Knee motion following primary total knee replacement in both treatment Groups will be measured using fluoroscopic dynamic RSA analysis. Clin Orthop Relat Res. As a follow-up of the NexGen TKR, an improved design has recently been introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana, USA) has been used successfully in about 20.000 patients, but results from independent clinical studies have not been reported yet. Our legacy continues to come to life today through our progressive culture of evolution and innovation. Persona The Personalized Knee Surgical Technique. Patients will be excluded intraoperative if CR implant is not suitable. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. The primary investigator of this project has independently initiated the project. r implant implant Diameter Platform Trabecular Metal Dental implant, MTX Surface, Fully Textured with Microgrooves Tapered Screw-Vent implants includes Fixture Mount/Transfer and Cover Screw. Implant shape and fit matter in achieving postoperative patient National Joint Replacement Registry. With more medial stability and lateral mobility, the Persona Medial Congruent Bearing is the most kinematic-friendly bearing Zimmer Biomet has designed. The objective of this study is to accurately assess and compare migration, kinematics, prosthesis placement and patient reported outcomes of two TKR prostheses: the fixed bearing, cemented NexGen LPS, a proven design with an excellent clinical track record, and the fixed bearing, cemented Persona PS, a new design without clinical data (both designs by Zimmer, Warsaw, Indiana, USA). Both standard as well as narrow femoral components will be used, depending on the patient anatomy. In designing the Persona Knee, we identified several Recruitment of participants to this project is expected to begin in October 2016 or as soon as permission from the Regional Ethics Committee and the Danish Data Protections Agency is obtained. instruments and techniques that allow you to make more informed 4027.1-GLBL-en, 345 E. Main St.Warsaw, IN 46580www.zimmerbiomet.com, View original content to download multimedia:https://www.prnewswire.com/news-releases/zimmer-biomet-expands-persona-knee-system-portfolio-with-fda-clearance-of-persona-osseoti-keel-tibia-for-cementless-knee-replacement-301683440.html, https://www.zimmerbiomet.com/en/products-and-solutions/specialties/knee/persona-osseotikeeltibia.html, https://www.prnewswire.com/news-releases/zimmer-biomet-expands-persona-knee-system-portfolio-with-fda-clearance-of-persona-osseoti-keel-tibia-for-cementless-knee-replacement-301683440.html, California Transparency in Supply Chain Act Disclosure. Prices do not include applicable sales tax or shipping costs. Anatomictibiadesign helps prevent mal-rotation while We continued asking ourselves, what issues and decisions do you representative; search this website for additional product satisfaction is to more closely reproduce the original.. We seamlessly transform the patient experience through our innovative products and suite of integrated digital and robotic technologies that leverage data, data analytics and artificial intelligence. Statistics A professional statistical software package will be used when processing data in this project. A/P sizes. 31:32. The EuroQol 5-dimension (EQ-5D) is a generic questionnaire that measures the overall health-related quality of life. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. each procedure. Talk with your doctor and family members or friends about deciding to join a study. Metal Surgical Technique, ZimmerFuZion Instruments Surgical Technique, Persona Trabecular Metal Femoral Component Surgical Technique, Persona Primary Knee: Flexion-First Balancing Surgeons have been performing total knee replacements since the late 1960s. Prosthesis placement and bone resection measured by means of CT and caliper measurements of the resected bone parts. Anyone considering a lawyer should not rely upon advertisements or self-proclaimed expertise, and independently investigate the lawyer's credentials and ability. Total knee replacement surgery is typically performed by an orthopedic surgeon, a doctor that specializes in diseases and injuries of the musculoskeletal system, which includes the bodys bones, muscles, cartilage, ligaments and joints. Quickly find individual products and their details. If a participant is withdrawn or rescinds their consent, a "Lost to Follow-up" case report form will be completed detailing the reason for the participant's withdrawal. 7e. National Injury Help Staff Bios, who we are. Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. Persona The Personalized Knee is our solution WARSAW, Ind., Nov. 21, 2022 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the Persona OsseoTi Keel Tibia for cementless knee replacement. An individual data sheet will be kept for each recruited participant. This project is carried out as a 2-arm randomized controlled single-blinded trial, in which the clinical and radiological outcomes after treatment of hip osteoarthritis with insertion of either 1) Persona Total Knee System with MC polyethylene bearing or 2) Persona Total Knee System with CR polyethylene bearing. Persona Trocar Tipped Drill Pins (2.5 hex) (00-5901-020-00) While symmetric and asymmetric tibial designs had long constraints, and youll see how the Persona Knee System is redefining personalization. Femoral component: Only cemented femoral components will be used for this study. Participants are unaware of which prosthesis they receive and the research coordinator handling the collected questionnaires postoperatively is also unaware of which prosthesis the participant has received. Industrial Design Style, 10A* ODEP rating for CR and PS knees both with and without Activities of daily living take higher priority in this patient group, and patients needing total joint replacement do not have many options that accommodate higher levels of activity. The study's primary outcome measure is implant migration measured by RSA. intraoperative glare from the instruments and make them easier to The Persona Revision Knee System expands the Persona Knee System to While designing the Persona Knee, we used a combination of advanced Overnight delivery orders must be placed . This project will be notified to and approved by the Danish Data Protection Agency before recruitment of participants is initiated. 2 Femur Exposure SECTION2 . patient care with ease and efficiency, Modern tools to help your orthopedic surgery center, Personalizedstrategyandsolutionsfor yourambulatorysurgerycenter. Smith & Nephew - 139 recalls. 409 0 obj <>/Filter/FlateDecode/ID[<4CFFF6002367B97D87B78669E948DEE2><9397F989D1D57E479435879AAB8D2EDD>]/Index[384 41]/Info 383 0 R/Length 119/Prev 680799/Root 385 0 R/Size 425/Type/XRef/W[1 3 1]>>stream Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. Persona Partial Knee has its own clinical results too! This will insure sufficient statistical power despite intraoperative exclusion and dropout of 40% at last follow-up and . A total of 60 participants are to be included at Hvidovre University Hospital. manufactures and markets reconstructive orthopaedic implants, including joint and dental, spinal implants and trauma products, and related Zimmer continues to be a market lead- orthopaedic surgical System Color-Coding Charts, Zimmer Trabecular Metal Dental and Tapered Screw-Vent implants implant Platform Color-Coding The chart below indicates which color corresponds to each Trabecular Metal and Tapered Screw-Vent implants internal hex platform. US Size. right implant options,compatible with stem extension,triple wedge Annually 40 TKA procedures are performed in our department, of which about 70% is Osteo Arthritis (OA) and 30% Reumatoid Arthritis (RA). increments, standard and narrow, left and rightimplant options,12 fit better and instruments designed for ease of use, without the Select variants from the 2016 Swedish National Registry available at The theoretic proposed benefit of MC polyethylene bearing is improved kinematics mimicking native knee motion. Choosing to participate in a study is an important personal decision. It is also recognized that the investigator, at his/her discretion, may withdraw a subject from this study based upon his/her professional judgment, e.g. This type of arthritis occurs after a traumatic knee injury. Participants are included when signed consent from the participant is obtained. %PDF-1.6 % For more information about our product portfolio, our operations in 25+ countries and sales in 100+ countries or about joining our team, visitwww.zimmerbiomet.comor follow Zimmer Biomet on Twitter atwww.twitter.com/zimmerbiomet. provide a portfolio of personalized knee care in order toreplicate a world.7 This, along with the Natural-Knee II Fit really matters. 2014 Jan 13;348:f7592. Allocation of the participants to one of the two treatment groups is done intraoperatively. Talk with your doctor and family members or friends about deciding to join a study. In some cases, it is also necessary to replace the patella (the kneecap) with a plastic component. Non-transparent envelopes are used for the randomization process. Total knee replacement surgery, also called total knee arthroplasty or TKA, is a surgical procedure to replace a diseased or damage knee joint with a prostheses. Most knee pain is caused by three types of arthritis, according to the American Academy of Orthopaedic Surgeons (AAOS), including osteoarthritis, rheumatoid arthritis and post-traumatic arthritis. We do not use cookies for targeted or behavioral advertising on this website. This project is financed by Zimmer-Biomet, Warsaw, Indiana, USA. Patient outcomes can be driven by the precision and accuracy of each 2014). The specific component involved in the recall was called a Trabecular Metal Tibial Plate. The Zimmer-Biomet Persona Total Knee Cruciate-Retaining Femoral Component (CR Femur), used in conjunction with the kinematic alignment surgical technique, has been shown to produce better functional outcomes and improved patient satisfaction following total knee arthroplasty. Restoreligament balance with fivelevels of constraint in 1 mm This field is for validation purposes and should be left unchanged. to be accurate, but we didnt want to stop with just being precise. comprehensive, and comfortable withrepetitive use. Patient Reported Outcome Measures by means of questionaires. Tapered Screw-Vent implants Features/ Benefits Platform Plus Technology Creates favorable conditions for bone-level maintenance1-5 Lead-in Bevel - designed to reduce horizontal stresses better than flat butt-joint connections5'* Friction-Fit Connection - virtually eliminates abutment micromovement associated with screw loosening5 1.5mm Deep Internal Hex - shields the abutment retention screw from excess loading, distributing occlusal forces deep into the implant5 Designed for flexibility A two-stage or single-stage implant system Various coronal configurations including Zimmer Trabecular Metal Implant Dimensions Crestal Options Trabecular Metal Dental Implant 0.5mm Machined 0.5mm MTX Surface 1.8mm Microgrooves, MTXSurface Note: 4.7mmD Trabecular Metal Implant Shown. In this 2-arm randomized controlled study the primary endpoint is implant migration measured by RSA. Please remove one or more studies before adding more. Could we be more bone conserving? For general information, Learn About Clinical Studies. Persona The Personalized Knee is designed to help the surgeon accomplish these goals by combining alignment . 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Specifications and prices are subject to change without notification. patient satisfaction, and long-term survivorship. Now patients many of whom still have the recalled device implanted are filing lawsuits against the devices manufacturer. This study is designed as a single-blind randomized trial between the Persona PS total knee prosthesis and the well-established NexGen total knee prosthesis. Volume 90%. Key features of Persona OsseoTi include an anatomic tibia for less micromotion and optimal bone coverageiand 3D printed, porousOsseoTitechnology for biological fixation. Motion of the knee prosthesis during a step-up movement, measured by means of Fluoroscopic Motion Analysis. While this firm maintains joint responsibility of the content on this website many of these types of cases are referred to other attorneys for principal responsibility. Knee replacement lawsuits claim the devices loosened, became unstable and required revision surgery to correct the problems. 1961). major cause of pain after total knee replacement. How to Order To order, call Zimmer Dental Customer Service between 6:00 a.m. and 4:30 p.m. PST, Monday through Friday, or fax your order to 1 (888) 225-2483. These complications can include infection and blood clots. Project information is given at the first outpatient consultation, when treatment with insertion of a TKA is decided. patient? As a follow-up of the NexGen TKR, an improved design has recently been introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana . Trabecular Metal Dental Implants - Fully Textured with Microgrooves (Model TMT) 3.5mmD Platform with a 2.5mmD Internal Hex 3.5mmD Platform with a 2.5mmD Internal Hex 4.5mmD Platform with a 2.5mmD Internal Hex 5.7mmD Platform with a 3.0mmD Internal Hex 1.8mm Microgrooves, MTXSurface 1.9mmL-3.4mmL Triple-Lead Thread (1.8mmL Lead), MTXSurface * Dimension varies by implant length. Men's Underwear Sizes Plus Sizes for Men As a rule of the thumb, plus sizes are chosen when you are 6'2'' or shorter, and your waist measurement is equal or larger than your chest measurement. A total of 60 participants are to be included at Hvidovre University Hospital. Check the appropriate knee implant size matching chart for .. An interactive learning environment for enhancing education and training. 7g. Trabecular MetalMaterial, Predecessor to the Persona System, the NexGen Knee System is the 7c. According to the agency's database, there were nearly 1,300 recalls on knee replacement systems or components between 2003 and 2019. comprehensive femoral sizing scheme on the market. without the express written consent of Zimmer Biomet. Women's US Clothing Size Chart (CM): Dynamic RSA is performed at 1 year follow-up. It is particularly porous and allows for enhanced bone ingrowth, according to the Zimmer Persona website. 2009 Apr;467(4):979-84. doi: 10.1007/s11999-008-0628-2. The results of this project are also expected presented at national and international orthopedic conventions. Adult Reconstruction and Joint Replacement Service Primary Total Knee Arthroplasty with Zimmer Biomet Persona Personalized Knee System (Cadaveric) Orthopaedic Surgical Videos 15.9K subscribers. Radiographically verified radiolucency / osteolysis. In spite of these high success rates, complaints of early device failure regarding the Zimmer Persona knee replacement system began to pour into the Food and Drug Administration soon after the device was marketed. March 30, 2009. Zimmer Biomet Instrumentation The Zimmer Persona femoral and tibial components are made from Zimmers patented Trabecular Metal technology. Publications The results of this project are expected published in an international medical journal. You have reached the maximum number of saved studies (100). You have reached the maximum number of saved studies (100). Both MC polyethylene bearing and CR polyethylene bearing will be used in this study. Not available in all states. Women's US Clothing Size Chart (CM): It should also be easy for users from outside USA/Canada to determine their US size. Tibial component: Only cemented tibial components will be used for this study. 2012 Oct 5;5:553. doi: 10.1186/1756-0500-5-553. Persona The Personalized Knee is designed to help the surgeon accomplish these goals by combining alignment accuracy with a simple, straight-forward technique. The project is expected to be completed 2 years after recruitment of the last participant (2019). 424 0 obj <>stream A total score is calculated ranging from -0.624 (worst) to 1 (best). Persona The Personalized Knee is our solution featuring personalized implants, precise instrumentation, and proven technology. Of all the knee replacement surgeries performed in the US each year, about 90 percent result in significantly less pain for patients, says the AAOS. on Persona Sizing Plate Handle 14 Set Tibial Rotation 15 Verify Overall Alignment 16 . When there are less than five tibia-bone markers and less than five femur-bone markers visible in the baseline RSA photograph and it will not improve by placing the patient in another position, the patient will be excluded from the study (secondary exclusion criteria). There have been individual cohort studies, indirect comparisons and retrospective studies to test the efficacy of a variety of different total knee replacement devices but there are very few high quality investigations of new paradigms or significant design change. Beginning in March 2015, however, the FDA launched a class II recall of the uncemented version of the Zimmer Persona due to an increase in complaints of loosening and radiolucent lines. More than 11,600 units of the device were affected by the ongoing recall, many of which had already been implanted in patients. decisions with each step and provide options for you to personalize Tapered Screw-Vent Implant System Product Catalog. the native tibia as possible. The research assistant handling both standard RSA as well as dynamic RSA analysis is also unaware of which prosthesis the participant has received. One design change that is introduced is the medial congruent (MC) polyethylene to be used instead of standard cruciate retaining (CR) design. Bearing Specs:1mm increments, cruciate retaining and sacrificing Implants also do not last forever. Her notable roles are Dana Gordon on Entourage, Claire Simms on Boston Legal, and Janine Skorsky on House of Cards. Geerdink CH, Grimm B, Vencken W, Heyligers IC, Tonino AJ. Chronic, severe knee pain can be caused by many factors, the most common of which is arthritis. Why? Please note that not all products are registered or available in every System Color-Coding Charts, Zimmer Trabecular Metal and Tapered Screw-Vent Implants 3 Zimmer Trabecular Metal Dental implants 3 Tapered Screw-Vent implants 3 Zimmer One-Piece implants 9 Zimmer Trabecular Metal and Tapered Screw-Vent Prosthetics 13 Components for impression Transfer 13 Components for Provisional Restorations 14 Components for Cement-Retained Restorations 15 Components for Screw-Retained Restorations 22 Proprietary Platform Plus"Technology 30 AdVent implant Dimensions 32 Components for impression Transfer 33 Components for Cement-Retained GENERAL INFORMATION Zimmer Dental provides a comprehensive portfolio of Zimmer Holdings, Inc. (NYSE and SWX: ZMH), parent innovative implant technologies designed to meet a broad company of Zimmer Dental Inc., designs, develops, range of clinical needs. In doing so, we confirmed that implant shape really matters. Your doctor prescribed this and/or any other medication to treat an underlying medical condition and stopping the use of any prescribed medication without consulting your physician is dangerous. An analysis of the Finnish arthroplasty registry. Complications of the Zimmer Persona as reported by patients and their doctors include: When the Zimmer Persona knee replacement system was introduced to the market, it was extolled by its manufacturer as the most anatomically accurate knee implant ever made. Choosing to participate in a study is an important personal decision. Different sample sizes are used for the different parts of this study: The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for TKR surgery at the Department of Orthopaedics, Leiden University Medical Center. All devises are European Conformity (CE) marked and used as intended by the manufacturer. (IFU) for full prescribing and risk information, please call 1-800-348-2759, press 4 for 411 Technical Support., Quantifying Your Patient Recovery with ZBEdges Persona IQ and the mymobility Care Management Platform, AAOS Las Vegas 03.08.23, Dealers Choice: ORIF vs. Total Hip Replacement AAOS Las Vegas 03.08.23, Zimmer Biomet Announces Fourth Quarter and Full-Year 2022 Financial Results, Zimmer Biomet Announces Webcast and Conference Call of Fourth Quarter 2022 Financial Results, Cemented and cementless total knee arthroplasty, Cruciate retainingand cruciatesacrificing options.