lateralising calcaneal osteotomy alone resulted in an average of 5.5-mm lateral shift. Release of abductor hallucis muscle fascia and the plantar fascia in these four specimens increased the lateral shift by an additional 7 mm on average. Hence, release of abductor hallucis muscle fascia resulted in an extra 4-mm shift on average compared with what is achieved with flexor retinaculum release. CONCLUSIONS: Abductor hallucis muscle fascia was discovered to be one of the main structures limiting the lateral shift in lateralising calcaneal osteotomy. Release of fascia over this muscle as well as the plantar fascia should help in improving lateral shift. Further experimental and clinical research is necessary to confirm the findings of this pilot study.

Clinical Study to Evaluate the Efficacy and Safety of a Hair Serum Product in Healthy Adult Male and Female Volunteers with Hair Fall.

BACKGROUND: Hair fall is a widespread problem among all genders, ages, and ethnicity with both physical and psychological effects. OBJECTIVE: This clinical study was designed to evaluate the efficacy and safety of a hair serum formulation containing amla extract, freeze-dried coconut water, and the micronutrient selenium along with sandalwood odorant and peanut shell extract in healthy male and female volunteers with hair fall. METHODS: A total of 42 subjects were enrolled and completed the study and they used the test product daily for 90 days. TrichoScan® was used to evaluate the efficacy of the test product for improving hair growth rate, hair density, anagen hair, telogen hair, and the density of vellus and terminal hair. Hair thinning and hair fall reduction were compared to its basline by both dermatologists and subject self-assessment questionnaires. RESULT AND DISCUSSION: After 90 days of test product application, there was a significant improvement in hair growth rate (<0.0001), hair density (<0.0001), vellus hair density (<0.0001), and terminal hair density (<0.0001) in comparison to baseline. There was a significant reduction in hair fall with bulb (<0.0001) and without bulb (<0.0001), and hair thinning (<0.0001) compared to the baseline measurement. Adverse events were not recorded during the study. No skin intolerance was reported during the study, and the test product was considered dermatologically safe to use.

Proximal fibular resection improves knee biomechanics and enhances tibial stress fracture healing in patients with osteoarthritis with varus deformity: a prospective, randomized control analysis.

BACKGROUND: The present study aimed to evaluate the functional outcome of single-stage total knee arthroplasty using long-stem tibial component with proximal fibular resection (PFR) for patients with knee osteoarthritis with varus deformity associated with tibial stress fracture. METHOD: A cohort of 62 patients with a mean age 71.63 ± 7.40 years who met the criteria were randomized to a study group and a control group. Patients in the study group underwent single-stage total knee arthroplasty using long-stem tibial component with PFR. The control group received conventional treatment. All patients were followed at 1, 3, 6 and 12 month(s) after surgery. Standard anteroposterior and lateral weight bearing knee X-rays were analyzed. Western Ontario and Mc-master Universities Osteoarthritis Index score (WOMAC) and the visual analog scale (VAS) score were used to assess the functional outcome. The level of significance was set at p < 0.05 levels. RESULTS: One patient in the study group was lost to follow-up, leaving 61 patients for final assessment. The WOMAC total score and mean VAS score were significantly better in study group than in control group at final follow-up (p < 0.05). All fractures were successfully united in a mean time of 12.26 ± 1.20 weeks in study group. A total of 16 patients in control group had delayed union, five had established nonunion and required further interventions. No complications relating to surgery was detected. CONCLUSION: Total knee arthroplasty with PFR for knee arthritis with varus deformity associated with tibial stress fractures restores limb alignment, improves biomechanics, enhances fracture healing and provides excellent functional outcome.

Circulating cytokines after hip and knee arthroplasty: a preliminary study.

UNLABELLED: Several studies show cytokine concentrations in the peripheral blood are associated with inflammatory activity and surgical trauma. Cytokine concentrations have more rapid increase and quicker return to normal values than either C-reactive protein or erythrocyte sedimentation rate - a matter of hours rather than weeks; some studies suggest they are better predictors of postoperative infection than C-reactive protein and erythrocyte sedimentation rate. Threshold levels of interleukin-6 after joint arthroplasty have been determined, but levels of other potentially useful cytokines (tumor necrosis factor-alpha, interleukin-8, interleukin-10, etc) are not known. We measured the serum levels of 25 different cytokines before and after hip and knee arthroplasties and identified those associated with surgical trauma. Peripheral venous blood samples (one preoperative and three postoperative) from 49 patients undergoing hip or knee arthroplasty were analyzed by laser chromatography. Three of the 25 cytokines had a relationship with postsurgical trauma, which included one deep infection. Serum levels of these three cytokines might be useful to identify periprosthetic infections during the early postoperative period when C-reactive protein and erythrocyte sedimentation rate remain elevated. LEVEL OF EVIDENCE: Level II, prognostic study. See the Guidelines for Authors for a complete description of levels of evidence.

The use of tranexamic acid to reduce blood loss in uncemented total hip arthroplasty for avascular necrosis of femoral head: a prospective blinded randomized controlled study.

BACKGROUND: The purpose of this prospective, double-blinded, randomized controlled study is to assess the efficacy of administration of intravenous tranexamic acid (TXA) for reducing blood loss in uncemented total hip arthroplasty (THA) for the treatment of osteonecrosis of femoral head. METHODS: Between April 2012 and March 2014, 73 patients with avascular necrosis of femoral head were treated in our center. The patients were randomized and allocated to study group (n = 36; treated with TXA) and control group (n = 37). Intra- and postoperative blood loss, blood transfusion, and incidence of deep vein thrombosis were assessed. A p value less than 0.05 was considered statistically significant. RESULTS: The intraoperative, postoperative, and total (clinical method and Gross' formula) blood loss were significantly greater in the control group (p < 0.05). On the first, second, and third postoperative days, the levels of hemoglobin and hematocrit were significantly better in the study group (p < 0.05). There was a significantly greater number of patients who required blood transfusion in the control group (p = .027). Deep vein thrombosis was not found in either group. CONCLUSIONS: A single dose of TXA used preoperatively may minimize intraoperative, postoperative, and total blood loss in uncemented THA for the treatment of osteonecrosis of femoral head, and may not increase the risk of prothrombotic complications.