Tapered Screw-Vent Implants - 1.0mm Machined Collar (Model TSV) 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 1mm Machined 1.5mm MTX Surface 1.8mmL Lead (Triple-Lead Thread) MTX Textured Titanium Surface 3mm MTXSurface* 3.7mmD Model TSV Tapered Screw-Vent Implant Dimensions Tapered Screw-Vent Implants - Full Texturing and Crestal Microgrooves (Model TSVT)* 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 4.7mmD Model TSVT Implant 3.9mmD Apex Diameter 6.0mmD Model TSVT Implant 5.2mmD Apex Diameter 0.5mm MTX Surface 1.8mm Microgrooves MTX Surface 1.8mmL Lead (Triple-Lead Thread) 0.36mmL Thread Depth 3.7mmD Model TSVT Implant 3.1mmD Apex Diameter MTX Textured Titanium Surface 4.1mmD Model TSVT Implant Zimmer One-Piece implants 1 Zimmer One-Piece Solutions Engineered to perform as well as the trusted and successful Tapered Screw-Vent Implant, Zimmer One-Piece Implants bring greater simplicity and convenience to the restoration process and deliver the esthetics your patients desire. The Vanguard Knee System offers an entire spectrum of knee stability, including: Two femoral stabilization options: cruciate retaining (CR) and posterior stabilized (PS) Ten femoral sizes Nine tibial sizes Five levels of bearing constraint Complete interchangeability between femoral and tibial components in the event of deep infection leading to replacement of the prosthesis or long-term immobilization because of comorbidity. When osteoarthritis occurs, the cartilage that cushions the bones of the knees softens and wears away, leaving the bones to rub against each other causing stiffness and pain. Participants are informed that a period of consideration of at least 2 weeks is an opportunity along with the right to a second consultation. Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA). Persona The Personalized Knee is our solution featuring personalized implants, precise instrumentation, and proven technology. Our General US Size Chart works with most clothing brands and manufacturers, but maybe not all. options including minimal constraint to full constraint, left and Now its time to listen to his victim. Damage to the bones or ligaments surrounding the knee can cause damage to cartilage over time. The participants will be included at Hvidovre University Hospital, (see participating centers). Within Total knee arthroplasty, design changes are introduced in attempt to improve knee kinematics, improve alignment and functionality, but those potential improvements need to be evaluated Recently, Zimmer-Biomet have introduced Persona Total Knee system with design changes that include asymmetric tibia plate, increased medial pivoting and more extensive choices in respect to poly thickness, all with the purpose to improve balancing, stability and longevity. Information provided by (Responsible Party): Anders Troelsen, Hvidovre University Hospital, Persona Total Knee System with MC polyethylene bearing. Data will also be aggregated and stored electronically. Seemlessly connect, products, services and technologies to elevate In this 2-arm randomized controlled study the primary endpoint is implant migration measured by RSA. Nov. 2022. Why? 2014). +r[k>mio;&;=&+)KwZ]v.=K+X ZAM=\oTs$ngQ%.f%1*Rbe~@"hl93[ 5k. Lancet. 2012). 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. Prices do not include applicable sales tax or shipping costs. An interactive learning environment for enhancing education and training. 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. The project will be reported to the Danish Data Protection Agency. Patient Reported Outcome Measures by means of questionaires. instruments and techniques that allow you to make more informed %%EOF 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. Only cemented femoral components will be used for this study. The storage of data will be done according to the rules posted by the Danish Data Protection Agency. The knee is the bodys largest joint. 0 This may result in knee pain and limited knee function. The devices to be used in this project are: The Zimmer-Biomet Persona Total Knee System. Building on a clinically proven legacy,11,12thePersona Overnight delivery is available, if requested. components with finer increments to helpsurgeonspersonalize the fit Arthritis can be caused by a disease or a traumatic injury. The Zimmer Persona femoral and tibial components are made from Zimmers patented Trabecular Metal technology. 32mm, Neutral, O.D. 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. Thanks to advances in technology and surgical techniques, the majority of knee replacements are successful and provide extensive pain relief to patients. When a persons knee joint becomes severely damaged due to disease or injury, he or she may be a candidate for total knee replacement surgery. increments, standard and narrow, left and rightimplant options,12 Arthritis is characterized by inflammation and stiffness in the joints and can reduce a persons range of motion. (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. Prior surgery on the affected knee that includes osteosynthesis, anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/or collateral ligament surgery. warnings, precautions, potential adverse effects and patient assemble, so we created a matte finish. J Bone Joint Surg Am. Body Measurements Table. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Product Manufactured in and Exported from the U.S.: Radiostereometric analysis (RSA) [TimeFrame:2 years after postoperatively], Radiostereometric analysis (RSA) [TimeFrame:3 months postoperatively], Radiostereometric analysis (RSA) [TimeFrame:1 year postoperatively], Oxford Knee Score (OKS) [TimeFrame:Change from preoperative to 3 months postoperative OKS], Oxford Knee Score (OKS) [TimeFrame:Change from preoperative to 1 year postoperative OKS], Oxford Knee Score (OKS) [TimeFrame:Change from preoperative to 2 years postoperative OKS], Oxford Knee Score - Activity & Participation Questionnaire (OKS-APQ) [TimeFrame:Change from preoperative to 3 months postoperatively], Oxford Knee Score - Activity & Participation Questionnaire (OKS-APQ) [TimeFrame:Change from preoperative to 1 year postoperatively], Oxford Knee Score - Activity & Participation Questionnaire (OKS-APQ) [TimeFrame:Change from preoperative to 2 years postoperatively], EuroQol 5-dimension (EQ-5D) [TimeFrame:Change from preoperative to 3 months postoperatively], EuroQol 5-dimension (EQ-5D) [TimeFrame:Change from preoperative to 1 year postoperatively], EuroQol 5-dimension (EQ-5D) [TimeFrame:Change from preoperative to 2 years postoperatively], Forgotten Joint Score (FJS) [TimeFrame:Change from preoperative to 3 months postoperatively], Forgotten Joint Score (FJS) [TimeFrame:Change from preoperative to 1 year postoperatively], Forgotten Joint Score (FJS) [TimeFrame:Change from preoperative to 2 year postoperatively], Dynamic RSA [TimeFrame:1 year postoperatively], Radiolucency / osteolysis [TimeFrame:immediate postoperatively and 1 and 2 years postoperatively], Adverse Events [TimeFrame:Through study completion, up to 2 years postoperatively], Clinical and radiological osteoarthritis of the knee set to receive a primary unilateral total knee replacement, Participants must be able to speak and understand Danish, Participants must be able to give informed consent and be cognitively intact, Participants must be able to complete all post-operative controls, Participants must not have severe comorbidities, American Society of Anesthesiologists Physical Status Classification System (ASA) score 3, Clinically suitable to receive a Cruciate Retaining (CR) implant (no severe deformity and/or ligament instability). Personal data regarding participants will be treated anonymously. Fit really matters. 384 0 obj <> endobj With 90+ years of trusted leadership and proven expertise, Zimmer Biomet is positioned to deliver the highest quality solutions to patients and providers. Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. Combine these enhancements with a full continuum of bearing Annual Report. Trabecular MetalMaterial, Predecessor to the Persona System, the NexGen Knee System is the the native tibia as possible. Open the catalog to page 1. ~(uw?Wv(y!!5MQTn%QcxM~ This will insure sufficient statistical power despite intraoperative exclusion and dropout of 40% at last follow-up and . Did you have to sacrifice stability for fit? if improved, would help restore a more natural feeling knee and The specific component involved in the recall was called a Trabecular Metal Tibial Plate. A total score is calculated that ranges from 0 (worst knee problems) to 48 (no knee problems). 2 Femur Exposure SECTION2 . A vision requires leadership to become reality. This project is financed by Zimmer-Biomet, Warsaw, Indiana, USA. With over 15 years and over 3 million implantations worldwide, Triathlon has a long clinical history. fit better and instruments designed for ease of use, without the 2008 Oct;90(10):2160-70. doi: 10.2106/JBJS.G.00870. wanted you to have instruments that feel good in your hand after In doing so, we confirmed that implant shape really matters. 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. Altered pain perception and / or neurologic affection due to diabetes or other disorders. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. You have reached the maximum number of saved studies (100). To make ordering easier, please have your customer number, the catalog number and the quantity of items you wish to order. A total score is calculated that ranges from 0 (high knee awareness) to 100 (low knee awareness). 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. A new operation. Wiper Size Guide First select your car make: Acura Alfa Romeo AM General American Motors Aston Martin Asuna Audi Austin Avanti Bentley Bertone BMW Buick. Adverse Events including intraoperative complications and revisions at any post-operative time points. The research assistant handling both standard RSA as well as dynamic RSA analysis is also unaware of which prosthesis the participant has received. 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). Participants may be excluded intraoperatively if the PCL is found insufficient and LPS prosthesis is required. Standard treatment Patients who decline to participate in the study as well as patients who are not included or excluded from the study will be treated with a standard Total Knee Arthroplasty (TKA) implant and standard surgical care. In vivo kinematics by means of fluoroscopy. -- New Porous Iteration of Anatomic Keeled Tibia Designed to Deliver Stable Initial and Biological Fixation Together with theClinically ProvenBenefits of the Persona KneeSystem --. Persona Partial Knee has its own clinical results too! 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. An XL is usually equivalent to 1X, and an XXL is like a 2X. iData on file with Zimmer Biomet: The Persona OsseoTi Keel Tibia Provides Strong Initial Fixation. Participant inclusion All participants will receive oral and written information about the project before consent. Therefore such design changes and proposed benefits need to be evaluated in a prospective clinical trail, with focus on patient safety, satisfaction and implant durability. Both MC polyethylene bearing and CR polyethylene bearing will be used in this study. Fit really matters. 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. (Clinical Trial). The theoretic proposed benefit of MC polyethylene bearing is improved kinematics mimicking native knee motion. Zimmer Persona is the brand-name of a total knee replacement system. instrumentation were designed to help you consistently achieve optimal outcomes. In this study 2 x 30 participants are included. We strive to alleviate pain and improve the quality of life for people around the world. Replacement Registry. Talk with your doctor and family members or friends about deciding to join a study. Ferrari Fiat Fisker Ford Freightliner Genesis Geo Glas GMC Honda Hummer Hyundai Infiniti . 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. 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). However, currently no studies exist evaluating outcome following use of MC polyethylene bearing. Why Should I Register and Submit Results? Amanda Pedersen | Aug 30, 2021. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269254. 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. [TimeFrame:2 Years], Knee Prosthesis motion by means of Fluoroscopy. Get to know Zimmer Biomets leadership team. featuring personalized implants, precise instrumentation, and proven technology. The manufacturer, Zimmer, says its recall is voluntary. Zimmer Biomet Persona Total Knee System with CR polyethylene bearing. capabilities and philosophies, precise in itsmeasurements, According to the company, the device is considered the first "smart" knee implant on the market for total knee replacement . This is a type of inflammatory arthritis that occurs when the protective lining of the knee joint, called the synovial membrane, becomes thickened and inflamed. Studies have shown that modern implant designs can potentially improve outcome. Patients will be excluded intraoperative if CR implant is not suitable. Polyethylene materials: Conventional polyethylene will be used for patients >65 years old and Vitamine-E infused poly insert for patients 65 years old. Vivacit-E Vitamin E Highly Crosslinked Polyethylene is designed with needs of each patient with our proven technology. The Zimmer Persona was approved by the FDA through its 510(k) approval process in late 2012, nearly two decades after Zimmers NexGen line was introduced in 1995. Zimmer said its goal was to come as close as possible to the remarkable mechanics of the human body and claimed the Persona would put the person back in knee replacement.. matters. of Primary Total Knee Replacement with Hybrid Fixation. http://myknee.se/en/ (pgs 42-43). Journal of Bone "With an increasing number of surgeons opting for cementless procedures for their patients, we are excited to expand our market-leading Persona Knee portfolio with the Persona OsseoTi Keel Tibia, a versatile and surgeon-centered solution for performing a cementless total knee replacement," said Ivan Tornos, Chief Operating Officer at Zimmer Biomet. Zimmer Biomet or its affiliates unless otherwise indicated, and must While symmetric and asymmetric tibial designs had long Co-authorship is awarded according to the Vancouver rules. "Adding the Persona OsseoTi Keel Tibia to our well-established and clinically proven Persona Knee System allows surgeons to better address the needs of their patients with a comprehensive single system solution for a cementless or cemented application. todays knee replacement systems, studies suggest that one in four The NexGen Complete Knee Solution Legacy Knee Posterior Stabilized (LPS) LPS-Flex Fixed Bearing Knee is designed to accommodate resumption of . Nicoll, D. and Cumulative Percent Revision of Primary Total Knee Replacement with Statistics A professional statistical software package will be used when processing data in this project. decisions with each step and provide options for you to personalize cases. In doing so, we confirmed Instrumentation and technology really matters. A/P sizes. Women's US Clothing Size Chart (CM): It should also be easy for users from outside USA/Canada to determine their US size. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. research tools to study hundreds of knees, creating a global bone All body measurements and statistics of Constance Zimmer, including bra size, cup size, shoe size, height, hips, and weight. Not available in all states. In what steps would you like better information before proceeding? With more medial stability and lateral mobility, the Persona Medial Brief Summary: The NexGen TKR (Zimmer, Warsaw, Indiana, USA) is a proven TKR design that has reported excellent medium and long-term results in clinical studies and in implant registries all around the world. 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. Wear5and Improved strength.6,7, Highly porous material designed to replicate the structure, function 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. "The predicted growth in the prevalence of arthritis in younger, active patients has made cementless total knee arthroplasty an increasingly essential option for surgeons," said Charles Lawrie, M.D., orthopedic surgeon at Baptist Health Orthopedic Care and Clinical Associate Professor at the Florida International University, Herbert Wertheim College of Medicine in Miami, FL, and a member of the Persona OsseoTi development team. Plate JF, Seyler TM, Stroh DA, Issa K, Akbar M, Mont MA. Surgeons have been performing total knee replacements since the late 1960s. The secondary objective is to assess and compare clinical data, kinematics, prosthesis placement and patient reported outcome measures. and physiological properties of cancellous bone8. Participant population in Denmark Study population will consist of 60 participants with knee osteoarthritis set to receive primary total knee arthroplasty. No abstract available. 1961). There is an increasing demand for joint replacement in a younger population (Mkel et al. The NexGen TKR (Zimmer, Warsaw, Indiana, USA) is a proven TKR design that has reported excellent medium and long-term results in clinical studies and in implant registries all around the world. However, currently no studies exist evaluating outcome following use of MC polyethylene bearing. Congruent Bearing is the most kinematic-friendly bearing Zimmer Zimmer Biomet isaglobal medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. Secondary outcomes are: Oxford Knee Score (OKS), Oxford Knee Score -Activity & Participation Questionnaire (APQ), anchoring questions, EQ-5D, Forgotten Joint Score and knee motion measured using dynamic RSA. BMC Res Notes. Total knee replacement can help restore a patients range of motion in the knee joint and substantially cut down on pain caused by the diseased or injured joint. Larger sizes? step within the surgical procedure. 2008). Annual Quickly find individual products and their details. representative; search this website for additional product Trabecular Metal Dental implant, MTX Surface, 0.5mm Machined Collar with Microgrooves includes Fixture Mount/Transfer and Cover Screw. FAQs About Bravelle Is there a reimbursement lawsuit? Those cookies that we do use are designed to permit you to use the site functions and browse our site in the way that is favorable to you. Please remove one or more studies before adding more. A more anatomically accurate implant was identified as one of Participant termination It is recognized that the subject's participation in this study is entirely voluntary, and that she/he may refuse to participate and may withdraw from participation at any time without jeopardy to any future medical care. For general information, Learn About Clinical Studies. Information provided by (Responsible Party): R.G.H.H. a NexGen knee, 1 in 5 knees implanted These complications can include infection and blood clots. Adelaide. Implants also do not last forever. The purpose of the proposed Randomized Clinical Trial (RCT) is to evaluate the outcome and safety of a newly designed polyethylene bearing by comparing it with a control group of patients implanted with an established polyethylene bearing. facilitating proper rotation andoptimal bone coverage.Studies