scholarly journals Subaxial Cervical Pedicular Screw Insertion via the Nonanatomic Axis: Technical Notes and Preliminary Clinical Report

2021 ◽  
pp. 219256822110156
Author(s):  
Yingbo Wang ◽  
Bo Hu ◽  
Jian Wu ◽  
Wei Chen ◽  
Zhong Wang ◽  
...  
Keyword(s):  
Clinical Report ◽  
Clinical Safety ◽  
Promising Alternative ◽  
Screw Insertion ◽  
Pedicular Screw ◽  
Intraoperative Management ◽  
Technical Details ◽  
Grade 3 ◽  
Axis Length ◽  
Pedicle Perforation

Study Design: Retrospective study. Objective: To report the technical details of subaxial cervical pedicular screw insertion via the nonanatomic axis (nAA-CPS) and evaluate its clinical safety and accuracy. Methods: The nAA-CPS technique was performed in 21 patients. Preoperative and intraoperative management-related details are described, and a manipulation protocol is presented. Clinical outcomes were used to assess the safety and accuracy of screws was evaluated using postoperative computed tomography (CT) according to the pedicle perforation grading system, and the nonanatomic pedicle transverse angle (nPTA) and nonanatomic pedicle axis length (nPAL) were assessed based on pre- and postoperative CT images. Results: According to “one constant entry point (EP) and two perpendicular trajectory angles” protocol, nAA-CPS was performed without much interference from the muscles. No intraoperative or postoperative neurovascular complications related to the technique were observed. Of the 112 inserted screws, 78 (69.64%) were assessed as grade 0, 24 (21.43%) as grade 1, 4 (3.57%) as grade 2 and 6 (5.36%) as grade 3. The overall rate of correct position (grades 0 and 1) was 91.07% (102/112), and the rate of malposition was 8.93% (10/112), including five screws implanted medially and the other five laterally. The nPTA was highly consistent on pre- and postoperative CT ( P < .05), while postoperative nPAL was significantly shorter than preoperative nPAL ( P > .05). Conclusions: Clinically, the accuracy and safety of nAA-CPS was similar to the traditional CPS technique. The protocol, derived from previous radiological studies and workshops, greatly helped standardize clinical manipulation; thus, nAA-CPS is a promising alternative to the traditional CPS.

scholarly journals Subaxial Cervical Pedicular Screw Insertion via the Nonanatomic Axis: Identification of Entry Point and Trajectory Based on a Radiographic Study and Workshop

2021 ◽  
pp. 219256822199631
Author(s):  
Yingbo Wang ◽  
Bo Hu ◽  
Jian Wu ◽  
Wei Chen ◽  
Zhong Wang ◽  
...  
Keyword(s):  
Pedicle Screw ◽  
Entry Point ◽  
Radiographic Study ◽  
Radiological Study ◽  
Screw Insertion ◽  
Novel Technique ◽  
Pedicular Screw ◽  
Cervical Pedicle ◽  
Axis Length ◽  
Anatomical Axis

Study Design: A radiological study and workshop. Objective: To propose a novel technique for subaxial cervical pedicle screw (CPS) insertion via the nonanatomic axis (nAA) and identify a new entry point (EP) and trajectory based on a radiological study. Methods: The new EP was determined to be the center of the upper half of the lateral mass, and the nAA was defined as the line connecting the EP and center of the pedicle. CT images of 493 subaxial cervical pedicles from 51 adults were utilized. The pedicle axis length (PAL/nPAL), pedicle transverse angle (PTA/nPTA), sagittal and transverse pedicle screw depth ratio (S-DO, T-DO), and sagittal and transverse angles (S-angle, T-angle) were measured in the anatomical axis (AA) and nAA. nAA-CPS insertions were conducted on dry specimens, and the positions of the screws were graded. Results: The nPTA (22.35° ± 1.57°), nPAL (23.75 ± 2.07 mm), T-DO (45.61% ± 3.10%), and S-DO (70.46% ± 4.44%) of the nAA-CPS were significantly different from the PTA (41.86° ± 2.77°), PAL (31.98 ± 2.40 mm), T-DO and S-DO of the AA-CPS (both 100% in ideal conditions), respectively ( P < .05). The T-angle and S-angle were 92.78° ± 3.07° and 92.18° ± 3.78°, respectively. A constant EP and consistent trajectory of the nAA-CPS identified by 2 perpendicular angles were summarized and utilized as the manipulation protocols of the workshop, and a perfect position was achieved in 80.00% (24/30) of screws. Conclusion: The nAA-CPS is a novel alternative to the classic CPS technique. A constant entry point and 2 perpendicular angles in the sagittal and transverse planes for identifying the trajectory of the nAA-CPS should be taken into account in the establishment of a manipulation protocol.

scholarly journals Safety of switching between rituximab biosimilars in onco-hematology

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Silvana A. M. Urru ◽  
Stefania Spila Alegiani ◽  
Anna Guella ◽  
Giuseppe Traversa ◽  
Annalisa Campomori
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Adverse Events ◽  
Prospective Observational Study ◽  
Randomized Trials ◽  
Lymphocytic Leukemia ◽  
Safety Signal ◽  
Efficacy And Safety ◽  
Clinical Safety ◽  
Study Population ◽  
Grade 3

AbstractComparable clinical efficacy and safety of the reference rituximab (MABTHERA) and its biosimilars has been established in randomized trials. However, safety concerns are often raised when switching from reference to biosimilar products and between different biosimilars. In this prospective observational study we aimed at evaluating the safety of switching between reference and biosimilar rituximab (TRUXIMA and RIXATHON) at Trento General Hospital (Italy). All patients (n = 83) with Non Hodgkin’s Lymphoma (NHL, n = 72) and Chronic Lymphocytic Leukemia (CLL, n = 11) who received rituximab between March 2018 and March 2019 were asked to take part in the study. In 2017 and 2018 two tenders were carried out and two different biosimilars became available in the hospital, these were used sequentially. Thus, patients with or without previous treatments with the originator rituximab either received a biosimilar or were switched between different biosimilars. The incidence of adverse events in these groups of patients is described. The study population received 465 rituximab infusions and all received biosimilars. Fifty patients (60%) experienced at least one switch between different biosimilars or between rituximab originator and biosimilar, whereas 33 (40%) received one of the two biosimilars and one patient received reference rituximab. Adverse events (n = 146) were reported in 71 patients (84.5%). Treatment-related grade 3–4 events were reported in 5 patients (5.9%), whereas grade 1 rituximab related infusion events were observed in 6 patients (7.1%). No safety signal emerged in association with the use of a specific biosimilar nor with the practice of switching. Adverse events were similar, in terms of seriousness and frequency, to those described in the literature, providing further support to the clinical safety of rituximab biosimilars.

THE COMPARISION OF RADIOLOGICAL DISTANCE DIFFERENCE BETWEEN THE PARS INTER-ARTICULARIS AND PEDICLE, AS A REPRODUCIBLE AND CONSISTENT GUIDE FOR PEDICULAR SCREW FIXATION TECHNIQUE, IN SPINAL LUMBAR SURGERIES.

2021 ◽  
pp. 61-63
Author(s):  
Bharath. V ◽  
Hemanth Kumar ◽  
Ashwanth Narayan ◽  
Venkatachalam .K ◽  
Ashwin. VY ◽  
...  
Keyword(s):  
Ct Images ◽  
Steady Increase ◽  
Lateral Border ◽  
X Ray ◽  
Screw Insertion ◽  
Pedicular Screw ◽  
Pars Interarticularis ◽  
Upward Direction ◽  
Anatomical Relationship ◽  
Distance Difference

The Inter-Pedicular and Inter-Pars distance was measured in a plain AP radiography (X-Ray) of 150 and 75 CT images normal patients between 18- 47 years of age. The aim of the study is to measure the normal Inter-Pedicular and Inter-Pars distance. We found that by studying the anatomical relationship between the inner or medial Pedicular border and the Pars outer or lateral border, gives the Orthopaedic Surgeon a reproducible and consistent guide towards exacting a pedicular screw placing. We found that both X-Ray and CT images shows steady increase in the Ipr and Ipd from L1 to L5, there is a minimal difference from L1-L2 and marked difference seen from L3 to L5, and showing the differences in distances are more in the males, compared to females. The Means of all the groups compared also proves that there is steady raise in the diameter of the IPR and IPD from L1 to L5, where there is dramatical and signicant change in the upward direction, noted from L3 to L5. The mean difference is almost constant from L1to L2. So this study, did essentially to help, establish that, the inner medial border of pedicle, is in near relationship to, the outer lateral border of the Pars-Interarticularis, which helps in establishing the latero-medial entry point for the pedicular screw insertion in the lumbar spine.

Pharmacology and safety factors affecting use of flat (rather than weight-based) dosing of tesetaxel, an orally administered taxane

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 2510-2510
Author(s):  
R. P. Warrell ◽  
M. Beeram ◽  
E. Spindler ◽  
K. Papadopoulos ◽  
A. Patnaik ◽  
...  
Keyword(s):  
Drug Exposure ◽  
Maximum Tolerated Dose ◽  
Repeat Dose ◽  
Breast Cancers ◽  
Phase 2 ◽  
Clinical Safety ◽  
Factors Affecting ◽  
Future Studies ◽  
Starting Dose ◽  
Grade 3

2510 Background: As a class, taxanes have wide interpatient (pt) pharmacokinetic (PK) variability at their effective dose, which has been associated with adverse reactions, especially neutropenia. Tesetaxel is an oral taxane with Phase 2 activity in pretreated pts with colorectal, non-small cell lung, gastric, and breast cancers. Tesetaxel is not a substrate for P-glycoprotein; it is associated with lower neurotoxicity at equi-myelotoxic does, and it displays a long terminal half-life in plasma (∼180 hrs). We explored PK and clinical safety to determine the feasibility of using flat dosing in future studies. Methods: PK parameters were evaluated in 21 pts treated at the maximum tolerated dose (27 mg/m2) either alone or in combination with capecitabine. We then compared actual dose (total mg) with the weight-based dose and correlated the incidence and severity of Grade 3–4 neutropenia with weight-based vs. flat dosing. Results: A total of 174 pts were treated with tesetaxel in Phase 2 trials at doses of 27 or 35 mg/m2 once every 3 weeks. For pts prescribed with weight-based dosing (27 mg/m2), mean Cmax in 3 separate cohorts was 24.6, 42.5, and 47.9 μg/L, with AUC0-inf of 1363, 1592, and 1663 h*μg/L, respectively. In 103 pts prescribed a dose of 27 mg/m2, 17% and 16% of pts received doses of 40 mg or 60 mg, respectively, whereas 67% received 50 mg. Correlations between drug exposure AUC0-inf and actual dose (mg and mg/m2) across the entire range of administered doses showed r2 values of 0.455 and 0.492, respectively. Similar correlations after a second repeat dose showed r2 values of 0.731 and 0.653, respectively. The incidence of Grade 3–4 neutropenia at 27 mg/m2 was 33%. Conclusions: PK and clinical safety suggest that weight-based dosing offers no substantial advantage compared with flat dosing. Future studies could incorporate a starting dose of 50 mg administered once every 3 weeks. Flat dosing should also be tested using different schedules, including weekly x 3 weeks and “metronomic dosing” (1–2 mg/d). [Table: see text]

A phase Ib study of napabucasin plus weekly paclitaxel in patients with advanced melanoma.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 9553-9553
Author(s):  
William Jeffery Edenfield ◽  
Carlos Becerra ◽  
Fadi S. Braiteh ◽  
Alexander I. Spira ◽  
Ryan J. Sullivan ◽  
...  
Keyword(s):  
Checkpoint Inhibitors ◽  
Braf Inhibitor ◽  
Progression Free Survival ◽  
Advanced Melanoma ◽  
Braf V600e ◽  
Weekly Paclitaxel ◽  
Combination Regimen ◽  
Clinical Safety ◽  
Grade 3 ◽  
Anti Tumor Activity

9553 Background: Napabucasin is a first-in-class cancer stemness inhibitor, identified by its ability to inhibit STAT3-driven gene transcription and spherogenesis of cancer stem cells (Li et al PNAS 112 (6):1839, 2015). Synergistic anti-tumor activity with paclitaxel was observed in pre-clinical testing, and a favorable clinical safety profile was established in a phase I/II trial in patients (pts) with advanced solid tumors. A phase 1b trial was established to evaluate the safety and preliminary signs of anti-cancer activity of the combination regimen in pts with advanced melanoma. Methods: Pts with melanoma were enrolled after failure of standard therapies for advanced disease. Napabucasin 480 or 500 mg orally twice daily was administered with paclitaxel 80 mg/m2 IV weekly for 3 of every 4 weeks. Adverse events were evaluated using CTCAE v4.03 and objective tumor assessments were obtained every 8 weeks and evaluated per RECIST 1.1 criteria. Results: A total of 12 pts with advanced melanoma were enrolled after a median 3 prior lines of therapy (including immune checkpoint inhibitors, BRAF-inhibitor if presence of BRAF V600E mutation). Protocol therapy was well tolerated with grade 3 AEs including diarrhea (n = 3), abdominal pain (n = 1), and fatigue (n = 1). Partial response (PR) was observed in 1 pt. Stable disease of at least 24 weeks or more was achieved by 33% of patients (n = 4) and the median progression-free survival (mPFS) was 3.7 months. Prolonged survival of 1 year or more was achieved by 33% of pts (n = 4), with a median overall survival (mOS) of 10.4 months. Conclusions: Napabucasin plus weekly paclitaxel has shown clinical safety and encouraging anti-tumor activity in a cohort of pts with previously treated advanced melanoma. The RP2D in combination with weekly paclitaxel was established to 480 mg orally bid. The data suggest that targeting stemness pathways with napabucasin may be a novel therapeutic strategy for melanoma. Clinical trial information: NCT01325441.

Clinical Safety and Efficacy of Rotational Atherectomy in Japanese Patients with Peripheral Arterial Disease Presenting Femoropopliteal Lesions: The J-SUPREME and J-SUPREME II Trials

2021 ◽  
pp. 152660282110457
Author(s):  
Osamu Iida ◽  
Kazushi Urasawa ◽  
Yoshisato Shibata ◽  
Yoshito Yamamoto ◽  
Hiroshi Ando ◽  
...  
Keyword(s):  
Japanese Patients ◽  
Arterial Disease ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Lesion Length ◽  
Clinical Safety ◽  
Safety And Efficacy ◽  
Occlusive Lesion ◽  
Grade 3 ◽  
Peripheral Arterial

Purpose: The purpose of the J-SUPREME (J-S) and J-SUPREME II (J-SII) trials was to evaluate the performance of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in the superficial femoral and popliteal arteries. Materials and Methods: The J-S and J-SII trials were both prospective, multicenter, single-arm clinical trials. Patients in J-S underwent Jetstream atherectomy followed by percutaneous transluminal angioplasty (PTA), whereas those in J-SII had adjunctive drug-coated balloon (DCB) treatment following atherectomy. Patients were adults with Rutherford category 2, 3, or 4 and had stenotic, restenotic, or occlusive lesion(s) with a degree of stenosis ≥70 in the superficial femoral artery and/or proximal popliteal artery. In J-S, lesions were required to be calcified, and in J-SII lesions were required to be severely calcified. Results: A total of 50 patients were enrolled in J-S (mean age 72.3±8.7 years, lesion length 82.0±41.5 mm, 36% calcification PACSS Grade 3, 22% Grade 4) and 31 patients in J-SII (mean age 72.5±7.7 years, lesion length 122.6±55.6 mm, 19.4% calcification PACSS Grade 3, 77.4% Grade 4). No bailout stenting or bypass conversions were required. No major adverse events (MAEs) were reported for either trial through 1 month. The 6-month primary patency for J-S, with PTA alone following atherectomy, was 40.4% (19/47). The 6-month primary patency for J-SII, with DCB treatment following atherectomy, was 96.7% (29/30). At 6-month post-procedure, 79.2% (38/48) of patients in J-S, and 100% (30/30) of patients in J-SII had improved by at least 1 Rutherford category. Conclusion: J-SUPREME trial results demonstrate procedural safety and efficacy of the Jetstream Atherectomy System and J-SII showed sustained patency through 6 months following combination treatment with Jetstream atherectomy and DCB.

scholarly journals Inhalational Isoflurane Sedation in Patients with Decompressive Craniectomy Suffering from Severe Subarachnoid Hemorrhage: A Case Series

2019 ◽  
Vol 7 (01) ◽  
pp. 27-33
Author(s):  
Felix Lehmann ◽  
Marcus Müller ◽  
Julian Zimmermann ◽  
Ági Güresir ◽  
Victoria Lehmann ◽  
...  
Keyword(s):  
Subarachnoid Hemorrhage ◽  
Decompressive Craniectomy ◽  
Deep Sedation ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Case Series ◽  
Neuroprotective Effects ◽  
Promising Alternative ◽  
Respiratory Parameters ◽  
High Doses ◽  
Grade 3

Abstract Background Severe aneurysmal subarachnoid hemorrhage (SAH) may lead to the necessity of decompressive craniectomy (DC) to treat refractory elevated intracranial pressure (ICP). In some patients, adequate deep sedation, as one part of conservative treatment, cannot be achieved. Recent investigations suggest that inhalative sedation might not be as detrimental as considered before, and therefore a treatment option. Materials and Methods A retrospective analysis of seven patients was performed who suffered from aneurysmal SAH (Hunt-Hess grade 3–5, Fisher's score 3) and underwent DC due to a critically elevated ICP. In these patients, the target sedation level could not be achieved even with high doses of intravenous sedatives. Thus, the sedative regimen was switched to inhaled anesthesia with isoflurane. Mean arterial pressure (MAP), ICP, cerebral perfusion pressure (CPP), levels of vasopressors, and respiratory parameters were analyzed. Results Deep sedation (Richmond Agitation-Sedation Scale [RASS] −5, mean–fractional end-expiratory gas concentration [mean-Fet] 0.78%) was rapidly achieved in all patients after commencing general anesthesia with isoflurane. ICP remained stable when comparing 1 hour before the onset of isoflurane sedation (1) with 6 (2), and 12 hours (3) after commencing isoflurane anesthesia (mean ICP [1] 13.83 mm Hg; [2] 12.57 mm Hg; [3] 11.14 mm Hg). The mean duration of application was 9 (± 4) days. CPP could be maintained above 70 mm Hg without the need for extended vasopressor usage. Conclusion In a setting of severe SAH and critically elevated ICP with the need for aggressive multimodal therapy, isoflurane was safely applied in those patients. Our sedation goal was rapidly achieved and critical rise in ICP was not observed. Further investigations are required to demonstrate that inhaled anesthesia with isoflurane can be a promising alternative option, as this drug has better controllable pharmacokinetics, no clinically relevant accumulation of the drug itself, and potential neuroprotective effects (so far reported in different animal models).

Dynamic Abutment: A method of redirecting screw access for implant-supported restorations: Technical details and a clinical report

2015 ◽  
Vol 113 (6) ◽  
pp. 516-519 ◽  
Author(s):  
Eva Berroeta ◽  
Ion Zabalegui ◽  
Terrence Donovan ◽  
Winston Chee
Keyword(s):  
Clinical Report ◽  
Technical Details

scholarly journals Osteodiscitis Post- COVID-19 Infection: A Case Series

2021 ◽  
Author(s):  
Majid Rezvani ◽  
Amirhosein Zohrevand ◽  
Najmeh Namazee ◽  
Soheil Fallahpour ◽  
Saeid Saghaei ◽  
...  
Keyword(s):  
Infectious Disease ◽  
Common Factor ◽  
Case Series ◽  
Case Presentation ◽  
Screw Insertion ◽  
Retrospective Assessment ◽  
Pedicular Screw ◽  
The Mean ◽  
Almost All ◽  
Clinical Conditions

Abstract Background: Coronavirus disease (COVID-19) is an infectious disease. It affects almost all organs of the human body. Lumbar osteodiscitis is an infection of the vertebral body and disc. The association of COVID-19 with osteodiscitis has not been reported in the literature so far. The purpose of this study was to describe a series of four cases manifested as post-COVID-19 osteodiscitis.Case presentation: We performed a retrospective assessment of the clinical, radiological, and microbiological features of adult post-COVID-19 patients who underwent surgery for unstable lumbar osteodiscitis at our hospital. The mean age of patients was 45.8±7.8 years. All the patients were treated according to their clinical conditions through a combined surgical approach as laminectomy, facetectomy, pedicular screw insertion, and fusion. The clear causes of infection were not recognized by routine methods, and COVID-19 was the only common factor in patients in the last 6 to 8 weeks.Conclusions: This case series suggest that osteodiscitis could be one of the possible side effects after COVID-19 infection.

scholarly journals A Randomized Evaluation of Vinorelbine Versus Gemcitabine Chemotherapy Mobilization of Stem Cells in Myeloma Patients

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1963-1963
Author(s):  
Barbara Jeker ◽  
Sarah Farag ◽  
Urban Novak ◽  
Ulrike Bacher ◽  
Behrouz Mansouri Taleghani ◽  
...  
Keyword(s):  
Stem Cells ◽  
Stem Cell ◽  
Conflicts Of Interest ◽  
Group Versus ◽  
Promising Alternative ◽  
Randomized Evaluation ◽  
Prospective Comparison ◽  
Prospective Phase ◽  
Cell Mobilization ◽  
Grade 3

Background: In myeloma patients, a non-myelosuppressive regimen combining a single dose of vinorelbine chemotherapy together with G-CSF is safe and effective to harvest peripheral blood progenitor and stem cells (PBSC) before autologous stem cell transplantation (ASCT). Considering its neurotoxic potential, vinorelbine may aggravate pre-existing bortezomib-induced polyneuropathy, and gemcitabine represents an alternative mobilization regimen. We have reported that monotherapy with gemcitabine together with G-CSF can be used as a promising alternative mobilization chemotherapy to vinorelbine, even more so as gemcitabine avoids neurotoxicity associated with vinorelbine Methods: In this prospective phase-II study (ViGeM Trial; NCT# 02791373), we compared in a 1:1 randomization the efficacy and toxicity of vinorelbine or gemcitabine with G-CSF (and, if needed, plerixafor) in 130 evaluable myeloma patients in first remission. The objective of the study is to demonstrate the non-inferiority of gemcitabine versus vinorelbine. The primary endpoint is mobilization success, which is defined as a collected apheresis product comprising at least 6.0×106 CD34+ cells/kg b.w. at day 8 after chemotherapy (vinorelbine or gemcitabine) together with G-CSF in the absence of plerixafor. Results: We observed successful CD34+ mobilization in 75% [95% confidence interval (CI): 63%-85%] of patients in the vinorelbine group versus 49% [95% CI: 36%-62%] with gemcitabine; the pre-specified non-inferiority margin -15% was not reached. More vinorelbine recipients achieved the collection goal in a single-day procedure (78% vs 60%). The median CD34+ yield was 11.4×106/kg b.w. in vinorelbine versus 8.7×106/kg in gemcitabine (P=0.001). At apheresis as well as day +100 following ASCT, polyneuropathy occurred more frequent in vinorelbine recipients. Special attention should be given to the fact that no patients with gemcitabine was observed with grade ≥ 3 polyneuropathy (Table 1). Finally, less patients in the vinorelbine group (1%) needed two apheresis days as compared to 14% in the gemcitabine group, respectively (P=0.007), whereas the use of rescue plerixafor was similar (11% versus 10%). Conclusion: This prospective comparison indicated that non-inferiority of gemcitabine as compared to vinorelbine chemotherapy together with G-CSF stimulation regarding CD34+ mobilization was not reached. Polyneuropathy was aggravated in the vinorelbine cohort, but not in gemcitabine recipients. Our study allows individualization of CD34+ mobilization regimens in myeloma patients. Disclosures No relevant conflicts of interest to declare. OffLabel Disclosure: Vinorelbine and gemcitabine are used for stem cell mobilization in this study and, thus, off-label.

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