Reduction of maillard browning in spray dried low-lactose milk powders due to protein polysaccharide interactions.

Lactose hydrolysed concentrated milk was prepared using ß-galactosidase enzyme (4.76U/mL) with a reaction period of 12 h at 4 °C. Addition of polysaccharides (5 % maltodextrin/ß-cyclodextrin) to concentrated milk either before or after lactose hydrolysis did not result in significant differences (p > 0.05) in degree of hydrolysis (% DH) of lactose and residual lactose content (%). Three different inlet temperatures (165 °C, 175 °C and 185 °C) were used for the preparation of powders which were later characterised based on physico-chemical and maillard browning characteristics. Moisture content, solubility and available lysine content of the powders decreased significantly, whereas, browning parameters i.e., browning index, 5-hydroxymethylfurfural, furosine content increased significantly (p < 0.05) with an increase in inlet air temperature. The powder was finally prepared with 5 % polysaccharide and an inlet air temperature of 185 °C which reduced maillard browning. Protein-polysaccharide interactions were identified using Fourier Transform infrared spectroscopy, fluorescence spectroscopy and determination of free amino groups in the powder samples. Maltodextrin and ß-cyclodextrin containing powder samples exhibited lower free amino groups and higher degree of graft value as compared to control sample which indicated protein-polysaccharide interactions. Results obtained from Fourier Transform infrared spectroscopy also confirmed strong protein-polysaccharide interactions, moreover a significant decrease in fluorescence intensity was also observed in the powder samples. These interactions between the proteins and polysaccharides reduced the maillard browning in powders.

Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report.

Physiologically based biopharmaceutics modeling (PBBM) is used to elevate drug product quality by providing a more accurate and holistic understanding of how drugs interact with the human body. These models are based on the integration of physiological, pharmacological, and pharmaceutical data to simulate and predict drug behavior in vivo. Effective utilization of PBBM requires a consistent approach to model development, verification, validation, and application. Currently, only one country has a draft guidance document for PBBM, whereas other major regulatory authorities have had limited experience with the review of PBBM. To address this gap, industry submitted confidential PBBM case studies to be reviewed by the regulatory agencies; software companies committed to training. PBBM cases were independently and collaboratively discussed by regulators, and academic colleagues participated in some of the discussions. Successful bioequivalence "safe space" industry case examples are also presented. Overall, six regulatory agencies were involved in the case study exercises, including ANVISA, FDA, Health Canada, MHRA, PMDA, and EMA (experts from Belgium, Germany, Norway, Portugal, Spain, and Sweden), and we believe this is the first time such a collaboration has taken place. The outcomes were presented at this workshop, together with a participant survey on the utility and experience with PBBM submissions, to discuss the best scientific practices for developing, validating, and applying PBBMs. The PBBM case studies enabled industry to receive constructive feedback from global regulators and highlighted clear direction for future PBBM submissions for regulatory consideration.

Development and verification of mechanistic vaginal absorption and metabolism model to predict systemic exposure after vaginal ring and gel application.

AIMS: The current work describes the development of mechanistic vaginal absorption and metabolism model within Simcyp Simulator to predict systemic concentrations following vaginal application of ring and gel formulations. METHODS: Vaginal and cervix physiology parameters were incorporated in the model development. The study highlights the model assumptions including simulation results comparing systemic concentrations of 5 different compounds, namely, dapivirine, tenofovir, lidocaine, ethinylestradiol and etonogestrel, administered as vaginal ring or gel. Due to lack of data, the vaginal absorption parameters were calculated based on assumptions or optimized. The model uses release rate/in vitro release profiles with formulation characteristics to predict drug mass transfer across vaginal tissue into the systemic circulation. RESULTS: For lidocaine and tenofovir vaginal gel, the predicted to observed AUC0-t and Cmax ratios were well within 2-fold error limits. The average fold error (AFE) and absolute AFE indicating bias and precision of predictions range from 0.62 to 1.61. For dapivirine, the pharmacokinetic parameters are under and overpredicted in some studies due to lack of formulation composition details and relevance of release rate used in ring model. The predicted to observed AUC0-t and Cmax ratios were well within 2-fold error limits for etonogestrel and ethinylestradiol vaginal ring (AFEs and absolute AFEs from 0.84 to 1.83). CONCLUSION: The current study provides first of its kind physiologically based pharmacokinetic framework integrating physiology, population and formulation data to carry out in silico mechanistic vaginal absorption studies, with the potential for virtual bioequivalence assessment in the future.

Development of a thin layer chromatography-based method to detect sorbitol presence in milk and its applicability in formalin preserved milk samples.

Sorbitol has been the new and emerging adulterant in dairy industry. The main aim of the study was to develop a method to detect sorbitol in milk, which is not affected by other sugars, polyols and formalin. Hence, a thin layer chromatographic (TLC) method was standardized to detect the sorbitol in milk. In the study 90 s duration for the impregnation of Silica gel 60F TLC plates with Cu- ions was found suitable to resolve sorbitol as a distinct spot. The standardized conditions were (1) developing solvent system consisting of n-propanol: ethyl acetate: water (7:1:2), (2) 0.5% of potassium permanganate in 0.1 M NaOH as color developing reagent. (3) Drying temperature (65°C/ 10 min.) after spraying the color developing reagent. The limit of detection was 0.2% of added sorbitol in milk. The standardized method could also detect the sorbitol in the presence of sucrose, glucose and polyols like mannitol and maltitol. In both cow and buffalo milk samples the standardized methodology performed well in detection of sorbitol. The method also performed well in sorbitol spiked formalin preserved milk samples. This method can be an alternative to the other methods involving costly equipment in detecting adulteration of milk with sorbitol.

Prospective comparative evaluation of intraoperative joint stability and component placement between posterior approach to hip and its quadriceps coxae sparing modification for primary hip arthroplasty.

Background: Efforts at minimizing the propensity of posterior approach of hip for post-operative dislocation after total hip arthroplasty have been a subject of continual research. We comparatively evaluated the posterior approach to hip and its quadriceps coxae sparing (QCS) modification with regard to joint stability and component placement.Questions/Purposes: (1) Does sparing of Quadriceps Coxae tendons vis a vis their sectioning in posterior approach help in achieving better intraoperative stability? (2) Does sparing of Quadriceps Coxae tendons come in the way of adequate surgical exposure sufficient to place hip components accurately? (3) Does sparing of Quadriceps Coxae tendons result in better early functional outcome? Methods: Seventy-two patients requiring THA were enrolled prospectively and randomized into two groups: group A (posterior approach) and group B quadriceps coxae sparing (QCS) approach. They were compared for intraoperative joint stability, accuracy of component placement, duration of surgery, blood loss, any event of hip dislocation, and functional outcome. Results: QCS approach resulted in better intraoperative hip stability as the hips tolerated a higher value of 43.50±3.5° mean internal rotation (at 90° of flexion and 20° of adduction) in this group versus a mean value of 33.50±5.5° in posterior approach group (p < 0.01). No significant difference was observed for femoral version, acetabular inclination, and acetabular version in the two groups (p > 0.05). There was no difference between the two groups in terms of duration of surgery, intraoperative blood loss, and functional outcome at one year (p > 0.05). No event of hip dislocation was observed in QCS approach, whereas, one such event happened in the posterior-approach group. Conclusion: Preservation of the QC tendons improves the intraoperative stability of THA and they do not cause any hindrance in the exposure required for optimum component placement.

A Phase-IV Non-interventional Study to Assess Virological Effectiveness, Safety, and Tolerability of DTG-based Antiretroviral Therapy in HIV-1 Infected Indian Persons Living with HIV.

BACKGROUND: Dolutegravir (DTG) is a novel yet preferential first-and-second-line treatment for persons living with HIV (PLH). Owing to its recent introduction, DTG-based regimens have not undergone a comprehensive, systematic evaluation regarding their real-world utilization and safety profile among a sizeable Indian population. OBJECTIVE: This study aimed to assess the 24-week immunovirological outcomes, anthropometric and metabolic changes, tolerability, and adverse events (AEs) of DTG-based antiretroviral (ART) regimens. METHODS: A single-centre phase-IV non-interventional observational study involving 322 ART-- naïve and treatment-experienced PLH initiating DTG-based-regimens until October 2022 were followed up for outcomes at 24 weeks. RESULTS: At 24 weeks, all PLH (n=113) in the naïve group, all PLH (n=67) in the first-line substitution group, 93.9% PLH (n=46) in the first-line failure group, and 95.7% PLH (n=89) in the second- line substitution group were virologically suppressed to plasma HIV-RNA <1000 copies/mL. Virological suppression rates to plasma HIV-RNA <200 copies/mL and <50 copies/mL were consistent among PLH who received DTG as first- or second-line ART. The mean-unadjusted weight gain observed was 3.5 kg (SE: 0.330), and it was significantly higher in PLH with poorer health at baseline (either HIV-RNA ≥ 1000 copies/ml or CD4 cell count <350 cells/µL). Overall, 27.3% PLH (n=88) gained ≥10% of their baseline body weight, corresponding to 3.7% incidence (n=10) of treatment-emergent clinical obesity [1]. DTG had an overall lipid-neutral effect, with an advantageous effect being observed in PLH switching from non-nucleoside analogue reverse-transcriptase inhibitors (NNRTI) or ritonavir-boosted protease inhibitors (b/PI), especially in dyslipidemic pre-treated PLH (median change in total cholesterol: 28.5 mg/dL and triglycerides: 51 mg/dL), possibly emanating from the withdrawal of the offending ART. The incidence of DTG-specific AEs, including CNS AEs, was low. Two PLH developed proximal myopathy and one developed transaminitis, warranting DTG discontinuation. Asymptomatic serum-CPK elevation and drug-induced transaminitis were seen in 25.2% (n=27) and 3.2% (n=10) PLH, respectively. No apparent negative effects on renal function were detected. CONCLUSION: Our results from a large Indian cohort indicate a favourable virological and metabolic response, with good tolerance of DTG-based ART at 24 weeks.

In silico study to recognize novel angiotensin-converting-enzyme-I inhibitors by 2D-QSAR and constraint-based molecular simulations.

Cardiovascular diseases (CVD) such as heart failure, stroke, and hypertension affect 64.3 million people worldwide and are responsible for 30% of all deaths. Primary inhibition of the angiotensin-converting enzyme (ACE) is significant in the management of CVD. In the present study, the genetic algorithm-multiple linear regressions (GA-MLR) method is used to generate highly predictive and statistically significant (R2 = 0.70-0.75, Q2LOO=0.67-0.73, Q2LMO=0.66-0.72, CCCex=0.70-0.78) quantitative structure-activity relationships (QSAR) models conferring to OECD requirements using a dataset of 255 structurally diverse and experimentally validated ACE inhibitors. The models contain simply illustratable Padel, Estate, and PyDescriptors that correlate structural scaffold requisite for ACE inhibition. Also, constraint-based molecular docking reveals an interaction profile between ligands and enzymes which is then correlated with the essential structural features associated with the QSAR models. The QSAR-based virtual screening was utilized to find novel lead molecules from a designed database of 102 thiadiazole derivatives. The Applicability domain (AD), Molecular Docking, Molecular dynamics, and ADMET analysis suggest two compound D24 and D40 are inflexibly linked to the protein binding site and follows drug-likeness properties.Communicated by Ramaswamy H. Sarma.

The Efficacy and Safety of a Combination of Thiocolchicoside and Etoricoxib in Low Back Pain (ESCoTEL): A Randomized Active-Controlled Trial.

Background Low back pain (LBP) is a global health concern. Management of LBP aims at pain relief facilitating improvement of functional ability. Non-steroidal anti-inflammatory drugs (NSAIDs) are the first line of therapy. However, the selection of NSAIDs is challenging given the range of underlying etiologies and severity. The current study aimed to compare the efficacy and safety of two available fixed-dose combinations (FDCs), namely, a dual FDC (DFC) of etoricoxib (60 mg) and thiocolchicoside (4 mg) versus a triple FDC (TFC) of chlorzoxazone (500 mg), diclofenac (50 mg), and paracetamol (325 mg). Methodology A total of 200 eligible adult subjects aged 18-70 years with a history of LBP and muscle spasm for ≤14 days and Wong-Baker Faces Pain score >4 were enrolled after obtaining written informed consent and randomized in a 1:1 allocation ratio to be treated with either DFC or TFC for 28 days. Efficacy was assessed based on the change in score from baseline (before treatment) to day 28 on the Wong-Baker Faces Pain Scale and the Oswestry Disability Index (ODI) questionnaire, as well as the proportion of subjects who improved upon treatment. Safety was assessed based on adverse events and clinical laboratory test results. Results A significant decrease in pain intensity (p < 0.001) and significant improvement in functional ability (p < 0.001) was observed after treatment with either DFC or TFC. The decrease in Wong-Baker Faces Pain score and ODI, from baseline, was comparable between the treatment groups. However, more subjects with very severe pain at baseline showed ≥30% improvement upon treatment with DFC than with TFC (~25% versus ~12%; p = 0.172). Also, significantly more crippled subjects with very severe functional disability showed improvement in the DFC group compared to the TFC group (~26% versus ~4%; p = 0.008). No adverse events or clinically relevant laboratory test results were evident. Conclusions Both DFC and TFC were comparable in efficacy and safety for the management of recent-onset LBP. However, significantly more subjects with very severe pain or functional disability showed improvement after 28 days when treated with DFC compared to TFC.

Development and application of DPPH impregnated paper based color sensor disc to detect vegetable oils addition in cow ghee.

Ghee is a premium product in Southeast Asia and is prone to adulteration with vegetable oils/ fats. The main aim of the study was to develop an easy-to-use paper-based sensor to detect this adulteration. Hence, a protocol involving hexane and acetonitrile for the extraction of synthetic antioxidants from adulterated ghee and its rapid detection using DPPH was standardized. Paper-based discs impregnated with 4 mM DPPH were developed. The developed paper-based disc sensors worked well and their response time was indirectly proportional to the antioxidant concentration (0.0025-0.02%). Using the developed disc sensors, the palm oil, and sunflower oil added to cow ghee @2.5% or more, and 1% or more, respectively could be detected. The shelf life of the developed sensors was 30 and 90 days at 30 °C and 4-6 °C, respectively. In stored cow ghee samples, the response time of the sensors increased as the storage period of ghee samples increased. The cutoff limit to declare the sample of cow ghee as unadulterated was fixed to 60 min. Based on the response time of the sensor, the level of detection of vegetable oils in stored cow ghee was found to be 2.5%.

Valorization of Sour Buttermilk (A Potential Waste Stream): Conversion to Powder Employing Reverse Osmosis and Spray Drying.

Reverse osmosis (RO) is known for the economic dewatering of dairy streams without any change in phase. At the household level, surplus milk is fermented and churned to obtain butter, which is subsequently heated to obtain clarified milk fat (ghee). The production of 1 kg ghee generates 15-20 kg sour buttermilk (SBM) as a by-product that is mostly drained. This causes a loss of milk solids and environmental pollution. The processing, preservation and valorization of SBM are quite challenging because of its low total solids (TS) and pH, poor heat stability and limited shelf life. This investigation aimed to transform SBM into a novel dried dairy ingredient. SBM was thermized, filtered, defatted and concentrated at 35 ± 1 °C, employing RO up to 3.62× (12.86%). The RO concentrate was subsequently converted into sour buttermilk powder (SBMP) by employing spray drying. SBMP was further characterized for its physicochemical, reconstitution and functional properties; rheological and morphological characteristics; and amino acid and fatty acid profiling, along with FTIR and XRD spectra. SBMP was "instant soluble-3 s" and exhibited excellent emulsion stability (80.70%), water binding capacity (4.34 g/g of protein), flowability (28.36°) and antioxidant properties. In nutshell, a process was developed for the valorization of sour buttermilk to a novel dairy ingredient by employing reverse osmosis and a spray-drying process.

Acquired Hallux Varus Deformity Correction: Pivotless Distraction Technique.

Acquired hallux varus deformity secondary to postburn contracture is a rare condition. It causes cosmetic disfigurement, pain, and inability to wear a shoe. Soft-tissue procedures and tendon transfers have been described for correction; however, these may require multiple operations and the outcome may be poor. We report a 6-year-old neglected case of hallux varus deformity secondary to burn contracture successfully managed by contracture release with pivotless distraction technique using a biplanar distractor and skin grafting with Z-plasty in the same procedure. The deformity was corrected to a lesser extent and with good functional outcomes. The scar was excised and Z-plasty was performed. The medial joint capsule was released. We used gradual differential distraction with monitoring on sequential radiographs. Pain-free flexion of 45° and extension of 40° were achieved and the patient was able to wear shoes after 4 weeks postoperatively. Hallux varus is a multidimensional deformity. A severe and rigid deformity might not respond well to tendon transfers in a single stage. Our described technique can be used to correct rigid hallux varus deformity with preservation of joint function.

Is Posterior Femoral Neck Cortex an Obstacle in Achieving Sagittal Plane Balance of Uncemented Straight Femoral Stem?

Summary of Background Data: There is a paucity of the literature that aims to improve sagittal plane balance of femoral stem in hip arthroplasty. We have comparatively evaluated the effect of trimming the posterior cortex left in situ after femoral neck osteotomy and counter-clockwise rotation of starting awl with respect to their ability to achieve neutral alignment of femoral stem in sagittal plane. Questions/Purposes: (1) Which of the two techniques under reference is more reliable in achieving a sagittal plane balance of the femoral stem in the femoral canal? (2) Does either of the two techniques have the potential to adversely affect other parameters for the optimum placement of femoral stem? Patients and Methods: This prospective study involved a total of 60 patients (age group of 18 to 60 years) who underwent primary total hip arthroplasty (THA) through a standard posterolateral approach. They were randomized into groups (1) PNCT (n = 30): femoral canal preparation was done by posterior neck cortex trimming method; (2) CCRA (n = 30): femoral canal preparation was done by counter-clockwise rotation of starting awl. Postoperatively, radiographs and computed tomography were obtained and angle of femoral stem with the femoral canal in coronal and sagittal plane, femoral stem tip deviation in coronal and sagittal plane, anteversion of the femoral stem, duration of canal preparation and blood loss were analyzed between the two groups. Results: Based on our results, there is a significantly better sagittal alignment of the femoral stem within the femoral canal, both in terms of angle of the femoral stem with the femoral canal (p < 0.001) and the deviation of the femoral stem tip from the center of the medullary canal (p < 0.001) when the posterior neck cortex was trimmed. Canal preparation by trimming the posterior neck cortex took a mean of 11.93 min (range 8-15 min) against the mean duration of 6.87 min (range; 5 min to 9 min) in the other group (p < 0.001). Conclusion: Trimming the posterior femoral neck cortex after neck osteotomy results in better sagittal plane balance of uncemented straight femoral stem. Level of Evidence: III.

A Comparative Evaluation of Combined Nerve Block Versus Periarticular Infiltration on Postoperative Pain Relief in Total Hip Arthroplasty.

Introduction: To minimize the side effects of the central neuraxial blockade to obtain postoperative pain relief, there has been an increasing preference for targeting the peripheral structures in patients undergoing total hip arthroplasty (THA). Patients and Methods: This prospective study was performed between September 2019 and September 2021 and involved 30 patients that were randomized to two groups. One group (n = 15) received combined nerve block (CNB) [obturator nerve, nerve to quadratus femoris, superior gluteal nerve, and femoral nerve], while another group (n = 15) received periarticular infiltrative analgesia (PIA). All the patients were given the same volume and composition of the drug cocktail (20 ml 0.5% ropivacaine, 1 ml (100 mcg) dexmedetomidine, and 29 ml normal saline). Results: The patients in group CNB had a significantly lower visual analog score (VAS) at 6, 12, 18, 24, 30, 36, 42 and 48 h after surgery (p < 0.05). Patients in group CNB required fewer (p < 0.001) doses of the rescue analgesic (1.67 ± 0.90 doses) as compared to group PIA (3.53 ± 0.64 doses). Time to the first rescue analgesia was significantly longer (p = 0.01) in group CNB (6.71 ± 2.36 h) as compared to group PIA (4.80 ± 1.26 h). However, patients in group PIA had significantly faster sensory (p < 0.001) and motor recovery (p < 0.001) as compared to group CNB. It took significantly longer (p < 0.001) to administer the nerve block (16.87 ± 1.80 min) as compared to periarticular infiltration (6.53 ± 1.18 min). There were no complications in either group. Conclusion: CNB registered significant superiority over PIA with respect to postoperative pain relief and time to rescue analgesia. However, the time taken to administer CNB was significantly higher and the patients in the PIA group had early recovery in sensory and motor modalities. Level of Evidence: III (therapeutic).

Elevating athletic performance: Maximizing strength and power in long jumpers through combined low-intensity blood flow restriction and high-intensity resistance training.

Purpose: This study aimed to evaluate the effects of low-intensity blood flow restriction (BFR) training and high-intensity resistance training (HI-RT) on the leaping performance of long-jumpers. Materials and methods: Long jump players were divided into two groups; one group (group A) receiving HI-RT (n = 8) and the other group (group B) receiving combined low-intensity BFR training plus HI-RT (n = 8). Muscle power and knee muscle strength was assessed at baseline, 3 weeks and 6 weeks of intervention. Results: 1-RM was found to be significantly different between Group A and Group B at 3 and 6 weeks. Further, IKDQR, IKDHR and IKDQL was significantly improved in group B as compared to group A both at 3 and 6 weeks. There was significant time effect, group effect and time-group interaction in the strength of quadriceps and hamstring of both left and right leg measured through isokinetic device. Post-hoc analysis for 1-RM in group B showed a significant improvement at baseline and 6 weeks and the broad jump was significant at baseline and 3 weeks and at baseline and 6 weeks. Conclusion: The combined effects of low-intensity BFR training and HI-RT is effective in improving the muscle strength and power of lower limbs in long jumpers.

A Rare Case of Cytomegalovirus Colitis with Subsequent Non-tubercular Mycobacteria Immune Reconstitution Inflammatory Syndrome.

Cytomegalovirus (CMV) colitis occurs commonly in immunocompromised patients with high mortality. CMV infection has also been reported in immunocompetent individuals and it has a varied clinical presentation. When HIV-infected patients are started on antiretroviral therapy (ART) there is a reconstitution of the immune system which results in the paradoxical worsening of existing conditions or development of new disease conditions known as immune reconstitution inflammatory syndrome (IRIS). In the setting of IRIS one of the most common infections to occur is non-tubercular mycobacteria (NTM). The infection generally develops when the CD4 count is < 50 cells/µL. Here we present a rare case of CMV colitis followed by NTM infection in the setting of IRIS, its management, and treatment outcomes.

Influence of exopolysaccharide EPSKar1-iron complexation on iron bioavailability and alleviating iron deficiency anaemia in Wistar rats.

The prevalence of iron deficiency anaemia is a significant issue worldwide, affecting individuals of all ages and often associated with inadequate iron bioavailability. Despite the use of ferrous salt supplements to address anaemia, their limited bioaccessibility and bioavailability in human GIT and adverse impact on food properties remain significant challenges. Hence, this study aims to explore the iron chelation mechanism of an exopolysaccharide EPSKar1 to enhance iron bioaccessibility, bioavailability, and anti-anaemic effects using cell culture and an anaemic rat model. EPSKar1 was extracted from Lacticaseibacillus rhamnosus Kar1 and complexed with FeSO4 to form "EPSKar1-iron". This novel complex, besides being bio-accessible after in vitro gastric digestion, demonstrated 61.27 ± 1.96% iron bioavailability to the Caco-2 cells. In line with these in vitro findings, intragastric administration of the EPSKar1-iron complex to anaemic Wistar rats at 25 and 50 mg per kg body weight significantly restored blood haemoglobin levels and re-established the morphological features of red blood cells. Furthermore, the apparent digestibility co-efficient and iron uptake improved significantly without adversely affecting the serum biochemical parameters in these anaemic rats. The levels of iron-transport proteins including serum transferrin and ferritin in tissue and plasma have increased remarkably upon oral administration of EPSKar1-iron at a higher dose of 50 mg per kg body weight. Oral supplementation of EPSKar1-iron did not foster adverse histological changes in the liver, kidneys, and spleen. In fact, the treatment with the EPSKar1-iron complex had a restitution effect on the tissue architecture, thereby ameliorating the tissue lesions. These findings collectively indicate that the EPSKar1-iron complex shows nutraceutical potential in enhancing the bioavailability of iron and could be a promising approach to tackle iron deficiency anaemia.

Accuracy of Patient-Specific, 3D-Printed Laminofacetal Based Trajectory-Guide for Pedicle Screw Placement in Subaxial Cervical and Thoracic Spine.

Background: Conventional methods of pedicle-screw placement have higher breach rates due to variations in pedicle trajectories. Objective: We studied the accuracy of patient-specific, three-dimensional (3D)-printed laminofacetal-based trajectory guide for pedicle-screw placement in the subaxial-cervical and thoracic spine. Materials and Methods: We enrolled 23 consecutive patients who underwent subaxial cervical and thoracic pedicle-screw instrumentation. They were divided into two groups: group A (cases without spinal deformity) and group B (cases with pre-existing spinal deformity). Patient-specific, 3D-printed laminofacetal-based trajectory guide for each instrumented level was designed. The accuracy of screw placement was assessed on postoperative computed tomography (CT) using the Gertzbein-Robbins grading. Results: A total of 194 pedicle screws (114 cervical and 80 thoracics) were placed using trajectory guides, of which 102 belonged to group B (34 cervical and 68 thoracics). Out of a total of 194 pedicle screws, 193 had clinically acceptable placement (grade A: 187; grade B: 6; and grade C: 1). In the cervical spine, 110 pedicle screws out of a total of 114 had grade A placement (grade B: 4). In the thoracic spine, 77 pedicle screws out of a total of 80 had grade A placement (grade B: 2; grade C: 1). Out of a total of 92 pedicle screws in group A, 90 had grade A placement, and the rest 2 had grade B breach. Similarly, 97 out of a total of 102 pedicle screws in group B were placed accurately, 4 had grade B and another had a grade C breach. Conclusions: Patient-specific, 3D-printed laminofacetal-based trajectory guide may help in accurate placement of subaxial cervical and thoracic pedicle screws. It may help reduce surgical time, blood loss, and radiation exposure.

Evaluation of vertebral shortening and interbody fusion with short segment pedicle screw fixation for unstable thoracolumbar fractures.

Background: Various operative procedures have been described for the treatment of traumatic paraplegia caused by unstable thoracolumbar fractures. We prospectively evaluated interbody fusion (IBF) with SS-PSF in these cases with regard to clinico-radiological outcome with the objectives: (1) Does IBF and short segment pedicle screw fixation (SS-PSF) prevent progression of kyphotic angle after surgery? (2) Can this procedure be safely performed in the setting of acute trauma?. Methods: Sixteen patients suffering from traumatic paraplegia caused by acute unstable thoracolumbar fractures were enrolled prospectively and underwent IBF with SS-PSF. They were evaluated for magnitude of shortening in spine, progression of kyphotic angle, and neurological improvement by American spinal injury association scale (ASIA). Results: Out of total sixteen, 14 patients were ASIA grade A and 2 were grade C, at the time of presentation. Thirteen out of these 14 remained grade A and one improved to B. Both the patients who had grade C involvement at the time of presentation improved to grade D at one-year follow-up. The mean blood loss was 750 ml (range; 650 ml-1150 ml). Mean kyphotic angle decreased from 20.6° (range; 13° to 37°) preoperatively to 6.2° (range; 3° to 10°) at postoperative day 2 (p = 0.002). Its mean value after 6 months was 6.5° (range; 3° to 11°). The procedure resulted in mean spinal column shortening of 18 mm (range; 16 mm-22 mm) in the spinal column. All the patients achieved bony union by a mean duration of 3.9 months (range; 3 months-6 months). Conclusions: IBF with SS-PSF has the shortest possible instrumented construct for thoracolumbar junction fusion done by posterior approach. The interbody fusion for unstable thoracolumbar junction fractures prevents the progression of kyphotic angle post-operatively. Level of evidence: Level 4.

Concomitant Ipsilateral Intracapsular and Extracapsular Femoral Neck Fractures in Young Individuals: A Report of 3 Cases.

CASES: Concomitant ipsilateral intracapsular and extracapsular fractures of the femoral neck, also termed "segmental fracture neck femur," are rare injuries, especially in physiologically young patients. We present 3 such cases that successfully underwent operative fixation with an extramedullary implant. CONCLUSION: Good clinical outcomes may be obtained after osteosynthesis with extramedullary fixation devices in concomitant ipsilateral intracapsular and extracapsular fractures of the femoral neck in young patients (<60 years). They should be followed for a long duration to look for avascular necrosis.