A New Lease on Life for One Million Knees

attune narrative

Our knee team is committed to Keep People Moving

DePuy Synthes is honoring its 125th anniversary this year – 125 years of determination and commitment to keep people moving through innovations that advance patient care in orthopaedics. With our strong history and legacy as a foundation, we traverse new and exciting Med Tech horizons year after year. Key developments in the areas of digital surgery, orthopaedic care, and co-creation with experts around the world help demonstrate both the clinical and economic value of our products and solutions.

As a global leader in orthopaedics, advancing care in the growing knee replacement market is amongst our key priorities. Why? Because, collectively, our knees are getting older – by the year 2100, those aged 80 and above will outnumber youngsters below the age of 5 by a factor of two to one.1 This global increase in life expectancy, which will multiply the number of us over the age of 80 six-fold from 141 million to 866 million during this century alone, is partially to blame for the rising strain on our knees.1  Here in Europe, people already have a 45% “lifetime risk” for knee osteoarthritis (OA).2

The foundation of our current knee portfolio is the ATTUNE Knee System, which is designed to provide increased stability throughout the range of motion as well as reduce anterior knee pain and dissatisfaction following surgery. From innovative types of implant technology such as cementless to digital surgical workflows to Patient Specific Alignment (PSA) – we are helping shape the future of knee surgery with the ATTUNE Knee.

“Data-driven innovation and surgical workflow improvements, fueled by new digital technologies and systems, will help drive our Total Knee Replacement (TKR) outcomes headfirst into the next significant wave of advancement for the knee space, as well as the overall orthopaedics industry.”

- Torbjorn Skold, Vice President of Joint Reconstruction, DePuy Synthes EMEA

 

A million ATTUNE Knees under our belt

As a team of devoted orthopaedic experts from around the world, we are proud of every physical movement made possible by our advancements. The fact that we have been able to help improve or restore mobility for so many individuals through one million ATTUNE Knee System implantations puts a new stamp on our orthopaedic passport.

Extensive experience matters, but outcomes matter more. Per the November 2020 Implant Summary Report from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man (NJR), the 7-year ATTUNE Knee implant cumulative revision rate is 2.1% (95% CI: 1.9, 2.9%), equivalent to 7-year survivorship of 97.9%, with 32,155 knees implanted.3 In addition, patients reported greater success and satisfaction with ATTUNE® Knee compared to all other Total Knee Arthroplasty (TKA) procedures combined.3 Outcomes like this do not come around every day; rather, they are the result of years of dedication of DePuy Synthes employees and the visionary experts we rely on to help us design, test and introduce our products.

We recently published a comprehensive white paper entitled “Advancing Patient Outcomes and Economic Value in Total Knee Arthroplasty: The Evidence of the ATTUNE® Knee System.” Authored by Dr. David Fisher, an orthopedic surgeon in the US, and Professor David Parkin, a health economic expert based in the UK, the report focuses on the approaches for evaluating knee replacement surgery from both a clinical and health economic perspective and assessed the data from the ATTUNE Knee Evidence Generation Program. In the white paper, Dr. Fisher and Professor Parkin concluded that, “Based on available data, the ATTUNE Knee appears to be advancing outcomes for patients and creating value for clinicians, providers and payors in a challenging and dynamic healthcare environment.”

The proof is in the outcomes 

Successful total knee arthroplasties are measured in several ways, including the five factors measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS): ability to participate in activities related to daily living, pain, symptoms, sports and recreation, and quality of life (QOL).4 Two 2-year studies of patient-reported outcomes (PROMs), evaluated whether a new primary, cemented multi-radius TKA system, such as the ATTUNE Knee System, demonstrated improvement versus currently available TKAs.5,6 Results from these two global studies showed improved patient reported outcomes with the ATTUNE Knee, including confidence in knee performance, increased activities of daily living and quality of life.6,8 In addition, at a minimum 1-year follow up, the ATTUNE Knee System demonstrated improved outcomes across a broad range of PROMs, with a significantly higher Oxford Knee Score and significant improvements in all KOOS sub-scores.7 At the 2-year follow-up point, KOOS sub-scores were significantly better for the ATTUNE Knee System in the areas of activities of daily living, sports and recreation and quality of life (QOL).8 ATTUNE Knee also performed significantly better in Patient Knee Implant Performance (PKIP).8

Ryan Haydon, hard hit by arthritis beginning in his early 40s, later received two ATTUNE knee implants.9 Running a large family farm posed many physical demands on him, but he also struggled with the lifestyle activities he loved, including sports, sailing and skiing. His pain progressed to the point where he could not even take a short walk to and from town. Before his knee replacements, he said, “if we had to walk home late one night when we couldn't get a taxi, it would take me probably about 40 minutes to an hour. I might have to stop about 4 times on the way.”

"To have the freedom to be able to move and walk and be pain-free is great for me and is great for those who live around me. It's a new lease of life."

- Ryan Haydon, ATTUNE patient in Sussex, U.K.

 

Smiling after his knee replacements, Mr. Haydon attests, “I can now strut into town in 15 minutes, no problem at all. It's the little things in life.”

Saving knees and saving costs – we are proud to do both

Healthcare systems around the world are trying to decipher how to navigate markets that are increasingly focused on getting more value for money. We are not just interested in technology for technology’s sake. We know that we must increase overall value by improving patient outcomes while reducing overall costs at the same time.

“We work hard to understand patient risks and identify bundle busters, decide upon the best implant, position and plan, deliver that plan in a way that is automated and makes it easier, and collect data in a way that is seamless to patients, makes the system better, more cost effective and supports the value equation.”

- Rajit Kamal, Vice President and Global Franchise Leader, Knees, DePuy Synthes

 

Clinical evidence shows, across various endpoints, that ATTUNE Knee patients across the UK, Germany, Italy and Netherlands reported a shorter in-patient length of stay (LoS) and reduced incidence of referral to rehabilitation, which is related to lower healthcare resource utilization and economic benefits for patients.10,11,12,13,14

As lifestyles become more active, knees struggle to keep up

The projections are almost staggering. A 2018 research study projected that by 2030, primary TKR is expected to grow by up to 189 percent to a projected level of 1.28 million procedures; by 2060, primary TKR is expected to reach 2.6 million, representing a sizeable 382 percent increase.15 The cementless TKR segment alone was expected to grow by 12.87% in 2020.16

But what is behind this exponential growth in knee replacements? The reasons are multifactorial – a rise in osteoarthritis compounded by a rising level of obesity fuels this trend.17 Younger patients are also seeking knee replacements; one study of 2 million knee replacements showed a 188% increase in procedures for 45- to 64-year-old patients. 27

Osteoarthritis is on the rise

Osteoarthritis, the most common form of arthritis,18 is a leading cause of disability with an estimated 250 million sufferers globally.19 Currently, about 40 million people across Europe are impacted by OA,2 of which nearly 9 million reside in the UK,20 and over 10 million in France, a country where OA is the #2 reason for consulting a doctor (after cardiovascular diseases).21

OA accounts for 50% of the total musculoskeletal disease burden and affects the lives of an estimated 10 to 15% of adults over the age of sixty worldwide.22 And the knee, accounting for 85% of the OA disease burden, is the joint most commonly affected by OA.19 In fact, osteoarthritis in the knee has doubled in prevalence since the mid-20th century,23 and now accounts for approximately 85 percent of the total global osteoarthritis burden. 24

The direct and indirect costs attributable to knee osteoarthritis are substantial, so interventions that alleviate the burden associated with osteoarthritis are, therefore, valued across multiple stakeholders.25 Multiple scientific studies in countries across the US and the EU have concluded that TKA is the most cost-effective means of managing osteoarthritis, according to standards that are widely accepted in developed countries.

TKR patients are getting younger

Another interesting trend is that younger patients are seeking earlier treatment for arthritic conditions.26 Over the past decade at least, candidates for TKR have started to trend younger.27  A 2014 study, for example, predicted that primary joint replacement rates would increase substantially over the following 15 to 20 years, not only due to ageing populations but also to increased use in patients under the age of sixty.27 The study attributed the trend at least partially to the pursuit of more active lifestyles.

Current study results suggest that ATTUNE Knee could assist patients in returning to their day-to-day routines more quickly.

The shifting age demographic is also affecting even younger populations as seen in the growing demand for cementless TKR for younger, more active patients. Globally, in fact, the cementless total knee replacement procedures are expected to increase by 22% between 2020 and 2024.28

Our knee implants combine the latest in design, kinematics, engineering and materials

The comprehensive ATTUNE® Knee System represents one of the largest R&D projects in the history of DePuy Synthes Joint Reconstruction. Our design mantra is “the right implant for the right patient in the right setting with the right surgical approach at the right cost” – a philosophy that has led to innovative implant designs. Introduced to help patients achieve stability and motion, the ATTUNE Knee System is a comprehensive, integrated knee system spanning primary and revision procedures.

Recent innovations in primary knee arthroplasty

Introduced last year, the ATTUNE Cementless Knee System is built upon the same patented technologies as the ATTUNE Knee System and Rotating Platform option, with the added benefit of biologic fixation with POROCOAT™ Porous Coating. The Cementless line maintains the ATTUNE GRADIUS™ Curve, similar to ATTUNE Primary Posterior Stabilized (PS) Femoral Component to provide stability through range of motion.29,30,31 The GLIDERIGHT Articulation encompasses a trochlear groove designed to accommodate patient variation and soft tissue interaction, and patella components designed to assist with patella tracking while maintaining bone coverage. The proprietary S-curve of the SOFCAM Contact is designed to provide a smooth engagement for gradual femoral rollback and stability in flexion, while reducing stresses transferred to the tibial spine.

The INTUITION™ Instruments combine surgical process with intuitive and efficient instruments to allow the surgeon to balance the soft tissue and precisely control the implant position and fit for each patient. Our ATTUNE Cementless Knee System has learned from the heritage of the LCS™ Cementless Knee System utilizing the same POROCOAT™ Porous Coating and coated lug philosophy, which has demonstrated 98.9% implant survivorship at 10 years.32  

Additionally, the ATTUNE S+™ Technology, designed to enhance tibial fixation with its innovative combination of macrolock features and a microblast surface finish on the tibial base, is yet another way that DePuy Synthes is driving evidence-based innovation intended to make continuous enhancements. These features are designed to provide greater residual pull off strength under a range of simulated intra-operative conditions and the presence of lipid infiltration.

Advancements on the revision side of the equation

Data indicate that loosening and instability are two of the top three most common knee arthroplasty failure mechanisms.33 The ATTUNE® Revision Knee System was designed to address instability via comprehensive implant features designed to optimize conformity and constraint, two factors critical in  providing a stable knee implant.

Revision TKA procedures are complex and may require extensive surgical expertise, therefore our development of several proprietary technologies has equipped orthopaedic surgeons with a comprehensive tool kit of products and techniques to perform TKAs. According to P J James, BM/BS (Hons), FRCS, FRCS (Orth), Consultant Orthopaedic Surgeon at Nottingham City Hospital in the U.K. after implanting his 28th patient with the system, “I believe the proprietary ATTUNE Knee Technologies such as the ATTUNE GRADIUS Curve and GLIDERIGHT Articulation have the potential to deliver improved outcomes in revision TKA compared to revision products I previously used.”

Today’s access to data and technology empowers us to perform personalized surgery

From day to day, new technologies change the way we work and live. As our world becomes more connected, more advanced and more intelligent due to a growing abundance of data, new capabilities arise that change the way surgery is performed. At DePuy Synthes, we are innovating, advancing, and consistently raising the bar in orthopaedics through the development and introduction of advanced technologies inside and outside of the OR.

Digital surgery leverages the combination of insights and technologies to deliver greater precision

VELYS™ Digital Surgery is an evolving platform of connected technologies leveraging data insights for our patients, surgeons and health care systems – pre-operatively, during surgical planning, and intra- and post-operatively. Over time, VELYS™ Digital Surgery will include technologies and data platforms that are currently in development, as well as enabling technologies available today to help enhance the surgical experience and patient outcomes.

Much of what this means for our knee solutions remains to be revealed, but for now, our vision is to add capabilities to the VELYS™ Digital Surgery portfolio and to create an intelligent system that will become smarter by continuously capturing real-time data and informing the surgical approach to optimize outcomes. For TKR surgeries, this will mean significant advancements due to increases in the quantity and quality of data and digital guidance.

In the meantime, the two recent advancements below – personalized implant planning and digitally-guided workflows – have significantly raised the bar when it comes to the planning and execution of knee replacement and revision procedures.

When innovation meets customization

The TRUMATCH® Personalized Solutions System, which offers pre-operative surgical planning and patient-specific guides for total knee replacement, has created new capabilities for using technology to design customized instruments. Utilizing proprietary software, the TRUMATCH Personalized Solutions design team will create a three-dimensional model of the whole leg, utilizing the surgeon’s surgical preferences to create a personalized Patient Proposal. Once the surgeon approves the details of the Patient Proposal, personalized patient-specific instruments are manufactured. TRUMATCH Personalized Solutions resection guides are delivered sterile, and surgery can take place any time over the next 180 days.

Digital workflows provide step-by-step guidance to the OR team

Digital workflows can enhance teamwork and drive consistency in the OR. The Surgical Process Institute (SPI)ᵻᵻ aims to transform surgery through the empowerment of surgical teams to deliver consistent, high-quality care and efficiency in their OR. To achieve this, we designed our SPI platform to support surgical teams during procedures, empowering them with synchronized digital workflow technology and real-time insights to reduce variability. Powered by SPI, the ATTUNE® Knee System will continue to deliver on its design promises and improved outcomes with a world-class implant system and complimentary digital workflows to support surgical teams performing knee replacements.

What’s next for the knee?

What will “move the needle” in knee replacement? First, additional investments in new technologies across the care continuum – and taking an even more holistic view – will change the knee replacement landscape as we know it today, as will new technologies for patient selection and surgical planning. Add artificial intelligence to predict natural knee kinematics and advancements in digital surgery, and the knee replacement landscape will start looking entirely different in no time. Wherever we decide to lead the pack in terms of technological advancements, one key element will always stay the same: we will forever focus on building a suite of solutions that addresses patient needs before, during and after surgery.

 

 

References:

1 The Lancet. Huge shifts in global age structure. https://www.thelancet.com/infographics/gbd-2019, last accessed November 2020

2 Sarah R. Kingsbury, Hillary J. Gross, Gina Isherwood, Philip G. Conaghan, Osteoarthritis in Europe: impact on health status, work productivity and use of pharmacotherapies in five European countries, Rheumatology, Volume 53, Issue 5, May 2014, Pages 937–947, https://doi.org/10.1093/rheumatology/ket463. https://academic.oup.com/rheumatology/article/53/5/937/1798271, last accessed November 2020

3National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. Implant Summary Report for DePuy ATTUNE CR and ATTUNE PS. NJR Database extract 5 November 2020. Licensed for use until 21 March 2021

4 Koos.nu. What is the KOOS? http://www.koos.nu/koospresentation.html, last accessed 27 November 2020

5 Pham T, van der Heijde D, Altman R, Anderson J, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T, Dougados M. OMERACT-OARSI Initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis and Cartilage, (2004) 12, 389–399

6 Fisher D, Parkin D. Optimizing the Value of Your Patients’ TKA: How to Leverage Data from Patient Reported Outcomes, Becker’s Hospital Review, webinar recording, Oct 2019, https://www.vumedi.com/video/optimizing-the-value-of-your-patients-tka-how-to-leverage-data-from-patient-reported-outcomes/, last accessed 15 November 2020

7 Bloch BV, Shahid M, James PJ. ATTUNE Has Improved Survivorship and Clinical Outcome Over PFC SIGMA – A Single Surgeon Series of 100 TKAs With Minimum 2 Years Follow-Up. British Association for Surgery of the Knee Annual Spring Meeting 2018, Poster 001

8 Hamilton WG, Brenkel I, Clatworthy M, Dwyer K, Himden S, Lesko J, Kantor S. Comparison of an Existing and New Total Knee Arthroplasty Implant Systems from the Same Manufacturer: A prospective, Multicenter Study, 2019. submitted to Arthroplasty Today, 2-year results also presented at 2019 AAOS, Las Vegas NV (poster PO614)

9 DePuy Synthes. UK ATTUNE patient case study. Data on file

10 Etter K, Lerner J, Kalsekar I, et al. Comparative Analysis of Hospital Length of Stay and Discharge Status of Two Contemporary Primary Total Knee Systems. The Journal of Knee Surgery. 2018 Jul;31(6):541-550. DOI: 10.1055/s-0037-1604442

11 Mantel J, Corso KA, Wei D, Holy CE, Muehlendyck C, Jayakumar P, Higgins M, Westbrook A. Economic Effectiveness Of The ATTUNE® Knee System: Analysis Of Real World Hospital Length Of Stay And Incidence Of Early Complications. Value in Health. 2017 Oct 1;20(9): A597

12 Brüggenjürgen B, Muehlendyck C, Gador L, Katzer A. Length of stay after introduction of a new total knee arthroplasty (TKA)—results of a German retrospective database analysis. Medical Device: Evidence and Research 2019:12 245-251

13 Pipino G, Paragò V, Corso K, Wigham R, 12. Holy C, Do Rego B. Economic outcomes of the ATTUNE® Knee System: Analysis of real world hospital length of stay in an Italian hospital. Value in Health. 2017 Oct 1;20(9):A595

14 Meermans G, Galvain T, Wigham R, Do Rego B, Schröer D. Comparative Analysis Investigating the Impact of Implant Design on Hospital Length of Stay and Discharge Destination in a Dutch Hospital with an Established Enhanced Recovery Program. August 2019. Journal of Arthroplasty. 35 (2020) 182-187

15AAOS 2018 Annual Media Center, Projected volume of primary and revision total joint replacement in the U.S. 2030 to 2060. 6 March 2018. https://aaos-annualmeeting-presskit.org/2018/research-news/sloan_tjr/, last accessed 14 November 2020.

16 Global Cementless Total Knee Arthroplasty (TKA) Market 2020 to 2024. Technavio. Release Summary. https://www.businesswire.com/news/home/20200728005744/en/Analysis-on-Impact-of-COVID-19--Global-Cementless-Total-Knee-Arthroplasty-TKA-Market-2020-2024-Evolving-Opportunities-with-B.-Braun-Melsungen-AG-and-Corin-Group-Plc-Technavio, last accessed 20 November 2020

17 University of Western Australia. Obesity linked to earlier need for knee replacements. Medical Xpress. 9 April 2020. https://medicalxpress.com/news/2020-04-obesity-linked-earlier-knee.html, accessed 27 November 2020

18 Moskowitz RW. The burden of osteoarthritis: clinical and quality-of-life issues. The American Journal of Managed Care, 01 Sep 2009; 15(8 Suppl): S223-9, PMID:19817508, https://europepmc.org/abstract/med/19817508, last accessed 18 October 2019

19 Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet, 2019; 393 (10182): p1745-1759. DOI: https://doi.org/10.1016/S0140-6736(19)30417-9, last accessed November 2020  

20 National Health System (NHS). NHS report. Arthritis. https://www.nhs.uk/conditions/arthritis/, last accessed November 2020

21 White paper of the "Etats généraux" of Osteoarthritis 2015-2016 edited by AFLAR, https://www.expanscience.com/en/osteoarthritis/expertise, last accessed 14 November 2020

22 Background paper 6.12. Osteoarthritis. 2013, R. Wittenauer

23 Wallace IJ et al. Knee osteoarthritis has doubled in prevalence since the mid-20th century. 2017. PNAS. Vol. 114: 9332-9336

24 Vos T, Allen C, Arora M, Barber RM, Bhutta ZA, Brown A, Carter A, Casey DC, Charlson FJ, Chen AZ, Coggeshall M. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. The Lancet. 2016 Oct 8;388(10053):1545-602. https://doi.org/10.1016/S0140-6736(16)31678-6

25 Leardini G, Salaffi F, Caporali R, et al. Direct and indirect costs of osteoarthritis of the knee. Clin Exp Rheumatol. 2004 Nov-Dec;22(6):699-706. https://www.ncbi.nlm.nih.gov/pubmed/15638043

26 Blue Cross Blue Shield. The Health of America. Planned Knee and Hip Surgeries are on the Rise in the U.S. January 23, 2019. https://www.bcbs.com/the-health-of-america/infographics/planned-orthopedic-procedures-including-knee-and-hip-replacement, last accessed 14 November 2020

27 Arthritis Foundation. The Risks of Early Knee Replacement Surgery. 2014. https://www.arthritis.org/health-wellness/treatment/joint-surgery/safety-and-risks/the-risks-of-early-knee-replacement-surgery, accessed November 2020

28Global Cementless Total Knee Arthroplasty (TKA) Market 2020-2024. BusinessWire. https://www.businesswire.com/news/home/20200728005744/en/Analysis-on-Impact-of-COVID-19--Global-Cementless-Total-Knee-Arthroplasty-TKA-Market-2020-2024-Evolving-Opportunities-with-B.-Braun-Melsungen-AG-and-Corin-Group-Plc-Technavio, last accessed 14 November 2020

29 Fitzpatrick, C.K., Clary, C.W., Rullkoetter, P.J. (2012b, February). The influence of design on TKR mechanics during activities of daily living. ORS Annual Meeting, Poster #2034

30 Clary, C.W., Fitzpatrick, C.K., Maletsky, L.P., Rullkoetter, P.J. (2012a, February). Improving dynamic mid-stance stability: an experimental and finite element study. ORS Annual Meeting, Poster #1044

31 Clary, C.W., Fitzpatrick, C.K., Maletsky, L.P., Rullkoetter, P.J. (2013). The influence of total knee arthroplasty geometry on mid-flexion stability: an experimental and finite element study. Journal of Biomechanics, 46: 1351-1357

32 Napier, R.J., et al., A prospective evaluation of a largely cementless total knee arthroplasty cohort without patellar resurfacing: 10-year outcomes and survivorship. BMC Musculoskelet Disord, 2018. 19(1): p. 205

33 Sharkey, Peter F., et al. “Why are total knee arthroplasties failing today—has anything changed after 10 years?” The Journal of arthroplasty 29.9 (2014): 1774-1778

 

Disclosure: Mr James is a royalty bearing design surgeon for the ATTUNE Knee System and the ATTUNE Revision Knee System.

 

ᵻᵻ Surgical Process Institute:

  • The Surgical Procedure Manager v2.0 or higher (the “Software”) is placed on the market by Surgical Process Institute Deutschland GmbH (“SPI”).
  • The Software is not a medical device. It is for use by (i) medical staff licensed for practice, and (ii) in a hospital setting, (“Authorized Users”).
  • The Software enables Authorized Users to document hospital generic and/or staff-specific process steps for certain medical interventions, such steps as designed and agreed to by the Authorized Users (the “Workflow”).
  • IMPORTANT: Certain workflows used in the Software come with pre-filled steps for implantation of medical devices marketed by the Johnson & Johnson Medical Device Companies (“JJMDC”) in line with the Instructions for Use and/or Surgical Technique Guide of such medical devices. However, those workflows do not Necessarily include all the RELEVANT information FOR SUCH medical devices and do not replace the FULL INFORMATION IN THE instructions FOR USE AND/OR surgical technique guide.  Please refer to https://www.e-ifu.com/  for the full information of the JJMDC medical devices. 
  • Where the Software displays the Workflow as designed and agreed by the Authorized User, SPI assumes no liability for the individual process steps, their accuracy, correctness, completeness or quality of the medical information and content as incorporated in the Software. The Authorized User remains solely responsible and liable towards its patients for the medical intervention carried out while using the Software.

 

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