JOURNEY◊ II AKS implant wear

How long do you want your knee implant to last?

Just like the surfaces of your natural knee joint, friction created when the surfaces of a knee implant rub together can cause these surfaces to wear down over time. This type of implant wear is a leading cause of knee replacement failure.

Conventional wisdom indicates that most knee implants should be expected to last 10 to 15 years before implant wear becomes an issue. At Smith & Nephew, we've always thought we could do better. And since today's more active knee patients are having surgery younger and living longer, we knew we had to do better.1

Enter a remarkable combination of advanced, low-friction materials that addresses implant wear on both surfaces of the implant. This combination, formerly known as VERILAST Technology includes the award-winning OXINIUM◊ Oxidized Zirconium, a ceramicised metal alloy for the femoral side (thigh bone), and a highly "cross-linked" plastic for the tibial side (shin bone). When these two surfaces work together in the joint, they do amazing things:

  • In rigorous lab testing, Smith & Nephew's LEGION◊ CR Knee made with the combination of our OXINIUM Technology and XLPE was subjected to 45 million cycles, or simulated steps. That's equal to around 30 years of physical activity.2
  • The data showed that after 5 million cycles, the LEGION CR Knee made with the combination of our OXINIUM Technology and XLPE showed 98% less wear than did the same knee made using traditional implant materials. And when LEGION CR knee with the combination of our OXINIUM Technology and XLPE kept "walking" out to 45 million cycles, it was again compared to the traditional knee's 5 million cycle data. Even with 40 million more cycles, the LEGION knee with the combination of our OXINIUM Technology and XLPE showed 81% less wear.2-8

So while we cannot say we've eliminated implant failure due to wear, we believe our 20 years of dedicated research is paying off for patients who want to rediscover their active lives.

Important safety notes

Individual results of joint replacement vary. Implants are intended to relieve knee pain and improve function, but may not produce the same feel or function as your original knee. There are potential risks with knee replacement surgery such as loosening, wear and infection that may result in the need for additional surgery. Patients should not perform high impact activities such as running and jumping unless their surgeon tells them that the bone has healed and these activities are acceptable. Early device failure, breakage or loosening may occur if a surgeon's limitations on activity level are not followed.

References

  1. Elena Losina, Ph.D., co-director, Orthopaedic and Arthritis Center for Outcomes Research, Brigham and Women's Hospital, Boston; William J. Robb III, M.D., chairman, Department of Orthopaedic Surgery, NorthShore University Health System, Evanston, Ill; Feb. 10, 2012, presentation, American Academy of Orthopaedic Surgeons, annual meeting, San Francisco.
  2. Testing concluded at 45 million cycles. ISO 14243-3 defines test completion at 5 million cycles.
  3. Goldsmith AA et al., "Comparative study of the activity of the total hip arthroplasty patients and normal subjects". J Arthrop, (16)5:613-619, 2001.
  4. Morbidity and mortality weekly report, 55(40):1089-1092, October 13, 2006.(//www.cdc.gov/mmwr/preview/mmwrhtml/mm5540a2.htm?s_cid=mm5540a2_e. Accessed on October 30, 2009).
  5. Gioe TJ et al., "Knee Arthroplasty in the young patient - Survival in a community registry". Clin Orthop Relat Res, 464:83-87, 2007.
  6. Wallbridge N and Dowson D. "The walking activity of patients with artificial hip joints". Eng Med 11:95, 1982
  7. Wimmer M A et al., "Joint motion and daily activity profile of total knee patients in comparison with the ISO knee wear simulator". Paper 0159, 48th ORS, 2002.
  8. Huddleston J I et al., "How often do patients with high-flex total knee arthroplasty use high flexion?",Clin Orthop Relat Res, 467:1898-1906, 2009.
  9. Naal F D et al., "How active are patients undergoing total joint arthroplasty? A systematic review", Clin Orthop Relat Res, DOI 10.1007/s11999-009-1135-9, published online: 28 October 2009.
  10. R. Papannagari, G. Hines, J. Sprague and M. Morrison, "Long-term wear performance of an advanced bearing knee technology," ISTA, Dubai, UAE, Oct 6-9, 2010.

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References

*Journey II BCS.

  1. Hall, et al. Unicompartmental knee arthroplasty (alias uni-knee): an overview with nursing implications. Orthopaedic Nursing. 2004;23(3):163-171. Accessed April 25, 2019.
    • Based on pre-surgical pain levels in UKA patients.
  2. Mayman DJ, Patel AR, Carroll KM. Hospital related clinical and economic outcomes of a bicruciate knee system in total knee arthroplasty patients. Poster presented at: ISPOR Symposium; May 19-23, 2018; Baltimore, Maryland, USA.
  3. Nodzo SR, Carroll KM, Mayman DJ. The Bicruciate Substituting Knee Design and Initial Experience. Techniques in Orthopaedics. 2018;33(1):37-41
    • Compared to non-JOURNEY II knees; Based on BCS evidence
  4. 1Short-term Range of Motion is Increased after TKA with an asymmetric bicruciatestabilized implant.AcceptedPoster Presentation, AAOS 2018 New Orleans. Kaitlin M. Carroll, Peter K. Sculco, Brian CMichaels,RichardL. Murphy, Seth A, Jerabek, David J. Mayman
  5. 2J Orthop. 2017 Jan 7;14(1):201- 206. doi: 10.1016/j.jor.2016.12.005. eCollection 2017. Bi-cruciate substituting total knee arthroplasty improved medio-lateral instability in mid-flexion range
  6.  In Vivo Kinematic Comparison of a Bicruciate Stabilized Total Knee Arthroplasty and the Normal Knee Using Fluoroscopy Trevor F. Grieco, MS a, *, Adrija Sharma, PhD a, Garett M. Dessinger, BS a, Harold E. Cates, MD b, Richard D. Komistek, PhD. The Journal of Arthroplasty, September 2017
  7. Testing concluded at 45 million cycles, ISO 14242-1 and 14243-3 define test completion at 5 million cycles. The results of laboratory wear simulation testing have not been proven to predict actual joint durability and performance in people. A reduction in wear alone may not result in improved joint durability and performance because other factors, such as bone structure, can affect joint durability and performance and cause medical conditions that may result in the need for additional surgery. These other factors were not studied as part of the testing.
  8. Iriuchishima T, Ryu K. Bicruciate substituting total knee arthroplasty improves stair climbing ability when compared with cruciate-retain or posterior stabilizing total knee arthroplasty. Indian J Orthop. 2019. doi:10.4103/ortho.IJOrtho_392_18.
  9. Smith JR, Picard F, Lonner J, et al. The accuracy of a robotically-controlled freehand sculpting tool for unicondylar knee arthroplasty. Congress of the International Society of Biomechanics. August 4-9, 2013. Natal, Brazil.
  10. Zardiackas, Lyle D., Kraay, Matthew J., Freese, Howard L, editors. Titanium, Niobium, Zirconium, and Tantalum for Medical and Surgical Applications ASTM special technical publication; 1471. Ann Arbor, MI: ASTM, Dec. 2005

Additional claim statements and support regarding Smith+Nephew implants and Robotics-assisted surgery

  • Implants that are built to last
  • LEGION◊CR Knee with VERILAST◊ technology was lab-tested for 45 million cycles (estimating 30 years of wear performance) and showed 81% less wear than similar 5-million cycle cobalt chrome implant.
    • Learn More
      • ISO 14243-3
      • VERILAST knee wear testing and results apply only to the VERILAST LEGION CR Primary Knee System only. Extended lab-testing for other VERILAST knee systems have not been performed. The results of laboratory wear simulation testing have not been proven to predict actual joint durability and performance in people. A reduction in wear alone may not result in improved joint durability and performance because other factors, such as bone structure, can affect joint durability and performance and cause medical conditions that may result in the need for additional surgery. These other factors were not studied as part of the testing.
  • Smith+Nephew implants may offer a more normal feeling knee
    • Based on JOURNEY◊ II BCS knee implant
    • Learn More
      • Verstaete MA, Van Onsem S, Zambianchi F, et al. Multi-centre evaluation of knee kinematics during different activities for anatomic total knee design. Poster presented at: 2nd World Arthroplasty Congress; 19-21 April, 2018; Rome, Italy.
      • Sharma A, Dessinger G, Cates H, Komistesk R. In vivo kinematic comparison for subjects having a bi-cruciate substituting TKA vs the normal knee. Poster presented at: 2nd World Arthroplasty Congress; 19-21 April, 2018; Rome, Italy.
      • Kosse NM, Heesterbeek PJC, Defoort KC, Wymenga AB, van Hellemondt GG. Improved maximal flexion after minor adaptations in implant design bicruciate-substituted total knee arthroplasty. Poster presented at 19th Congress of the European Federation of National Associations of Orthopaedics and Traumatology (EFORT); May 30 – June 1 2018; Barcelona, Spain.
  • 89% of patients were able to take the stairs again after surgery.
    • Based on JOURNEY◊ II BCS knee implant patients
      • Iriuchishima T and Ryu K. Bicruciate substituting total knee arthroplasty improves stair climbing ability when compared with cruciate-retain or posterior stabilizing total knee arthroplasty. Indian J Orthop. 2019. DOI:10.4103/ortho.IJOrtho_392_18
  • A robotics-assisted knee replacement with Smith+Nephew implants may get you back in the game six months sooner than traditional knee replacement surgery
    • Based on UKA patients
      • Canetti R, Batailler C, Bankhead C, Neyret P, Servien E, Lustig S. Faster return to sport after robotic-assisted lateral unicompartmental knee arthroplasty: a comparative study. Arch Orthop Trauma Surg. 2018;138(12):1765-1771
  • Over 90% of patients who had a Smith+Nephew knee replacement surgery returned to work within 6 months.
      • Harris AI, Luo TD, Lang JE, Kopjar B. Short-term safety and effectiveness of a second-generation motion-guided total knee system. Arthroplast Today. 2018;4:240–243. 1
  • Robotics-assisted surgery with Smith+Nephew implants may lead to a faster rehabilitation and shorter recovery time than traditional knee surgery when following your doctor’s recovery plan and physical therapy recommendations.
    • Claim 19 & 20 (PCS REC.015)
  • Due to its improved accuracy, Smith+Nephew robotics-assisted UKA has lower revision rates* compared to conventional techniques
    • Shown in clinical studies with follow-up of up to 5.5 years
      • Batailler C, White N, Ranaldi FM, Neyret P, Servien E, Lustig S. Improved implant position and lower revision rate with robotic-assisted unicompartmental knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2019;27(4):1232-1240.
      • Battenberg AK, Netravali NA, Lonner JH. A novel handheld robotic-assisted system for unicompartmental knee arthroplasty: surgical technique and early survivorship. J Robot Surg. 2019;14(1):55-60.
      • Gregori A. 5 Yr Experience Semi Active Robotic Partial Knee Replacement: The Financial Impact. Poster presented at: SICOT;October, 2018; Montreal, Canada.
  • A study has shown Smith+Nephew robotic technology has demonstrated faster return to sport (4.2 vs 10.5 months) when compared to conventional techniques*
        • *n= 28 (n=11 robotic procedures), p<0.01
          • Canetti R, Batailler C, Bankhead C, Neyret P, Servien E, Lustig S. Faster return to sport after robotic-assisted lateral unicompartmental knee arthroplasty: a comparative study. Arch Orthop Trauma Surg. 2018;138(12):1765-1771
  • Robotics-assisted surgery with Smith+Nephew implants may help patient get discharged sooner
    • Study of UKA patients
      • Sephton BM, et al. EKS Arthroplasty Conference. May 2-3, 2019; Valencia, Spain.
      • Shearman AD, et al. EKS Arthroplasty Conference. May 2-3, 2019; Valencia, Spain.
  • Robotics-assisted surgery with Smith+Nephew implants may provide patients with a smoother recovery
    • Based on JOURNEY II family of implants
      • Mayman DJ, Patel AR, Carroll KM. Hospital Related Clinical and Economic Outcomes of a Bicruciate Knee System in Total Knee Arthroplasty Patients. Poster presented at: ISPOR Symposium; May 19-23, 2018; Baltimore, Maryland, USA.
  • Robotics-assisted surgery with Smith+Nephew implants may help patients regain function faster
      • Shearman AD, et al. EKS Arthroplasty Conference. May 2-3, 2019; Valencia, Spain.

Additional statements and support regarding Knee Replacement

  • More than 90% of people who have knee replacement surgery experience dramatic relief in knee pain and are better able to perform common activities.
    • Based on pre-surgical pain levels
      • American Academy of Orthopaedic Surgeon website, http://orthoinfo.aaos.org/topic.cfm
  • The majority of patients experience profound improvements in their physical activity after having knee replacement surgery.
    • Based on pre-surgical activity levels
      • Brandes M, et. al., “Changes in physical activity and health-related quality of life during the first year after total knee arthroplasty.” Clin Orthop Relat Res. 1991 Dec;(273):151-6. https://www.ncbi.nlm.nih.gov/pubmed/20981812 Accessed Wednesday, April 17, 2019