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.
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