One-Year NDI and VAS Outcomes from the Single-Level PEEK-on-Ceramic SimplifyTM Disc FDA IDE Trial

Abstract INTRODUCTION Cervical radiculopathy remains highly prevalent and costly in the U.S. healthcare system. While ACDF has remained the most popular surgical treatment modality, minimally invasive advancements such as posterior micro-endoscopic discectomy/foraminotomy (pMED) has emerged as a motion preserving and less invasive alternative. To date, the comparative effectiveness and cost-effectiveness of pMED vs. ACDF remains unclear. METHODS Patients undergoing surgery for single-level radiculopathy without myelopathy resulting from foraminal stenosis or foraminal disc herniation without instability over a one-year period were prospectively enrolled into an institutional database. Baseline, post -operative 3-months, and 12-months VAS-Arm and Neck, NDI, EQ −5D, and return to work(RTW) status were collected. Direct healthcare cost(payer perspective) and indirect cost (work-day losses multiplied by median gross-of-tax wage and benefits rate) was assessed. RESULTS >Total 20 ACDF and 28 pMED patients were identified. Baseline demographics, symptomatology, and co-morbidities were similar between the cohorts. For pMED vs. ACDF, mean length of surgery (48.1 ± 20.0 vs. 69.9 ± 11.6 minutes, P < 0.0001) and estimated blood loss (20.3 ± 9.3 vs. 31.8 ± 15.4 mL, P = 0.04) was reduced. There was no 90-day morbidity or re-admission for either cohort. One(3.6%) pMED patient required a subsequent ACDF; no patients in the ACDF cohort required re-operation by one-year. pMED and ACDF cohorts demonstrated similar improvement in arm-VAS(3.1 vs. 2.6, P = 0.66), neck-VAS(2.0 vs. 3.2, P = 0.24), NDI(9.0 vs. 6.8, P = 0.24), and EQ-5D(0.17 vs. 0.15, P = 0.82). Ability to RTW(93.8% vs. 94.1%, P = 1.0) and median time to RTW(3.7[0.9- 8.1] vs. 3.6[2.1-8.5] weeks, P = 0.85) were similar. pMED was associated with significantly reduced direct cost (p>0.001) but similar indirect cost (P = 0.43), resulting in an average total cost savings of $7689(P < 0.01) per case with similar QALY-gain (0.17 vs. 0.15, P = 0.82). CONCLUSION For single-level unilateral-radiculopathy resulting from foraminal stenosis or lateral disc herniation without segmental instability, pMED was equivalent to ACDF in safety and effectiveness. pMED represents a minimally invasive, motion preserving alternative to select patients with cervical radiculopathy without the need for implant costs with concomitant significant cost saving.

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Local Control and Toxicity of Multilevel Spine Stereotactic Body Radiotherapy

Neurosurgery ◽

10.1093/neuros/nyz348 ◽

2019 ◽

Author(s):

Whitney H Beeler ◽

Kelly A Speth ◽

Michael T Broderick ◽

Neil K Jairath ◽

Dena Ballouz ◽

...

Keyword(s):

Local Control ◽

Stereotactic Body Radiotherapy ◽

Time To Event ◽

Mixed Effect ◽

Cox Models ◽

Single Level ◽

Mixed Effect Models ◽

Random Intercept ◽

Significant Difference ◽

One Year

Abstract BACKGROUND Spine stereotactic body radiotherapy (sSBRT) is commonly limited to 1 or 2 vertebral levels given a paucity of efficacy and toxicity data when more than 2 levels are treated. OBJECTIVE To prove our hypothesis that multilevel sSBRT could provide similar rates of local control (LC) (primary endpoint) and toxicity as single-level treatment using the same clinical target, planning target, and planning organ-at-risk volumes. METHODS We analyzed consecutive cases of sSBRT treated from 2013 to 2017. Time-to-event outcomes for single-level and multilevel cases were compared using mixed effect Cox models and differences in toxicity rates were evaluated using linear mixed effect models. All models incorporate a patient-level random intercept to account for any within-patient correlation across cases. RESULTS There were 101 single-level and 84 multilevel sSBRT cases (2-7 continuous vertebral levels). One-year LC was 95% vs 85%, respectively. After adjusting for baseline covariates, dose delivered, and accounting for within-patient correlation, there was no significant difference in time to local failure (hazard ratio, HR 1.79 [0.59-5.4]; P = .30). Pain improved in 83.5% of the 139 initially symptomatic tumors. There were no significant differences in grade 2+ acute or late toxicities between single-level and multilevel sSBRT. CONCLUSION With rigorous patient immobilization, quality assurance, and image guidance, multilevel sSBRT provides high rates of LC, similar to single-level treatment, without need for larger planning volume margins. Efforts to improve prognostication and case selection for multilevel sSBRT are warranted to ensure that the benefits of improved LC over palliative radiation are justified.

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NS-07MANAGEMENT OF PAEDIATRIC SINGLE LEVEL VERTEBRAL HEMANGIOMAS PRESENTING WITH MYELOPATHY WITH MORE THAN ONE YEAR FOLLOWUP

Neuro-Oncology ◽

10.1093/neuonc/now078.07 ◽

2016 ◽

Vol 18 (suppl 3) ◽

pp. iii128.3-iii128

Author(s):

Pankaj Singh ◽

Dattaraj Sawarkar ◽

P. Sarat Chandra ◽

Sashank Kale ◽

Bhawani Shankar Sharma

Keyword(s):

Single Level ◽

One Year ◽

Vertebral Hemangiomas

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Assessing decoupling of above and below canopy air masses at a Norway spruce stand in complex terrain

10.5194/egusphere-egu2020-7739 ◽

2020 ◽

Author(s):

Georg Jocher ◽

Milan Fischer ◽

Ladislav Šigut ◽

Marian Pavelka ◽

Pavel Sedlák ◽

...

Keyword(s):

Global Radiation ◽

Sonic Anemometer ◽

Turbulence Characteristic ◽

Forest Site ◽

Raw Data ◽

Air Masses ◽

Single Level ◽

Routine Manner ◽

Telegraphic Approximation ◽

One Year

Concurrent below (0.14 &#8226; canopy height) and above canopy sonic anemometer vertical velocity (w) measurements reveal frequent decoupling events between the air masses below and above the canopy at a dense spruce forest stand in mountainous terrain. Decoupling events occurred predominantly during nighttime but not exclusively. Several single-level approaches based on steady state and integral turbulence characteristic tests as well as u* filtering and two-level CO2 flux filtering methods are tested. These tests aimed at evaluating the filtering schemes to address decoupling and its effect on above canopy derived eddy covariance CO2 fluxes. In addition to the already existing two-level filtering approach based on the correlation of &#963;w above and below canopy, two new filtering methods are introduced based on w raw data below and above the canopy. One is a telegraphic approximation agreement, which assumes coupling when w both above and below canopy are pointing in the same direction. Another one evaluates the cross correlation maximum between below and above canopy w data. This study suggests that none of the single-level approaches can detect decoupling when compared to two-level filtering approaches. It further suggests that the newly introduced two-level approaches based on w raw data may have advantages in comparison to the conventional &#963;w approach regarding their flexibility on shorter time scales than one year. We tested the correlation of the newly introduced filtering approaches with the parameters u*, global radiation, buoyancy forcing across the canopy and wind shear across the canopy. In any case, this correlation was not existing or weakly positive, suggesting that concurrent below and above canopy measurements are mandatory for addressing decoupling sufficiently. Sonic anemometer measurements near the forest floor and above the canopy are sufficient to apply the new procedures and can be implemented in a routine manner at any forest site globally.

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Between ‘Savage Man’ and ‘Most Faithful Englishman’ Manteo and the Early Anglo-Indian Exchange, 1584–1590

Itinerario ◽

10.1017/s0165115300044545 ◽

2000 ◽

Vol 24 (2) ◽

pp. 146-169 ◽

Cited By ~ 1

Author(s):

Michael Leroy Oberg

Keyword(s):

North Carolina ◽

Chesapeake Bay ◽

One Year ◽

Anglo Indian

In August of 1587 Manteo, an Indian from Croatoan Island, joined a group of English settlers in an attack on the native village of Dasemunkepeuc, located on the coast of present-day North Carolina. These colonists, amongst whom Manteo lived, had landed on Roanoke Island less than a month before, dumped there by a pilot more interested in hunting Spanish prize ships than in carrying colonists to their intended place of settlement along the Chesapeake Bay. The colonists had hoped to re-establish peaceful relations with area natives, and for that reason they relied upon Manteo to act as an interpreter, broker, and intercultural diplomat. The legacy of Anglo-Indian bitterness remaining from Ralph Lane's military settlement, however, which had hastily abandoned the island one year before, was too great for Manteo to overcome. The settlers found themselves that summer in the midst of hostile Indians.

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Some Biological Applications of High Voltage Electron Microscopy

Proceedings, annual meeting, Electron Microscopy Society of America ◽

10.1017/s0424820100051505 ◽

1974 ◽

Vol 32 ◽

pp. 298-299

Author(s):

Hans Ris

Keyword(s):

High Voltage ◽

Chromosome Structure ◽

Nerve Fibers ◽

Good Resolution ◽

High Voltage Electron Microscopy ◽

Voltage Electron ◽

University Of Wisconsin ◽

High Voltage Electron ◽

One Year ◽

The University

The High Voltage Electron Microscope Laboratory at the University of Wisconsin has been in operation a little over one year. I would like to give a progress report about our experience with this new technique. The achievement of good resolution with thick specimens has been mainly exploited so far. A cold stage which will allow us to look at frozen specimens and a hydration stage are now being installed in our microscope. This will soon make it possible to study undehydrated specimens, a particularly exciting application of the high voltage microscope.Some of the problems studied at the Madison facility are: Structure of kinetoplast and flagella in trypanosomes (J. Paulin, U. of Georgia); growth cones of nerve fibers (R. Hannah, U. of Georgia Medical School); spiny dendrites in cerebellum of mouse (Scott and Guillery, Anatomy, U. of Wis.); spindle of baker's yeast (Joan Peterson, Madison) spindle of Haemanthus (A. Bajer, U. of Oregon, Eugene) chromosome structure (Hans Ris, U. of Wisconsin, Madison). Dr. Paulin and Dr. Hanna are reporting their work separately at this meeting and I shall therefore not discuss it here.

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Osseointegration interface of calcified bone and endosseous implants

Proceedings, annual meeting, Electron Microscopy Society of America ◽

10.1017/s0424820100130110 ◽

1992 ◽

Vol 50 (2) ◽

pp. 1096-1097

Author(s):

K.E. Krizan ◽

J.E. Laffoon ◽

M.J. Buckley

Keyword(s):

Structure And Function ◽

Titanium Implants ◽

En Bloc ◽

Endosseous Implants ◽

Ultrastructural Studies ◽

The Past ◽

Cacodylate Buffer ◽

One Year ◽

And Function

With increase use of tissue-integrated prostheses in recent years it is a goal to understand what is happening at the interface between haversion bone and bulk metal. This study uses electron microscopy (EM) techniques to establish parameters for osseointegration (structure and function between bone and nonload-carrying implants) in an animal model. In the past the interface has been evaluated extensively with light microscopy methods. Today researchers are using the EM for ultrastructural studies of the bone tissue and implant responses to an in vivo environment. Under general anesthesia nine adult mongrel dogs received three Brånemark (Nobelpharma) 3.75 × 7 mm titanium implants surgical placed in their left zygomatic arch. After a one year healing period the animals were injected with a routine bone marker (oxytetracycline), euthanized and perfused via aortic cannulation with 3% glutaraldehyde in 0.1M cacodylate buffer pH 7.2. Implants were retrieved en bloc, harvest radiographs made (Fig. 1), and routinely embedded in plastic. Tissue and implants were cut into 300 micron thick wafers, longitudinally to the implant with an Isomet saw and diamond wafering blade [Beuhler] until the center of the implant was reached.

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Effectiveness of a 24-hour nicotine patch in conjunction with a cognitive behavioural programme: one year outcome transdermal

Addiction ◽

10.1046/j.1360-0443.1997.921274.x ◽

1997 ◽

Vol 92 (1) ◽

pp. 27-31

Author(s):

Robyn L. Richmond ◽

Linda Kehoe ◽

Abilio Cesar De Almeida Neto

Keyword(s):

Nicotine Patch ◽

Cognitive Behavioural ◽

One Year

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Resources: Internet Resources for the Independent Medical Evaluator – 2007

Guides Newsletter ◽

10.1001/amaguidesnewsletters.2007.julaug02 ◽

2007 ◽

Vol 12 (4) ◽

pp. 4-7

Author(s):

Christopher R. Brigham ◽

Jenny Walker

Keyword(s):

Head Trauma ◽

Clonic Seizure ◽

Acute Subdural Hematoma ◽

Orbital Fracture ◽

Orbital Wall ◽

First Occurrence ◽

One Year ◽

The One ◽

Neurological Injuries ◽

Medial Orbital Wall

Abstract Rating patients with head trauma and multiple neurological injuries can be challenging. The AMA Guides to the Evaluation of Permanent Impairment (AMA Guides), Fifth Edition, Section 13.2, Criteria for Rating Impairment Due to Central Nervous System Disorders, outlines the process to rate impairment due to head trauma. This article summarizes the case of a 57-year-old male security guard who presents with headache, decreased sensation on the left cheek, loss of sense of smell, and problems with memory, among other symptoms. One year ago the patient was assaulted while on the job: his Glasgow Coma Score was 14; he had left periorbital ecchymosis and a 2.5 cm laceration over the left eyelid; a small right temporoparietal acute subdural hematoma; left inferior and medial orbital wall fractures; and, four hours after admission to the hospital, he experienced a generalized tonic-clonic seizure. This patient's impairment must include the following components: single seizure, orbital fracture, infraorbital neuropathy, anosmia, headache, and memory complaints. The article shows how the ratable impairments are combined using the Combining Impairment Ratings section. Because this patient has not experienced any seizures since the first occurrence, according to the AMA Guides he is not experiencing the “episodic neurological impairments” required for disability. Complex cases such as the one presented here highlight the need to use the criteria and estimates that are located in several sections of the AMA Guides.

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