Six-Year Follow-up of a Randomized Controlled Trial of i-FACTOR Peptide-Enhanced Bone Graft Versus Local Autograft in Single-Level Anterior Cervical Discectomy and Fusion.

Background: Previous analyses of the US Food and Drug Administration (FDA) Investigational Device Exemption study demonstrated the superiority of i-FACTOR compared with local autograft bone in single-level anterior cervical discectomy and fusion (ACDF) at 12 and 24 months postoperatively in a composite end point of overall success.

Objective: To report the final, 6-year clinical and radiological outcomes of the FDA postapproval study.

Methods: Of the original 319 subjects enrolled in the Investigational Device Exemption study, 220 participated in the postapproval study (106 i-FACTOR and 114 control).

Segmental Motion of Cervical Arthroplasty Leads to Decreased Adjacent-Level Degeneration: Analysis of the 7-Year Postoperative Results of a Multicenter Randomized Controlled Trial.

Background: Cervical artificial disc replacement (C-ADR) has become a common and accepted surgical treatment for many patients with cervical disc degeneration/herniation and radiculopathy who have failed nonoperative treatment. Midterm follow-up studies of the original investigational device exemption trials comparing C-ADR to traditional anterior cervical discectomy and fusion (ACDF) have revealed C-ADR patients have less adjacent-level disease and fewer reoperations at 5 to 7 years. The purpose of this study was to examine the relationship of radiographic adjacent-level disease (R-ALD) with the amount of index-level segmental range of motion (ROM) in C-ADR patients using the long-term follow-up data from the ProDisc-C investigational device exemption trial.

Gravitational Test beyond the First Post-Newtonian Order with the Shadow of the M87 Black Hole.

The 2017 Event Horizon Telescope (EHT) observations of the central source in M87 have led to the first measurement of the size of a black-hole shadow. This observation offers a new and clean gravitational test of the black-hole metric in the strong-field regime. We show analytically that spacetimes that deviate from the Kerr metric but satisfy weak-field tests can lead to large deviations in the predicted black-hole shadows that are inconsistent with even the current EHT measurements.

Two-Year Clinical and Radiological Outcomes in Patients With Diabetes Undergoing Single-Level Anterior Cervical Discectomy and Fusion.

Study Design: Secondary analysis of data from the multicenter, randomized, parallel-controlled Food and Drug Administration (FDA) investigational device exemption study.

Objective: Studies on outcomes following anterior cervical discectomy and fusion (ACDF) in individuals with diabetes are scarce. We compared 24-month radiological and clinical outcomes in individuals with and without diabetes undergoing single-level ACDF with either i-FACTOR or local autologous bone.

Improving blood product utilization at an ambulatory surgery center: a retrospective cohort study on 50 patients with lumbar disc replacement.

Background: There is minimal literature discussing anterior lumbar spine surgery in ambulatory surgery centers (ASCs). The main concern with the anterior approach to the lumbar spine is the potential for injury to great vessels. In our facility, there are two units of crossmatched blood available in addition to cell saver during the procedure.

Prevalent lightning sferics at 600 megahertz near Jupiter's poles.

Lightning has been detected on Jupiter by all visiting spacecraft through night-side optical imaging and whistler (lightning-generated radio waves) signatures. Jovian lightning is thought to be generated in the mixed-phase (liquid-ice) region of convective water clouds through a charge-separation process between condensed liquid water and water-ice particles, similar to that of terrestrial (cloud-to-cloud) lightning. Unlike terrestrial lightning, which emits broadly over the radio spectrum up to gigahertz frequencies, lightning on Jupiter has been detected only at kilohertz frequencies, despite a search for signals in the megahertz range .

Challenges and Solutions for Lumbar Total Disc Replacement Implantation.

: Long-term data are now available to support the safety and efficacy of lumbar total disc replacement (TDR). Five-year randomized and controlled trials, meta-analyses, and observational studies support a similar or lower risk of complications with lumbar TDR compared with fusion. The panel concluded that published data on commercially available lumbar TDR devices demonstrate minimal concerns with late-onset complications, and that the risk of adjacent segment degeneration and reoperations can be reduced with lumbar TDR versus fusion.

Foreword: Proceedings From the First Annual Lumbar Total Disc Replacement Summit.

: This publication focuses on proceedings from the First Annual Lumbar Total Disc Replacement Summit, held October 25, 2016 in Boston, MA. The Summit brought together 17 thought leading surgeons who employed a modified-Delphi method to determine where consensus existed pertaining to the utilization of lumbar total disc replacement as a standard of care for a subpopulation of patients suffering from degenerative disc disease.

i-Factor™ Bone Graft vs Autograft in Anterior Cervical Discectomy and Fusion: 2-Year Follow-up of the Randomized Single-Blinded Food and Drug Administration Investigational Device Exemption Study.

Background: i-Factor™ Bone Graft (Cerapedics Inc, Westminster, Colorado) is a composite bone substitute material consisting of P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral suspended in an inert biocompatible hydrogel carrier. A pivotal, noninferiority, US FDA Investigational Device Exemption study demonstrated the benefits of i-Factor™ compared to local autograft bone in single-level anterior cervical discectomy and fusion at 1-yr postoperative.

Objective: To report 2-yr follow-up.

Geographic variations in clinical presentation and outcomes of decompressive surgery in patients with symptomatic degenerative cervical myelopathy: analysis of a prospective, international multicenter cohort study of 757 patients.

Background Context: Degenerative cervical myelopathy (DCM) is a progressive degenerative spine disease and the most common cause of spinal cord impairment in adults worldwide. Few studies have reported on regional variations in demographics, clinical presentation, disease causation, and surgical effectiveness.

Purpose: The objective of this study was to evaluate differences in demographics, causative pathology, management strategies, surgical outcomes, length of hospital stay, and complications across four geographic regions.

Implications of the ammonia distribution on Jupiter from 1 to 100 bars as measured by the Juno microwave radiometer.

The latitude-altitude map of ammonia mixing ratio shows an ammonia-rich zone at 0-5°N, with mixing ratios of 320-340 ppm, extending from 40-60 bars up to the ammonia cloud base at 0.7 bars. Ammonia-poor air occupies a belt from 5-20°N.

Five-Year Reoperation Rates of 2-Level Lumbar Total Disk Replacement Versus Fusion: Results of a Prospective, Randomized Clinical Trial.

Study Design: Long-term analysis of prospective randomized clinical trial data.

Summary Of Background Data: Lumbar total disk replacement (TDR) has been found to have equivalent or superior clinical outcomes compared with fusion and decreased radiographic incidence of adjacent level degeneration in single-level cases.

Objective: The purpose of this particular analysis was to determine the incidence and risk factors for secondary surgery in patients treated with TDR or circumferential fusion at 2 contiguous levels of the lumbar spine.

Bone substitutes and expanders in Spine Surgery: A review of their fusion efficacies.

Study Design: A narrative review of literature.

Objective: This manuscript intends to provide a review of clinically relevant bone substitutes and bone expanders for spinal surgery in terms of efficacy and associated clinical outcomes, as reported in contemporary spine literature.

Summary Of Background Data: Ever since the introduction of allograft as a substitute for autologous bone in spinal surgery, a sea of literature has surfaced, evaluating both established and newly emerging fusion alternatives.

Vortices in Saturn's Northern Hemisphere (2008-2015) Observed by Cassini ISS.

We use observations from the Imaging Science Subsystem on Cassini to create maps of Saturn's Northern Hemisphere (NH) from 2008 to 2015, a time period including a seasonal transition (i.e., Spring Equinox in 2009) and the 2010 giant storm.

A century of ecosystem change: human and seabird impacts on plant species extirpation and invasion on islands.

We used 116 years of floral and faunal records from Mandarte Island, British Columbia, Canada, to estimate the indirect effects of humans on plant communities via their effects on the population size of a surface-nesting, colonial seabird, the Glaucous-winged gull (Larus glaucescens). Comparing current to historical records revealed 18 extirpations of native plant species (32% of species historically present), 31 exotic species introductions, and one case of exotic introduction followed by extirpation. Contemporary surveys indicated that native species cover declined dramatically from 1986 to 2006, coincident with the extirpation of 'old-growth' conifers.

Efficacy of i-Factor Bone Graft versus Autograft in Anterior Cervical Discectomy and Fusion: Results of the Prospective, Randomized, Single-blinded Food and Drug Administration Investigational Device Exemption Study.

Study Design: A prospective, randomized, controlled, parallel, single-blinded noninferiority multicenter pivotal FDA IDE trial.

Objective: The objective of this study was to investigate efficacy and safety of i-Factor Bone Graft (i-Factor) compared with local autograft in single-level anterior cervical discectomy and fusion (ACDF) for cervical radiculopathy.

Summary Of Background Data: i-Factor is a composite bone substitute material consisting of the P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral and suspended in an inert biocompatible hydrogel carrier.

ProDisc-C Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion for Single-Level Symptomatic Cervical Disc Disease: Seven-Year Follow-up of the Prospective Randomized U.S. Food and Drug Administration Investigational Device Exemption Study.

Background: In patients with single-level cervical degenerative disc disease, total disc arthroplasty can relieve radicular pain and preserve functional motion between two vertebrae. We compared the efficacy and safety of cervical total disc arthroplasty with that of anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical degenerative disc disease between C3-C4 and C6-C7.

Methods: Two hundred and nine patients at thirteen sites were randomly treated with either total disc arthroplasty with ProDisc-C (n = 103) or with ACDF (n = 106).

Cometary science. Subsurface properties and early activity of comet 67P/Churyumov-Gerasimenko.

Heat transport and ice sublimation in comets are interrelated processes reflecting properties acquired at the time of formation and during subsequent evolution. The Microwave Instrument on the Rosetta Orbiter (MIRO) acquired maps of the subsurface temperature of comet 67P/Churyumov-Gerasimenko, at 1.6 mm and 0.

Anterior versus posterior surgical approaches to treat cervical spondylotic myelopathy: outcomes of the prospective multicenter AOSpine North America CSM study in 264 patients.

Study Design: A prospective observational multicenter study.

Objective: To help solve the debate regarding whether the anterior or posterior surgical approach is optimal for patients with cervical spondylotic myelopathy (CSM).

Summary Of Background Data: The optimal surgical approach to treat CSM remains debated with varying opinions favoring anterior versus posterior surgical approaches.

Efficacy and safety of surgical decompression in patients with cervical spondylotic myelopathy: results of the AOSpine North America prospective multi-center study.

Background: Cervical spondylotic myelopathy is the leading cause of spinal cord dysfunction worldwide. The objective of this study was to evaluate the impact of surgical decompression on functional, quality-of-life, and disability outcomes at one year after surgery in a large cohort of patients with this condition.

Methods: Adult patients with symptomatic cervical spondylotic myelopathy and magnetic resonance imaging evidence of spinal cord compression were enrolled at twelve North American centers from 2005 to 2007.

Mild diabetes is not a contraindication for surgical decompression in cervical spondylotic myelopathy: results of the AOSpine North America multicenter prospective study (CSM).

Background Context: Cervical spondylotic myelopathy (CSM) is a chronic spinal cord disease and can lead to progressive or stepwise neurologic decline. Several factors may influence this process, including extent of spinal cord compression, duration of symptoms, and medical comorbidities. Diabetes is a systemic disease that can impact multiple organ systems, including the central and peripheral nervous systems.

ProDisc-C and anterior cervical discectomy and fusion as surgical treatment for single-level cervical symptomatic degenerative disc disease: five-year results of a Food and Drug Administration study.

Study Design: Randomized controlled trial.

Objective: Analyze the clinical outcomes at 5 years comparing cervical total disc replacement (TDR) with ProDisc-C (Synthes Spine USA Products; LLC, West Chester, PA) with anterior cervical discectomy and fusion (ACDF).

Summary Of Background Data: Previous reports of 2- and 4-year results have shown that ProDisc-C, a TDR for surgical treatment of patients experiencing single-level symptomatic cervical disc disease between C3 and C7, is safe and effective.

Perioperative and delayed complications associated with the surgical treatment of cervical spondylotic myelopathy based on 302 patients from the AOSpine North America Cervical Spondylotic Myelopathy Study.

Object: Rates of complications associated with the surgical treatment of cervical spondylotic myelopathy (CSM) are not clear. Appreciating these risks is important for patient counseling and quality improvement. The authors sought to assess the rates of and risk factors associated with perioperative and delayed complications associated with the surgical treatment of CSM.