2018: Year of Ortho Stability

The orthopedic community has seen its share of turmoil over the last ten years, ranging from Chris Christie’s deferred prosecutions, industry consolidation, the decline of physician-owned practices, rising payor influence and structural realignment from the Affordable Care Act.

But 2018 was practically a year of tranquility.

Readers of Orthopedics This Week, according to Google Analytics, clicked their way to stories in 2018 which focused on stability. Stability in the industry. Stability in technology and science, and reflections on some great surgeons.

So here we bring you the top stories of 2018 as chosen by you, our readers.

The Industry

The top industry story of 2018 encapsulated technical innovation, entrepreneurial inspiration and the magical convergence of medicine and business.

K2M Acquired by Stryker

At the end of August, K2M, Inc. agreed to be acquired by Stryker Corporation for $1.4 billion. K2M, which had become a leader in the minimally invasive sector of the spinal implant market, had sales of $258 million the previous year.

K2M was founded by two surgeons and two brothers.

The two surgeons were John Kostuik, M.D., former President of North American Spine Society (NASS), Scoliosis Research Society, (SRS) and Chief of Orthopedics at Johns Hopkins and Tom Errico, M.D. At age 69, he told Errico, one of his former fellows, “Tom, I’m looking for something to do.” Errico said, “Maybe we should start a company.”

So, they called their friend, Eric Major. Major had been the CEO of American Osteomedix and sales executive for Interpore Cross, Aesculap and Synthes Spine. Eric then called in his brother, Lane. Hence the name K2M (Kostuik and two Majors.)

The company’s first product was a top-loading spinal system featuring off-axis screw height adjustment and offering a complete array of screws, rod connectors, and hooks, coupled with easy-to-use instrumentation. The company revitalized the deformity sector of the spine market.

Tariff Threat

Threatening industry stability in 2018 was the April announcement by the Trump Administration of its intent to impose a 25% tariff on a large number of medical devices and drugs, including orthopedic products imported from China.

Making Chinese products more expensive in the U.S. sounds like a good deal for U.S. manufacturers, but Indiana, home of Vice President Pence, is the orthopedic manufacturing capital of the world. If the Chinese retaliated, U.S. orthopedic manufacturers would be particularly vulnerable.

By September, Healthcare ITNewsreported that orthopedic implants had been given an exemption from the tariffs. Perhaps it was Mike Pence keeping Indiana great.

Zimmer Biomet/FDA Squabble

Another disruptive story for one company continued to capture our reader’s attention—Zimmer Biomet’s ongoing regulatory problems and subsequent inventory disruption at the former Biomet North Campus plant in Warsaw, Indiana, following a 2016 FDA inspection.

The disruption impacted sales and earnings, resulting in the ouster of the company’s CEO Dave Dvorak.

In 2018, the company and agency traded public barbs over follow up inspections and a new Warning Letter in which the FDA demanded a meeting. The next inspection is scheduled to take place sometime in the Spring of 2019.

The Surgeons

Readers continued to show strong interest in stories about surgeon accomplishments, as well as learning from the mistakes of those behaving badly.

Richard Rothman Legacy

At the top of the accomplishment list was the celebration of the founder of the Rothman Orthopaedic Institute in Philadelphia, Richard Rothman, M.D., after his passing in October.

Alex Vaccaro, M.D., now the President the Institute, said of his dear friend, “Dick cared deeply about others’ well-being … and ‘held’ each person with his eyes, offering them his presence. He was devoted to his employees and spent time at the end of each day walking around and chatting with people in different departments.”

Born in nearby Cheltenham, Pennsylvania, he pursued his love of history at the University of Pennsylvania, then obtained a Ph.D. in anatomy from Thomas Jefferson University in Philadelphia. After earning an M.D. from the Perelman School of Medicine at the University of Pennsylvania in 1962, Rothman returned to Jefferson for a residency.

Seven years after graduating from medical school, he went to England and learned how to perform hip replacement surgery from John Charnley. Charnley was so impressed with Rothman that when Walter Annenberg sought out Charnley for hip surgery, Charnley sent him to Rothman. Annenberg was grateful and provided millions to the Rothman Institute.

Rothman would eventually perform more than 50,000 hip and knee procedures and after retirement worked with companies in developing newer and better procedures. He was instrumental in the development of the Accolade total hip system (now made by Stryker Corporation), which has become one of the most prominent and widely used hip systems in the United States, Australia, Canada, and Asia. The Stryker Accolade has been used in over 200,000 patients to date.

He was also active in the development improvement of highly cross-linked polyethylene bearings including Crossfire and X3, as well as the continued development of the Trident shell.

“It’s like a cliché,” said Vaccaro, “but he was truly larger than life, always smiling and full of interesting stories. He drove himself forward with curiosity, had an entertaining persona, and was deeply insightful and calm.”

Dean Lorich Fierceness

Less calm was Dean Lorich, M.D., associate director of the Orthopedic Trauma Service at Hospital for Special Surgery (HSS) and director of the Orthopedic Trauma Service at New York Presbyterian Hospital. Lorich passed away on December 10, 2017 at the age of 54.

Lorich was a fierce surgeon warrior who was the first to run to disaster when people needed a surgeon. As we reported in the 2010 story called, “Cry, The Beloved Surgeon,” Lorich led a team from HSS who immediately flew to aid the victims of the 2010 earthquake in Haiti before government relief efforts could be organized.

When he returned, shaken by what he found, he sharply criticized the severe inadequacies on the part of the U.S. government and non-governmental organizations. His criticism sparked great debate about how the government would respond to future catastrophes.

David Helfet, M.D., Chief Emeritus of the Orthopedic Trauma Service at HSS, said Lorich was a, “superb, well-respected surgeon, teacher, colleague and friend to me and the entire Hospital for Special Surgery and NewYork-Presbyterian community. It is truly a great loss—throughout his 18-year career he impacted the lives of thousands of patients both near and far.”

The Shamed

Sadly, not all stories chosen by readers were about heroic or outstanding surgeons.

There were also those who cheated, harmed and violated their Hippocratic Oath to their patients and colleagues.

In April, a federal grand jury in Florida convicted Johnny Clyde Benjamin, M.D., for the 2016 fentanyl overdose death of a patient. The jury said Benjamin was guilty of conspiracy to possess with intent to distribute the fentanyl. He was also convicted of four other drug-related charges linked to Crowley’s death.

In July, Benjamin was given a life sentence.

In one bizarre episode of this “Breaking Bad” case, Benjamin tried to board a plane to Philadelphia carrying thousands of counterfeit pills supplied by a DEA informant for $16,000.

He arrived at the Orlando Melbourne International Airport wearing his scrubs and carrying thousands of blue pills in his carry-on bag. Airport police confiscated the pills and Benjamin returned with a prescription written that day to retrieve what he called his “cancer medication.”

His lawyer said he planned to file an appeal.

Readers also continued to follow the ongoing efforts to bring spine surgeon Atiq Durrani, M.D. to justice.

Last December we reported that the Pakistani hospital where Durrani had fled after facing allegations of medical malpractice and False Claims in Ohio, had suspended his license.

Durrani was arrested in Ohio in 2013 after being indicted on 46 federal charges, including performing unnecessary surgeries. Other allegations claimed that Durrani had another surgeon operate in his name, allowed other employees to write Oxycodone prescriptions on orders he pre-signed, knowingly left a guide wire inside a patient during surgery without giving them notice, and billing private and public healthcare benefits programs for fraudulent services.

In June 2015, we reported that we found him. In Lahore, Pakistan, where he had set up his own spine surgery clinic and joined the hospital staff of Doctors Hospital and Medical Centre.

We repeatedly asked the hospital for comment about the allegations against Durrani that he had started a high-profile practice at the hospital. Our requests went unanswered.

In September, a reader claiming to be a nurse at the hospital left us a reader comment saying that he is still secretly working in the hospital.

Then on December 12, a Pakistani website, thenews.com, reported that Pakistani regulators have put Doctors Hospital on notice to explain why Durrani has been practicing there when his license is suspended. The hospital has reportedly not responded.

March of Technology

But what our readers really craved this past year was news about new tools and treatments available for their patients. Our expert judges identified the top ten spine and sport medicine technologies for the Orthopedics This Week Annual Technology Awards

Top Ten Spine Technologies

Eight prominent surgeons considered and judged the best new technologies in 2018. The surgeons included:

• Paul A. Anderson, M.D.: Professor at the University of Wisconsin School of Medicine and Public Health,
• Scott Boden, M.D.: Chairman of the Department of Orthopaedics, Director of Emory Orthopaedics & Spine Center and Chief Medical Officer Emory University Orthopaedics & Spine Hospital,
• Boyle Cheng, Ph.D.: Dr. Cheng is Professor of Neurosurgery at Drexel University – Allegheny General Hospital,
• Reginald Davis, M.D.: FACS: Dr. Davis is the Director of Clinical Research at the Laser Spine Institute,
• Ira L. Fedder, M.D.: Dr. Fedder is a fellowship-trained orthopedic surgeon with Towson Orthopaedic Associates in Maryland,
• Jeffrey A. Goldstein, M.D.: Dr. Goldstein is the chief of the Spine Service for Education and program director of the Spine Fellowship in the Department of Orthopedic Surgery at NYU Langone,
• Scott Webb, D.O.: Dr. Webb is Surgical Director of Florida Spine Institute,
• Hansen A. Yuan, M.D.: Dr. Hansen A. Yuan is the retired Professor of Orthopaedic and Neurological Surgery at the State University of New York Upstate Medical University.

Augmedics’ xvisionis an augmented reality surgical navigation system that is designed to give surgeons a form of “X-ray vision.” The net effect is that surgeons can simultaneously look at their patient while also seeing the anatomy below and the position of instruments—without averting their eyes to a remote screen.

DiFusion Technologies, Inc.’s ZFUZE – PEEK Compositeis a revolutionary new biomaterial which solves the one setback polyetheretherketone (PEEK) had in non-osteointegration, while maintaining attractive and similar bone modulus and visualization benefits.

Green Sun Medical’s Dynamic Scoliosis Braceapplies continuous corrective pressure to the spine while allowing the patients to move and function as normal teenagers. While wearing the brace, sensor data will be transmitted through Bluetooth to mobile devices and then accessed with a cloud-based server. Physicians will be able to monitor their patients in real time to ensure that they are receiving the proper treatment.

K2M, Inc.’s Mojave PL 3D Expandable Interbody Systemis a 3D-printed fusion device which allows surgeons to independently control anterior and posterior heights in the lumbar spine. This capability is not available with any other product on the market today.

MiRus, LLC’s Europa Pedicle Screw Systemis the smallest thoracolumbosacral pedicle screw system on the market, yet it is two to three times stronger and four times more fatigue resistant than standard Titanium and Cobalt Chromium pedicle screw systems.

MiRus, LLC’s Galileo Spine Alignment Systemprovides real-time measurement and monitoring of segmental and/or global spine alignment without repeated imaging.

Power T Handle, LLC’s “Power T Handle”is a single-use device that allows surgeons to manually insert screws in either a traditional fashion or with power using the integrated power capabilities. The device mimics the footprint of traditional surgical instruments while also providing critical tactical feedback when desired and seamless on-demand power.

RTI Surgical, Inc.’s TETRAfuse 3D Technologyis the first 3D printed polymer-based interbody fusion device to incorporate a nanorough surface that has demonstrated, in a pre-clinical study, more notable trabecular bone ingrowth compared to PEEK and titanium-coated PEEK.

Simplify Medical, Inc.’s Simplify Discis a three-piece, non-metallic cervical artificial disc comprised of PEEK endplates with a ceramic core. The disc is designed to be MRI-compatible, including minimal artifact, thereby reducing or eliminating the need for future CT scans and the risks associated with ionizing radiation.

SurGenTec’s ALARA Access Needlesystem is an inexpensive solution to provide radiation reduction to the surgeon which any surgeon, hospital or ambulatory surgical center can afford or have access to. The company had an independent physicist perform a study and it showed that Alara cut radiation exposure by 15x when compared to using a Kocher clamp.

Tyber Medical LLC’s ProTi 360 (TyPEEK) Interbody Systemis a spinal fusion interbody device comprised of a PEEK core surrounded on all exterior-facing surfaces by an integrated titanium surface layer designed to enhance primary implant stability and stimulate accelerated osseointegration.

Top Ten Sport Medicine Technologies

Carestream Health’s Onsight 3D Extremity Systemrelies on cone beam CT (CBCT) technology to capture weight bearing and other types of patient extremity images. It delivers high-quality, low-dose 3D imaging for orthopedic and sports medicine practices, hospitals, imaging centers, urgent care facilities and other healthcare providers.

Quadrant Biosciences Inc.’s ClearEdge Brain Health Toolkitmonitors brain health after a concussion through functional assessment. The company has partnered with the Hall of Fame Players Foundation to monitor the brain health of retired National Football League athletes.

Stryker Corporation’s Cobra Suture Passeris the market’s first reusable suture passer for arthroscopic rotator cuff repair with a rigid stainless-steel needle. No disposable needles. No needle migration. Avoids needle breakage and is able to pass through calcified cuffs.

PolyPhysics, Inc.’s Frog-Skindelivers cold therapy in a wrap to treat overuse or extensive training soft tissue injuries. The skin is made from an engineered elastic composite material that regulates skin temperature during cold therapy. Frog-Skin therapy wraps also provide soft adaptive compression, conforming to numerous body locations, body types and sizes.

IncludeHealth Inc.’s Platformpairs HIPAA compliant cloud software with connected, inclusive rehabilitation/fitness equipment to offer users better outcomes at a more affordable cost. Subscriptions are offered on a monthly basis.

iTrace Biomedical Inc.’s Intelligent Medical Device Platform for Pain Managementis a portable device that delivers heat, cold, wearable ultrasounds, and TENS (transcutaneous electrical nerve stimulation) to treat sports injuries.

The platform is connected to a cloud-based server which allows for tracking of pain therapy data, compliance, and the outcome of prescribed therapies (i.e., pain score feedback provided by patients) thus helping doctors/trainers/physiotherapists determine personalized therapy modality and dosage.

KATOR LLC’s Knotless Arthroscopic TransOsseous Repair Systemtackles rotator cuff repair and Achilles tendon reattachment procedures. The system delivers suture patterns required but with only two anchors instead of the historically needed four anchors. This reduces cost and anchor load in the tuberosity.

Arthrex, Inc.’s Minimally Invasive Quad Tendon Harvest Set and Fiberloop with FiberTag Fixationgives surgeons doing cruciate ligament reconstruction a faster and less invasive way to safely harvest a graft of a desired length and diameter through a smaller incision. The technology makes autografts, which have been shown to be superior to allografts especially in younger patients, more accessible.

MTF Biologics’ (in conjunction with Missouri Orthopedic Institute & ConMed) Missouri Osteochondral Preservation System (MOPSSM)is an innovative allograft designed to more completely preserve donated cartilage, bone, meniscus, ligament and intervertebral disc during the required disease testing period and the storage period before transplantation. The method offers the use of closed containers, serum-free media that includes dexamethasone, and the ability to be stored at room temperature.

Because fresh osteochondral allografts are in limited supply. Longer preservation times with the system means more allografts will be available when needed.

Stryker Corporation’s Pivot Guardian Distractor Systemis the first-ever post-free hip distraction system. The system reduces groin complications, minimizes heel slip, and improves range of motion for hip arthroscopy. It also gives surgeons better visibility.

2019

By the end of 2018, external political forces and economic cycles drove down stock market valuations of orthopedic companies. But patients continue to need care and surgeons will continue to offer those patients the latest and best technologies available.

Welcome to 2019.