Capsule In Patients Research Articles

Safety and efficacy of an herbal formulation in patients with renal calculi - A 28 week, randomized, double-blind, placebo-controlled, parallel group study

BackgroundUrolithiasis is a growing problem worldwide. Many a times, asymptomatic stones are kept under observation. Many herbal preparations are available for the same, but they lack proper scientific documentation. ObjectiveTo study the anti-urolithiatic effect of an herbal preparation, Subap Plus (IP) capsules in patients with asymptomatic renal calculi of size ranging from 4 to 9 mm. Material and methodsThis was a prospective, randomized, double-blind, placebo-controlled clinical trial conducted in a tertiary care hospital in Pune, India.Patients with asymptomatic renal calculi of 4–9 mm size were randomized (1:1, block randomization) to one of the group Subap Plus (treatment group) or placebo (placebo group). The study outcome included change in visual analog scale (VAS), change in the surface area and density of calculi and their expulsion. Statistical analysis was performed using student's t-test and Chi-square test. ResultsA total of 120 patients were screened and 84 were enrolled who met the eligibility criteria, of which 65 patients completed the trial (treatment, n = 34; placebo, n = 31). The VAS score significantly decreased in the treatment group (6.9–1.8) than placebo group (7.2–6.8) (p < 0.001). The surface area and density were decreased by 47.58% (p < 0.008) and 43.01% (p < 0.001), respectively, in the treatment group than the placebo group. The expulsion of calculi was significantly higher in the treatment group than placebo group (20.59 vs. 3.23%, p < 0.03). ConclusionPatients treated with herbal formulation showed better expulsion rate and reduction in surface area and density than the placebo group.

An open-label, multi-center, prospective, interventional, clinical study to evaluate the efficacy and safety of Ayuvigo forte capsules in patients suffering from oligospermia

Background: Oligospermia refers to semen with a low concentration of sperms. Oligospermia is one of the common causative factors of male infertility. Objectives: The objective of this study was to assess the efficacy and safety of Ayuvigo forte capsule in patients suffering from oligospermia. Materials and Methods: This was an open-label, prospective, interventional, multi-center clinical study. A total of 30 patients were completed the study. All patients were advised to consume two Ayuvigo forte capsules twice daily orally after meals with a cup of milk for 90 days. Data describing quantitative measures are expressed as a mean ± standard deviation. Results: The mean total sperm count, mean progressive sperm motility, and total number of spermatozoa increased significantly (P 0.05) changes were observed in mean serum luteinizing hormone, follicle-stimulating hormone, prolactin, safety laboratory parameters, and vitals. Excellent overall efficacy and tolerability were observed in majority of patients. Conclusion: Ayuvigo forte capsule is safe and effective for the management of oligospermia.

An open-label, prospective, multicenter, clinical study to evaluate efficacy of Ayuartis capsules in patients suffering from osteoarthritis of the knee(s).

Background:The management of chronic degenerative joint disorders such as osteoarthritis (OA) with ayurvedic medicines provides a safe and effective alternative. Ayurvedic medicines possess analgesic, anti-inflammatory, anti-oxidant and immunomodulator activities.Aims:The main aim of the study was to assess the efficacy of Ayuartis capsule in patients suffering from OA of the knee(s).Materials and Methods:Thirty-one patients suffering from OA knee(s) were recruited after evaluating them as per inclusion/exclusion criteria. Patients were advised to take two Ayuartis capsules twice daily orally for 90 days. Knee joint(s) pain was assessed on the Visual Analog Scale. Patients’ joint pain, stiffness, and physical functions were assessed on the Western Ontario McMaster University Osteoarthritis (WOMAC) index. Quality of life (QOL) and the time required to walk 50 feet was evaluated. Patients were called for follow-up visits on every 15th day till 90 days. Adverse events and vitals were recorded at every visit. Safety laboratory investigations were done before and after the completion of trial.Statistical Analysis:Data describing quantitative measures are expressed as mean ± standard deviation. The comparison of variables representing categorical data was performed using pair t-test.Results:The mean joint pain reduced significantly by 53.82% on day 90. The mean WOMAC combined score, pain score, stiffness score and difficulty score reduced significantly by 50.88%, 54.96%, 58.76% and 49.02%, respectively on day 90. A significant improvement was observed in mean QOL of patients. A significant reduction in mean time required to walk 50 feet was observed. Majority of the patients had shown good overall improvement and excellent tolerability to the trial drug.Conclusion:Ayuartis capsule is a safe and effective medicine for the treatment of OA of the knee(s).

Validation of Diagnostic and Performance Characteristics of the Wireless Motility Capsule in Patients With Suspected Gastroparesis

It is a challenge to make a diagnosis of gastroparesis. There is good agreement in results from wireless motility capsule (WMC) analysis and gastric emptying scintigraphy (GES), but the diagnostic yield of WMC is unclear and the accuracy of this method has not been validated. We compared the performance characteristics of WMC vs GES in assessing gastric emptying in patients with suspected gastroparesis. We performed a prospective study of 167 subjects with gastroparesis (53 with diabetes and 114 without) at 10 centers, from 2013 through 2016. Subjects were assessed simultaneously by GES and with a WMC to measure gastric emptying and regional transit. Delayed gastric emptying by GES was defined as more than 10% meal retention at 4 hrs whereas delayed gastric emptying by WMC was defined as more than 5 hrs for passage of the capsule into the duodenum; a severe delay in gastric emptying was defined as a gastric emptying time of more than 12 hrs by WMC or more than 35% retention at 4 hrs by GES. Rapid gastric emptying was defined as less than 38% meal retention at 1 hr based on by GES or gastric emptying times less than 1:45 hrs by WMC. We compared diagnostic and performance characteristics of GES vs WMC. Delayed gastric emptying was detected in a higher proportion of subjects by WMC (34.6%) than by GES (24.5%) (P=.009). Overall agreement in results between methods was 75.7% (kappa=0.42). In subjects without diabetes, the WMC detected a higher proportion of subjects with delayed gastric emptying (33.3%) than GES (17.1%) (P < .001). A higher proportion of subjects with diabetes had delayed gastric emptying detected by GES (41.7%) compared with non-diabetic subjects (17.1%) (P=.002). Severe delays in gastric emptying were observed in a higher proportion of subjects by WMC (13.8%) than by GES (6.9%) (P = .02). Rapid gastric emptying was detected in a higher proportion of subjects by GES (13.8%) than by WMC (3.3%) (P < .001). Regional and generalized transit abnormalities were observed in 61.8% subjects and only detected by WMC. Although there is agreement in analysis of gastric emptying by GES vs WMC, WMC provides higher diagnostic yield than GES. WMC detects delayed gastric emptying more frequently than GES and identifies extra-gastric transit abnormalities. Diabetic vs non-diabetic subjects have different results from GES vs WMC. These findings could affect management of patients with suspected gastroparesis. ClinicalTrials.gov no: NCT02022826.

Multicenter, randomized, double-blind clinical trial to evaluate efficacy and safety of combined glucosamine sulfate and chondroitin sulfate capsules for treating knee osteoarthritis

ObjectivesTo compare the efficacy and safety of a new fixed dose combination of glucosamine sulfate and chondroitin sulfate capsules (GS/CS) versus the fixed dose combination of glucosamine hydrochloride and chondroitin sulfate (Cosamin DS®) in capsules in patients with osteoarthritis (OA) of the knee.MethodsMulticenter, randomized, double-blind study. Participants with knee OA Kellgren-Lawrence grades 1 to 3 and VAS of symptoms ≥4 cm were randomized to receive GS/CS or Cosamin DS® over 12 weeks. The primary efficacy endpoint was the evaluation of the analgesic efficacy by the investigator. Secondary efficacy endpoints included: joint pain and swelling, investigator efficacy of the medication, and the use of rescue medication. Adverse events and drug tolerability were analyzed.ResultsOne hundred patients were randomized, and 50 patients were allocated to each group. The analgesic efficacy evaluated by the investigator in the GS/CS group was 88.9, 95%CI: 75.2, 95.8% and in the Cosamin DS® group was 85.4%; 95%CI: 70.1, 93.4%. The mean reduction in the pain intensity was significant in both groups (p < 0.001), with no difference between them. The primary efficacy analysis demonstrated the non-inferiority of the GS/CS group compared with the Cosamin DS® group; the lower limit of the 90% confidence interval (CI) between the two groups (− 8.39%) was higher than the established margin of non-inferiority of − 10.00%. Improvement in other efficacy outcomes was observed, again without differences between groups. Adverse events were similar between groups and both presented good tolerability.ConclusionsThe new fixed-dose formulation of GS/CS is effective in treating knee OA, presenting a good safety and tolerability profile. Trial Registration(https://clinicaltrials.gov/ct2/show/NCT00955552?term=NCT00955552&rank=1; ClinicalTrials.gov; register number NCT00955552; First randomized patient: 08/17/2010).

A multicenter, double-blind, randomized controlled trial comparing magnetic resonance imaging evaluation of repaired versus unrepaired interportal capsulotomy in patients undergoing hip arthroscopy for femoroacetabular impingement.

ABSTRACTThe purpose of this study was to evaluate the magnetic resonance imaging (MRI) appearance of the hip capsule in patients with femoroacetabular impingement (FAI) undergoing hip arthroscopy with capsular repair versus non-repair. A multicenter clinical trial was performed with 31 patients (49 hips) undergoing hip arthroscopy for treatment of FAI. A small- to moderate-sized interportal capsulotomy was performed. Each hip was randomized to capsular repair versus non-repair of the interportal capsulotomy. MRI was performed at 6 and 24 weeks postoperatively and was analyzed by two musculoskeletal radiologists. Patients and the radiologists were blinded to the treatment applied. Capsular defect size and capsule thickness were recorded on each scan. Mean patient age was 31.4 years. Capsular repair was performed in 23 (46.9%) hips. Mean capsulotomy length was 35 mm at Center X and 23 mm at Center Y. At 6 weeks postoperatively, a healed hip capsule (with no apparent capsulotomy defect) was observed in 10 (43.4%) hips that underwent capsular repair and 4 (15.4%) hips that did not undergo capsular repair (P = 0.13). At 24 weeks postoperatively, 25/30 hips (83.3%) achieved complete closure of the capsulotomy defect, with no significant difference between treatment groups. Repair of an interportal capsulotomy following hip arthroscopy for FAI results in a non-significantly higher percentage of healed hip capsules at 6 weeks postoperatively compared with leaving the capsule unrepaired, though the difference normalizes by 24-week follow-up. Repair of a small- to moderate-sized interportal capsulotomy does not provide a radiographic advantage following hip arthroscopy for FAI.

The dimensions of the hip capsule can be measured using magnetic resonance imaging and may have a role in arthroscopic planning.

The purpose of this study was to systematically evaluate the dimensions and thickness of the hip joint capsule. Secondarily, the study assessed whether there were any described correlations between capsule thickness and stability of the hip joint. Four databases (PubMed, Ovid [MEDLINE], Cochrane Database, and EMBASE) were searched from database inception to May 2018, and two reviewers independently and in duplicate screened the resulting literature. Methodological quality of all included papers was assessed using the Methodological index for non-randomized studies (MINORS) criteria. Mean differences were combined in a meta-analysis using a random effects model when possible. A total of 14 studies (1 level I, 1 level II, 4 level III, 5 level IV) were identified including 796 patients (1013 hips) with a mean age of 39.5years (range 2-95). Of the included patients, 55.2% were female and they were followed up for a mean of 7.6months (range 1-12.5months). The thickness of the capsule was measured in cadaveric specimens, ultrasound, and magnetic resonance imaging (MRI), with MRI measurements reported most consistently and with the least variation. Mean thickness of the anterior capsule in patients without hip disease on MRI ranged from 4.4 and 4.7mm. Mean thickness of the anterior capsule in patients with FAI ranged between 4.9 and 5.0mm. Males had significantly thicker capsules than females (mean difference = 1.92mm, 0.35-3.49, P = 0.02). Clinical laxity of the hip joint, as well as female gender was correlated with thinner anterior joint capsules. The thickness of the anterior hip capsule can be measured consistently using MRI. A thinner anterior capsule may be associated with clinical laxity of the hip joint. The relevance of capsular thickness on postoperative instability following hip arthroscopy is poorly understood and warrants further investigation. The thickness of the anterior hip capsule, as measured on MRI, has the potential to be used as part of the clinical decision-making in capsular management strategies. IV.

Scheimpflug Camera Measurement of Optical Density of the Corneal Epithelium, Stroma, and Endothelium in Patients with Pseudoexfoliation Syndrome.

BackgroundThe present study evaluated the optical density of particular layers of the cornea and anterior lens capsule in patients with pseudoexfoliation syndrome (PEX).Material/MethodsSixty patients with cataract and PEX (mean age 76.6±5.6 years, range 62–88 years) were compared to 55 controls with cataract without PEX syndrome (mean age 76.3±6.09 years, range 62–90 years; P>0.05). The anterior segment of one eye was examined in each patient using Pentacam HR by Oculus before the planned cataract surgery.ResultsThe average optical density of the corneal epithelium, stroma, and endothelium was 25.3±6.09% and 19.9±3.41% (P<0.001), 23.1±5.5% and 19.2±3.6% (P<0.0001), and 14.6±3.4% and 12.3±2.1% (P<0.0001) in the PEX and control groups, respectively. The optical density of the anterior lens capsule was 13.6±4.2% in the PEX group and 9.74± 2.23% in the control group (P<0.0001). The average thickness of the cornea was 555 μm and 556 μm and the average optical density of endothelial cells 2240/mm2 and 2323/mm2 in the PEX and control groups, respectively (P<0.05).ConclusionsIn patients with PEX, increased optical density was observed not only in the structures with pseudoexfoliative material detectable by a slit-lamp), but also in the corneal epithelium and stroma. The increased optical density was not associated with reduced endothelial cell density or increased central cornea thickness.

An Open Label Study to Evaluate Safety and Efficacy Of Unex® Capsules In Patients With Urinary Disorders

An Open Label Study to Evaluate Safety and Efficacy Of Unex® Capsules In Patients With Urinary Disorders

MR findings of the orbit in patients with Vogt-Koyanagi-Harada disease.

We aimed to evaluate the MR findings of the orbit in patients with Vogt-Koyanagi-Harada disease (VKHD). We included 14 patients with clinically diagnosed VKHD, who underwent orbital MR imaging before treatment between May 2011 and August 2017. The mean duration from initial symptom onset to MR imaging was 16days (range, 2-36days). Fat-suppressed gadolinium-enhanced T1-weighted images were obtained in six patients. We retrospectively assessed the choroids and Tenon's capsules for the presence of thickening on unenhanced images and abnormal enhancement on contrast-enhanced images. Bilateral choroidal thickening was observed in 14 patients (100%) on T1-weighted images and in 12 patients (85.7%) on T2-weighted images. Choroidal thickening showed posterior pole predominance in 11 patients (78.6%) and diffusely distributed in the remaining three patients (21.4%). Bilateral Tenon's capsule thickening was observed in five patients (35.7%) on T1-weighted images and in 14 patients (100%) on T2-weighted images. On contrast-enhanced images, the choroids and Tenon's capsules were abnormally enhanced in six patients (100%). MR imaging sensitively detected abnormalities of the choroids and Tenon's capsules in patients with VKHD. Bilaterality and predominant posterior pole distribution were characteristic of choroidal VKHD.

MRI Evaluation of Repaired Versus Unrepaired Interportal Capsulotomy in Simultaneous Bilateral Hip Arthroscopy: A Double-Blind, Randomized Controlled Trial.

Techniques used in hip arthroscopy continue to evolve, and controversy surrounds the need for capsular repair following this surgical intervention. The purpose of this study was to evaluate the magnetic resonance imaging (MRI) appearance of the hip capsule in patients with femoroacetabular impingement (FAI) who underwent simultaneous bilateral hip arthroscopy through an interportal capsulotomy with each hip randomized to undergo capsular repair or not undergo such a repair. This double-blind, randomized controlled trial included 15 patients (30 hips), with a mean age of 29.2 years, who underwent simultaneous bilateral hip arthroscopy utilizing a small (<3-cm) interportal capsulotomy for the treatment of FAI. The first hip treated in each patient was intraoperatively randomized to undergo capsular repair or no capsular repair. The contralateral hip then received the opposite treatment. MRI was performed at 6 and 24 weeks postoperatively, and the scans were analyzed by 2 musculoskeletal radiologists. The patients and the radiologists were blinded to the treatment performed on each hip. Capsular dimensions were measured at the level of the healing capsulotomy site and, for hips with a persistent defect, at locations both proximal and distal to the defect. These values were then analyzed at both time points to assess the rate and extent of capsular healing. At 6 weeks postoperatively, a continuous hip capsule (with no apparent capsulotomy defect) was observed in 8 hips treated with capsular repair and 3 hips without such a repair. Of the 19 hips with a discontinuous capsule at 6 weeks, 17 were available for follow-up at 24 weeks postoperatively; all 17 demonstrated progression to healing, with a contiguous appearance without defects and no difference in capsular dimensions between treatment cohorts. Arthroscopic repair of a small interportal hip capsulotomy site yields an insignificant increase in the percentage of continuous hip capsules seen on MRI at 6 weeks postoperatively compared with no repair. Repaired and unrepaired capsulotomy sites progressed to healing with a contiguous appearance on MRI by 24 weeks postoperatively. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Treatment of Danhong Injection Combined with Naoxintong Capsule in Acute Coronary Syndrome Patients Undergoing PCI Operation: Study for a Randomized Controlled and Double-Blind Trial.

Objective This double-blind and randomized placebo-controlled trial evaluated the safety and efficacy of Danhong injection combined with Naoxintong capsule in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI). Methods ACS patients scheduled to undergo PCI (n = 130) were equally and randomly apportioned to either a treatment or control group. After PCI, the treatment group received Danhong injection combined with Naoxintong capsule for 12 weeks, while the control group was given placebo. Both groups were otherwise treated with conventional secondary prevention of coronary artery disease. The groups were primarily evaluated for clinical efficacy and cardiovascular events. Evaluative indicators of safety included adverse events, platelet count, and liver, renal, and blood coagulation functions. Result No cardiovascular events or adverse reactions were observed in either group. The treatment group demonstrated better signs of clinical efficacy, including left ventricular ejection fraction, higher nitric oxide levels, and lower levels of endothelin-1 (ET-1) and von Willebrand factor (VWF). Conclusion ACS patients treated with Danhong injection combined with Naoxintong capsule after PCI demonstrated better improvement with regard to markers associated with atherosclerosis and adverse cardiovascular events, without apparent adverse effects. Thus, Danhong injection combined with Naoxintong capsule was safe and effective for treating ACS patients after PCI.

Electron Microscopic Investigation of Anterior Lens Capsule and Epithelium in Patients with Diabetes Mellitus

Purpose: To evaluate the histopathologic alterations of organelles in the epithelium of the anterior lens capsule. Methods: The interventional study included 26 eyes; of which 11 had non-proliferative diabetic retinopathy (diabetic group) and cataract, and 15 had age-related cataract (control group). We investigated the anterior lens capsule in patients with diabetes mellitus by using electron microscopy and to compare it between diabetic eyes and healthy eyes. Anterior capsule samples were obtained by circular continuous capsulorhexis during phacoemulsification procedures. All the samples were fixed and conventionally processed for electron microscopy analysis. Results: Demographic characteristics of the diabetic group and the control group were similar (p > 0.05). In the diabetic group, electron dense cells with an apoptotic appearance were seen and these cells had an apoptotic nucleus and prominent mitochondrial crystalysis. In addition, there was dilatation of the endoplasmic reticulum cistern. In the control group, lens epithelial cells and all their elements had a normal pattern. Neither cells with an apoptotic appearance nor mitochondrial crystalysis was seen, but there was dilatation of the endoplasmic reticulum cistern. Conclusions: Diabetes mellitus can engender structural abnormalities of organelles in the epithelium of the anterior lens capsule including mitochondrial crystalysis, dilatation of the endoplasmic reticulum cistern and apoptotic dense nucleus. It can be suggested that diabetes mellitus affects organelles of anterior lens epithelium in eyes with cataracts, while it causes non-proliferative changes in the retina.

Efficacy and Safety of Zhenyuan Capsule for Coronary Heart Disease with Abnormal Glucose and Lipid Metabolism: Study Protocol for a Randomized, Double-Blind, Parallel-Controlled, Multicenter Clinical Trial.

Background Coronary heart disease (CHD) and abnormal glucose and lipid metabolism are closely associated and generally coexist. The Qi and Yin deficiency syndrome is a common disease pattern encountered in traditional Chinese medicine. We designed a protocol to determine the effectiveness and safety of Zhenyuan capsules for CHD with abnormal glucose and lipid metabolism. Methods This multicenter, randomized, double-blind, parallel-controlled trial was designed in accordance with the CONSORT. We will recruit 200 eligible male patients aged 45–75 years from three participating centers and randomly assign them to treatment and control groups (1 : 1). The primary indicators are glycosylated hemoglobin, fasting blood glucose, 2-hour postprandial blood glucose, and triglyceride levels. The secondary indicators are the Seattle Angina Questionnaire, TCM symptom indicators, ultrasonic cardiography finding, coagulation indicator, and P-selectin level. Measurements will be performed at baseline (T0), the end of the run-in period (T1), and weeks 4 (T2), 8 (T3), and 12 (T4) of the treatment period. Adverse events will be monitored during the trial. Discussion This study aims to evaluate the efficacy and safety of Zhenyuan capsules in patients with CHD and abnormal glucose and lipid metabolism. The results will provide critical evidence of the usefulness of the Chinese herbal medicine for CHD with abnormal glucose and lipid metabolism. Trial Registration This trial is registered with the Chinese Clinical Trials Registry, with identifier number ChiCTR-TRC-14004639, May 4, 2014.

A COMPARATIVE STUDY BETWEEN THE EFFICACY OF NIFEDIPINE AND HYDRALAZINE IN SEVER PREECLAMPSIA IN THE THIRD TRIMESTER OF PREGNANCY AND COMPARISON THE PERINATAL OUTCOME IN SULAIMANI MATERNITY TEACHING HOSPITAL

Background Preeclampsia is an idiopathic disorder of pregnancy characterized by proteinuric hypertension; hydralazine is an arterial vasodilator antihypertensive drug. Nifedipine is a calcium channel blocker antihypertensive drug. Objective To compare the effect of intravenous hydralazine and oral immediate release nifedipine capsule in patients with severe preeclampsia in their 3rd trimester of pregnancy and compare the early perinatal outcome. Material and Methods A prospective cohort study set at Sulaimani Maternity Teaching Hospital, Sulaimani, Iraq, throughout period of January first 2015 to September first 2015. The study includes 50 patients diagnosed with sever preeclampsia (blood pressure ≥ 160/110 mmHg and &gt; 1 gram proteinuria) in the third trimester of pregnancy, who admitted to Emergency Department of Sulaimani Maternity Teaching Hospital from January, first 2015 to September, first 2015. Patients had been divided into two groups, the first 25 patients had received hydralazine and the second 25 patients received nifedipine. The blood pressure and fetal heart rate recorded before and after the treatment, the target blood pressure: Systolic blood pressure &lt; 160 mmHg and diastolic blood pressure &lt; 110 mmHg. Results Both drugs were ultimately effective in reaching the therapeutic goal because there were no failures requiring crossover in either study group. Patients received intravenous hydralazine achieved the therapeutic blood pressure more rapidly in (38.0±14.0) minutes (mean±SD) as compared with (51.3±23.9) minutes who received oral immediate release nifedipine. P=0.05. Both drugs had no effect on fetal heart rate but they had many maternal side effects especially with hydralazine which associated with more palpitation than nifedipine (12% versus 8%). In mode of delivery, 72% of women from hydralazine group and 52% of women from nifedipine group their pregnancies are terminated by caesarean section, while 36% of women from nifedipine group and 20% of women from hydralazine group were delivered vaginally. Conclusion Both drugs are efficient in controlling the blood pressure in sever preeclampsia and no significant difference in perinatal outcome. Nifedipine needed longer period but less number of doses to reach the goal blood pressure. Because the nifedipine’s oral bioavailability and less frequent side effects, it more preferable anti-hypertensive therapy in emergency cases compared to the hydralazine.

Validation of Performance Characteristics of the Wireless Motility Capsule in Patients With Gastroparesis Symptoms

Validation of Performance Characteristics of the Wireless Motility Capsule in Patients With Gastroparesis Symptoms

Surgical Treatment of Segond Fractures in Acute Anterior Cruciate Ligament Reconstruction.

Background:The Segond fracture is an avulsion-type fracture located on the anterolateral aspect of the tibia associated with a ligament recently termed the anterolateral ligament. This injury has been described as pathognomonic for an anterior cruciate ligament (ACL) tear and is associated with a higher grade pivot shift.Purpose:To present and report 2-year clinical outcomes of a surgical technique for acute ACL reconstruction with fixation of a concomitant Segond fracture.Study Design:Case series; Level of evidence, 4.Methods:A retrospective chart review was performed of patients who underwent acute reconstruction for a complete ACL tear with concomitant Segond fracture fixation between January 2010 and December 2014; surgery was performed by a single surgeon. Patients underwent direct Segond fracture repair by either suture alone, suture anchor, or cannulated screw fixation based on the size of the lesion, followed by a 2-incision hamstring autograft intra-articular reconstruction. Pre- and postoperative KT-1000 arthrometer assessment, Lachman test, and pivot-shift test were performed, and patients were administered validated subjective outcome surveys.Results:Twelve patients met inclusion criteria for this review. The measured pre- and postoperative objective and subjective scores were significantly improved in all patients. Side-to-side anterior laxity was significantly improved in all patients based on Lachman and KT-1000 arthrometer testing. A significant pivot shift demonstrated preoperatively (3+, n = 11 [92%]; 2+, n = 1 [8%]) was corrected after fixation, except in 1 patient (8%), who maintained a 1+ pivot shift. Lysholm, Tegner, and International Knee Documentation Committee subjective and objective scores were significantly improved. At a minimum 2-year follow-up, no patients reported rerupture, and only 1 patient (8%) underwent a subsequent procedure (a meniscectomy). No major or minor complications were reported, and all patients returned to their previous activity levels at a mean of 6 months postoperatively.Conclusion:Direct repair of the Segond fracture and plication of the anterolateral capsule in patients with an ACL rupture and a high-grade pivot shift demonstrate good clinical outcomes, restoration of rotational stability, and maintenance of knee range of motion at 2 years postoperatively, with no major complications.

Virtual bioequivalence for achlorhydric subjects: The use of PBPK modelling to assess the formulation-dependent effect of achlorhydria

Majority of bioequivalence studies are conducted in healthy volunteers. It has been argued that bioequivalence may not necessarily hold true in relevant patient populations due to a variety of reasons which affect one formulation more than the other for instance in achlorhydric patients where elevated gastric pH may lead to differential effects on formulations which are pH-sensitive with respect to release or dissolution. We therefore examined achlorhydria-related disparity in bioequivalence of levothyroxine and nifedipine formulations using virtual bioequivalence within a physiologically-based pharmacokinetic (PBPK) modelling framework. The in vitro dissolution profiles at neutral pH were incorporated into PBPK models to mimic the achlorhydria with in vitro–in vivo relationship established using bio-relevant pH media. The PBPK models successfully reproduced the outcome of the bioequivalence studies in healthy volunteers under the normal conditions as well as under proton pump inhibitor-induced achlorhydria. The geometric mean test/reference ratios for Cmax and AUC between levothyroxine tablet and capsule in patients receiving proton pump inhibitor were 1.21 (90%CI, 1.13–1.29) and 1.09 (90%CI, 1.02–1.17), respectively. Extension of the virtual bioequivalence study to Japanese elderly, who show high incidence of achlorhydria, indicated bio-inequivalence which Cmax and AUC ratios between nifedipine control-released reference and test formulations were 3.08 (90%CI, 2.81–3.38) and 1.57 (90%CI, 1.43–1.74), respectively. Virtual bioequivalence studies through the PBPK models can highlight the need for conduct of specific studies in elderly Japanese populations where there are discrepancies in pH-sensitivity of dissolution between the test and reference formulations.

Optical Coherence Tomographic Imaging of Posterior Episclera and Tenon's Capsule.

To investigate structural features of the posterior episclera and Tenon's capsule in patients with high myopia. This hospital-based observational study included highly myopic eyes (myopic refractive error > -8 diopters or axial length ≥26.5 mm) in which the posterior sclera in its full thickness could be visualized on swept-source optical coherence tomography (OCT) images in all 12 radial scans centered on the fovea. We assessed the posterior episclera and Tenon's capsule. The study included 278 eyes of 175 patients (mean age, 60.9 ± 11.4 years; range, 32-89 years; axial length, 30.7 ± 1.9 mm; range, 26.5-36.6 mm). The episclera was detected outside of the sclera in 164 eyes (59.0%) and appeared as a relatively uniform structure with a reflectivity slightly lower than scleral reflectivity. In these eyes, mean scleral thickness was 197 ± 73 μm in the foveal region and 164 ± 64 μm and 146 ± 59 μm at 1000 and 2500 μm temporal to the fovea, respectively. The posterior episclera was visualized in the region temporal to the fovea. Mean episcleral thickness detected in 77 eyes was 80 ± 27 μm and 82 ± 30 μm at 1000 μm and 2500 μm temporal to the fovea, respectively. Tenon's capsule was detected in 11 of the 278 eyes (4.0%) as structurally, loosely connected tissue with a meshwork-like appearance. The measured thickness in four eyes was 60 ± 32 μm. In 25 eyes with extremely thin sclera (<100 μm at 1000 μm temporal to the foveola), the mean thickness of the sclera and episclera were 87 ± 11 μm and 65 ± 15 μm, respectively. Swept-source OCT applied to a subset of highly myopic eyes with significant thinning of the retina and choroid allowed visualization of the posterior sclera and episclera, and in some cases, also Tenon's capsule.

Magnetic Resonance Imaging Comparison of Repaired versus Non-Repaired Hip Capsule in Patients Undergoing Hip Arthroscopy for Femoroacetabular Impingement: A Double-Blind, Randomized Controlled Trial

Objectives:Techniques used in hip arthroscopy continue to evolve and controversy surrounds the need for capsule repair following surgical intervention. The purposes of this study were to evaluate the magnetic resonance imaging (MRI) appearance of the hip capsule in patients with femoroacetabular impingement (FAI) undergoing hip arthroscopy with capsular repair versus non-repair.Methods:A multicenter clinical trial was performed with 35 patients (50 hips) undergoing hip arthroscopy for treatment of FAI. Each hip was preoperatively randomized to capsular repair versus non-repair. MRI evaluation was performed by a radiologist at 6 and 24 weeks postoperatively. Patients and the radiologist were blinded to the randomization. Capsular defect size and the thickness of the capsule at the capsulotomy site and at locations both proximal and distal to the defect were recorded on each scan to determine their change over time.Results:Compared to patients without capsular repair, those with capsular repair demonstrated significantly decreased mean capsular gapping at articular and muscular portions of the hip capsule at 6 weeks postoperatively (p < 0.001). This difference normalized between the two cohorts by 24 weeks postoperatively, with a significantly decreased mean capsular gapping at articular and muscular attachment sites of the hip capsule compared to 6 weeks postoperatively (p < 0.03). Defects were readily apparent on MRI imaging in regions where the capsule was not repaired. In contrast, irregular capsular thickening without a discrete defect was visible in most cases where the capsule was repaired at the time of arthroscopy. The appearance was variable after 24 weeks. The capsular defects that did close universally showed closure of the defect beginning at the muscular side of the capsule with bridging of capsular tissue then filling in on the articular side.Conclusion:Arthroscopic hip capsule repair results in significantly less capsule gapping at 6-week follow-up compared with non-repair, though the difference in gap size normalizes by 24-week follow-up.