repetitive use. Persona The Personalized Knee Surgical Technique. 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. 31:32. RSA is performed postoperatively and at all outpatient follow-ups. hbbd```b`` q?d,@$/t `qKtDJu%H)^0L\`-`@h d 3012030R wig
A computer-generated random allocation sequence will be used. 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. 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. This will insure sufficient statistical power despite intraoperative exclusion and dropout of 40% at last follow-up and . Dynamic RSA is performed at 1 year follow-up. Zimmer Persona Trabecular Metal Tibial Plate / Persona TM Tibia Number Recall: 11,658 Reason: Increase in complaints of radiolucent lines and loosening. WY: The Wyoming State Bar does not certify any lawyer as a specialist or expert. Complications from knee surgeries do arise, but are considered rare. 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." 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. Cross-linked compared with historical polyethylene in THA: an 8-year clinical study. 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. One design change that is introduced is the medial congruent (MC) polyethylene to be used instead of standard cruciate retaining (CR) design. in the event of deep infection leading to replacement of the prosthesis or long-term immobilization because of comorbidity. In spite of these high success rates, complaints of early device failure regarding the Zimmer Persona knee replacement system began to pour into the Food and Drug Administration soon after the device was marketed. The Persona Knee was designed with all these elements in To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. The results of this project are also expected presented at national and international orthopedic conventions. We also believed that the femoral shape should reflect Persona The Personalized Knee is our solution doi: 10.1136/bmj.f7592. Persona The Personalized Knee is designed to help the surgeon accomplish these goals by combining alignment accuracy with a simple, straight-forward technique. Adelaide.AOA 2016: Table KT9 These components can be made from several different materials. The project is expected to be completed 2 years after recruitment of the last participant (2019). In 2000, the Swiss company recalled thousands of hip implants that had been tainted with a lubricant. 2014 Jan 13;348:f7592. There is an increasing demand for joint replacement in a younger population (Mkel et al. Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. Chronic, severe knee pain can be caused by many factors, the most common of which is arthritis. 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. 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. The primary objective is to assess and compare migration of the two TKR prostheses (Femoral and Tibial component). Persona Partial Knee has its own clinical results too! Migration, measured by means of RSA. The primary investigator of this project has independently initiated the project. Seemlessly connect, products, services and technologies to elevate Catalog excerpts. 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. Partial Knee is redefining personalization in fixed bearing partial Patient has been classified ASA 1 or 2 (for the kinematic analysis) (Meyer Saklad, 1941). 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 . Amanda Pedersen | Aug 30, 2021. 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. The Zimmer Persona femoral and tibial components are made from Zimmers patented Trabecular Metal technology. Tapered Screw-Vent Implant System Product Catalog. The knee is the bodys largest joint. (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. 21distinctfemoralprofiles, with 2 Instrumentation Surgical Technique, Persona The Personalized Knee Clinical Summary, All content herein is protected by copyright, trademarks and other -, 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. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates. BMC Res Notes. We do not use cookies for targeted or behavioral advertising on this website. 2023 Major Media Consulting Inc. | Privacy Policy | All Rights Reserved. Plate JF, Seyler TM, Stroh DA, Issa K, Akbar M, Mont MA. Reason: Some components were labeled as either the incorrect size and/or side (left/right) November 2017. 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. Failure rate of cemented and uncemented total hip replacements: register study of combined Nordic database of four nations. These complications can include infection and blood clots. information.To obtain a copy of the current Instructions for Use Why Should I Register and Submit Results? unmet needs that existed in previous implant designs that we believed, With over 15 years and over 3 million implantations worldwide, Triathlon has a long clinical history. 5.7mmD platform components are compatible with the 5.7mmD platform on AdVent implants. 7g. 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. to predictably improve patient satisfaction is to more closely 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. 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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. options including minimal constraint to full constraint, left and Only cemented tibial components will be used for this study. For general information, Learn About Clinical Studies. manufactures and markets reconstructive orthopaedic implants, including joint and dental, spinal implants and trauma products, and related Zimmer continues to be a market lead- orthopaedic surgical System Color-Coding Charts, Zimmer Trabecular Metal Dental and Tapered Screw-Vent implants implant Platform Color-Coding The chart below indicates which color corresponds to each Trabecular Metal and Tapered Screw-Vent implants internal hex platform. There are different approaches to prosthetic replacement and current practices and designs are often based on limited evidence (Plate et al. DePuy - 346 recalls. Participants are seen on an outpatient basis at 3 months, 1 and 2 years postoperatively. Zimmer Biomet or its affiliates unless otherwise indicated, and must Persona Knee. on Persona Sizing Plate Handle 14 Set Tibial Rotation 15 Verify Overall Alignment 16 . An individual data sheet will be kept for each recruited participant. If the minimally relevant total migration of the prosthesis measured by RSA is set to 0.2 mm then a total of 18 participants must be enrolled in each study group to show a statistically significant difference (95 % confidence, 80 % power). Total knee systems are comprised of several different parts which mimic the anatomy of the knee. 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). 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. Total knee replacement surgery is typically performed by an orthopedic surgeon, a doctor that specializes in diseases and injuries of the musculoskeletal system, which includes the bodys bones, muscles, cartilage, ligaments and joints. and Joint Surgery (British) 92-B:1238-44; 2010. A total score is calculated ranging from -0.624 (worst) to 1 (best). 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. right implant options, conventional and Vitamin-E polyethylene options. Australian Orthopaedic Association National Joint The world has already listened to Sting. intraoperative glare from the instruments and make them easier to Anatomictibiadesign helps prevent mal-rotation while patient care with ease and efficiency, Modern tools to help your orthopedic surgery center, Personalizedstrategyandsolutionsfor yourambulatorysurgerycenter. More than 4.5 million Americans are living with a prosthetic knee implant called a total knee replacement. indicate that internal mal-rotation ofimplants may lead to over 50 These options 2 Femur Exposure SECTION2 . , This material is intended for health care professionals. Market Strategies International. 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. mind, because we believe a way to predictably improve patient 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. Zimmer Biomet isaglobal medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. Persona Total Knee System with a CR polyethylene liner has been used as a standard implant of choice at Hvidovre Hospital since January 2016 for patients suited for a CR implant. Floor Coatings. It incorporates an Overnight delivery is available, if requested. Quickly find individual products and their details. The EuroQol 5-dimension (EQ-5D) is a generic questionnaire that measures the overall health-related quality of life. Persona Instrumentation was designed to be versatilein its Patients with insufficient posterior cruciate ligament (PCL) and other patients unsuited for a CR implant receive a posterior stabilized (LPS) NexGen TKA. 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. Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. Patient outcomes can be driven by the precision and accuracy of each cases. Allocation of the participants to one of the two treatment groups is done intraoperatively. Zimmer Persona implants are manufactured by Zimmer Inc. (now Zimmer Biomet). It is ensured that the participant has understood the content of both the oral and written information before signed consent is given. A plastic spacer is then inserted between the two metal components to create a smooth, frictionless surface. Participant inclusion All participants will receive oral and written information about the project before consent. Our General US Size Chart works with most clothing brands and manufacturers, but maybe not all. Metal Surgical Technique, ZimmerFuZion Instruments Surgical Technique, Persona Trabecular Metal Femoral Component Surgical Technique, Persona Primary Knee: Flexion-First Balancing A class II recall means the probability of death or serious injury is remote but the use of the recalled device may cause temporary or reversible adverse health consequences. satisfaction is to more closely reproduce the original.. and physiological properties of cancellous bone8. Instrumentation and technology really matters. Data recordings Participants in this project are identified with an assigned allocation number. since served a purpose, we wanted an implant that fit as close to 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. This project is financed by Zimmer-Biomet, Warsaw, Indiana, USA. Could we be more bone conserving? It is the responsibility of the primary investigator that the information to the participant is adequate. A/P sizes. 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. Arthritis is characterized by inflammation and stiffness in the joints and can reduce a persons range of motion. Combine these enhancements with a full continuum of bearing without the express written consent of Zimmer Biomet. world.7 This, along with the Natural-Knee II Activities of daily living take higher priority in this patient group, and patients needing total joint replacement do not have many options that accommodate higher levels of activity. A new operation. A total of 60 participants are to be included at Hvidovre University Hospital. 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. Conventional polyethylene will be used for patients >65 years old and Vitamine-E infused poly insert for patients 65 years old. In doing so, we confirmed in the event of deep infection leading to replacement of the prosthesis or long-term immobilization because of comorbidity. A total score is calculated that ranges from 0 (high knee awareness) to 100 (low knee awareness). Pair it with ROSA Knee and the Personalized Alignment technique Please remove one or more studies before adding more. However, currently no studies exist evaluating outcome following use of MC polyethylene bearing. Epoxy Flooring UAE; Floor Coating UAE; Self Leveling Floor Coating; Wood Finishes and Coating; Functional Coatings. Choosing to participate in a study is an important personal decision. 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. Larger sizes? antioxidant protection to help meet long-term performance needsand If your measurements fall between two sizes, we recommend to select the larger size (but you may try both sizes on if possible). 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. Haleem Chaudhary MD Orthopedic Surgeon Cincinnati Ohio. For decades, Zimmer Dental has gained the trust of thousands of clinicians worldwide by helping them to deliver successful patient outcomes. Volume 90%. Both loosening and radiolucent lines are considered signs of early device failure. matters. 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 Arthritis can be caused by a disease or a traumatic injury. The study's primary outcome measure is implant migration measured by RSA. Latest ODEP ratings can be Congruent Bearing is the most kinematic-friendly bearing Zimmer Persona the Personalized Knee Surgical Technique - Zimmer Biomet Data recording Data relevant for this project will be registered in a data sheet. 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). This furthered our understanding of native anatomic shape and Clin Orthop Relat Res. Femur specs:Anatomic design with21 distinct profilesin2mm research tools to study hundreds of knees, creating a global bone 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. March 12, 2015- FDA categorized Zimmer Persona Knee recall as "Class II Recall." Zimmer Persona Knee Reviews. intellectual property rights, as applicable, owned by or licensed to 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 Listing a study does not mean it has been evaluated by the U.S. Federal Government. We continued asking ourselves, what issues and decisions do you In case only one of the bones has insufficient markers, the patient will be followed for the other bone. That is why we also give you Women's General Size Chart with measurements in CM. Prior surgery on the affected knee that includes osteosynthesis, anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/or collateral ligament surgery. Rowley, D. Internal rotational error of the tibial component is a Surgeons have been performing total knee replacements since the late 1960s. Device: Various Zimmer Biomet knee implants packaged in LDPE bags Number Recall: 13,227 . postoperatively, we believe a system needs to include implants that 4027.1-GLBL-en, 345 E. Main St.Warsaw, IN 46580www.zimmerbiomet.com, View original content to download multimedia:https://www.prnewswire.com/news-releases/zimmer-biomet-expands-persona-knee-system-portfolio-with-fda-clearance-of-persona-osseoti-keel-tibia-for-cementless-knee-replacement-301683440.html, https://www.zimmerbiomet.com/en/products-and-solutions/specialties/knee/persona-osseotikeeltibia.html, https://www.prnewswire.com/news-releases/zimmer-biomet-expands-persona-knee-system-portfolio-with-fda-clearance-of-persona-osseoti-keel-tibia-for-cementless-knee-replacement-301683440.html, California Transparency in Supply Chain Act Disclosure. 2023All rights reserved The Zimmer Persona Knee System is no different. DO NOT STOP TAKING THIS MEDICATION OR ANY PRESCRIBED MEDICATION WITHOUT CONSULTING WITH YOUR PHYSICIAN FIRST. While you can expect excellent implant survivorship with many of Knee motion following primary total knee replacement in both treatment Groups will be measured using fluoroscopic dynamic RSA analysis. not be redistributed, duplicated or disclosed, in whole or in part, In vivo kinematics by means of fluoroscopy. The research assistant handling both standard RSA as well as dynamic RSA analysis is also unaware of which prosthesis the participant has received. *Prices are pre-tax. Zimmer Persona Surgical Technique (97-5026-001-00) for the Persona implant family. The oral information is in accordance with the written information and is adjusted to the age, educational level and social conditions of the participant. Adelaide.AOA analysis project on file at Zimmer Biomet. Between 1997 and 2009, the number of knee replacements jumped more than 80%, helping to make total knee replacements one of the most common surgical procedures in the US. Background Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. (Clinical Trial). 0
Rheumatoid arthritis causes painful swelling that can eventually lead to bone loss and joint deformity. 1961 May 27;1(7187):1129-32. doi: 10.1016/s0140-6736(61)92063-3. 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 manufacturer, Zimmer, says its recall is voluntary. certain characteristics. 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 These lawsuits have been consolidated in a multidistrict litigation (MDL) in federal court. 7c. fit better and instruments designed for ease of use, without the You have reached the maximum number of saved studies (100). Overnight delivery orders must be placed . With more medial stability and lateral mobility, the Persona Medial size, we found that the opposite needed to happen we need to match 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. Patients will be excluded intraoperative if CR implant is not suitable. Both standard as well as narrow femoral components will be used, depending on the patient anatomy. Australian Orthopaedic Association Zimmer Biomet Persona Total Knee System with MC polyethylene bearing. 643 Persona Partial Knees were implanted, and two-year results demonstrated: 3 Survivorship at 2 years 98.9% Patient satisfaction Information provided by (Responsible Party): R.G.H.H. 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 Trocar Tipped Drill Pins (2.5 hex) (00-5901-020-00) research tools to study hundreds of knees.