Implants also do not last forever. Please remove one or more studies before adding more. Cup with Spacers, 49 mm. 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. in the event of deep infection leading to replacement of the prosthesis or long-term immobilization because of comorbidity. The Zimmer Persona femoral and tibial components are made from Zimmers patented Trabecular Metal technology. The project is expected to be completed 2 years after recruitment of the last participant (2019). One design change that is introduced is the medial congruent (MC) polyethylene to be used instead of standard cruciate retaining (CR) design. create ergonomic instrumentation.6 We wanted to reduce for each patient and restore the unique identity of every knee anatomy. Persona The Personalized Knee is our solution Persona Trocar Tipped Drill Pins (2.5 hex) (00-5901-020-00) Talk with your doctor and family members or friends about deciding to join a study. While designing the Persona Knee, we used a combination of advanced research tools to study hundreds of knees, creating a global bone atlas. Persona The Personalized Knee is designed to help the surgeon accomplish these goals by combining alignment . Patient Reported Outcome Measures by means of questionaires. With that, the Persona Anatomic Tibia All sensitive personal data regarding participants will be stored in accordance with guidelines presented by the Personal Data Act. intraoperative glare from the instruments and make them easier to warnings, precautions, potential adverse effects and patient In 2015, Zimmer will be starring as Julia on new TV series Un-Real. Open the catalog to page 1. Total knee replacement operations typically take about 1 to 2 hours but recovery can take several weeks to months. Recruitment is expected completed after a period of 1 year. 7h. 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. since served a purpose, we wanted an implant that fit as close to It is ensured that the participant has understood the content of both the oral and written information before signed consent is given. For more information about the Persona OsseoTi Keel Tibia, visit https://www.zimmerbiomet.com/en/products-and-solutions/specialties/knee/persona-osseotikeeltibia.html. research tools to study hundreds of knees. todays knee replacement systems, studies suggest that one in four For a list and description of some of such risks and uncertainties, see Zimmer Biomet's periodic reports filed with theU.S.Securities and Exchange Commission (SEC). Industrial Design Style, 10A* ODEP rating for CR and PS knees both with and without Anatomically accurate implants designed for optimal fit and function, Precise instrumentation with personalized control, Proven technology built on a legacy of clinical performance. Polyethylene materials: Conventional polyethylene will be used for patients >65 years old and Vitamine-E infused poly insert for patients 65 years old. Trabecular Metal Dental implant, MTX Surface, 0.5mm Machined Collar with Microgrooves includes Fixture Mount/Transfer and Cover Screw. not be redistributed, duplicated or disclosed, in whole or in part, 2009). No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers. These components can be made from several different materials. Personal data regarding participants will be treated anonymously. was designed with all these elements in mind, because we believe a way Persona Total Knee System with a CR polyethylene liner. Rheumatoid arthritis causes painful swelling that can eventually lead to bone loss and joint deformity. Overnight delivery is available, if requested. Adelaide.AOA were designed to help youconsistently achieve optimal Zimmer Persona knee implants are one such device that did not require additional clinical data for approval. The primary investigator of this project has independently initiated the project. 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. Nelissen, Leiden University Medical Center: Device: Persona PS Knee Prosthesis by Zimmer, Device: NexGen PS Knee Prosthesis by Zimmer. The research assistant handling both standard RSA as well as dynamic RSA analysis is also unaware of which prosthesis the participant has received. Tapered Screw-Vent Implant System Product Catalog. Successful total knee arthroplasty depends in part on re-establishment of normal lower extremity alignment, proper implant design and orientation, secure implant fixation, and adequate soft tissue balancing and stability. Australian Orthopaedic Association National Joint Studies have shown that modern implant designs can potentially improve outcome. Overnight delivery is available, if requested. representative; search this website for additional product Improvements in surgical techniques and implant materials have helped make total knee replacements one of the most successful procedures in all of medicine, according to the AAOS. 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. comprehensive femoral sizing scheme on the market. Zimmer Biomet Persona Total Knee System with CR polyethylene bearing. Zimmer Persona implants are manufactured by Zimmer Inc. (now Zimmer Biomet). innovative approach designed to improve intraoperative efficiency, provide a portfolio of personalized knee care in order toreplicate a 2008 Oct;90(10):2160-70. doi: 10.2106/JBJS.G.00870. 2016: Table KT10 Cumulative Percent Revision of Primary Total Knee To make ordering easier, please have your customer number, the catalog number and the quantity of items you wish to order. intellectual property rights, as applicable, owned by or licensed to Data will also be aggregated and stored electronically. The cookie settings on this website are currently set to allow certain types of cookies. PPTX. The lines between traditional medtech and digital healthcare continue to blur, and a perfect example of this trend is Zimmer Biomet's Persona IQ smart knee implant, which is now FDA cleared. 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. 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. Stratification is performed per diagnosis group (OA/RA). NexGen. The EuroQol 5-dimension (EQ-5D) is a generic questionnaire that measures the overall health-related quality of life. most widely used and clinically proven total knee system in the As a follow-up of the NexGen TKR, an improved design has recently been introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana . The lawyers at National Injury Help are currently accepting cases for a Zimmer Persona Knee Implant Lawsuit involving the uncemented Trabecular Metal Tibial Plate component. found at http://www.odep.org.uk. Zimmer Biomet- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. Catalog Number: 8065-546-32 All Lot numbers. List: Every abusive Catholic Church priest, clergy member named in every state in the past year. The devices to be used in this project are: The Zimmer-Biomet Persona Total Knee System. Rowley, D. Internal rotational error of the tibial component is a Building on a clinically proven legacy,11,12thePersona BMJ. patient care with ease and efficiency, Modern tools to help your orthopedic surgery center, Personalizedstrategyandsolutionsfor yourambulatorysurgerycenter. Ourmost comprehensivekneesystem, including anatomically accurate Women's US Clothing Size Chart (CM): The Forgotten Joint Score (FJS) measures the degree of joint awareness. According to the company, the device is considered the first "smart" knee implant on the market for total knee replacement . Choosing to participate in a study is an important personal decision. Participant population in Denmark Study population will consist of 60 participants with knee osteoarthritis set to receive primary total knee arthroplasty. Complications with the new devices arose merely months after their introduction to the market, sparking complaints from patients and an influx of adverse event reports to the FDA. antioxidant protection to help meet long-term performance needsand Zimmer Inc., based in Warsaw, Ind., was founded more than 80 years ago and is now one of the largest orthopedic device companies in the world. As for the RSA study all consecutive patients ("usual care") are included to prevent selection bias in the migration analysis. Arthritis can be caused by a disease or a traumatic injury. The manufacturer, Zimmer, says its recall is voluntary. Arthroscopy with meniscectomy / cartilage surgery / house cleaning is allowed. In case only one of the bones has insufficient markers, the patient will be followed for the other bone. Amanda Pedersen | Aug 30, 2021. Biomet has designed. According to the agency, 11,658 devices are affected by the recall. Australian Orthopaedic Association 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. [TimeFrame:1 Year], Patient is diagnosed with osteoarthritis or rheumatoid arthritis and requiring primary knee arthroplasty. Arthritis is characterized by inflammation and stiffness in the joints and can reduce a persons range of motion. knee design. 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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568123. A nurse is present when the information is given. to patients of different ethnicity, gender, and stature.4-5 Joint Replacement | Orthopaedic Devices | Hip | Knee | Shoulder Patients who received the uncemented device may be eligible for financial compensation in the form of a settlement. Annual 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. "In addition to the spike-keel design, the Persona OsseoTi Keel Tibia offers the added convenience of a new cemented option with the same bone prep as the cementless option so that surgeons can make an intraoperative decision between a cementless or cemented approach based on bone quality and the unique needs of their patient.". Allocation of the participants to one of the two treatment groups is done intraoperatively. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Why Should I Register and Submit Results? world.7 This, along with the Natural-Knee II iData on file with Zimmer Biomet: The Persona OsseoTi Keel Tibia Provides Strong Initial Fixation. In this 2-arm randomized controlled study the primary endpoint is implant migration measured by RSA. Zimmer Persona Trabecular Metal Tibial Plate / Persona TM Tibia Number Recall: 11,658 Reason: Increase in complaints of radiolucent lines and loosening. View this study on Beta.ClinicalTrials.gov. Thanks to advances in technology and surgical techniques, the majority of knee replacements are successful and provide extensive pain relief to patients. 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 . 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. The secondary objective is to assess and compare clinical data, kinematics, prosthesis placement and patient reported outcome measures. was created. Charnley J. Arthroplasty of the hip. US Size. 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. At the end of the project all patient related data are destroyed. Persona The Personalized Knee is our solution featuring personalized implants, precise instrumentation, and proven technology. Complications from knee surgeries do arise, but are considered rare. design locking mechanism, no lock-down screws or through holds, made ofTivaniumAlloy. Recruitment is expected completed after a period of 1.5 year. ~(uw?Wv(y!!5MQTn%QcxM~ Did you have to sacrifice stability for fit? certain characteristics. 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. mmincrements available in standard andnarrow provide the most Seemlessly connect, products, services and technologies to elevate Patients will be excluded intraoperative if CR implant is not suitable. Restoreligament balance with fivelevels of constraint in 1 mm of Primary Total Knee Replacement with Hybrid Fixation. Tibial component: Only cemented tibial components will be used for this study. Fit really matters. Fit really matters. 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. Replacement with Cementless Fixation. DePuy - 346 recalls. Information provided by (Responsible Party): R.G.H.H. Distribution to any other recipient is prohibited., For product information, including indications, contraindications, (Clinical Trial), Migration and Kinematics of the New Persona PS Versus the Proven NexGen LPS Knee - a Randomized Controlled Trial Using Radiostereometric Analysis and Fluoroscopy, 21 Years to 90 Years (Adult, Older Adult), Dep. By addressing those opportunities in the Persona Knee, we believe 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 Failure rate of cemented and uncemented total hip replacements: register study of combined Nordic database of four nations. [TimeFrame:2 Years], Knee Prosthesis motion by means of Fluoroscopy. 31:32. The world has already listened to Sting. Now patients many of whom still have the recalled device implanted are filing lawsuits against the devices manufacturer. Would finer sizing increments help you more closely replace Vivacit-E Vitamin-E Highly Crosslinked Polyethylene If your measurements fall between two sizes, we recommend to select the larger size (but you may try both sizes on if possible). 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. Participant inclusion All participants will receive oral and written information about the project before consent. mind, because we believe a way to predictably improve patient Prior surgery on the affected knee that includes osteosynthesis, anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/or collateral ligament surgery. Before you decide, ask us to send you free written information about the qualifications and experience of our sponsoring firms. 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