Advanced instrumentation for surgical simplicity

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1 Advanced instrumentation for surgical simplicity *smith&nephew GENESIS II MIS Total Knee Instrumentation

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3 All the benefits of MIS TKA, without radically changing your surgical approach The GENESIS II minimally invasive technique allows you to build on your current approach, using instrumentation specifically designed for the challenges of MIS. So, you are able to move through the adoption phase in steps, gradually reducing the incision and arthrotomy through a series of procedures. GENESIS II Minimally Invasive Instrumentation works with a variety of minimally invasive approaches, including the midvastus, median parapatellar, quad-split, tri-vector and subvastus. With all approaches, the technique emphasizes soft tissue management, lack of intrusion into the quad tendon, preservation of the suprapatellar pouch and lateral displacement of the patella. Mini Midvastus Approach Training designed to shorten the learning curve Minimally invasive cadaver courses enable you to progress in your skills at a comfortable pace. Courses are a combination of lecture, surgical demonstration and cadaver workshops. Conducted by surgeon experts, these training courses are scheduled around low surgeon/cadaver ratios. This ensures that you have the opportunity to interact directly with an experienced surgeon and practice procedures in a no-risk environment. Many surgeons choose to participate in the Visiting Surgeon Program, which allows you to scrub in with the host surgeon, observe and ask questions as live surgery progresses. MIS Surgeon Training Course Instrumentation available in ACF or DCF DCF Valgus Alignment Guide ACF Valgus Alignment Guide

4 GENESIS II: The straightforward approach to MIS At Smith & Nephew, we think that integrating MIS into your surgical practice shouldn t be difficult. That s why we ve taken an evolutionary, not revolutionary, approach to developing a minimally invasive system. In 21, we began developing a MIS TKA approach in conjunction with, and validated by, orthopaedic surgeons. We built on the success of our previous innovations, developing instrumentation that is specifically designed to work well in small incisions, while minimizing the impact on soft tissue. That s why GENESIS II Minimally Invasive Instrumentation offers no clinical compromises and no complicated techniques just an efficient way of incorporating MIS into your practice. Options to accommodate your preference Smith & Nephew knows that there are many approaches to TKA. And the GENESIS II MIS TKA Instrumentation was developed to work with them. ACF or DCF Instrumentation Extra or intramedullary alignment for tibial preparation One-step conversion to Posterior Stabilized DCF sizing guide accommodates anterior or posterior cortex referencing Minimally invasive by design GENESIS II MIS TKA Instrumentation has been specifically designed to perform well in small incisions with less impact on soft tissue. Reduced dimensions and profiles, along with rounded geometry, allow for excellent visualization and precision. Tibial Cutting Block PS Housing Resection Block

5 Published results These retrospective/prospective matched studies of standard total knee patients versus MIS total knee patients show tangible patient benefits in the form of improved clinical outcomes, such as faster return to flexion, less pain, and diminished hospital stay without compromising alignment. Minimally Invasive Total Knee Replacement through a Mini Midvastus Approach: A Comparative Approach A study by Dr. Steven B. Haas of Hospital for Specialty Surgery not only shows a faster early return to flexion through the GENESIS II Minimally Invasive approach, but also a sustained one. This study compared 4 consecutive TKAs using the GENESIS II Minimally Invasive Technique and Instrumentation with an age- and sex-matched cohort of TKAs performed with the standard technique and instrumentation (control). The MIS group achieved motion significantly faster than the control group at four- to six-week and three-month milestones, and improved ROM was sustained by the MIS group at both the six-month and one-year follow-ups (Figs. 1-2). 1 Degrees GENESIS II MIS TKA and Flexion (Figs. 1-2) ROM Post-op 4 to 6 Weeks ROM Post-op 1 Year MIS TKA Control MIS TKA Control Postoperative Knee Society scores were also higher in the MIS group. There was no difference in X-ray alignment. There were neither infections nor extensor mechanism or neurovascular complications. Minimally Invasive Total Knee Replacement through a Mini Midvastus Incision: An Outcome Study Results posted by Dr. Richard S. Laskin of Hospital for Specialty Surgery indicate that the GENESIS II Minimally Invasive Technique helped patients regain flexion more rapidly than the standard TKA technique. 2 This return to flexion began immediately post-op, with MIS groups reaching their functional milestones which would have permitted discharge from the hospital approximately 2% faster than the cohort of standard patients. Furthermore, the MIS patients continued to have greater flexion at six weeks evaluation (Fig. 3). Degrees GENESIS II MIS TKA Daily Flexion Progress (Fig. 3) POD 1 POD 2 POD 3 POD 4 Postoperative Days (POD) Standard Median Parapatellar MIS POD 5 POD 6 Also at six weeks post-op, the change in Knee Score was statistically higher in the MIS group and the average visual analog and total amount of pain medication was lower. The radiographic alignment and position of all the components were normal in both groups. DCF Sizing Guide ACF Sizing Guide DCF Distal Femoral Cutting Block

6 Reproducible results Because the GENESIS II MIS approach has not required a radical change in surgical technique, positive results have not been limited to academic learning centers. Below are just two examples of how orthopaedic surgeons are seeing improved patient outcomes in their daily practices with GENESIS II MIS.* Case study 1 Dr. Mark Snyder, Director, Deaconess Hospital Total Joint Replacement Center, Cincinnati, OH, has collected preliminary results from a prospective study with matched historical controls of GENESIS II MIS versus standard TKA. Among the statistically significant differences in the two groups were: more problem pain (deviation from the standard protocol) for the standard group, a faster return to full activities (work and ADLs with no ambulatory aids) for the MIS group (Fig. 4) and higher patient satisfaction at six weeks for the MIS group, though the groups were not statistically different at six months. However, at a minimum one-year follow-up, 63% of the MIS group was able to squat/kneel/garden, as opposed to 3% of the standard group (Fig. 5). Weeks to Full Activity Return to Full Activities (Fig. 4) (No Ambulatory Aids, Back to Work, Usual ADLs) 14 p< Able to Participate (%) MIS TKA Conventional MIS TKA 18/ Squat/Kneel/Garden (Fig. 5) (At Minimum 1-Year Follow-up) p<.1 63% 3% Conventional 3/1 Case study 2 Dr. Craig Levitz, Chairman of Orthopedic Surgery, South Nassau Communities Hospital, Long Island, NY, has seen dramatic differences in recovery among his MIS patients as compared to those with a traditional total knee replacement since he began doing GENESIS II MIS TKAs in 22. When compared with his traditional TKA patients, MIS patients are far more functional: a smaller percentage of the MIS group go to rehab (Fig. 6) and the average time until return to work for the MIS group is three times shorter than for the standard group (Fig. 7). Dr. Levitz noted that among the 1 standard total knee patients, only 2% of those indicated for bilateral staged TKA came back within two years and the average return time was 1.3 years. Within the MIS group, 93% of those who were indicated for bilateral staged TKA returned for surgery within a year, and the average time for return was 15 weeks. % Participation in Rehab Traditional vs. MIS TKA Rehabilitation (Fig. 6) MIS TKA Traditional TKA Number of Days Post-TKA Return to Work (Fig. 7) MIS TKA Traditional TKA * Anecdotal data, in press. ACF Distal Femoral Cutting Block DCF Femoral A-P Cutting Block ACF Femoral A-P Cutting Block

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8 1 Haas, SB, et al. Minimally Invasive Total Knee Replacement through a Mini Midvastus Approach: A Comparative Approach. Clinical Orthopaedics and Related Research. 1(428):68-73, November 24 2 Laskin, RS et al. Minimally Invasive Total Knee Replacement through a Mini Midvastus Incision: An Outcome Study. Clinical Orthopaedics and Related Research. 1(428):74-8, November 24. Orthopaedics Smith & Nephew, Inc. 145 Brooks Road Memphis, TN USA Telephone: Information: Orders and Inquiries: Trademark of Smith & Nephew. Reg. US Pat. & TM Off. 25 Smith & Nephew, Inc. Printed in USA /5