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SI-6603 (condoliase) is a chemonucleolytic agent approved in Japan in 2018 for the treatment of lumbar disc herniation (LDH) associated with radicular leg pain. Condoliase, a mucopolysaccharidase with high substrate specificity for glycosaminoglycans (GAGs), offers a unique mechanism of action through the degradation of GAGs in the nucleus pulposus. As LDH management is currently limited to conservative approaches and surgical intervention, condoliase could offer a less invasive treatment option than surgery for patients with LDH. The Discovery 6603 study (NCT03607838) evaluated the efficacy and safety of a single-dose injection of SI-6603 (condoliase) vs sham for the treatment of radicular leg pain associated with LDH. A randomized, double-blind, sham-controlled, phase 3 study conducted across 41 sites in the United States. Male and female participants (N=352; aged 30–70 years) with contained posterolateral LDH and unilateral radiculopathy/radicular leg pain for greater than 6 weeks. The primary endpoint was the change from baseline (CFB) in average worst leg pain score at 13 weeks, assessed using the 100-mm visual analogue scale. Key secondary endpoints were CFB in average worst leg pain score at 52 weeks, herniation volume at 13 weeks, and Oswestry Disability Index (ODI) score at 13 weeks. Safety evaluations included adverse events (AEs) and imaging findings. Participants were randomized 1:1 to receive a single intradiscal injection of condoliase (1.25 units) or sham injection followed by 52 weeks of observation. The primary and key secondary endpoints were assessed using a mixed model for repeated measures (MMRM) analysis and a protocol-specified multiple imputation (MI) sensitivity analysis on the modified intention-to-treat (mITT) population. A prespecified serial gatekeeping algorithm was used for multiple comparisons. Safety endpoints included AEs, laboratory tests, vital signs, imaging (by X-ray and magnetic resonance imaging [MRI]), and occurrence of posttreatment lumbar surgery. Of the 352 randomized participants, 341 constituted the mITT population (condoliase n=169; sham n=172) and the safety population (condoliase n=167; sham n=174). For the primary endpoint, the condoliase group showed significantly greater improvement in CFB in worst leg pain at Week 13 (least squares mean [LSM] CFB: −41.7) compared with sham injection (−34.2; LSM difference: −7.5; 95% confidence interval [CI]: −14.1, −0.9; p=.0263) based on the MMRM analysis. CFB in worst leg pain at Week 52 favored condoliase vs sham, but the difference was not statistically significant (p=.0558), which halted the serial gatekeeping testing algorithm and dictated that the CFB in herniation volume and ODI scores at Week 13 would be considered nonsignificant, regardless of their p-values. Treatment group differences in CFB in herniation volume and ODI score favored the condoliase group vs sham at all timepoints. The MI sensitivity analysis showed differences in CFB in worst leg pain at Week 13 (p=.0223) and Week 52 (p=.0433) in favor of the condoliase group. Treatment-emergent AEs (TEAEs) were more common in the condoliase group (≥1 TEAE: 71.9%; ≥1 treatment-related TEAE: 28.1%) compared with the sham group (≥1 TEAE: 60.3%; ≥1 treatment-related TEAE: 10.3%). Of the TEAEs, spinal MRI abnormalities and back pain occurred most frequently. No treatment-related serious AEs occurred. Condoliase met its primary endpoint of significantly improving radicular leg pain at Week 13 and was generally well tolerated in patients with LDH. Chemonucleolysis with condoliase has the potential to provide a less invasive treatment option than surgery for those unresponsive to conservative treatment strategies. [ABSTRACT FROM AUTHOR]

Brachytherapy can be used for the treatment of every localized prostate cancer, notably as boost for intermediate- and high-risk prostate cancer. With the incidence of prostate cancer increasing significantly during the next decades and brachytherapy developing, we conducted a descriptive survey to analyse the current status of prostate brachytherapy in France to see if the future demands could be met. All radiotherapy centres that declared providing brachytherapy were found from the French national institute of cancer registry and they were asked to reply to an online form in April 2018. Fifty-two of the 54-brachytherapy centres (96%) replied the form and 34 centres did prostate brachytherapy. Among those centres, 32 performed iodine 125 low-dose rate brachytherapy as monotherapy, 19 provided brachytherapy boost (eight centres low-dose rate 125I; seven centres high-dose rate; four centres both). Among the centres not performing brachytherapy boost, 18 wanted to do, eight did not want and nine did not reply. The main reasons for reluctance towards brachytherapy boost were: organization constraints (three centres), refer patients to a nearby brachytherapy centre (one centre), technical issues (two centres) and lack of strong scientific evidences (two centres). In terms of human resources, the mean number of trained physicians and physicists were two (range: 1–6) and three (range: 1–5) respectively. In France, the future needs for prostate brachytherapy cannot be met by the current health supply. Health authorities should firstly reimburse brachytherapy boost and redefine an optimal training and organization of centres such that every patient with prostate cancer can receive optimal treatment. [ABSTRACT FROM AUTHOR]

Résumé La rechute locorégionale en territoire irradié des cancers des voies aérodigestives supérieures est de pronostic défavorable, aussi bien locorégionalement qu’à distance. La réirradiation est souvent proposée soit de façon exclusive, soit associée à une chimiothérapie, et parfois après une chirurgie de rattrapage en fonction des facteurs histopronostiques. Les données de toxicité de la réirradiation sont acceptables étant donné le pronostic défavorable. Des schémas d’irradiation hyperfractionnés avec split course ou normofractionnés sans split course sont possibles, avec une efficacité semble-t-il similaire. Si le volume tumoral est réduit, une réirradiation stéréotaxique peut être proposée. Enfin, si le centre de traitement est équipé de protonthérapie, cette technique pourrait être envisagée pour apporter une meilleure protection des tissus sains. Il n’y a pas de standards actuels concernant le mode de réirradiation et dans ce contexte, des essais sont nécessaires afin de déterminer la meilleure technique d’irradiation. En revanche, on s’accorde pour recommander une dose totale avoisinant les 60 Gy (à raison de 2 Gy par fraction). D’autres essais analysant l’association avec de nouvelles chimiothérapies pourraient être d’intérêt, notamment avec les anti-PD1/PD-L1. Locoregional relapse in previously irradiated region for head and neck tumours is associated with a bad locoregional and distant prognosis. Reirradiation might be exclusive, or feasible in addition with surgery and/or chemotherapy, according to histopronostic factors. Data show that reirradiation is feasible with some severe toxicity due to the bad prognosis of this situation. Hyperfractionnated regimen with split course or normofractionnated regimen without split course are possible with similar efficacy. If tumour size is small, stereotactic ablative radiotherapy may be considered, and if the treatment centre has proton therapy, it could be proposed because of better organs at risk sparing. There is no standard regarding reirradiation schedules and several trials have to be done in order to determine the best technique. Nevertheless, it is agreed that a total dose of 60 Gy (2 Gy per fraction) is needed. Other trials testing the association with new systemic agents have to be performed, among them agents targeting the PD1/PD-L1 axis. [ABSTRACT FROM AUTHOR]

Objective To compare radiologic and clinical outcomes, including rates of dysphagia and dysphonia, using a no-profile stand-alone intervertebral spacer with integrated screw fixation versus an anterior cervical plate and spacer construct for single-level anterior cervical discectomy and fusion (ACDF) procedures. Methods This multicenter, randomized, prospective study included 54 patients with degenerative disc disease requiring ACDF at a single level at C3–C7. Twenty-six patients underwent single-level ACDF with stand-alone spacers, and 28 with plate fixation and spacers. Analyses were based on comparison of perioperative outcomes, radiologic and clinical metrics, and incidence of dysphagia and/or dysphonia. Results Mean patient age was 48.8 ± 10.1years (53.7% female). No significant differences were observed between groups in operative time (101.8 ± 34.4 minutes, 114.4 ± 31.5 minutes), estimated blood loss (44.8 ± 76.5 mL, 82.5 ± 195.1 mL), or length of hospital stay (1.2 ± 0.6 days, 1.3 ± 0.6 days). Mean visual analog scale pain scores and Neck Disability Index scores improved significantly from preoperative to last follow-up (10.8 ± 2.6 months) in both groups ( P < 0.05). Mean Voice Handicap Index and Eating Assessment Tool scores improved significantly from discharge to last follow-up in both groups ( P < 0.05). From discharge to 6 months, the stand-alone spacers group consistently demonstrated greater improvement in Voice Handicap Index. Preoperative intervertebral disc and neuroforaminal heights increased significantly across treatment groups ( P < 0.01), and no cases required surgical revision at index or adjacent levels. Conclusions Anterior cervical discectomy and fusion with stand-alone spacers resulted in similar clinical and radiologic outcomes as compared with plate and spacers and may help minimize postoperative dysphonia. [ABSTRACT FROM AUTHOR]

Immunotherapy for advanced melanoma has progressed dramatically in the last five years with the approval of immune checkpoint inhibitors targeting cytotoxic T lymphocyte-associated protein 4 (CTLA-4) and programmed cell death protein 1 (PD-1). Inhibition of these targets can break cancer-immune tolerance and result in durable objective responses with significantly improved tolerability over cytokine-based immunotherapy. Ipilimumab is an inhibitor of CTLA-4 and the first-in-class immune checkpoint inhibitor to demonstrate an improvement in overall survival in melanoma. Pembrolizumab and nivolumab target PD-1 and have improved single agent activity and tolerability in comparison to ipilimumab. The combination of nivolumab and ipilimumab results in even better response rates, reductions in tumor volume and progression free survival but at the expense of considerable autoimmune effects. Autoimmune side-effects and non-standard response kinetics represent a new challenge associated with cancer therapies that practitioners will have to become more familiar with as checkpoint inhibitors increasingly become part of mainstream oncological practice. Ongoing areas of investigation include drug development against novel immune targets; alternative treatment modalities, such as genetically modified oncolytic viruses; optimization of immunotherapy combination strategies; and the identification of reliable biomarkers to better guide treatment selection. [ABSTRACT FROM AUTHOR]

Résumé L’expérience actuelle de l’irradiation partielle et accélérée du sein permet de distinguer au moins deux pré-requis indispensables au succès thérapeutique : le strict respect de ses indications et l’emploi d’une technique parfaitement évaluée et maîtrisée. Les techniques permettant de délivrer une irradiation partielle et accélérée du sein postopératoire sont la curiethérapie interstitielle, la curiethérapie endocavitaire et la radiothérapie externe. Après sélection appropriée des candidates, toutes les modalités d’irradiation nécessitent une définition la plus exacte possible du volume-cible et le respect de critères dosimétriques propres à chaque technique. Les données à venir des essais randomisés devraient permettre d’approfondir la connaissance de tous ces paramètres et d’apporter des réponses concernant la comparaison des différentes techniques. Accelerated Partial Breast Irradiation (APBI) appears to be an efficient therapeutic modality provided that it uses strict selection criteria and a reliable and well-managed technique. The techniques that enable to deliver postoperative APBI are interstitial brachytherapy, endocavitary brachytherapy and external beam radiation therapy. Once an appropriate selection of the candidates is made, each radiation technique needs an exact target volume definition and a strict compliance with its own dosimetric constraints. Results of ongoing randomized trials should increase our knowledge of all these parameters, and give us responses about the comparison of the different techniques. [ABSTRACT FROM AUTHOR]

Abstract: The spontaneous regression of a lumbar herniated disc is a common occurrence. Studies using imaging techniques as well as immunohistologic analyses have attempted to explain the mechanism for regression. However, the exact mechanism remains elusive. Understanding the process by which herniated discs disappear in the absence of surgery may better guide treatment. Recent case reports, radiographic and immunohistologic studies show that the extent of extrusion of the nucleus pulposus is related to a higher likelihood of regression. To our knowledge, Patient 3 is the first report of spontaneous regression occurring within 2months. This occurrence was discovered intraoperatively. We present three illustrative patients. Patient 1, a 53-year-old man, presented with a large L2–L3 disc herniation. His 2year follow-up MRI revealed a complete regression of the extruded fragment. Patient 2, a 58-year-old man, presented with an L3–L4 disc herniation with cephalad migration of a free fragment. MRI 9months later showed no free fragment but progression of a disc bulge. Intraoperative exploration during the L3–L4 microdiscectomy confirmed the absence of the free fragment. Patient 3, a 58-year-old woman, presented with a large L2–L3 disc extrusion with cephalad migration. An imaging study performed 2months after the initial study revealed an absence of the free fragment. Our case reports demonstrate the temporal variance in disc regression. While the time course and extent of regression vary widely, the rapid time in which regression can occur should caution surgeons contemplating discectomy based on an MRI performed a significant period prior to surgery. [Copyright &y& Elsevier]

Abstract: Flow-induced structural anisotropy could result when a complex fluid system is removed from equilibrium by means of hydrodynamic forces. In this paper, a general theory is developed to model flow-induced anisotropic behavior of complex viscoelastic systems such as polymer solutions/melts and suspensions. The rheological properties are characterized by viscosity and relaxation time tensors. We consider a second-rank tensor as a measure of the microstructure. We consider the effect of the flow on the structural changes, i.e. the evolution of the microstructure tensor is governed by a relaxation-type differential equation. We also propose that the viscosity and the relaxation time tensors depend on the second-rank microstructure tensor, that is as the microstructure tensor changes with the applied rate of deformation, the viscosity and relaxation time tensors evolve accordingly. As an example we consider the elongational flows of two complex fluids. [Copyright &y& Elsevier]

Abstract: We performed a numerical study for the cessation of Couette flow of non-Newtonian fluids with a yield stress. We solved this problem by employing our recently developed constitutive model for such fluids [H. Zhu, Y.D. Kim, D. De Kee, Non-Newtonian fluids with a yield stress, J. Non-Newton. Fluid Mech. 129 (2005) 177]. In the numerical simulation we adopted the finite volume method with an implicit scheme in time. We computed the finite stopping times for fluids with different yield stresses and shear thinning properties. Our numerical results show that the yield stress play a important role in determining the finite stopping times for non-Newtonian fluids with a yield stress; on the other hand, the shear thinning property does affect the finite stopping times in that the larger the degree of shear thinning, the longer the finite stopping time. The present study is an extension of the previous work by Chatzimina et al. [M. Chatzimina, G.C. Georgiou, I. Argyropaidas, E. Mitsoulis, R.R. Huilgol, Cessation of Couette and Poiseuille flows of a Bingham plastic and finite stopping times, J. Non-Newton. Fluid Mech. 129 (2005) 117], in which only Bingham fluids are considered. [Copyright &y& Elsevier]

Abstract: The diffusion process of a simple fluid through a complex polymer/clay nanocomposite membrane embedding a complex interface is modeled using the generalized bracket/General Equation for Non-Equilibrium Reversible and Irreversible Coupling (GENERIC) formalism. The complex interface is characterized, on a mesoscopic level of description, by a second-order area tensor A. A set of governing equations describing the time evolution of concentration, flux, internal structure (of the complex polymeric membrane) and area tensor is obtained. Four parameters appear in the governing equations. Two parameters characterize the importance of elasticity and mixing and the remaining two parameters account for the effects of the complex interface. An extension of Fick''s second law, which includes the convective fluxes due to the change of polymer internal structure and complex interface, is derived for the flux evolution. The model describes the diffusion process quantitatively quite well. [Copyright &y& Elsevier]

This paper presents a technique for postural loading on the upper body assessment (LUBA). The proposed method is based on the new experimental data for composite index of perceived discomfort (ratio values) for a set of joint motions, including the hand, arm, neck and back, and the corresponding maximum holding times in static postures. Twenty male subjects participated in the experiment designed to measure perceived joint discomforts. The free modulus technique of the magnitude estimation method was employed to obtain subjects' discomforts for varying joint motions. The developed postural classification scheme was based on the angular deviation levels from the neutral position for each joint motion. These were divided into groups with the same degree of discomforts based on the statistical analysis. Each group was assigned a numerical discomfort score relative to the perceived discomfort value of elbow flexion, which exhibited the lowest level among all joint motions investigated in this study, and, therefore, was set as a reference point. The criteria for evaluating stresses of working postures were proposed based on the four distinct action categories, in order to enable practitioners to apply appropriate corrective actions. The proposed scheme can be used for evaluating and redesigning static working postures in industry. [ABSTRACT FROM AUTHOR]

Pembrolizumab significantly improved overall survival (OS) versus ipilimumab for unresectable advanced melanoma in KEYNOTE-006 (NCT01866319); 10-year follow-up data are presented. Patients with unresectable stage III or IV melanoma were randomly assigned (1:1:1) to pembrolizumab 10 mg/kg i.v. every 2 weeks or every 3 weeks for ≤2 years (pooled), or ipilimumab 3 mg/kg i.v. every 3 weeks for four cycles. After KEYNOTE-006, patients could transition to KEYNOTE-587 (NCT03486873) for long-term follow-up. Eligible patients could receive second-course pembrolizumab. The primary endpoint was OS; modified progression-free survival (PFS; censored at date last known alive), modified PFS on second-course pembrolizumab, and melanoma-specific survival were exploratory. Of 834 patients randomly assigned in KEYNOTE-006 (pembrolizumab, n = 556; ipilimumab, n = 278), 333 (39.9%) were eligible for KEYNOTE-587; 211/333 patients (25.3%) transitioned to KEYNOTE-587 (pembrolizumab, n = 159; ipilimumab, n = 52) and 122 (14.6%) did not. For patients who transitioned to KEYNOTE-587 (n = 211), median time from randomization in KEYNOTE-006 to data cut-off for KEYNOTE-587 (1 May 2024) was 123.7 months (range, 122.0-127.3 months). Median OS was 32.7 months [95% confidence interval (CI) 24.5-41.6 months] for pembrolizumab and 15.9 months (95% CI 13.3-22.0 months) for ipilimumab [hazard ratio (HR), 0.71 (95% CI 0.60-0.85)]; 10-year OS was 34.0% and 23.6%, respectively. Among patients who completed ≥94 weeks of pembrolizumab, median OS from week 94 was not reached (NR; 95% CI NR-NR); 8-year OS rate was 80.8%. Median modified PFS was 9.4 months (95% CI 6.7-11.6 months) for pembrolizumab and 3.8 months (2.9-4.3 months) for ipilimumab [HR, 0.64 (95% CI 0.54-0.75)]. Among patients who received second-course pembrolizumab, median modified PFS from start of second course was 51.8 months (95% CI 11.0 months-NR); 6-year modified PFS was 49.2%. Median melanoma-specific survival was 51.9 months (95% CI 30.0-114.7 months) for pembrolizumab and 17.2 months (13.9-25.9 months) for ipilimumab [HR, 0.66 (95% CI 0.55-0.81)]. These results confirm that pembrolizumab provides long-term survival benefits in advanced melanoma, supporting it as a standard of care in this setting. • The 10-year follow-up of KEYNOTE-006 confirms that pembrolizumab provides long-term survival benefit in advanced melanoma. • The 10-year OS rate was 34.0% in the combined pembrolizumab arm versus 23.6% in the ipilimumab arm. • OS favored pembrolizumab versus ipilimumab across subgroups, including in patients with poor prognostic features. • Median MSS was also improved with pembrolizumab versus ipilimumab [51.9 versus 17.2 months; HR, 0.66 (95% CI 0.55-0.81)]. • For patients who received second-course pembrolizumab (n = 16), the 6-year modified PFS from start of second course was 49.2%. [ABSTRACT FROM AUTHOR]

Objectif de l’étude L’objectif de l’étude était, comparer la probabilité de survie sans mastectomie à 10 ans observée après irradiation partielle et accélérée à celles estimées avec et sans irradiation totale du sein, chez les patientes âgées atteintes d’un cancer du sein localisé. Matériel et méthode Les patientes incluses avaient plus de 66 ans, étaient atteintes d’un cancer du sein infiltrant, des stade pT1 ou pT2 N0 M0, traitées par chirurgie conservatrice avec marges saines. L’irradiation partielle accélérée du sein a été réalisée par curiethérapie interstitielle de haut débit de dose de 32 à 34 Gy en huit à dix fractions. Albert et al. ont établi un nomogramme afin de prédire la probabilité de survie sans mastectomie à 10 ans avec et sans irradiation totale du sein chez les patientes âgées de 66 à 79 ans. Pour chaque patiente traitée, la probabilité de survie sans mastectomie à 10 ans avec et sans irradiation totale du sein a été calculée avec le nomogramme d’Albert et comparée à celle observée après irradiation partielle accélérée du sein. La toxicité a également été relevée. Résultats Nous avons inclus 79 patientes prises en charge par irradiation partielle accélérée du sein entre 2005 et 2016 dans le centre Antoine-Lacassagne. L’âge médian était de 77 ans (extrêmes : 66–89 ans). Il s’agissait essentiellement de tumeurs de stade pT1 (91,1 %) et d’histologie canalaire infiltrante (93,7 %). Une hormonothérapie adjuvante a été mise en place pour 72 patientes (91,1 %). Avec un suivi médian de 96,8 mois, une seule mastectomie a été réalisée chez une patiente de 85 ans, 88 mois après la curiethérapie. La probabilité de survie sans mastectomie à 10 ans observée pour la population traitée était de 97,4 %. Les probabilités de survie sans mastectomie à 10 ans estimées avec le nomogramme d’Albert sans radiothérapie et avec irradiation totale du sein étaient respectivement de 92,7 % et 96,3 %. Aucune toxicité de grade 3 ou plus n’a été observée. Conclusion La probabilité de survie sans mastectomie à 10 ans observée après irradiation partielle accélérée du sein est supérieure à celle estimée avec le nomogramme d’Albert sans radiothérapie et au moins non inférieure à celle estimée avec irradiation totale du sein. Chez les patientes âgées, l’irradiation partielle accélérée du sein semble être une bonne alternative entre l’irradiation totale du sein et l’absence d’irradiation. [ABSTRACT FROM AUTHOR]

Actuellement, la curiethérapie de prostate peut-être utilisée pour tous les cancers localisés de la prostate, notamment en complément d'irradiation pour ceux de pronostic intermédiaire ou défavorable. Son taux d'incidence augmentant significativement dans les prochaines décennies et l'utilisation de la curiethérapie se développant, nous avons réalisé une enquête nationale afin d'estimer l'offre de soin nécessaire pour subvenir aux besoins. Tous les centres ayant déclaré utiliser la curiethérapie à l'Institut national de cancer (INCa) ont été sollicités pour répondre à un questionnaire en ligne (avril 2018). Cinquante-deux des 54 centres qui déclaraient faire de la curiethérapie ont répondu au questionnaire (soit 96 %) et 34 centres faisaient de la curiethérapie de prostate. Parmi ces centres, 32 utilisaient la curiethérapie exlusive de prostate de bas débit de dose par implant d'iode 125, et 19 utilisaient la curiethérapie de prostate en complément d'irradiation (bas débit de dose : huit, haut débit de dose : sept, les deux techniques : quatre centres). Parmi les centres qui ne faisaient pas de curiethérapie de prostate en complément d'irradiation, 18 souhaitaient l'utiliser, huit ne voulaient pas et neuf n'ont pas répondu. Les raisons évoquées pour ne pas faire de la curiethérapie de la prostate en complément d'irradiation étaient : les contraintes organisationnelles (trois réponses), la possibilité de référer les patients à un centre de proximité (une réponse), les problèmes techniques (deux réponses) et l'absence de niveau de preuve scientifique (deux réponses). En ce qui concerne les ressources humaines, il y avait en moyenne deux médecins (extrêmes : 1–6 médecins) et trois physiciens(extrêmes : 1–5 physiciens) formés par centre. En France, l'état actuel de la curiethérapie de la prostate ne permet pas de répondre aux demandes futures. La formation ainsi que l'organisation des services et la prise en charge incluant un remboursement adéquat de la curiethérapie en complément d'irradiation doivent être organisés pour obtenir une offre de soin optimale. [ABSTRACT FROM AUTHOR]

Short- and mid-term studies have shown the effectiveness of cervical disc arthroplasty (CDA) to treat cervical disc degeneration. Upon completion of the 7-year Mobi-C FDA study, follow-up continued on a subset of CDA patients in the FDA study. The purpose of this study is to report the 10-year outcomes of a multicenter experience with cervical arthroplasty for 1- and 2-level pathology. This was a prospective cohort study of patients treated with cervical disc replacement at one or two contiguous levels using the Mobi-C® Cervical Disc. Following completion of the 7-year FDA post approval study, follow-up continued to 10 years for consenting patients at 9 high-enrolling centers. The primary inclusion criteria were cervical degenerative disc at one or two contiguous levels and no prior cervical operations. Outcome measures included NDI, VAS neck and arm pain, patient satisfaction, secondary surgical procedures (removals, revisions, reoperations, or additional fixation) and adverse events. Radiographic end points included segmental and global range of motion, sagittal alignment, adjacent level degeneration (ALD) and heterotopic ossification (HO). Radiographic ALD was defined with the Kellgren-Lawrence scale. HO was classified by the system adapted from McAfee and Mehren. Independent radiologists (Medical Metrics, Inc., Houston, TX) conducted radiographic evaluations. From the original enrollment of 257 CDA patients at 9 sites, 231 patients were eligible for follow-up after 7 years. Ten-year follow-up was obtained from 187 patients (81% follow-up). The longest follow-up was 11.2 years. Radiographs were obtained from 170 patients at 10 years. There were no significant differences in preoperative characteristics between these patients and the original FDA cohort. Ten years after CDA, patients continued to show significant improvement from baseline NDI, VAS neck and arm pain, and neurologic function. Outcomes at 10 years were improved from results at 7 years for NDI at one (14.2 vs 18.7; p=0.12) and two levels (15.6 vs 19.7; p=0.02). Comparable results were observed for neck and arm pain. These improvements were less than the MCID for NDI and pain. There were no significant differences in outcomes between 1- and 2-level CDA at 10 years. Segmental flexion-extension range of motion remained significantly higher (p<0.01) than preop ROM. Segmental and global ROM, and sagittal alignment were maintained from 7 to 10 years. Clinically relevant ALD at 10 years was not significantly different from the 7-year incidence (p>0.05). The incidence of clinically relevant HO at 10 years was not significantly different from the 7-year incidence for 1-level (30.7% vs 29.6%; p=0.88) or 2-level (41.7% vs 39.2%; p=0.70) CDA patients. Only 2 subsequent surgeries were reported after 7 years. One patient underwent supplemental fixation at the index level 9.5 years after CDA. The other case was ACDF at a nonadjacent level unrelated to the CDA. Total incidence of subsequent surgery after 10 years was 4.7% (12/257) at the index level and 3.5% (9/257) at an adjacent level. At 10-years, both 1- and 2-level CDA demonstrate sustained improvement of NDI, pain scores, range of motion and sagittal alignment compared to baseline. Progression of ALD and HO from 7 to 10 years was minimal. Our results through 10 years demonstrate that CDA with Mobi-C continues to be a safe and effective surgical treatment for patients with 1- or 2-level cervical degenerative disc disease. Unavailable from authors at time of publication. [ABSTRACT FROM AUTHOR]

Total disc arthroplasty (TDA) is a popular treatment for cervical degenerative disc because it preserves motion, decreasing the potential for adjacent level disease. However, oversizing the disc may occur due to limited options in artificial disc height and may diminish this motion preservation. In this study, 1- and 2-level disc arthroplasties with mobile core devices (MCD) at C5-C6 and C4-C5 were compared to oversized devices and 2-level fusions. Eight cadaveric cervical (C2-T1) spine specimens (average age: 43 ± 12 years) were prepared with cranial and caudal ends embedded in bone cement. Each vertebra was instrumented with optoelectronic markers for motion capture. Each specimen was tested using a six degree-of-freedom kinematic spinal simulator up to 2 Nm in three cycles of flexion/extension. All specimens were tested at four intervention points: intact, ALL resection, 1-level TDA @ C5-C6 with an MCD (Mobi-C, Zimmer Biomet), and 2-level TDA @ C4-C6 with MCDs. After these interventions, the specimens were separated into two equal groups (A and B) with two additional interventions: 2-level TDA with overstuffing or increasing the height of the MCD by 1 mm at C5-C6 (Group A) or C4-C5 (Group B), and 2-level fusion @ C4-C6. All moment and motion capture data were imported into Matlab, and the 3rd test cycle was analyzed. Maximum ranges of motion, normalized as percent of intact, were analyzed for the index (C4-C5 and C5-C6) and adjacent (C3-C4 and C6-C7) levels. Two-way ANOVA with one way repeated-measures was performed with post-hoc Tukey's tests to measure changes in maximum ranges of motion. Flexion/Extension, Interventions 1-4: No significant differences were observed between all four interventions at C3-C4 and C4-C5. At C5-C6, significantly greater flexion/extension was measured with ALL resection compared to intact and 1-level TDA interventions. Finally, at C6-C7, ALL resection produced significantly higher range of motion vs 2-level TDA. Flexion/Extension, Group A, Interventions 1,3-6: At C3-C4 and C6-C7, no significant differences were measured between any of the interventions. At C4-C5, intactROM was significantly larger than 2-level TDA, overstuffed TDA @ C5-C6, and 2-level fusion @ C4-C6. In addition, 1-level TDAROM was significantly larger than 2-level TDA and 2-level fusion. Finally, ROM for 2-level TDA and overstuffed TDA @ C5-C6 were both significantly larger than 2-level fusion. At C5-C6, intact, 1-level, and 2-level TDA ROM were significantly larger than the overstuffed TDA @ C5-C6 and the 2-level fusion interventions. Also, the overstuffed TDA @ C5-C6 ROM was significantly larger than the 2-level fusion. Flexion/Extension, Group B, Interventions 1,3-6: At C3-C4 and C6-C7, no significant differences were measured between any of the interventions. At C4-C5, Intact ROM was significantly larger than 2-level TDA, overstuffed TDA @ C4-C5, and 2-level fusion. 1- and 2-level TDA ROM were both significantly larger than overstuffed TDA @ C4-C5 and 2-level fusion. Finally, overstuffed TDA @ C4-C5 ROM was significantly larger than 2-level fusion. At C5-C6, ROM of all interventions was significantly larger than 2-level fusion. Mobile-core disc arthroplasty device maintained range of motion at the index levels, and did not increase motion in adjacent levels in both 1- and 2-level disc arthroplasty implantations. In addition, implanting with oversized devices caused significant decreases in range of motion. Unavailable from authors at time of publication. [ABSTRACT FROM AUTHOR]

Objectif de l’étude La curiethérapie en boost est proposée comme une technique de choix pour les cancers de la prostate de risques intermédiaire et défavorable dans beaucoup d’études rétrospectives et prospectives. Actuellement, trois essais randomisés comparent la curiethérapie et la radiothérapie externe, mais avec des différences de techniques, de doses, de fractionnement et de durée d’hormonothérapie. Ainsi, nous avons réalisé une méta-analyse des essais randomisés pour analyser les résultats carcinologiques. Matériel et méthode Il a été fait une revue systématique des bases de données Medline et Cochrane jusqu’au 30/4/18 et seuls les essais randomisés comparant la curiethérapie et la radiothérapie externe en boost ont été inclus pour une analyse selon PRISMA (Preferred reporting items for systematic review and meta-analysis). La qualité de la revue a été évaluée selon AMSTAR (Assessing the methodological quality of systematic reviews) et les articles individuels selon CONSORT (Consolidated standards of reporting trials). Huit articles sur les trois essais randomisés ont été analysés. Résultats Il y avait une différence significative de rechutes biochimiques en faveur de la curiethérapie hazard ratio [HR] : 0,49 ; intervalle de confiance à 95 %[IC 95 %] : 0,37–0,66 ; p < 0,01. Il n’y avait pas de différence significative de survie globale (HR : 0,92 ; 95 % IC : 0,64–1,33 ; p = 0,65), de toxicité urinaire tardive de grade 3 (risque relatif [RR] : 2,19 ; IC 95 % : 0,76–6,30 ; p = 0,15) ni de toxicité digestive tardive de grade 3 (RR : 1,85 ; IC 95 % : 1,00–3,41 ; p = 0,05). Conclusion Cette méta-analyse apporte un niveau de preuve supplémentaire en faveur de la curiethérapie en boost pour les cancers de la prostate de risques intermédiaire et défavorable, pouvant la proposer en niveau de preuve 1 et grade de recommandation A. En revanche, l’analyse de la toxicité doit être évaluée avec prudence. [ABSTRACT FROM AUTHOR]

BACKGROUND CONTEXT Short- and mid-term studies have demonstrated that cervical disc arthroplasty (CDA) can maintain or restore range of motion and sagittal alignment in select patients with cervical disc degeneration. Upon completion of the 7-year Mobi-C FDA study, follow-up continued out to 10 years on a subset of CDA patients from high-enrolling centers in the FDA study. This is an analysis of the radiographic outcomes of the first 98 CDA patients with 10-years follow-up. PURPOSE The purpose of this study is to present preliminary radiographic outcomes of the first 98 (approximately 50%) patients followed for 10-years in a multicenter study of cervical arthroplasty for one- and two-level pathology. STUDY DESIGN/SETTING This was a prospective cohort study of patients treated with cervical disc replacement at one or two contiguous levels using the Mobi-C Cervical Disc. Following completion of the 7-year FDA post approval study, follow-up was extended to 10 years for consenting patients at seven high-enrolling centers. PATIENT SAMPLE The inclusion criteria for this study was adult patients (>18 years) with radiculopathy or myelopathy and cervical spondylosis at one or two contiguous levels and no prior cervical operations. OUTCOME MEASURES All radiographic evaluations were conducted by independent radiologists (Medical Metrics, Inc., Houston, TX, USA). Radiographic endpoints included segmental and global range of motion, sagittal alignment, adjacent level degeneration (ALD) and heterotopic ossification (HO). The Kellgren-Lawrence scale of disc degeneration was used to define radiographic ALD. HO was classified using the system adapted from McAfee and Mehren. HO grades 3 and 4 were classified as clinically relevant due to restricted ROM. METHODS Ten-year radiographic follow-up was obtained from 98 CDA patients (53 2-level; 45 1-level) at seven centers. All radiological endpoints for the study cohort including HO were evaluated at 10 years, and were compared to the 7-year data for the group using statistical tests that were 2-sided, with p values<.05 considered significant. RESULTS There were no significant differences in demographic factors or preoperative patient-reported outcomes between these patients and the original FDA cohort. Both segmental flexion-extension (FE) and lateral bending (LB) range of motion remained significantly greater (p<.001) than preop ROM, and mean segmental ROM was maintained from 7 to 10 years (p>.05). Global (C2-C6) flexion-extension and sagittal alignment also were maintained from 7 to 10 years (p>.05). Clinically relevant ALD (Grades III-IV) at 10 years was not significantly different from the 7-year incidence for one-level (25.0% vs. 26.2%; p=.47) or 2-level (17.0% vs. 13.7%; p=.16) CDA patients. The incidence of clinically relevant HO at 10 years was not significantly different from the 5-year incidence for one-level (28.9% vs. 33.3%; p=.88) or 2-level (35.8% vs. 26.9%; p=.21) CDA patients. From 7 to 10 years, 94% of patients had no progression of HO. Although patients with Grade 3/4 HO had diminished ROM, range of motion at the affected level(s) remained stable in these patients from 7 years (FE 3.7°; LB 2.7°) to 10 years (FE 3.5°; LB 2.6°). CONCLUSIONS We demonstrate continued maintenance of radiographic performance of cervical arthroplasty out to 10 years. At 10-year follow-up, both one- and two-level arthroplasty demonstrate sustained range of motion and sagittal alignment in comparison to baseline values. Progression of ALD and HO was limited from 7 to 10 years in these patients. Our preliminary results through 10 years demonstrate that total disc arthroplasty with Mobi-C continues to be an effective surgical treatment for patients with one- or two-level cervical degenerative disc disease. FDA DEVICE/DRUG STATUS The Mobi-C is approved for this indication. [ABSTRACT FROM AUTHOR]

Objectif La validation des images de repositionnement journalière relève d’une compétence des manipulateurs sous la responsabilité médicale. Ainsi, nous avons voulu étudier la concordance de la validation des tomographies coniques (CFBCT) de repositionnement par des manipulateurs avec celle des médecins et vérifier si une marge du volume cible prévisionnel (PTV) de 7 mm était suffisante dans le cadre d’une arcthérapie volumétrique modulée pour cancer du sein. Patientes et méthodes Étude rétrospective, monocentrique, randomisée incluant 146 patients, avec prise en compte de deux images par patiente pour évaluer la concordance du recalage de tomographies coniques par des manipulateurs avec celle de deux médecins, dans le cadre du traitement du cancer du sein, toutes indications confondues. Le recalage effectué par les manipulateurs et la bonne couverture des volumes cibles ont été analysés par deux médecins. Un écart de validation de 5 % a été fixé comme seuil d’acceptabilité. Les causes de non-validation ont été différenciées selon une variation anatomique de la patiente au fil du traitement ou à une différence de recalage entre médecin et manipulateurs. La réaction du manipulateur (replanification, appel du médecin, etc.) a été étudiée pour chaque cas. Résultats Sur 292 images analysées, dix recalages n’ont pas été acceptés (soit 3,4 % des images). Les principales causes de non validation étaient une modification de morphologie de la patiente dans cinq cas (50 %) et une différence de recalage médecin/manipulateur dans cinq (50 %). La marge systématique de volume cible prévisionnel de 7 mm permettait une bonne couverture des volumes cibles pour 272 images analysées (soit 93 %). Conclusion La concordance du recalage manipulateur/médecin était inférieure au seuil fixé. Une marge minimale de volume cible prévisionnel de7 mm paraît obligatoire pour le traitement du cancer du sein avec nécessité de définir la valeur optimale. Par ailleurs, une formation initiale et continue des manipulateurs est nécessaire pour maintenir la qualité des traitements. [ABSTRACT FROM AUTHOR]

Objectif de l’étude Évaluer l’efficacité et la toxicité d’une ré-irradiation par CyberKnife ® ou curiethérapie pour le traitement de rattrapage d’une récidive locale de cancer de prostate. Matériel et méhode Entre 2011 et 2015, 28 patients ont été traités par ré-irradiation prostatique, délivrée par CyberKnife ® ( n = 18) ou curiethérapie à haut débit de dose ( n = 10), pour une récidive locale de cancer de prostate initialement prise en charge par radiothérapie. Le schéma d’irradiation était de 35 Gy en cinq fractions de 7 Gy par jour. La survie sans récidive biologique (a été analysée selon la méthode de Kaplan-Meier, et les courbes ont été comparées avec le test du Log rank . La toxicité aiguë et tardive a été cotée selon l’échelle Common terminology criteria for adverse events , version 4.03. Résultats Avec un suivi médian de 15,5 mois (7–28), un patient pris en charge par curiethérapie HDD et deux par CyberKnife ® n’ont pas connu de baisse de leur PSA. Chez les patients pris en charge par curiethérapie de haut débit de dose, le nadir du PSA était de 0,66 ng/mL (0,23–1,13) et était atteint en six mois (EI = 5–8). Cinq patients ont été atteints d’une récidive biochimique, survenue en 13 mois (EI = 10–26). Un seul patient a souffert d’une complication urinaire transitoire de grade ≥ 3. Après Cyberknife ® , le nadir du PSA était de 0,89 ng/mL (0,29–1,4) et a été atteint en 7,5 mois (4,5–10). Dix cancers ont récidivé biologiquement en 5,5 mois 4–6). Trois patients ont connu une complication urinaire résolutive, deux de grade 3 et une de grade 4. Aucun patient n’a connu de complication sexuelle ou digestive de grade ≥ 3. Conclusion La ré-irradiation des récidives locales des cancer de prostate est une technique faisable et relativement peu toxique. D’autres investigations sont nécessaires pour confirmer ces résultats prospectivement. [ABSTRACT FROM AUTHOR]

Objectifs Évaluation de la toxicité et de l’efficacité de la ré-irradiation pulmonaire stéréotaxique par CyberKnife ® . Patients et méthodes Inclusion dans une étude monocentrique rétrospective de tous patients recevant un traitement par CyberKnife ® dans le poumon, ayant déjà reçu une radiothérapie thoracique, toutes histologies confondues. Les patients ont été suivis au minimum par une imagerie et une consultation à 3 mois puis annuellement. Le critère de jugement principal était la toxicité de grade 3 ou plus selon l’échelle la Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. Les critères de jugement secondaires étaient l’obtention du contrôle local, la survie sans progression et la survie globale, en particulier dans le sous-groupe des patients atteints de cancer pulmonaire non à petites cellules. Résultats Cinquante-quatre patients ont été ré-irradiés de mai 2007 à juin 2013, 29 pour un cancer pulmonaire non à petites cellules et 16 en plein volume de la première radiothérapie. La durée de suivi médiane était de 1,4 an [0,8 ;2,2] et six patients (11 %) ont souffert d’une toxicité de grade 3 ou plus, deux pariétale, deux cardiaque, une oesophagienne, une vasculaire et trachéale. En analyse individuelle clinique et dosimétrique, seule la toxicité vasculaire et trachéale chez le même patient pourrait être imputable à la ré-irradiation. Les probabilités de contrôle local, de survie sans progression et de survie globale toutes histologies confondues étaient respectivement de 67 %, 42 %, 80 % à 1 an et de 54 %, 14 %, 68 % à 2 ans. En ce qui concerne les patients atteints de cancer pulmonaire non à petites cellules, elles étaient respectivement de 65 %, 47 % et 76 % à 1 an et 44 %, 16 % et 60 % à 2 ans. Conclusion La ré-irradiation pulmonaire par CyberKnife ® semble faisable avec peu de toxicité mais doit être démontrée par des études prospectives dans une population plus importante. [ABSTRACT FROM AUTHOR]

Objectifs Analyse de la faisabilité et de l’efficacité de la curiethérapie de haut débit de dose des tumeurs de la tête et du cou. Matériel et méthodes Étude monocentrique, rétrospective, avec analyse des dossiers des patients ayant eu une curiethérapie de haut débit de dose dans la prise en charge des tumeurs de la tête et du cou. Les critères cliniques, dosimétriques, les sites de récidives et les complications selon la Common Terminology Criteria for Adverse Events v4.0 ont été relevés. Résultats D’octobre 2006 à septembre 2014, parmi 22 patients âgés en moyenne de 67 ans, 16 patients ont eu une curiethérapie comme traitement initial, dont cinq exclusivement, pour des tumeurs des lèvres, neuf après chirurgie (deux des lèvres, une du plancher buccal, cinq de bord de la langue et une de la base de la langue) et deux en complément d’une radiothérapie externe (une des lèvres avec irradiation ganglionnaire et une du bord de la langue en complément d’une radiothérapie externe). La curiethérapie a aussi été utilisée pour les récidives en territoire irradié chez deux patients, exclusivement pour une du bord de la langue et une de la base de la langue, et en barrage après une chirurgie chez quatre patients pour une tumeur du plancher buccal et trois de la base de la langue. Les doses moyennes prescrites étaient de 35G y en neuf fractions, avec une dose initiale de 6 Gy à j1 et 4 Gy en moyenne deux fois par jour de j2 à j5. Les valeurs moyennes des D90 et D100 (doses dans 90 % et 100 % du volume), V100, V150, V200 (volumes recevant 100 %, 150 % et 200 % de la dose prescrite), DHI ( dose homogeneity index ), et DNR ( dose non-uniformity ratio ) étaient respectivement de 35 Gy, 23 Gy, 91 %, 41 %, 19 %, 0,55 et 0,45. Il n’y a eu aucune complication supérieure de grade de plus de 2. Les récidives étaient locales pour six (quatre du bord de la langue, une des lèvres et une de la base de la langue), ganglionnaires pour cinq (deux des lèvres et trois du bord de la langue) et métastatiques pour trois (une du plancher buccal et deux du bord de la langue). Après un suivi en moyenne de 28 mois, dix patients sont décédés, la moitié d’une évolution locale. Conclusion La curiethérapie de haut débit de dose semble être une technique acceptable en termes de tolérance. En revanche, l’efficacité doit être évaluée sur une population plus importante et moins hétérogène. [ABSTRACT FROM AUTHOR]

Background: As early detection of recurrent melanoma maximizes treatment options, patients usually undergo post-operative imaging surveillance, increasingly with FDG-PET/CT (PET). To assess this, we evaluated stage 3 melanoma patients who underwent prospectively applied and sub-stage-specific schedules of PET surveillance. Patients and methods: From 2009, patients with stage 3 melanoma routinely underwent PET +/- MRI brain scans via defined schedules based on sub-stage-specific relapse probabilities. Data were collected regarding patient characteristics and outcomes. Contingency analyses were carried out of imaging outcomes. Results: One hundred and seventy patients (stage 3A: 34; 3B: 93; 3C: 43) underwent radiological surveillance. Relapses were identified in 65 (38%) patients, of which 45 (69%) were asymptomatic. False-positive imaging findings occurred in 7%, and 6% had treatable second (non-melanoma) malignancies. Positive predictive values (PPV) of individual scans were 56%-83%. Negative scans had predictive values of 89%-96% for true non-recurrence [negative predictive values (NPV)] until the next scan. A negative PET at 18months had NPVs of 80%-84% for true non-recurrence at any time in the 47-month (median) follow-up period. Sensitivity and specificity of the overall approach of sub-stage-specific PET surveillance were 70% and 87%, respectively. Of relapsed patients, 33 (52%) underwent potentially curative resection and 10 (16%) remained disease-free after 24months (median). Conclusions: Application of sub-stage-specific PET in stage 3 melanoma enables asymptomatic detection of most recurrences, has high NPVs that may provide patient reassurance, and is associated with a high rate of detection of resectable and potentially curable disease at relapse. [ABSTRACT FROM AUTHOR]

Objectif Le mélanome muqueux fait partie des maladies rares et il existe peu de référentiels sur leur prise en charge. Nous avons ainsi décidé de réaliser une étude rétrospective et descriptive des patients traités à Nancy, comparant nos résultats avec ceux de la littérature, afin d’éclaircir une stratégie thérapeutique. Matériels et méthodes Étaient inclus tous patients atteints d’un mélanome muqueux traités à l’institut de cancérologie Lorraine ou au centre hospitalo-universitaire de Nancy avec analyse de leurs caractéristiques, prises en charges, facteurs pronostiques et résultats en termes de survies globale et sans progression. Résultats Trente-deux patients ont été inclus. L’âge médian était de 70,5 ans. Il y avait une prédominance des tumeurs des fosses nasales (53 %) et de stade III (78 %) selon la classification de l’American Joint Committee on Cancer de 2010 (septième édition). La prise en charge initiale était principalement chirurgicale dans 81 % des cas avec une radiothérapie adjuvante associée chez 47 % des patients. La radiothérapie adjuvante, par comparaison à la chirurgie seule, a donné des meilleurs résultats en termes de durées de survie globale médiane (95,6 mois contre 28,9 mois) et de survie sans progression médiane (18,2 mois contre 8 mois). Les récidives étaient principalement métastatiques chez 69 % des patients, à l’origine de décès. Les autres facteurs pronostiques retenus dans notre série étaient la réponse initiale au traitement et la localisation tumorale, avec par ordre décroissant la fosse nasale (51,6 mois), la cavité orale (30,2 mois) et les sinus (10,3mois) Conclusion La prise en charge évolue avec l’avancée technique permettant un bon taux de contrôle local mais il persiste le défi de la maîtrise de l’évolution métastatique fatale. [ABSTRACT FROM AUTHOR]

Blumenthal et al (2013) found that segmental facet joint angle (FJA) >50°, disc height (DH) >6.5mm and segmental translation (ST) >1.25mm were associated with higher rates of reoperation in patients who had decompression only, without fusion, for symptomatic degenerative spondylolisthesis (DS). An ongoing FDA IDE study (NCT03115983) is comparing spondyloplasty (decompression and dynamic sagittal tether (DST) stabilization vs decompression and transforaminal lumbar interbody fusion (TLIF) for symptomatic DS. Radiographic measures including those identified by Blumenthal may identify signals among subgroups with clinical success or failure. The purpose of this analysis is to assess composite clinical success (CCS) among spondyloplasty and TLIF subjects having a PDI. Post-hoc analysis of data from a multi-center, prospective IDE study of spondyloplasty vs TLIF for symptomatic DS (NCT03115983). A total of 299 subjects enrolled in the IDE trial of spondyloplasty (N=140) vs TLIF (N=159). Full study inclusion criteria provided at clinicaltrials.gov (NCT03115983). Primary outcome measure CCS was defined as patients meeting all of the following through 24-months: successful index implantation; 15-point improvement on the Oswestry Disability Index (ODI); no device integrity failure defined as device breakage, separation, dislocation or disassembly; no subsequent surgical intervention (SSI) at the index or adjacent segments; and no decrease in neurologic status unless attributable to a concurrent medical condition or other unrelated cause. PDI were defined as ST>1.25mm, FJA>50° or DH>6.5mm as measured on preoperative radiographs. CCS rates were calculated for each subgroup of patients having or not having each individual PDI, all PDI, any PDI or no PDI in each of the two treatment arms. Influence of each PDI was assessed using student's t-test to compare subjects with and without the PDI. Too Long Text characters = 69300 max allowed in xls 32,250. There was no identifiable relationship between any of the preoperative radiographic parameters and clinical success in either the spondyloplasty or TLIF groups. Notably, failures in the spondyloplasty group were not associated with higher preoperative mobility, disc height, anterolisthesis or FJ angle, as has been seen in decompression alone. LimiFlex Dynamic Sagittal Tether (Investigational/Not Approved), Standard of Care TLIF instrumentation and graft materials (Approved for this indication) [ABSTRACT FROM AUTHOR]

Durable outcome for patients with DS usually requires decompression and fusion. Spondyloplasty is an investigational procedure utilizing a dynamic sagittal tether (DST) for segmental stabilization after decompression for DS as an alternative to fusion. Evaluate propensity score (PS) adjusted outcomes comparing decompression and DST stabilization versus decompression and TLIF for symptomatic grade I DS at 2 years after surgery. Concurrently enrolled multi-center IDE trial with propensity score matching of groups. All patients had Grade I DS on a lateral radiograph at one level and spinal canal stenosis at one or two levels with ODI≥35 and VAS-leg/hip≥50. Full inclusion criteria are detailed at clinicaltrials.gov (NCT03115983). Primary outcome measure was composite clinical success (CCS) where a patient had to satisfy 5 criteria at 24-months follow-up: successful index implantation; improvement of at least 15 points on the Oswestry Disability Index (ODI); no decrease in neurologic status at 24 months compared to baseline unless attributable to a concurrent medical condition or other unrelated cause; no subsequent surgical intervention (SSI) at the index or adjacent levels; and no device integrity failure (breakage, separation/disassembly or dislocation). Secondary outcomes included individual components of the CCS. Patients were enrolled into the trial at either investigational spondyloplasty or control TLIF sites. A propensity score (PS) model was developed, achieving excellent balance between trial groups. Differences between groups were calculated using average treatment effect of the treated (ATT) weighted analyses of the PS subclasses per FDA requirements. The trial was designed as a noninferiority study, with a -12.5% noninferiority margin as tested with a 95% single sided confidence interval (CI) of the between-group difference. All 140 spondyloplasty and 125 TLIF subjects were selected into the PS model, the equivalent of randomization. Mean±SD preoperative age of the spondyloplasty/TLIF subjects was 65.8±7.7/64.5±8.9yrs, BMI 28.1±4.7/29.3±5.3kg/m2, ODI 52.6±11.9/51.7±13.5, 42.1%/29.6% male. CCS, individual component success, between-group differences and 95% and 97.5% single-sided CI are presented in the table below. The spondyloplasty group demonstrated a 15.9% higher overall success rate, with 95% CI +2.9% > -12.5%, demonstrating noninferiority. With a 97.5% single sided lower CI of +0.4%, superiority of the spondyloplasty group was also demonstrated for the primary CCS (p=0.022). The spondyloplasty group demonstrated higher success rates on each of the individual components, however none of these differences were significant. Reoperation rates (SSI) at index or adjacent levels at 24 months were 7.8% in the spondyloplasty group and 10.1% in the TLIF group. Spondyloplasty – comprising surgical decompression and segmental stabilization with a dynamic sagittal tether – demonstrated superiority over TLIF at 24 months in the treatment of symptomatic degenerative spondylolisthesis. More durable outcomes, including lower reoperation rates, is the primary motivation to add instrumented fusion to surgical decompression for DS, and in this study, the spondyloplasty group had a lower reoperation rate vs TLIF. Longer-term follow-up will demonstrated if this benefit is maintained. LimiFlex Dynamic Sagittal Tether (Investigational/Not Approved), Standard of Care TLIF instrumentation and graft materials (Approved for this indication). [ABSTRACT FROM AUTHOR]

Background context Intraoperative imaging is essential in spinal surgery to both determine the correct level and place implants safely. Surgeons have a variety of options: C-arm fluoroscopy (C-arm), portable X-ray (XR) radiography, and portable cone-beam computed tomography (O-arm). Although these modalities have their respective advantages and disadvantages, direct comparison of radiation exposure to either the patient or the operating room (OR) staff has not been made. Purpose To determine the amount of radiation exposure to patients and OR staff during spine surgery with C-arm, XR, and O-arm. Study design An experimental model to assess radiation exposure to OR staff and phantom patient during spine surgery. Methods A plastic phantom was created to emulate patient volume and absorption scattering characteristics of a typical sized adult abdominal volume. Radiation exposure was measured with ion chamber dosimeters to determine entrance phantom and scatter exposures at common positions occupied by OR staff for C-arm, XR, and O-arm in typical image acquisition during spinal surgery. Results Single lateral (LAT)/posterior-anterior entrance patient radiation exposure for C-arm was on average 116/102 mR, single-exposure XR for LAT/anterior-posterior (AP) was 3,435/2,160 mR, and single-exposure O-arm for LAT/AP was 4,360/5,220 mR. O-arm surface exposure LAT/AP was equivalent to 38/41 C-arm and 1.5/2.4 XR exposures. The surgeon and surgeon assistant had higher levels of scatter radiation for C-arm, followed by O-arm and XR. For the LAT C-arm acquisition, a 7.7-fold increase in radiation exposure was measured on the X-ray tube side compared with the detector side. The anesthesiologist scatter radiation level for a single acquisition was highest for O-arm, followed by XR and C-arm. The radiologic technologist scatter radiation level was highest for XR, followed by O-arm and fluoroscopy. Overall radiation exposure to OR staff was less than 4.4 mR for a single acquisition in all modalities. Conclusions Assessment of radiation risk to the patient and OR staff should be part of the decision for utilization of any specific imaging modality during spinal surgery. This study provides the surgeon with information to better weigh the risks and benefits of each imaging modality. [ABSTRACT FROM AUTHOR]

Abstract: A modified Herschel–Bulkley model [E. Mitsoulis, S.S. Abdali, Flow simulation of Herschel–Bulkley fluids through extrusion dies, Can. J. Chem. Eng. 71 (1993) 147–160] predicts an infinite apparent viscosity at vanishing shear rate. Furthermore, the dimensions of one parameter depend on another parameter. In this contribution, we propose a generalized model based on earlier work by De Kee and Turcotte [D. De Kee, G. Turcotte, Viscosity of biomaterials. Chem. Eng. Commun. 6 (1980) 273–282] and on the work of Papanastasiou [T.C. Papanastasiou, Flows of materials with yield, J. Rheol. 31 (1987) 385–404] to solve the problems associated with the modified Herschel–Bulkley model. Compared to the responses of the Papanastasiou model and the modified Herschel–Bulkley model, the proposed generalized model provides the expected improvements and is capable of predicting successfully the rheological behavior (viscosity and yield stress) of Carbopol 980 dispersions. [Copyright &y& Elsevier]

Abstract: Background: In North America, the largest number of neurosurgical cases stemming from parasitic infections involves the larval form of Taenia solium, the infectious organism causing neurocysticercosis. This infection of the central nervous system (CNS) is most commonly seen in areas with significant immigrant populations and can often present particular challenges to treating physicians. Methods: A review of the literature was performed, highlighting the epidemiology, parasitology, and clinical manifestations of neurocysticercosis. Particular attention was paid to 4 locations of neurocysticercosis lesions: parenchymal, subarachnoid/cisternal, intraventricular, and spinal. Results: Both medical and surgical interventions may be necessary for adequate treatment of neurocysticercosis, depending on various factors, including location of lesion. Conclusions: A review of neurocysticercosis, with particular attention paid to location of disease involvement in the CNS, provides important information to the clinical management of this disease. [Copyright &y& Elsevier]

External beam radiotherapy and brachytherapy are major treatments in the management of cervical cancer. For early-stage tumours with local risk factors, brachytherapy is a preoperative option. Postoperative radiotherapy is indicated according to histopathological criteria. For advanced local tumours, chemoradiation is the standard treatment, followed by brachytherapy boost, which is not optional. We present the update of the recommendations of the French Society of Oncological Radiotherapy on the indications and techniques for external beam radiotherapy and brachytherapy for cervical cancer. [ABSTRACT FROM AUTHOR]

Background: Degenerative cervical myelopathy represents the most common form of non-traumatic spinal cord injury. This trial investigated whether riluzole enhances outcomes in patients undergoing decompression surgery for degenerative cervical myelopathy.Methods: This multicentre, double-blind, placebo-controlled, randomised, phase 3 trial was done at 16 university-affiliated centres in Canada and the USA. Patients with moderate-to-severe degenerative cervical myelopathy aged 18-80 years, who had a modified Japanese Orthopaedic Association (mJOA) score of 8-14, were eligible. Patients were randomly assigned (1:1) to receive either oral riluzole (50 mg twice a day for 14 days before surgery and then for 28 days after surgery) or placebo. Randomisation was done using permuted blocks stratified by study site. Patients, physicians, and outcome assessors remained masked to treatment group allocation. The primary endpoint was change in mJOA score from baseline to 6 months in the intention-to-treat (ITT) population, defined as all individuals who underwent randomisation and surgical decompression. Adverse events were analysed in the modified intention-to-treat (mITT) population, defined as all patients who underwent randomisation, including those who did not ultimately undergo surgical decompression. This study is registered with ClinicalTrials.gov, NCT01257828.Findings: From Jan 31, 2012, to May 16, 2017, 408 patients were screened. Of those screened, 300 were eligible (mITT population); 290 patients underwent decompression surgery (ITT population) and received either riluzole (n=141) or placebo (n=149). There was no difference between the riluzole and placebo groups in the primary endpoint of change in mJOA score at 6-month follow-up: 2·45 points (95% CI 2·08 to 2·82 points) versus 2·83 points (2·47 to 3·19), difference -0·38 points (-0·90 to 0·13; p=0·14). The most common adverse events were neck or arm or shoulder pain, arm paraesthesia, dysphagia, and worsening of myelopathy. There were 43 serious adverse events in 33 (22%) of 147 patients in the riluzole group and 34 serious adverse events in 29 (19%) of 153 patients in the placebo group. The most frequent severe adverse events were osteoarthrosis of non-spinal joints, worsening of myelopathy, and wound complications.Interpretation: In this trial, adjuvant treatment for 6 weeks perioperatively with riluzole did not improve functional recovery beyond decompressive surgery in patients with moderate-to-severe degenerative cervical myelopathy. Whether riluzole has other benefits in this patient population merits further study.Funding: AOSpine North America. [ABSTRACT FROM AUTHOR]

Background Context: Lumbar discectomy is largely successful surgical procedure; however, reherniation rates in patients with large annular defects are as high as 27%. The expense associated with a revision surgery places significant burden on the healthcare system.Purpose: To compare the direct health care costs through 5 years follow-up of conventional discectomy (Control) with those of discectomy supplemented by an adjunctive annular closure device (ACD) in high-risk patients with large annular defects.Study Design: This was a cost-effectiveness study.Methods: All-cause index level reoperations were reviewed from a multicenter, randomized controlled superiority trial that allocated 554 high-risk discectomy patients with large annular defects to either control or ACD. Medicare and private insurer (Humana) direct costs were derived from a commercially available payer database to estimate costs in the US healthcare system, including those associated with facility, surgeon, imaging, follow-up visits, physical therapy, and injections. A 50:50 split between Medicare and commercial insurers was assumed for the base case analysis. The analysis was also performed on a 80:20 commercial:Medicare payer basis. For the base case scenario, a 2-year time horizon and outpatient cost setting was established for the index procedure. Repeat discectomy was assumed to be performed on a 60:40 outpatient-to-inpatient basis. Complications requiring surgery, revisions, and/or fusion were assumed to be managed in the inpatient setting. Total costs of reoperation and per-patient costs of reoperation were compared between groups for both forms of insurers. One author received consulting fees of <$50,000 for the completion of this study, and the other eight authors did not have any financial associations with the current work. Funding for this study was provided by Intrinsic Therapeutics, but all analyses, interpretation, and writing were performed independently by the authors.Results: At two years follow-up, use of the ACD reduced the rate of symptomatic reherniations in a large defect population to 13% compared with 25% in the control group (p<.001). This reduction in symptomatic reherniations in the ACD group translated to a savings of $2,802 per patient in direct health care costs compared with Control at 2 years and $5,315 per patient by 5 years based on 50% private and 50% public (Medicare) payer split. Under the scenario of 80:20 private:public insurance reimbursement, the estimated direct cost savings were $3,215 and $6,099 per patient at 2- and 5-years postoperatively, respectively, with the use of the ACD.Conclusions: Symptomatic reherniation and reoperation rates were nearly double among control patients compared with ACD-treated patients, which translated to markedly greater per-patient healthcare costs in the control group, where the ACD was not used. [ABSTRACT FROM AUTHOR]

Objectif de l’étude Évaluer l’efficacité et la toxicité d’une curiethérapie de haut débit de dose de complément dans les carcinomes épidermoïdes du canal anal. Matériel et méthode Étude rétrospective monocentrique portant chez des patients traités par irradiation externe (avec ou sans chimiothérapie), avec complément de curiethérapie de haut débit de dose, pour un carcinome épidermoïde du canal anal localisé. La surveillance clinique a été réalisée tous les six mois. Les résultats oncologiques sont analysés avec : les survies sans récidive locale, sans colostomie, sans métastase, sans évènement et globale. La toxicité aiguë et tardive a été recueillie (Common Terminology Criteria for Adverse Events V4.0). Résultats De mai 2005 à janvier 2018, 46 patients ont été traités. La médiane de suivi était de 61 mois (extrêmes : 10–145 mois), l’âge médian de 65 ans (extrêmes : 34–84 ans) avec une sex-ratio hommes/femmes de 0,24. Il s’agissait de 13 tumeurs de stade T1 (21,7 %), 34 T2 (73,9 %), deux T3 (4,3 %), six N+ (13,1 %). La radiothérapie externe a délivré à une dose médiane de 45 Gy (extrêmes : 36–52 Gy) en 25 fractions et la curiethérapie de haut débit de dose de 12 Gy (extrêmes : 10–18 Gy) en trois fractions. L’étalement médian était de 58 jours (extrêmes : 41–101 j) avec un intervalle médian entre la radiothérapie externe et la curiethérapie de 17 jours (extrêmes : 4–60 j). L’analyse des résultats carcinologiques a montré des taux à 5 ans de survie sans récidive locale de 81,2 %, de survie sans maladie de 88,7 %, de survie sans événement de 70 % et de survie globale de 90 %. Toutes les amputations abdominopérinéales ont été réalisées en cas de rechute locale (quatre patients, 8,7 %) conduisant à un taux de survie sans colostomie à 5 ans de 79,5 %. La toxicité urinaire aiguë était fréquente (grade 1 : 41,3 % ; grade 2 : 4,3 %). La toxicité digestive aiguë était : grade 1 : 71,7 % ; grade 2 : 6,5 % ; grade 3 : 2,2 %. La toxicité urinaire tardive était : grade 1 : 4,3 % ; grade 2 : 2,2 % ; grade 4 : 2,2 %. La toxicité digestive tardive était : grade 1 : 56,5 % ; grade 2 : 8,7 % ; grade 3 : 2,2 % ; grade 4 : 2,2 %. Conclusion Dans la prise en charge du carcinome du canal anal, le complément par curiethérapie de haut débit de dose semble être un traitement présentant un profil de toxicité acceptable sur le long terme, plus court qu’un complément de radiothérapie externe avec une irradiation partielle du canal anal. [ABSTRACT FROM AUTHOR]

Objective Percutaneous vertebroplasty (VP) and medial branch block (MBB) are used to treat osteoporotic vertebral compression fractures (VCF). We compared the clinical outcomes, radiologic changes, and economic results of MBB with those of VP in treating osteoporotic VCFs. Methods A total of 164 patients with 1-level osteoporotic VCF were reviewed retrospectively. The clinical outcomes were measured with a visual analogue scale (VAS) and the Oswestry Disability Index (ODI). To compare economic costs between groups, total hospital costs at the last follow-up day were calculated. Results The patients were divided into 2 groups: 72 patients in the conservative group treated by MBB (MBB group) and 92 patients in the group who underwent VP (VP group). The VAS and ODI scores improved significantly within postoperative week 1 in the VP group compared with the MBB group. However, the VAS and ODI scores did not differ between the groups after 1 postoperative year. After 2 years of follow-up, 14 new fractures occurred in the VP group and 3 in the MBB group. The improvement in compression ratio was statistically greater in the VP group than in the MBB group. However, after 2 years the radiologic changes between groups did not differ statistically. After the final follow-up visits, the hospital costs were significantly lower in the MBB group. Conclusions After 2 years of follow-up, VP and MBB both had similar efficacy in terms of pain relief and radiologic changes. MBB was more cost effective than VP. Thus, MBB alone can be a possible alternative to VP in patients with 1-level osteoporotic VCFs. [ABSTRACT FROM AUTHOR]

Objective The purpose of this study was to determine reference values for the sagittal plane alignment of the thoracolumbar junction (TLJ) in a young adult Korean population. Methods Thoracolumbar computed tomography (CT) scans of 1000 individuals (age range, 20–39 years; 500 men and 500 women) from Hanyang University Health Care Center were reviewed. All subjects had no spinal pathology or a history of previous spinal surgery. The segmental (each level from T11 to L2) and global (T11-L1 and T11-L2) Cobb angles of the TLJ of the spine were measured in midsagittal CT scans. Moreover, comparisons between the 2 age groups (20s and 30s) and sexes were performed. Results The segmental Cobb angles of T11, T12, L1, and L2 were 6.5° ± 3.9°, 5.5° ± 4.1°, 2.2° ± 4.7°, and −3.3° ± 5.3°, respectively. The global Cobb angles of T11-L1 and T11-L2 were 6.5° ± 5.2° and 0.5° ± 6.1°, respectively. There were no differences in the sagittal alignment between the 2 age groups. Women presented less kyphotic and more lordotic alignment in the lumbar spine (L1 and L2) than men; however, the thoracic spine (T11 and T12) alignment was not different between the 2 groups. Conclusions This study provides reference values with a wide physiologic range for the sagittal alignment of the TLJ of the spine in a young adult Korean population. Highlights • We provide reference values for sagittal alignment of the TLJ in young Korean adults. • There is a large range of physiologic values in the sagittal alignment. • Our results can help treat patients with posttraumatic vertebral fractures. [ABSTRACT FROM AUTHOR]