8 Spine Technology and News Highlights July 2018

Neel Anand, MD, Comments on TOPS™ System FDA/IDE Pivotal Study

The Anand Spine Group enrolled the first patient in Los Angeles into the Premia Spine national FDA IDE pivotal study of an updated version of its TOPS™ System—the first Total Posterior Spine System.

Primary investigator, Neel Anand, MD, MCh, Orth, Professor of Orthopaedic Surgery and Director of Spine Trauma at Cedars-Sinai Medical Center stated, “This study allows us to measure the efficacy of this motion-preserving device for the surgical treatment of degenerative spondylolisthesis and lumbar spinal stenosis.” Besides the new TOPS being designed with a 30% smaller footprint, the surgical technique is simpler than the original device. Dr. Anand commented that one of the key improvements is the way the device articulates and moves, making it safer.

TOPS Designed to Treat a Different Patient Population
Artificial disc technology may be at the forefront, but TOPS is truly the only posterior, non-fusion, motion-preserving device that’s available right now. The pathologies are different. An artificial disc is intended to replace a disc that’s degenerated—the disc is the problem—but the facet joints need to be reasonably good with no instability for an artificial disc. TOPS is exactly the opposite, and is designed for lumbar instability, spondylolisthesis up to Grade 1, arthritic facet joints and lumbar spinal stenosis (LSS).

“For the first time, we now have an option for posterior motion preservation. There have been other posterior motion preservation devices that were studied in the past, including Stabilimax and ACADIA Facet Replacement. However, these studies have all been completed or withdrawn. So, at this moment, TOPS is the only device available for the patient with facet arthritis, stenosis, and degenerative spondylolisthesis,” stated Dr. Anand, who was primary investigator on both the Stabilimax and ACADIA studies.

Reasoning With Patients Who Balk at Randomization
Sometimes patients don’t want to be randomized. Dr. Anand explains, “Unfortunately, in this trial, you will be randomized 2:1. That means you have a 67% chance of getting the TOPS device and a 33% chance of being fused. But when I discuss this with a patient, I let him (or her) know that the 67% is the only chance you have in the United States for a motion-preserving device that’s implanted from the back. And, hopefully, that’s going to be better.”

Corporate News: Bioventus Sells BMP Development Program to Viscogliosi Brothers

Bioventus entered into a definitive agreement to divest its bone morphogenetic protein (BMP) development program to a new company formed by Viscogliosi Brothers, LLC, a private equity investment firm focused on neuromusculoskeletal technologies. The transaction is expected to close by the end of the third quarter.

The BMP portfolio includes the next-generation BMP in development and a BMP program for soft tissue indications. Bioventus will receive an equity stake and will have an observational board seat in the new company formed by Viscogliosi Brothers to work on the BMP program.

Source
Bioventus. Bioventus enters into definitive agreement to divest bmp development program to Viscogliosi Brothers, LLC [press release]. July 23, 2018. Available at: https://www.bioventusglobal.com/bioventus-enters-definitive-agreement-divest-bmp/.

New Technology: CarboClear Carbon Fiber Pedicle Screw System for Spine Cancer Patients

CarboFix Orthopedics’ CarboClear® Pedicle Screw System was approved by the U.S. Food and Drug Administration. Made of continuous carbon fibers reinforced polymer, the system is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced-stage tumors involving the thoracic and lumbar spine with limited life expectancy, according to a news release.

The system’s advantages include no backscattering or attenuation during radiation therapy, radiolucency, and no CT/MRI artifacts, according to CarboFix Orthopedics.

Source
SpineMarketGroup. CarboFix’s CarboClear, Carbon Fiber Pedicle Screw System Has Been Cleared to Be Used in the United States by the FDA. July 26, 2018. Available at: http://www.thespinemarketgroup.com/carbofixs-carboclear-carbon-fiber-pedicle-screw-system-has-been-cleared-to-be-used-in-the-united-states-by-the-fda/.

New Technology: NuVasive Launches MAGEC® X for Early-Onset Scoliosis

NuVasive, Inc., announced the launch of MAGEC® X for use in the MAGEC system—a treatment for early-onset scoliosis that uses magnetic technology within adjustable growing rods and an external remote controller to externally distract implanted rods. MAGEC X has a 68% performance increase in titanium rod fatigue testing across all rod diameters in the portfolio over the previous generation of this system and now includes both 4.5 mm and 5.0 mm diameter rods, according to NuVasive.

“NuVasive’s MAGEC X 5.0mm solution is unique because it allows you to upsize your rod with low-profile screws, giving you the flexibility at the time of surgery to use a larger rod without having to change your screws—that’s really key,” Dr. Peter Sturm, Alvin H. Crawford Chair of Spine Surgery, Cincinnati Children's Hospital Medical Center, said in a press release. “Further, the upgrade of the internal components in MAGEC X rods gives me even more confidence in the performance of a system that has radically changed how we treat this challenging patient population.”

Source
NuVasive. NuVasive Launches MAGEC X For Early Onset Scoliosis Treatment [press release]. July 19, 2019. https://www.prnewswire.com/news-releases/nuvasive-launches-magec-x-for-early-onset-scoliosis-treatment-300683395.html.

National Guideline Clearinghouse Loses Funding

Federal funding to support the National Guideline Clearinghouse (NGC) through the Agency for Healthcare Research and Quality (AHRQ) ended on July 16, 2018. The AHRQ is exploring options to support the repository of evidence-based clinical practice guidelines in the future “and will continue to do so even while the site remains offline,” according to a statement from the agency.

In addition, the independent nonprofit ECRI Institute, which developed and maintained the clearinghouse since it launched 20 years ago, announced that it would continue to provide clinical guidelines. “ECRI Institute’s new guideline resource will provide a centralized repository of current, properly vetted evidence-based clinical practice guideline summaries and other information. An interim website will launch this fall, with many additional features planned for the near future,” according to an ECRI news release.

Sources
Agency for Healthcare Research. Statement about the National Guideline Clearinghouse (NGC). Available at: https://www.ahrq.gov/gam/updates/index.html.

ECRI Institute. ECRI institute to continue clinical guideline work shuttered by federal government. July 17, 2018. Available at: https://www.ecri.org/press/Pages/ECRI_Guideline_Website.aspx.

Online Calculator Estimates Risk of Chronic Opioid Use After Lumbar Spinal Fusion

Patients taking opioids before lumbar spinal fusion are at five times higher risk for chronic opioid use at 1 year, according to a retrospective study of more than 26,500 patients published online ahead of print in Spine. The authors created an online calculator to help surgeons estimate the risk of prolonged post-operative opioid use in patients undergoing spinal fusion surgery.

Prescription filling rates at both 3 months and 1 year post-operatively were markedly higher for patients undergoing anterior and/or lumbar spinal fusion procedures who filled opioid prescriptions within three months pre-operatively (n=15,488 [58%]) than for those who were opioid naïve (54% vs 14% and 42% vs 9%, respectively). Pre-operative opioid use was the strongest predictor of continued opioid use at one year. Other risk factors included depression/anxiety, alcohol abuse, and drug dependence (other than opioids).

The findings and online tool can be used to identify patients at risk for chronic opioid use who may benefit from opioid discontinuation prior to lumbar surgery, the study authors noted.

Source
Kalakoti P, Hendrickson NR, Bedard NA, Pugely AJ. Opioid utilization following lumbar arthrodesis: trends and factors associated with long-term use. Spine (Phila Pa 1976). 2018 Jul 24. doi: 10.1097/BRS.0000000000002734. [Epub ahead of print]

When Is Surgery Too Risky?

Researchers called for shared decision-making when determining whether the risks for surgical complications may outweigh the potential benefits of an operation, in an essay published July 26 in The New England Journal of Medicine. Decision-making should include when and for how long to delay surgery until risk factors can be modified, and when risk factor modification should be abandoned in the interest of alleviating a patient’s surgically correctable conditions—even when risky.

“Ethical use of health care resources, surgeon ability and experience, and patient wishes all come into play when risk factors known to predict poorer surgical outcomes are present, including obesity, smoking, diabetes and age,” lead author Ira L. Leeds, MD, said in a Johns Hopkins Medical press release. “Our essay highlights the realities for both surgeons and patients at a time of increasing focus on transparency, high value care, public reporting of clinical outcomes, and accountability, along with patient suffering in making decisions to operate or not operate.”

By current quality measures, selecting the healthiest patients for operation is an easy way to improve surgical outcomes and, in turn, personal and institutional quality rankings. However, surgeons are ethically obligated to center decision-making on the patient.

Deferring surgery may be helpful in the long run for some patients who are sick or debilitated, but in other cases the decision to defer surgery may be ethically unbalanced by favoring the effects on an institution or society as a whole over the suffering of the individual, according to the researchers. The researchers called for effective shared decision-making, with clear communication to patients about surgical risks and responsibilities, clear guidelines on modifiable risk factors from professional societies, and consistent support from insurance companies.

Sources
Leeds IL, Efron DT, Lehmann LS. Surgical gatekeeping - modifiable risk factors and ethical decision making. N Engl J Med. 2018;379(4):389-394.

Johns Hopkins Medical. Surgeons discuss options when the risks of surgery may be too high [press release]. July 26, 2018. Available at: https://www.hopkinsmedicine.org/news/media/releases/surgeons_discuss_options_when_the_risks_of_surgery_may_be_too_high.

Why Surgical Checklists Sometimes Don’t Work

Surgical checklists—such as instrument and sponge counts—are essential components of surgical safety initiatives, but as described in a recent article in The New York Times Magazine, human and system factors sometimes hinder the efficacy of these checklists. Author Siddhartha Mukherjee, MD, DPhil, reviewed studies in which surgical checklists to reduce human errors were effective, and cases in which these tools had no discernible impact either because of lack of complete adherence to the protocol or a host of “unknown unknowns.”

“In medicine, we often expect robust interventions, typically proved by randomized trials, to keep working when moved from one context to the next,” Dr. Mukherjee wrote. “But not everything applies everywhere; context can be crucial. Every intervention cannot be tested in every context—that strategy would bust the bank—and so we use our best judgment to extend the data from one study to another.”

Source
Mukherjee S. Surgical checklists save lives — but once in a while, they don’t. Why? The New York Times Magazine. May 13, 2018:14.

Updated on: 08/03/18
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