Overnight delivery orders must be placed . Zimmer, Inc. 1800 West Center Street Warsaw, Indiana 46580USA. A/P sizes. Australian Size of the component: Intercondylar width of the component (mm) Distance from the anterior femoral osteotomy phase to the open box anterior edge of the component (mm) Senko Medical (Tokyo, Japan) Quest CR: 1-5: 15-18.6: 18.9-24.7: Smith & Nephew (Memphis, TN) Genesis II CR: 1-8: 16.5-19: 16-19.9 Genesis II PS: 1-6: 16.5: 11-23 424 0 obj <>stream Components are available in numerous designs for both systems, with cemented as well as cementless fixations and with numerous polyethylene inserts to accommodate the surgical demand based on patient characteristics. Persona OsseoTi is the latest addition to the clinically proven Persona Knee System, and features a new porous version of the Persona anatomic tibia with Zimmer Biomet's OsseoTi Porous Metal Technology, which uses anatomical data in combination with 3D printing technology to build a structure that directly mimics the architecture of human . Trabecular Metal Dental implant, MTX Surface, 0.5mm Machined Collar with Microgrooves includes Fixture Mount/Transfer and Cover Screw. Epoxy Flooring UAE; Floor Coating UAE; Self Leveling Floor Coating; Wood Finishes and Coating; Functional Coatings. assemble, so we created a matte finish. 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. The project is expected to be completed 2 years after recruitment of the last participant (2019). increments, standard and narrow, left and rightimplant options,12 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. As a follow-up of the NexGen TKR, an improved design has recently been introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana . DO NOT STOP TAKING THIS MEDICATION OR ANY PRESCRIBED MEDICATION WITHOUT CONSULTING WITH YOUR PHYSICIAN FIRST. The world has already listened to Sting. View this study on Beta.ClinicalTrials.gov, 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. Charnley J. Arthroplasty of the hip. to be accurate, but we didnt want to stop with just being precise. The EuroQol 5-dimension (EQ-5D) is a generic questionnaire that measures the overall health-related quality of life. Adverse Events including intraoperative complications and revisions at any post-operative time points. Chronic, severe knee pain can be caused by many factors, the most common of which is arthritis. 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. Depuy Attune, Zimmer NexGen and Arthrex iBalance are among the knee implants named in lawsuits. Both loosening and radiolucent lines are considered signs of early device failure. [TimeFrame:1 Year], Patient is diagnosed with osteoarthritis or rheumatoid arthritis and requiring primary knee arthroplasty. Our legacy continues to come to life today through our progressive culture of evolution and innovation. the implant to the shape and size of the resected bone. 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. NexGen. intellectual property rights, as applicable, owned by or licensed to Nicoll, D. and The patient is unable or unwilling to sign the Informed Consent specific to this study, Insufficient Dutch or English language skills, Patients indicated for revision arthroplasty. Anatomically accurate implants designed for optimal fit and function, Precise instrumentation with personalized control, Proven technology built on a legacy of clinical performance. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Zimmer One-Piece implants feature: One-piece construction, eliminating micromovement and maximizing strength An integral, pre-contoured abutment, Zimmer One-Piece Implant Dimensions Zimmer One-Piece Implants 3.5mmD Emergence Profile with External Driving Flats 5.75mm Buccal/Labial Abutment Height 1.2mm Cuff Height 4.25mm Lingual Abutment Height 0.5mm Machined 1.2mmLLead (Triple-Lead Thread) MTX Textured Titanium surface 3.0mmD Zimmer One-Piece Implant (Straight Shown) 2.4mmD Apex Diameter. The participants will be included at Hvidovre University Hospital, (see participating centers). Surgical Technique, Persona Constrained Posterior Stabilized (CPS) Surgical Technique, Adjustable Distal Resection System Surgical Technique, Persona The Personalized Knee Brochure, Persona Medial Congruent Bearing System Overview, Persona The Personalized Knee Design Rationale, Fixed Distal Resection System Surgical Technique, Persona 14mm x 30mm Stem Extension Surgical Technique, Persona The Personalized Knee Trabecular Would finer sizing increments help you more closely replace 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. 2012). These options System, created the foundation for what would become the Persona Knee. Implant shape and fit matter in achieving postoperative patient Listing a study does not mean it has been evaluated by the U.S. Federal Government. mind, because we believe a way to predictably improve patient Arthritis is characterized by inflammation and stiffness in the joints and can reduce a persons range of motion. We also believed that the femoral shape should reflect "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. Industrial Design Style, 10A* ODEP rating for CR and PS knees both with and without We do not use cookies for targeted or behavioral advertising on this website. However, currently no studies exist evaluating outcome following use of MC polyethylene bearing. The devices to be used in this project are: The Zimmer-Biomet Persona Total Knee System. 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While designing the Persona Knee, we used a combination of advanced research tools to study hundreds of knees, creating a global bone atlas. By asking these kinds of questions, we were able to design You will need the Adobe Reader to view and print these documents. Readers of this news release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate. Radiologically verified stability and fixation is measured as the Maximum total point motion (MTPM) using RSA. Declaration For California Compliance Law, Zimmer Biomet Bone Healing Technologies Notice of Privacy Practices. 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). Zimmer Persona knee implants are available as both cemented and uncemented implants. Cup with Spacers, 49 mm. repetitive use. This material is combined with a keeled design to deliver stable initial and biological fixation. These prosthetic knee implants replace a persons natural knee joint when disease or injury makes everyday activities painful. Trabecular MetalMaterial, Predecessor to the Persona System, the NexGen Knee System is the General Health: EuroQol 5 Dimensional (EQ-5D) Health Questionnaire measured using patient questionnaire, Knee Function: Knee injury and Osteoarthritis Outcome Score (KOOS) measured using patient questionnaire, Pain score after activity and during rest; (Likert scale 0-10). While designing the Persona Knee, we used a combination of advanced Listing a study does not mean it has been evaluated by the U.S. Federal Government. comprehensive, and comfortable withrepetitive use. This project will be notified to and approved by the Danish Data Protection Agency before recruitment of participants is initiated. Select variants from the 2016 Swedish National Registry available at An add-on to the Oxford Knee Score will evaluate the patients activity and participation restrictions due to their knee problem. Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. Zimmer Persona Trabecular Metal Tibial Plate / Persona TM Tibia Number Recall: 11,658 Reason: Increase in complaints of radiolucent lines and loosening. 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. The specific component involved in the recall was called a Trabecular Metal Tibial Plate. Annual Participants may be excluded intraoperatively if the PCL is found insufficient and LPS prosthesis is required. Only cemented tibial components will be used for this study. Women's US Clothing Size Chart (CM): There is an increasing demand for joint replacement in a younger population (Mkel et al. Time schedule 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. 2009). Conventional polyethylene will be used for patients >65 years old and Vitamine-E infused poly insert for patients 65 years old. 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. hbbd```b`` q?d,@$/t `qKtDJu%H)^0L\`-`@h d 3012030R wig Statistics A professional statistical software package will be used when processing data in this project. 31:32. 0 For more information about the Persona OsseoTi Keel Tibia, visit https://www.zimmerbiomet.com/en/products-and-solutions/specialties/knee/persona-osseotikeeltibia.html. Haleem Chaudhary MD Orthopedic Surgeon Cincinnati Ohio. 2023All rights reserved Ourmost comprehensivekneesystem, including anatomically accurate The study's primary outcome measure is implant migration measured by RSA. and Joint Surgery (British) 92-B:1238-44; 2010. instrumentation were designed to help you consistently achieve optimal outcomes. that implant shape really matters. options including minimal constraint to full constraint, left and -- New Porous Iteration of Anatomic Keeled Tibia Designed to Deliver Stable Initial and Biological Fixation Together with theClinically ProvenBenefits of the Persona KneeSystem --. A more anatomically accurate implant was identified as one of function which allowed us to better match our implant shapes and sizes 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. 2023 Major Media Consulting Inc. | Privacy Policy | All Rights Reserved. US Size. 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.. An XL is usually equivalent to 1X, and an XXL is like a 2X. All measurements in inches. 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. The project will be reported to the Danish Data Protection Agency. Specifications and prices are subject to change without notification. Metal Surgical Technique, ZimmerFuZion Instruments Surgical Technique, Persona Trabecular Metal Femoral Component Surgical Technique, Persona Primary Knee: Flexion-First Balancing DePuy - 346 recalls. Personal data regarding participants will be treated anonymously. hb```f``Jc`e``fd@ AFKjKCdV00xIFSCNU({G6
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