Participant inclusion All participants will receive oral and written information about the project before consent. Nelissen, Leiden University Medical Center, Total Knee Replacement with Persona PS Knee Prosthesis by Zimmer, Total Knee Replacement with NexGen PS Knee Prosthesis by Zimmer. and Joint Surgery (British) 92-B:1238-44; 2010. Participants are included when signed consent from the participant is obtained. 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. 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. 1961). PDF Zimmer Knee System - Zimmer Biomet Participants are informed about the right to having a dependent present when project information is given. Listing a study does not mean it has been evaluated by the U.S. Federal Government. The Persona Revision Knee System expands the Persona Knee System to Patient outcomes can be driven by the precision and accuracy of each National Joint Replacement Registry. As for the RSA study all consecutive patients ("usual care") are included to prevent selection bias in the migration analysis. 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. In vivo kinematics by means of fluoroscopy. Cup with Spacers, 49 mm. According to the agency, 11,658 devices are affected by the recall. Tibial component: Only cemented tibial components will be used for this study. 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 The Persona OsseoTi Keel Tibia is also complemented with a new cemented implant option to enable seamless versatility for the surgeon during the procedure. right implant options,compatible with stem extension,triple wedge patients arent fully satisfied with the feel of their new knee.1-3. Persona Versus NexGen - Full Text View - ClinicalTrials.gov Participant population in Denmark Study population will consist of 60 participants with knee osteoarthritis set to receive primary total knee arthroplasty. BMC Res Notes. Specifications and prices are subject to change without notification. Prices do not include applicable sales tax or shipping costs. In case only one of the bones has insufficient markers, the patient will be followed for the other bone. This project is financed by Zimmer-Biomet, Warsaw, Indiana, USA. comprehensive femoral sizing scheme on the market. Wiper Size Guide | Wiper Blade Sizes | Wiper Blades USA Zimmer Biomet- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. matters. 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. Persona The Personalized Knee Surgical Technique - Zimmer Biomet TV Persona The Personalized Knee is our solution featuring personalized implants, precise instrumentation, and proven technology. 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. Systems so successful and looked for ways to further enhance those designs.. Overnight delivery orders must be placed by 4:00 p.m. PST. Annually 40 TKA procedures are performed in our department, of which about 70% is Osteo Arthritis (OA) and 30% Reumatoid Arthritis (RA). Patients will be excluded intraoperative if CR implant is not suitable. System, created the foundation for what would become the Persona Knee. The simple one-piece design allows for a single-stage protocol, saving time and resulting in less trauma to soft tissue, and less discomfort for your patients. Both loosening and radiolucent lines are considered signs of early device failure. Non-transparent envelopes are used for the randomization process. 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 Damage to the bones or ligaments surrounding the knee can cause damage to cartilage over time. Eventually parts wear out and need to be replaced, but it is estimated up to 85 percent of artificial knees still work after 20 years. Information provided by (Responsible Party): R.G.H.H. warnings, precautions, potential adverse effects and patient 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. Persona The Personalized Knee is designed to help the surgeon accomplish these goals by combining alignment . Market Strategies International. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. 7d. research tools to study hundreds of knees, creating a global bone The manufacturer, Zimmer, says its recall is voluntary. 1961). needs of each patient with our proven technology. 7h. decisions with each step and provide options for you to personalize The oral information is in accordance with the written information and is adjusted to the age, educational level and social conditions of the participant. to deliver personalized patient care. Femoral component: Only cemented femoral components will be used for this study. 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. Persona | The Personalized Knee by Zimmer Biomet 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. Both standard as well as narrow femoral components will be used, depending on the patient anatomy. Knee Replacement Lawsuit | Loosening Claims & Settlements - Drugwatch.com Men's Belt Size Chart To our belt size guide. Altered pain perception and / or neurologic affection due to diabetes or other disorders. 0 Zimmer Persona Knee Replacement - Haleem Chaudhary, M.D Orthopaedic Surgeon Personal data regarding participants will be treated anonymously. Instrumentation Surgical Technique, Persona The Personalized Knee Clinical Summary, All content herein is protected by copyright, trademarks and other 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. Persona Total Knee System with a CR polyethylene liner. Distribution to any other recipient is prohibited., For product information, including indications, contraindications, Patients with insufficient posterior cruciate ligament (PCL) and other patients unsuited for a CR implant receive a posterior stabilized (LPS) NexGen TKA. Amanda Pedersen | Aug 30, 2021. Participants may be excluded intraoperatively if the PCL is found insufficient and LPS prosthesis is required. (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. Building on a clinically proven legacy,11,12thePersona Failure rate of cemented and uncemented total hip replacements: register study of combined Nordic database of four nations. It is caused when a persons immune system mistakenly attacks his or her own body tissues. percent of painfulTotal Knee Arthroplasty (TKA) Only cemented tibial components will be used for this study. FDA Clears Zimmer Biomet's Smart Knee Implant | mddionline.com Australian Smith & Nephew - 139 recalls. 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. Unlike osteoarthritis, rheumatoid arthritis is an autoimmune disorder. If your measurements fall between two sizes, we recommend to select the larger size (but you may try both sizes on if possible). Information provided by (Responsible Party): Anders Troelsen, Hvidovre University Hospital, Persona Total Knee System with MC polyethylene bearing. cases. -, All Zimmer Dental catalogs and technical brochures, SAFESCRAPER TWIST Cortical Bone Collector, THE CHAIRSIDE ATTACHMENT PROCESSING MATERIAL, Packaging for Zimmer One-Piece Implants, SwissPlus Implant System Product Catalog, Trabecular MetalTM Dental Implant Brochure. right implant options, conventional and Vitamin-E polyethylene options. The primary investigator of this project has independently initiated the project. The Persona Partial Knee carries forward design elements of the Zimmer Miller Galante (M/G) Uni, which showed 98% survivorship at 10 years and 90% at 20 years 1 . Women's US Clothing Size Chart (CM): Patient Reported Outcome Measures by means of questionaires. Persona The Personalized Knee is our solution Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially. Migration, measured by means of RSA. indicate that internal mal-rotation ofimplants may lead to over 50 mmincrements available in standard andnarrow provide the most 32mm, Neutral, O.D. We strive to alleviate pain and improve the quality of life for people around the world. The Oxford Knee Score (OKS) measures knee pain and function. Lancet. A total of 60 participants are to be included at Hvidovre University Hospital. Why Should I Register and Submit Results? most widely used and clinically proven total knee system in the Open the catalog to page 1. The Persona Knee was designed with all these elements in Radiologically verified stability and fixation is measured as the Maximum total point motion (MTPM) using RSA. satisfaction. In doing so, we confirmed that implant shape really matters. In this 2-arm randomized controlled study the primary endpoint is implant migration measured by RSA. 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. postoperatively, we believe a system needs to include implants that face intraoperatively. Makela KT, Eskelinen A, Pulkkinen P, Paavolainen P, Remes V. Total hip arthroplasty for primary osteoarthritis in patients fifty-five years of age or older. Zimmer Biomet or its affiliates unless otherwise indicated, and must The knee is the bodys largest joint. Our legacy continues to come to life today through our progressive culture of evolution and innovation. Joint Replacement | Orthopaedic Devices | Hip | Knee | Shoulder 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 OsseoTiPorous Metal Technology, which uses anatomical data in combination with 3D printing technology to build a structure that directly mimics the architecture of human cancellous or spongey bone. The Zimmer Persona has been the subject of numerous recalls, mostly for unintentional manufacturing defects. analysis project on file at Zimmer Biomet. The study's primary outcome measure is implant migration measured by RSA. 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. comprehensive, and comfortable withrepetitive use. Radiolucent lines, which are tiny cracks between the device and the bone where fluid and debris can get trapped, can also lead to bone loss, a condition called osteolysis. Select variants from the 2016 Swedish National Registry available at Australian Orthopaedic Association Why? compromises inherent with many systems today. facilitating proper rotation andoptimal bone coverage.Studies assemble, so we created a matte finish. Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. 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. 2008 Oct;90(10):2160-70. doi: 10.2106/JBJS.G.00870. No abstract available. The companies with the most recalls have also faced significant numbers of lawsuits: Zimmer - 355 recalls. Project information is given at the first outpatient consultation, when treatment with insertion of a TKA is decided. Total knee replacement operations typically take about 1 to 2 hours but recovery can take several weeks to months. 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. counseling information, see the package insert or contact your local
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