Top Orthopedic Stories From 2017

Many Americans were in pain in 2017. Figuratively and literally.

Figuratively, after a divisive election, the pain manifested itself in street violence and 24 hour a day shouting on tribal media outlets.

Literally, people with body and psychic pain medicated themselves into a national opioid crisis. Americans, as the great historian Daniel Boorstin noted, have a nervous and ambitious “Go-Go” culture which has been self-medicating since the days of snake oil salesmen and magic elixirs to calm nerves and relieve pain.

Orthopedics played a part in the opioid crisis. Patients demanded relief and if prescriptions were not given, physician popularity grades plummeted and in one tragic case, a spine surgeon in Indiana paid for his caution in prescribing opioids with his life.

Our readers reflected these concerns by gravitating to stories that reported on drug-free pain therapies and tackled dramatic changes in practice managements (MACRA, MIPPS, ACA, etc. and the 15 hours a week everyone is now spending doing bleeping paperwork).

So, here in descending order are the top ten orthopedic stories of 2017 from the pages of Orthopedics This Week.

10. Bradshaw, NFL Great, Receives MicroPort Evolution Knee

NFL legend Terry Bradshaw said his knee pain had become so excruciating he couldn’t sleep comfortably, stand upright, or walk up and down stairs. So, his doctor recommended total knee replacement surgery that was performed by C. Lowry Barnes, M.D. at the University of Arkansas.

Barnes gave Bradshaw a MicroPort Evolution Knee. Bradshaw was so happy he immediately signed up to become a paid spokesperson for the company.

9. Freezing Knee Nerves Kills Pain

A story about iOvera, a nonsurgical pain treatment for patients with arthritis and other knee and joint issues developed by Vinod Dasa, M.D., an orthopedic surgeon at Louisiana’s State University (LSU) Health Sciences Center, attracted more reader comments than any other story of the year.

With iOvera, the surgeon temporarily freezes the nerves around the knee, alleviating a patient’s pain while avoiding nerve damage or surgery.

8. Sarcomas: What Do You Know?

James Wittig, M.D., Chief of Orthopedic Oncology and Associate Professor of Orthopedic Surgery at Mount Sinai Medical Center in New York City, has been on a mission to get his colleagues to pay attention to young patients who come in with dull aching pain which is often seen as a mechanical problem.

In fact, these patients may be in the early stages of bone sarcoma and if misdiagnosed—unlike most orthopedic conditions—can result in death.

“Listen to your gut. If things don’t add up, you may be looking at a tumor, says Wittig.

7. 80 Year Olds CAN Safely Undergo Spine Surgery

A study led by Jeff Rihn, M.D., an orthopedic surgeon at the Rothman Institute, found that patients 80 and older can derive significant benefit from surgical treatment for lumbar spinal stenosis with and without degenerative spondylolisthesis. And the bonus? These patients had no higher overall complication rate and no higher mortality when compared to patients younger than age 80.

Rihn and his researchers reviewed Spine Patient Outcomes Research Trial (SPORT) data and published the results in The Journal of Bone & Joint Surgery.

Rihn said it was somewhat surprising that there was not a higher complication rate in this patient population given their advanced age and greater baseline medical comorbidities. “This finding, however, suggests that surgery can be a relatively safe option for treating these conditions in this patient population.”

6. Lessons of Whistleblowers

Two stories stood out in 2017.

The first goes all the way back to a whistleblower suit first filed in 2005 over bone stimulating devices.

A medical services consultant made the case that multiple device companies were selling osteogenesis stimulators to Medicare beneficiaries when they should have been renting them. He accused the companies of advising their physician and hospital customers on how to fill out the Medicare claims, resulting in violations of the Federal False Claims Act.

The companies eventually paid fines and settled with the government. All these cases disappeared in the rear-view mirror of the companies a long time ago, but our readers continue to revisit this story for lessons to remember.

A second whistleblower case involved firing an accountant.

Patricia Katz went to work for SpineFrontier in February 2011 as a senior accountant. She was fired in March 2012. The company basically said she was too opinionated and mishandled confidential human resources information. She said she was fired because she was pushing for a better compliance program and reported her misgivings to the FDA.

Katz sent an anonymous email to the FDA to get clarification on her concerns. The FDA agreed with her and she forwarded her correspondence with the FDA to her bosses. The FDA eventually issued a public Warning Letter to the company.

The lesson here for all device makers. If you send your staff for compliance training, prepare to have a good compliance program. And if you fire them for having strong opinions about the compliance, expect to get sued.

5. DePuy Synthes Agrees to Sell ProDisc Back to VBs

Anthony, Marc and John Viscogliosi (VBs) sold the ProDisc lumbar artificial disc replacement technology to Synthes in 2003 for $350 million.

In September 2017, the brothers, through Centinel Spine, bought the technology back from DePuy Synthes for an undisclosed price.

“Centinel Spine’s acquisition of ProDisc is absolutely positive for ProDisc as well as for spinal arthroplasty in general”, said Jack Zigler, M.D., one of the principals at The Texas Back Institute and the first U.S. surgeon to implant ProDisc L. “The Viscogliosi Brothers were instrumental in recognizing the value of spinal arthroplasty and bringing that technology into the U.S. They have personal experience with several of the pivotal IDE studies for both cervical and lumbar arthroplasty, as well as with the benefits of non-fusion technologies.”

The technology developed by a French orthopedic surgeon, Thierry Marnay, M.D., was revolutionary at the time because it obviated the need to fuse the spine—then considered the gold standard treatment for treating disc degeneration.

ProDisc L received FDA approval in 2006. The first cervical artificial disc replacement (Prestige) was approved in July 2007.

4. Zimmer’s Manufacturing Pains and Dvorak’s Downfall

When Zimmer Holding’s Inc. acquired Biomet Inc., it gained a Biomet manufacturing facility in Warsaw, Indiana.

After the acquisition, the FDA inspected the Biomet-legacy North Campus facility and issued, in the words of one regulatory expert, one of the “longest and most serious” 483s ever encountered. The 483s were not just technical violations, but ones that potentially went to safety, e.g., whether products were properly sterilized, or steps adequately documented so that the safety is known.

Product ship holds were issued and Dave Dvorak, Zimmer Biomet’s CEO, made multiple management changes including a new SVP, Global Operations and Logistics and a new VP, Quality Assurance, in addition to several other positions.

But the financial damage had been done. Sales were disrupted. Wall Street investors sold.

On July 11, 2017 Dvorak fell on the sword and resigned.

Dvorak made his mark on industry and surgeon relationships after former U.S. Attorney Chris Christie threatened to prosecute device makers for providing improper inducements to surgeons to use their products. The company, by far, had the highest annual payment amounts ($134 million) to surgeons. But under Dvorak’s realignment, over 75% of those payments then went for royalties.

After Dvorak’s departure, Daniel Florin, the company’s CFO, took over as Interim CEO.

On December 19, 2017, the company announced the permanent appointment of Bryan Hanson, then Medtronic plc’s president of the Minimally Invasive Therapies Group, as the new CEO.

3. Best Sports Medicine Technologies for 2017

Innovation and fixing patients remained the main interest of readers of OTW as the third most read article for the year named the ten winning companies with the BEST new sports medicine technologies for 2017. The winners in alphabetical order were:

Arthrex, Inc. for its InternalBrace™ Ligament Augmentation System, which augments the repair of the native ATFL ligament. The system provides a “check-rein” or “internal seatbelt” to allow the ligaments to heal in a more physiologic manner, at appropriate tension.

Bioelectronics Corporation was named for its ActiPatch (Pulsed Shortwave Therapy), a wearable, low-power, pulsed shortwave therapy device for adjunctive treatment of osteoarthritis of the knee and plantar fasciitis. The device provides continuous, new information to peripheral nerves and is key to mitigating central sensitization, and this is accomplished by the ActiPatch.

Breg, Inc.’s Breg Flex is a first-of-its-kind remote therapy monitoring device. It is mobile and uses sensor technology to gather objective, real-time data. Incorporated into the system are iOS and Android software engines (one for the clinician and one for the patient). Breg Flex’s sensor tracks activity and range-of-motion within 5 degrees of accuracy for flexion and extension and then communicates that data via Bluetooth.

Freeze Sleeve, LLC developed a revolutionary cold therapy compression sleeve called the Freeze Sleeve, which provides 360 degrees of cold therapy and compression coverage to arms or legs. The sleeve is applied directly to the skin and will not burn so it is safe for use by children and adults.

MuscleSound, LLC’s MuscleSound is an ultrasound that looks inside the muscles, measures the rate with which the muscle stores, generates and replenishes energy and, therefore, can track rehabilitation following injury in novel and more effective ways.

NCS Lab SRL developed a surgical instrument called the Taylor Stitcher which allows the physician to create transosseous curved tunnels for treating lesions to the shoulder rotator cuff. It works in both an arthroscopic and mini-open surgical technique. The system uses a 1.9 mm diameter nitinol needle which is activated and in one single step the physician creates the transosseous tunnel and pass the suture/shuttle.

OrthoNOW introduced a mobile app which patients can use to notify an OrthoNOW Center that they are in route, the reason they are going, and what time they expect to arrive. The app also locates the nearest OrthoNOW Center and provides contact interface to the Center.

Smith & Nephew’s Meniscal Root Repair Instrumentation is set of instruments designed to arthroscopically treat meniscal root tears by locating the posterior meniscal root footprint and fixating them back to their native locations. Seven instruments were designed for this technique.

The company won a second award for its Suspension Fixation for Bone Graft Healing. The system is a new approach which uses the shortening of sutures to draw two structures together under tension. The technology uses sutures and extra-cortical endobuttons to approximate the graft to the host glenoid bone. It has not yet been cleared by the FDA for U.S. sale.

Suture Innovations LLC‘s SutureDart allows surgeons to perform bone sparing drilling and passage of sutures though transosseous tunnels in a single step. SutureDart can be used for soft tissue to bone (e.g., patella tendon rupture) or bone to bone (e.g., syndesmosis).

2. Best Spine Technologies for 2017

Innovations in spine continue to attract readers as the ten companies with the BEST new spine care technologies for 2017 were:

7D Surgical‘s Flash Align creates individual virtual models of each spine vertebrae from a preoperative image set, which are used to characterize the shape of the spine intraoperatively.

Amniox Medical/Tissue Tech‘s RESPINA UC/AM is Cryopreserved Umbilical Cord/Amniotic Membrane Matrix for use in microdiscectomies. It is an easy to use, fully resorbable biological matrix that aids in the restorative healing of minimally invasive microdiscectomy procedures.

LifeWalker Mobility Products/Protostar Inc. developed a next-generation medical walker called the Upright Medical Walker that allows patients to walk longer, with less spine pain, and requires less oxygen than a standard rollator.

Lite Run Inc.’s ExoSuit uses differential air pressure inside a specially-designed suit to effectively unweight some of patient’s body weight onto Lite Run’s proprietary walker. A patient’s effective body weight may be reduced by over 50%.

Mighty Oak Medical created the X-Caliber Porous Pedicle Screw which provides improved biomechanical pedicle fixation, regardless of bone quality or the forces being applied to the screw. X-Caliber includes both porous and solid aspects which are fused together into a single solid construct.

Orthofix Inc.‘s STIM onTRACK Mobile App is a mobile application designed for use with smartphones and other mobile devices. It helps patients adhere to their prescriptions, including daily treatment reminders, a device usage calendar, links to educational resources, and access to Orthofix’s Patient Care team.

TrackX Technology’s TrackX tracks surgical instruments in real surgical time using ultra low dose radiation imaging. allows surgeons to substantially reduce the number of X-rays needed to accurately and safely advance instrumentation, place implants and restore anatomy—all while using low-dose imaging and reducing overall OR time.

TranS1 developed the Pylon MIS Posterolateral Graft Delivery System, a reusable spinal instrument which allows surgeons to perform one of the gold standards of fusion (posterolateral gutter fusion) through a minimally invasive approach. It is an all-in-one instrument and requires only a single instrument pass above or below the level(s) to be fused.

VersaSpine, LLC’s VersaSpine Dual-Ended Minimally Invasive Pedicle Screw System is a minimally invasive patented pedicle screw implantation system, based upon the novel dual-socket pedicle screw which allows both anterior and/or posterior fixation.

ZygoFix, Ltd‘s ZLOCK Facet Fusion System is a posterior stabilization system designed to lock the facet joint of the lumbar spine. The ZLOCK anchors into both superior and inferior articulating processes, immobilizing its motion and providing stabilization.

1. Innovative Pain Therapies

The number one read story in OTW in 2017 was all about a drug-free pain therapy for plantar fasciitis and osteoarthritis. The therapy was a winner of one of our aforementioned best new Sports Medicine Technology Awards for 2017.

The interest of readers points to a hunger for more innovations in pain management where several new approaches, some with new formulations of old drugs (lower doses, longer lasting, safer) and non-drug ideas like distracted pain management, are being developed.

BioElectronics Corp.’s ActiPatch provides 720 hours (90, 8-hour treatments) of on/off therapy. Most users obtain relief with only 8 hours per day of use, and the device generally last several months, depending on use. ActiPatch is described by BioElectronics as “an adjunctive or alternative therapy to pain killers, including narcotics.”

As Americans come to grips with the opioid crisis, orthopedic surgeons, providers and technology developers will do what they always do—find solutions. In 2017 we recognized and admitted there is a problem. We look forward to reporting on the solutions to arrive in 2018.