Elizabeth Hofheinz, M.P.H., M.Ed. • Tue, December 27th, 2016

For many years the standard in training airline pilots has been pre-flight simulators. This helps them become more skilled at flying the actual plane. This is a comfortable thought isn’t it? Exactly! Well, recent developments in shoulder replacement surgery allow surgeons to simulate surgery and this benefits not only the patient, but also the hospital. Jon J.P. Warner, M.D. is chief of the Massachusetts General Hospital Shoulder Service and co-Director of the Boston Shoulder Institute. He and his colleagues are bringing clarity to the operating room via patient-specific planning for shoulder replacement.

Dr. Warner told OTW, “Joint replacement is expensive and the results are unpredictable; and unlike total hip and knee surgery, most orthopedic surgeons have limited experience with shoulder replacement surgery. Since shoulder replacement surgery is performed at a volume of <15% hip or knee replacement surgery, 90% of all shoulder replacements in the U.S. are performed by surgeons who do less than 5 procedures each year. Thus these surgeons may not have enough experience to avoid some common problems. These problems may include incorrect size selection and inaccurate placement of the shoulder replacement components.”

“For shoulder replacement you must select a size that matches the patient’s anatomy, meaning that you have to have a full complement of instruments and implants on hand. To do a single operation the device manufacturer must deliver roughly $75,000 in inventory of instruments and implants; and if the surgeon opens a tray and doesn’t use it then it’s $100 to sterilize it. This economic reality challenges both the hospital and the company to provide cost-effective care.”

READ THE REST HERE

Elizabeth Hofheinz, M.P.H., M.Ed. • Tue, December 27th, 2016

For many years the standard in training airline pilots has been pre-flight simulators. This helps them become more skilled at flying the actual plane. This is a comfortable thought isn’t it? Exactly! Well, recent developments in shoulder replacement surgery allow surgeons to simulate surgery and this benefits not only the patient, but also the hospital. Jon J.P. Warner, M.D. is chief of the Massachusetts General Hospital Shoulder Service and co-Director of the Boston Shoulder Institute. He and his colleagues are bringing clarity to the operating room via patient-specific planning for shoulder replacement.

Dr. Warner told OTW, “Joint replacement is expensive and the results are unpredictable; and unlike total hip and knee surgery, most orthopedic surgeons have limited experience with shoulder replacement surgery. Since shoulder replacement surgery is performed at a volume of <15% hip or knee replacement surgery, 90% of all shoulder replacements in the U.S. are performed by surgeons who do less than 5 procedures each year. Thus these surgeons may not have enough experience to avoid some common problems. These problems may include incorrect size selection and inaccurate placement of the shoulder replacement components.”

“For shoulder replacement you must select a size that matches the patient’s anatomy, meaning that you have to have a full complement of instruments and implants on hand. To do a single operation the device manufacturer must deliver roughly $75,000 in inventory of instruments and implants; and if the surgeon opens a tray and doesn’t use it then it’s $100 to sterilize it. This economic reality challenges both the hospital and the company to provide cost-effective care.”

READ THE REST HERE

By Christina Jewett – December 21, 2016

Five years ago, Dr. Ira Kirschenbaum, an orthopedic surgeon in the Bronx who replaces more than 200 knees each year, would have considered it crazy to send a patient home the same day as a knee replacement operation.

And yet there he was this year, as the patient, home after a few hours. A physician friend pierced his skin at 8 a.m. at a Seattle-area surgery center. By lunch, Kirschenbaum was resting at his friend’s home, with no pain and a new knee.

“I’m amazed at how well I’m doing,” Kirschenbaum, 59, said recently in a phone interview, nine weeks after the operation.

What felt to Kirschenbaum like a bold experiment may soon become far more standard. Medicare, which spends several billions of dollars a year on knee replacements for its beneficiaries — generally Americans 65 and over — is contemplating whether it will help pay for knee replacement surgeries outside the hospital, either in free-standing surgery centers or outpatient facilities.

The issue is sowing deep discord in the medical world, and the debate is as much about money as medicine. Some physicians are concerned that moving the surgeries out of hospitals will land vulnerable patients in the emergency room with uncontrolled pain, blood clots or other complications.

But proponents of the change say it can give patients more choice and potentially better care, as well as save Medicare hundreds of millions of dollars. Already, an “overwhelming majority” of commenters said they want to allow the surgeries out of hospitals, according to recent rule-making documents.

The final decision, which could come within a year, would also act as a test of sorts for Donald Trump and his new administration. They will weigh whether to limit government controls, as Trump has often suggested, or to bend to pressure from hospitals and doctors, many of whom oppose the change.

READ THE REST HERE

WARSAW, Ind., Dec. 19, 2016 /PRNewswire/ — DePuy Synthes*, part of the Johnson & Johnson Family of Companies, today announced that implant survivorship data from the 2016 Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) confirm positive early results for DePuy Synthes’ ATTUNE® Knee System.¹ These data add to other recent registry evidence which has shown that survivorship for the ATTUNE Knee compares favorably to other knee systems in its class.² In addition, recently-presented interim data have shown improved patient reported outcomes measures with the ATTUNE Knee compared to other leading knee systems.³

Per the 2016 AOANJRR, in which 4,831 ATTUNE Knees are being tracked, the ATTUNE Knee estimated cumulative percent revision was 0.5% (ATTUNE Cruciate Retaining Knee), 0.4% (ATTUNE Posterior Stabilized Knee) at one year.¹ This compares favorably to the overall class of cemented total knee arthroplasty (TKA) at one year, which has an estimated cumulative percent revision of 1.0%.¹

In addition, interim results from an ongoing study of patients implanted with ATTUNE Posterior Stabilized (PS)TKA Knees showed a reduced incidence of symptomatic crepitus that was half of that compared to non-ATTUNE PS TKA Knees at a minimum of one year .⁴

“There is a steady cadence of evidence for the ATTUNE Knee that suggests improved outcomes and functional performance^3,5, helping patients get back sooner with a reduced hospital length of stay,” said Paul Voorhorst, Vice President of Clinical Research for DePuy Synthes Joint Reconstruction. “We are committed to ongoing monitoring of both the outcomes and economic benefits of this new technology.”

From a health economics standpoint, a large U.S. hospital administrative database review showed ATTUNE Knee patients had a 39% lower odds of discharge to a skilled nursing facility compared to patients  who received a TKA with a Triathlon® Knee.⁶ 

“These promising early results are encouraging for patients, healthcare providers and payers, and underline the importance of our robust evidence generation program for the ATTUNE Knee,” said Christina Farup, Vice President, Health Economics and Market Access, Johnson & Johnson Medical Devices. “We designed the ATTUNE Knee System with both patients and providers in mind to help health care systems increase patient satisfaction, improve clinical outcomes and reduce overall health care costs.”

The ATTUNE Knee evidence generation program gathers information from many sources, including other joint registries. In addition to the AOANJRR, the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man (NJR) also indicated that the ATTUNE Knee System compares favorably to other cemented total knee systems in its class.² Per the 2016 NJR, the ATTUNE Knee estimated cumulative percent revision was 1.39% at 3 years (98.61% survivorship) for 4,463 knees, comparing favorably to the class of Cemented TKA that has an estimated cumulative percent revision of 1.50%.²

Advancements in TKA surgery systems, such as the ATTUNE Knee, may not only benefit patients, but the healthcare system as a whole because patients may be able to leave the hospital sooner and return to normal activity. A 2013 study published in The Journal of Bone and Joint Surgery found that societal savings, such as decreased disability costs, return to independent living, and increased work productivity, far exceeded direct costs [of TKA surgery].⁷

Global thought-leader surgeons, engineers, and experts in fields of study such as kinematics, anthropometrics, polyethylene wear and design collaborated to develop and test the ATTUNE Knee System. Extensive research and science has gone into the design to help improve functional outcomes for patients, performance for surgeons, and efficiency for providers.

About DePuy Synthes
DePuy Synthes, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive portfolios of orthopaedic solutions in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, neurological, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*DePuy Synthes represents the products and services of DePuy Orthopaedics, Inc. and its subsidiaries.

The third party trademarks used herein are the trademarks of their respective owners.

© DePuy Synthes 2016. All rights reserved.

References:

DSUS/JRC/1216/1887

SOURCE DePuy Synthes

WARSAW, Ind., Dec. 14, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced positive outcomes associated with the use of its Trabecular Metal^™ Cups in more than 9,500 patients undergoing revision hip arthroplasty.  The data, which stemmed from a new report by the National Joint Registry (NJR) for England, Wales, Northern Ireland and the Isle of Man, documented that Trabecular Metal Cups were associated with lower infection rates and a significant reduction in subsequent hip revision rates.

Specifically, the independent analysis conducted by NJR demonstrated the following*:

• Trabecular Metal Cups used in revision total hip arthroplasty (THA) have been shown to be 21 percent less likely to be re-revised due to infection (statistically significant, p-value=0.036).^1,2
• For high risk patients with a first revision indication being infection, Trabecular Metal Cups appear to be 35 percent less likely to be re-revised for infection. Due to the limited sample size, this has not reached statistical significance (not statistically significant, p-value=0.108).³
• Trabecular Metal Cups used in revision THA have been shown to be 11 percent less likely to be re-revised for any reason (statistically significant, p-value=0.015).¹

NJR is a government-led registry that monitors the performance of joint replacement implants and the effectiveness of joint replacement procedures, with a focus on improving clinical standards.  The report retrospectively analyzed outcomes related to 9,573 revision procedures using cementless Trabecular Metal Cups and 30,452 revision procedures using non-Trabecular Metal cementless cups, from April 2003 through July 2015.  The complete NJR report can be found at www.zimmerbiomet.com/TM.

“Infection, implant loosening, pain and dislocation are the most common reasons for revision joint replacement surgery,” said Dan Williamson, Zimmer Biomet Group President of Joint Reconstruction. “Our Trabecular Metal acetabular devices are designed to meet the long-term performance needs of hip implant patients.  The NJR report reinforces their value in significantly reducing hip revision rates in a large clinical patient population and yielding better outcomes in comparison to traditional non-Trabecular Metal implants.”

Zimmer Biomet’s Trabecular Metal Material is a unique, highly porous biomaterial made from elemental tantalum with structural, functional and physiological properties similar to bone.  The material, which features a 100 percent open, engineered and interconnected pore structure to support bony in-growth and vascularization, has been used in a variety of orthopaedic applications for more than 19 years.⁴

“Infection after orthopaedic procedures has moved into center stage,” says Javad Parvizi, M.D., an orthopaedic surgeon at the Rothman Institute at Thomas Jefferson University Hospital in Philadelphia.  “Based on recent data from various sources, it appears that Trabecular Metal implants have unique properties that allow them to reduce the incidence of infection after revision total hip arthroplasty.  This finding is encouraging and should provide impetus for us to design studies that unravel the exact anti-infective properties of Trabecular Metal implants.”

*The statements have not been evaluated by the FDA for Zimmer Biomet Trabecular Metal Cups and do not alter the cleared indications for use.

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see our periodic reports filed with the SEC.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports.  Accordingly, such forward-looking statements speak only as of the date made.  Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this news release.

___________________________________
¹ According to NJR data from 2003 to 2015 where 9,573 Trabecular Metal and 30,452 non-Trabecular Metal cups were used in revision THA and based on hazard ratios adjusted by patient gender, age group, and indications (osteoarthritis/non-osteoarthritis).

² NJR data shows a higher percentage of Trabecular Metal cups were used with antibiotic bone cement compared to all other non-Trabecular Metal cementless cups.

³ According to NJR data from 2003 to 2015 where 628 Trabecular Metal and 2,114 non-Trabecular Metal cups were used in revision THA and based on hazard ratios adjusted by patient gender, age group, and indications (osteoarthritis/non-osteoarthritis).

⁴ Karageorgiou, V. and Kaplan, D. “Porosity of 3D Biomaterial Scaffolds and Osteogenesis.” Biomaterials, 26 (27): 5474-91, September 2005

SOURCE Zimmer Biomet Holdings, Inc.