Ceramic bone graft substitute vs autograft in XLIF: a prospective randomized single-center evaluation of radiographic and clinical outcomes.

PURPOSE OF THE STUDY: The objective of this prospective, parallel, randomized, single-center study is to evaluate the clinical success of a commercial ceramic bone graft substitute (CBGS) for autograft in eXtreme Lateral Interbody Fusion (XLIF) procedures. Please confirm if the author names are presented accurately and in the correct sequence (given name, middle name/initial, family name). Author 1 Given name: [Cristiano Magalhães], Last name [Menezes]. Author 2 Given name: [Gabriel Carvalho], Last name [Lacerda]. Author 5 Given name: [Erica Godinho], Last name [Menezes]. Also, kindly confirm the details in the metadata are correct.yes METHODS: Forty-five adult subjects were consecutively enrolled and randomized into a single-level XLIF procedure using either CBGS or iliac crest bone graft autograft (30 and 15 subjects, respectively). The primary outcome was fusion rate at 12, 18, and 24 months. Secondary outcomes were pain and disability measured by HRQOL questionnaires. Kindly check and confirm whether the corresponding author and his corresponding affiliations is correctly identified.yes RESULTS: The fusion rates for both CBGS and autograft groups at the 24-month follow-up were 96.4% and 100%, respectively. For the CBGS group, mean ODI, mean back pain, and mean worst leg pain significantly improved at the 24-month follow-up by 76.7% (39.9-9.3), 77.6% (7.3-1.6), and 81.3% (5.1-1.0), respectively. For the autograft group, mean ODI, mean back pain, and mean worst leg pain significantly improved during the same time period by 77.1% (35.9-8.2), 75.6% (6.1-1.5), and 86.0% (6.6-0.9), respectively (all time points between groups, p < 0.05). CONCLUSION: The results of this prospective, randomized study support the use of CBGS as a standalone bone graft substitute for autograft in single-level XLIF surgery. The clinical performance and safety outcomes reported here are consistent with published evidence on CBGS. Improvements in patient-reported back pain, leg pain, and disability outcomes were comparable between the CBGS and autograft groups.

Edaphic niche characterization of four Proteaceae reveals unique calcicole physiology linked to hyper-endemism of Grevillea thelemanniana.

Endemism and rarity have long intrigued scientists. We focused on a rare endemic and critically-endangered species in a global biodiversity hotspot, Grevillea thelemanniana (Proteaceae). We carried out plant and soil analyses of four Proteaceae, including G. thelemanniana, and combined these with glasshouse studies. The analyses related to hydrology and plant water relations as well as soil nutrient concentrations and plant nutrition, with an emphasis on sodium (Na) and calcium (Ca). The local hydrology and matching plant traits related to water relations partially accounted for the distribution of the four Proteaceae. What determined the rarity of G. thelemanniana, however, was its accumulation of Ca. Despite much higher total Ca concentrations in the leaves of the rare G. thelemanniana than in the common Proteaceae, very few Ca crystals were detected in epidermal or mesophyll cells. Instead of crystals, G. thelemanniana epidermal cell vacuoles contained exceptionally high concentrations of noncrystalline Ca. Calcium ameliorated the negative effects of Na on the very salt-sensitive G. thelemanniana. Most importantly, G. thelemanniana required high concentrations of Ca to balance a massively accumulated feeding-deterrent carboxylate, trans-aconitate. This is the first example of a calcicole species accumulating and using Ca to balance accumulation of an antimetabolite.

Intraspecific variation in fruit-frugivore interactions: effects of fruiting neighborhood and consequences for seed dispersal.

The extent of specialization/generalization continuum in fruit-frugivore interactions at the individual level remains poorly explored. Here, we investigated the interactions between the Neotropical treelet Miconia irwinii (Melastomataceae) and its avian seed dispersers in Brazilian campo rupestre. We built an individual-based network to derive plant degree of interaction specialization regarding disperser species. Then, we explored how intraspecific variation in interaction niche breadth relates to fruit availability on individual plants in varying densities of fruiting conspecific neighbors, and how these factors affect the quantity of viable seeds dispersed. We predicted broader interaction niche breadths for individuals with larger fruit crops in denser fruiting neighborhoods. The downscaled network included nine bird species and 15 plants, which varied nearly five-fold in their degree of interaction specialization. We found positive effects of crop size on visitation and fruit removal rates, but not on degree of interaction specialization. Conversely, we found that an increase in the density of conspecific fruiting neighbors both increased visitation rate and reduced plant degree of interaction specialization. We suggest that tracking fruit-rich patches by avian frugivore species is the main driver of density-dependent intraspecific variation in plants' interaction niche breadth. Our study shed some light on the overlooked fitness consequences of intraspecific variation in interaction niches by showing that individuals along the specialization/generalization continuum may have their seed dispersed with similar effectiveness. Our study exemplifies how individual-based networks linking plants to frugivore species that differ in their seed dispersal effectiveness can advance our understanding of intraspecific variation in the outcomes of fruit-frugivore interactions.

Pharmacokinetic and pharmacodynamic evaluation of a nanotechnological topical formulation of lidocaine/prilocaine (nanorap) in healthy volunteers.

BACKGROUND: Nanorap is a new nanotechnological formulation for topical anesthesia composed of lidocaine (2.5%) and prilocaine (2.5%). This study evaluated the pharmacokinetics of Nanorap. For the determination of lidocaine and prilocaine in human plasma, a new method using high-performance liquid chromatography coupled with tandem mass spectrometry was developed. Nanorap pharmacodynamic (PD) and its physical proprieties were also evaluated. METHODS: Nanorap was administered by topical application of 2 g to healthy volunteers, and blood samples were collected for the pharmacokinetics analysis. The drugs were extracted from plasma by liquid-liquid extraction with ether/hexane (80/20, vol/vol). The chromatography separation was performed on a Genesis C18 analytical column 4 µm (100 × 2.1 mm i.d.) with a mobile phase of methanol/acetonitrile/water (40/30/30, for lidocaine, and 50/30/20, for prilocaine, vol/vol/vol) + 2 mM of ammonium acetate and ropivacaine as internal standard. The drugs were quantified using a mass spectrometer with an electrospray source in the electrospray ionization positive mode configured for multiple reaction monitoring. The PD of Nanorap was evaluated with the use of a visual analog scale. Nanorap was characterized by cryofracture. RESULTS: The chromatography run-time was 5.5 minutes for lidocaine and 3.3 minutes for prilocaine, and the lower limit of quantification was 0.05 ng/mL for both drugs. Mean Cmax was 6.62 and 1.72 ng/mL for lidocaine and prilocaine, respectively. Median Tmax was 6.5 hours for both drugs. Nanocapsules had a mean size of 88 nm and mean drug association of 92.5% and 89% for lidocaine and prilocaine, respectively. The PD study showed that Nanorap has a sufficient analgesic effect (>30% reduction in pain) after 10 minutes of application. CONCLUSIONS: A new simple, selective, and sensitive method for determination of lidocaine and prilocaine in human plasma was developed. Nanorap generated safe plasma levels of the drugs and satisfactory analgesic effect.

Polypeptide A9K at nanoscale carbon: a simulation study.

The amphiphilic nature of surfactant-like peptides is responsible for their propensity to aggregate at the nanoscale. These peptides can be readily used for a non-covalent functionalization of nanoparticles and macromolecules. This work reports an observation of supramolecular ensembles consisting of ultrashort carbon nanotubes (USCNTs), graphene (GR) and A9K polypeptides formed by lysine and arginine. The potential of mean force (PMF) is used as a major descriptor of the CNT-A9K and GR-A9K binding process, supplementing structural data. The phase space sampling is performed by multiple equilibrium molecular dynamics simulations with position restraints, where applicable. Binding in all cases was found to be thermodynamically favorable. Encapsulation in the (10,10) USCNT is particularly favorable. The curvature of the external surface does not favor binding. Thus, binding of A9K at GR is stronger than its binding at the outer sidewall of USCNTs. Overall, the presented results favor non-covalent functionalization of nanoscale carbons that are considered interesting in the fields of biomaterials, biosensors, biomedical devices, and drug delivery systems.

Tumescent local anesthesia with ropivacaine in different concentrations in bitches undergoing mastectomy: plasma concentration and post-operative analgesia.

OBJECTIVE: To compare two concentrations of ropivacaine administered for tumescent local anesthesia (TLA) in dogs undergoing mastectomy. STUDY DESIGN: Prospective randomized clinical study. ANIMALS: Seventeen bitches of various breeds, aged 12 ± 2 years and weighing 10 ± 6.5 kg requiring total unilateral or bilateral mastectomy. METHODS: Dogs were premedicated with acepromazine (0.04 mg kg(-1) ) and morphine (0.4 mg kg(-1) ) intramuscularly. Anesthesia was induced with propofol (2.5 mg kg(-1) ) and midazolam (0.2 mg kg(-1) ) intravenously, followed by intubation and maintenance with isoflurane and TLA. Dogs were randomly allocated to receive TLA either with 0.1% ropivacaine (group G1) or with 0.05% ropivacaine (group G05). TLA was performed by insertion of a multihole needle under the skin and infusion of ropivacaine and lactated Ringer's solution at a fixed volume of 15 mL kg(-1) . Ropivacaine concentrations in arterial blood were measured by high-performance liquid chromatography. Post-operative pain was assessed using two scales (University of Melbourne pain scale and a modified composite measure pain scale) and von Frey filaments, 4 hours after TLA and at 1 hour intervals until sensitivity was regained. A score above 30% of the maximum possible score was considered a positive indicator of pain. RESULTS: Peak plasma concentrations of ropivacaine were measured 240 minutes after TLA in G1. Low concentrations were measured in G05 for 60 minutes, with subsequent increase. Analgesic rescue and return of sensitivity occurred at 7 ± 2.3 and 7 ± 1.9 hours (mean ± SD) after TLA for G1 and G05, respectively. CONCLUSIONS AND CLINICAL RELEVANCE: Tumescent local anesthesia with ropivacaine provided satisfactory post-operative analgesia that lasted for several hours, with no difference in duration between the concentrations. No serious side effects were attributed to TLA. Results indicated that 0.05% ropivacaine provided adequate analgesia for mastectomy, however, more studies are required to support this conclusion.

Human Adipose-Derived Stem Cells Reduce Cellular Damage after Experimental Spinal Cord Injury in Rats.

Traumatic spinal cord injury (SCI) is a devastating condition without an effective therapy. Cellular therapies are among the promising treatment strategies. Adult stem cells, such as mesenchymal stem cells, are often used clinical research for their immunomodulatory and regenerative potential. This study aimed to evaluate the effect of human adipose tissue-derived stem cells (ADSC) infusion through the cauda equina in rats with SCI. The human ADSC from bariatric surgery was isolated, expanded, and characterized. Wistar rats were subjected to blunt SCI and were divided into four groups. Two experimental groups (EG): EG1 received one ADSC infusion after SCI, and EG2 received two infusions, the first one after SCI and the second infusion seven days after the injury. Control groups (CG1 and CG2) received infusion with a culture medium. In vivo, cell tracking was performed 48 h and seven days after ADSC infusion. The animals were followed up for 40 days after SCI, and immunohistochemical quantification of myelin, neurons, and astrocytes was performed. Cellular tracking showed cell migration towards the injury site. ADSC infusion significantly reduced neuronal loss, although it did not prevent the myelin loss or enhance the area occupied by astrocytes compared to the control group. The results were similar when comparing one or two cell infusions. The injection of ADSC distal to the injured area was shown to be a safe and effective method for cellular administration in spinal cord injury.

Comparison Between Surgical and Conservative Treatment for AOSpine Type A3 and A4 Thoracolumbar Fractures without Neurological Deficit: Prospective Observational Cohort Study.

Objective To compare the clinical results between conservative (CS) and surgical treatment (CXS) of A3 and A4 fractures without neurological deficit. Methods Prospective observational study of patients with thoracolumbar fractures type A3 and A4. These patients were separated between the surgical and conservative groups, and evaluated sequentially through the numeric rating scale (NRS), Roland-Morris disability questionnaire (RMDQ), EuroQol-5D (EQ-5D) quality of life questionnaire, and Denis work scale (DWS) up to 2.5 years of follow-up. Results Both groups showed significant improvement, with no statistical difference in pain questionnaires (NRS: CXS 2.4 ± 2.6; CS 3.5 ± 2.6; p > 0.05), functionality (RMDQ: CS 7 ± 6.4; CXS 5.5 ± 5.2; p > 0.05), quality of life (EQ-5D), and return to work (DWS). Conclusion Both treatments are viable options with equivalent clinical results. There is a tendency toward better results in the surgical treatment of A4 fractures.

International and Multicenter Prospective Controlled Study of Dysphagia After Anterior Cervical Spine Surgery.

BACKGROUND: In the context of anterior approach to the cervical spine, dysphagia is a common complication and still without a clear distinction of risk factors. OBJECTIVE: To analyze the risk factors of dysphagia after cervical spine surgery. METHODS: Multicenter prospective study evaluated patients who underwent anterior cervical spine surgery for degenerative pathologies, studying surgical, anesthesia, base disease, and radiological variables (preoperatively, 24 hours, 1 and 3 weeks, and 6 months after surgery), with control group matched. Postoperative dysphagia was assessed by Swallowing Satisfaction Index and Swallowing Questionnaire; besides, based on multiple logistic regression model, a risk factor analysis correlation was applied. RESULTS: In total, 233 cervical patients were evaluated; most common level approached was C5-C6 (71.8%). All showed same decreasing trade for dysphagia incidence-with more cases on cervical group ( P < .05); severe cases were rare. At postoperative day 1, identified risk factors were approach to C3-C4 (4.11, P < .01), loss of preoperative cervical lordosis (2.26, P < .01), intubation attempts ≥2 (3.10, P < .01), and left side approach (1.85, P = .02); at day 7, body mass index ≥30 (2.29, P = .02), C3-C4 (3.42, P < .01), and length of surgery ≥90 minutes (2.97, P = .005); and at day 21, C3-C4 were kept as a risk factor (3.62, P < .01). CONCLUSION: A high incidence level of dysphagia was identified, having a clear decreasing trending (number of cases and severity) through postoperative time points; considering possible risk factors, strongest correlation was the approach at the C3-C4 level-statistically significant at the 24 hours, 7 days, and 21 days assessment.

Quantification of cyproheptadine in human plasma by high-performance liquid chromatography coupled to electrospray tandem mass spectrometry in a bioequivalence study.

A rapid, sensitive and specific method to quantify cyproheptadine in human plasma using amitriptyline as the internal standard (IS) is described. The analyte and the IS were extracted from plasma by liquid-liquid extraction using a diethyl-ether/dichloromethane (70/30; v/v) solvent. After removing and drying the organic phase, the extracts were reconstituted with a fixed volume of acetonitrile/water (50/50 v/v)+0.1% of acetic acid. The extracts were analyzed by high performance liquid chromatography coupled to electrospray tandem mass spectrometry (LC-MS/MS). Chromatography was performed isocratically using an Alltech Prevail C18 5 µm analytical column, (150 mm x 4.6 mm I.D.). The method had a chromatographic run time of 4 min and a linear calibration curve ranging from 0.05 to 10 ng/mL (r2 > 0.99). The limit of quantification was 0.05 ng/mL. This HPLC/MS/MS procedure was used to assess the bioequivalence of cyproheptadine in two cyproheptadine + cobamamide (4 mg + 1 mg) tablet formulations (Cobactin® [cyproheptadine + cobamamide] test formulation supplied from Zambon Laboratórios Farmacêuticos Ltda. and Cobavital® from Solvay Farma (standard reference formulation)). A single 4 mg + 1 mg [cyproheptadine + cobamamide] dose of each formulation was administered to healthy volunteers. The study was conducted using an open, randomized, two-period crossover design with a 1-week washout interval. Since the 90% CI for Cmax and AUCs ratios were all within the 80-125% bioequivalence limit proposed by the US Food and Drug Administration, it was concluded that the cyproheptadine test formulation (Cobactin®) is bioequivalent to the Cobavital® formulation for both the rate and the extent of absorption of cyproheptadine.