Considering this success rate, it came as a shock when a new-generation knee implant manufactured by one of the largest orthopedic companies in the world was recalled due to device failure merely three years after it was introduced to the market. Patient outcomes can be driven by the precision and accuracy of each Wear5and Improved strength.6,7, Highly porous material designed to replicate the structure, function Keywords provided by R.G.H.H. View this study on Beta.ClinicalTrials.gov. Zimmer Persona Trabecular Metal Tibial Plate / Persona TM Tibia Number Recall: 11,658 Reason: Increase in complaints of radiolucent lines and loosening. We anticipate that inclusion can be accomplished within a 2 year period. 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. Specifications and prices are subject to change without notification. Select variants from the 2016 Swedish National Registry available at Persona Knee. 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. 21distinctfemoralprofiles, with 2 Knee implants, like the Zimmer Persona, are made up of three different components, including the femoral component, the tibial component and a plastic spacer that acts as the menisci. Thanks to advances in technology and surgical techniques, the majority of knee replacements are successful and provide extensive pain relief to patients. The oral information is in accordance with the written information and is adjusted to the age, educational level and social conditions of the participant. * While the implant platform color code for the 4.1mmD Tapered Screw-Vent implant is green, the implant surgical sequence is color-coded white on the surgical kit surface. AOA 2016: Table KT11 Cumulative Percent Revision DePuy - 346 recalls. Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. globally is a NexGen Knee. 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. Prosthesis placement and bone resection measured by means of CT and caliper measurements of the resected bone parts. 2023 Major Media Consulting Inc. | Privacy Policy | All Rights Reserved. See our US Plus Size Chart. Persona Ti-Nidium Femoral Components can be differentiated from CoCr components Weight 0.1310 kg - 0.3933 kg (0.29 lb - 0.87 lb) 0.0681 kg - 0.2031 kg (0.15 lb - 0.45 lb) Persona Tinidium Femoral Components are around 50% of the weight of CoCr Components Sizing Narrow:1-11 Standard: 1-12 Narrow:1-6 Standard: 4-12 Persona Ti-Nidium Implants include 2008). doi: 10.1136/bmj.f7592. The storage of data will be done according to the rules posted by the Danish Data Protection Agency. Zimmer Persona implants are manufactured by Zimmer Inc. (now Zimmer Biomet). Due to the changing demographics of joint replacement, the population of younger patients are seeking options that not only correct their disease or deformity, but do not limit them in activity (Geerdink et al. Femoral component: Only cemented femoral components will be used for this study. Diabetes genital infection lawsuit claims & settlements, Opioid birth defects lawsuit claims & settlements, Opioid Heart Birth Defects Lawsuit Claims & Settlements, Opioid Lawsuit Claims & Settlements | Painkiller Lawsuit Attorneys, Connecticut Opioid Lawsuit Claims & Settlements, Kentucky Opioid Lawsuit Claims & Settlements, Maine Opioid Lawsuit Claims & Settlements, Maryland Opioid Lawsuit Claims & Settlements, Massachusetts Opioid Lawsuit Claims & Settlements, New Hampshire Opioid Lawsuit Claims & Settlements, Rhode Island Opioid Lawsuit Claims & Settlements, West Virginia Opioid Lawsuit Claims & Settlements, Testosterone therapy Lawsuit Claims & Settlements Blood clots, Heart attack, stroke, List of Xarelto Questions Frequently Asked Questions, TDF HIV drug lawsuits for some patients who have experienced kidney disease & bone fractures, Testim Lawsuit Claims & Settlements for Blood clots, Heart attack, Stroke, Uloric Lawsuit Attorneys Claims & Settlements for Uloric, Zinbryta Class Action Lawsuit Claims & Settlements, Zostavax Shingles Vaccine Lawsuit Claims & Settlements, Bard 3DMAX Mesh Lawsuit Claims & Settlements, Bard Sepramesh IP Composite Mesh Lawsuits, Bard Ventralex ST Hernia Patch Lawsuit Claims & Settlements, BHR Hip Implant Lawsuit Claims & Settlements, Biomet Comprehensive Shoulder Implant Lawsuit, Bird/Lime Scooter Accident Injury Lawyers & Attorneys, Chemours GenX Lawsuit Claims & Settlements, DePuy Attune Knee Replacement Lawsuit Claims & Settlements, Essure Removal Doctors & Tubal Reversal Doctors, Essure Lawyers & Attorneys Alameda County CA, Ethicon Physiomesh Lawsuit Claims & Settlements, Hearing Loss 3M Military Earplug Lawsuit Claims & Settlements, Metal Hip Replacement Lawsuit Settlements & Claims 2018, Stryker Hip Replacement Lawsuit Claims & Settlements, Stryker V40 Recall Lawsuit Claims & Settlements, Wright Hip Replacement Lawsuit, Claims & Settlements, Las hermanas-E tienen una agenda apretada de nuevo en Washington, Juez dictamin la creacin de demandas masivas de Essure en California, Demanda de Implante de Hombro Comprehensive de Biomet, Resolucin de Reclamaciones de demanda de Bravelle, Demanda de Parlisis Cerebral, Acuerdos de Demanda, Demanda contra el Implante Anticonceptivo Essure, Demanda de Malla para Reparacin de Hernias C-Qur de Atrium, Demanda de Inhibidores de la Bomba de Protones (PPI), Demanda de Taxotere por prdida de cabello, Demanda de Zofran por Defectos Congnitos, Contact Us today for a FREE, Immediate Case Evaluation. 384 0 obj
<>
endobj
Pre-Surgical & Post-Surgical Patient Insights & Needs As a follow-up of the NexGen TKR, an improved design has recently been introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana . The research assistant handling both standard RSA as well as dynamic RSA analysis is also unaware of which prosthesis the participant has received, A Prospective Randomized Control Study on CR vs MC Polyethylene Bearing With Persona Total Knee System in Total Knee Arthroplasty, Active Comparator: CR polyethylene bearing, 18 Years and older (Adult, Older Adult), Anders Troelsen, Professor, Hvidovre University Hospital. Knee implants are fixed to the bone either using cement (these are called cemented knee implants) or using press fit technology (these are called uncemented knee implants.) Project design Project type 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. Report. Pair it with ROSA Knee and the Personalized Alignment technique to deliver personalized patient care. Quickly find individual products and their details. The Zimmer Persona was approved by the FDA through its 510(k) approval process in late 2012, nearly two decades after Zimmer's 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." 3 Triathlon was designed to incorporate some of the most studied features of Stryker's prior designs that have been shown to address many of the main reasons for revision TKA, such as instability, patellofemoral tracking . , This material is intended for health care professionals. Cadillac Checker Chevrolet Chrysler Citroen Coda Daewoo Daihatsu DeLorean DeSoto Dodge Eagle Edsel. iData on file with Zimmer Biomet: The Persona OsseoTi Keel Tibia Provides Strong Initial Fixation. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. repetitive use. to be accurate, but we didnt want to stop with just being precise. We took the elements that made the NexGen Knee and Natural-Knee II A plastic spacer is then inserted between the two metal components to create a smooth, frictionless surface. The manufacturer, Zimmer, says its recall is voluntary. satisfaction is to more closely reproduce the original.. Information provided by (Responsible Party): R.G.H.H. Ongoing research and development programs for knee replacement are increasingly taking account of the needs of the changing characteristics of the late stage OA knee population. 424 0 obj
<>stream
Those studies that do exist have usually been undertaken to address a combination of design changes and many involve only short-term assessments (Mkel et al. Haleem Chaudhary MD Orthopedic Surgeon Cincinnati Ohio. facilitating proper rotation andoptimal bone coverage.Studies This site does not provide legal advice. 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. 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. US Size. A nurse is present when the information is given. Zimmer Persona is the brand-name of a total knee replacement system. 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 . 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. the implant to the shape and size of the resected bone. Floor Coatings. This project is carried out as a 2-arm randomized controlled single-blinded trial, in which the clinical and radiological outcomes after treatment of knee osteoarthritis with insertion of either 1) Persona Total Knee System with MC polyethylene bearing or 2) Persona Total Knee System with CR polyethylene bearing are compared. The research assistant handling both standard RSA as well as dynamic RSA analysis is also unaware of which prosthesis the participant has received. 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. Open the catalog to page 1. in the event of deep infection leading to replacement of the prosthesis or long-term immobilization because of comorbidity. those needs. intellectual property rights, as applicable, owned by or licensed to Persona The Personalized Knee Surgical Technique, Persona Kinematically Aligned Total Knee Arthroplasty Conventional polyethylene will be used for patients >65 years old and Vitamine-E infused poly insert for patients 65 years old. Nelissen, Prof. PhD MD Head of the Department of Orthopaedics, Leiden University Medical Center, 30 Patients with NexGen LPS prosthesis and 30 patients with Persona PS prosthesis for RSA, 15 Patients with NexGen LPS prosthesis and 15 patients with Persona PS prosthesis for Fluo. It is made up of the lower end of the thighbone (femur), the upper end of the shinbone (tibia) and the kneecap (patella). 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