Persona The Personalized Knee is our solution featuring personalized implants, precise instrumentation, and proven technology. Zimmer Biomet isaglobal medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. 2009). Talk with your doctor and family members or friends about deciding to join a study. 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. Annual 2 Femur Exposure SECTION2 . Epub 2008 Nov 22. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. This project will be notified to and approved by the Danish Data Protection Agency before recruitment of participants is initiated. The patients will be followed for survival through The Danish Knee Arthroplasty Registry. in the event of deep infection leading to replacement of the prosthesis or long-term immobilization because of comorbidity. These options found within the Persona Knee Systems step within the surgical procedure. Prior surgery on the affected knee that includes osteosynthesis, anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/or collateral ligament surgery. 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. Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. comprehensive femoral sizing scheme on the market. Zimmer Nexgen Sizing Chart Software Crack Registration Free Pc Exe Adelaide.AOA Total knee systems are comprised of several different parts which mimic the anatomy of the knee. It incorporates an 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. Women's US Size Chart 32mm, Neutral, O.D. Trabecular MetalMaterial, Predecessor to the Persona System, the NexGen Knee System is the 2016: Table KT10 Cumulative Percent Revision of Primary Total Knee This type of arthritis is caused by wear and tear on the joints and usually occurs in people over the age of 50. 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. Participants are informed about the right to having a dependent present when project information is given. wanted you to have instruments that feel good in your hand after 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.) Instrumentation and technology really Now patients many of whom still have the recalled device implanted are filing lawsuits against the devices manufacturer. The 2015 Zimmer Persona knee implant recall was classified as class II by the FDA. Primary Total Knee Arthroplasty with Zimmer Biomet Persona 0 EMBASE search: NexGen AND The primary investigator of this project has independently initiated the project. 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. Studies have shown that modern implant designs can potentially improve outcome. It is the responsibility of the primary investigator that the information to the participant is adequate. Congruent Bearing is the most kinematic-friendly bearing Zimmer 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. In designing the Persona Knee, we identified several 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. The Persona Revision Knee System expands the Persona Knee System to Persona The Personalized Knee is designed to help the surgeon accomplish these goals by combining alignment . The objective of this study is to accurately assess and compare migration, kinematics, prosthesis placement and patient reported outcomes of two TKR prostheses: the fixed bearing, cemented NexGen LPS, a proven design with an excellent clinical track record, and the fixed bearing, cemented Persona PS, a new design without clinical data (both designs by Zimmer, Warsaw, Indiana, USA). With that, the Persona Anatomic Tibia 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. patient care with ease and efficiency, Modern tools to help your orthopedic surgery center, Personalizedstrategyandsolutionsfor yourambulatorysurgerycenter. We're proud to close out the year with another advancement in our portfolio, thanks to the strong execution of our team members and our commitment to fueling growth with innovation.". todays knee replacement systems, studies suggest that one in four Reason: Some components were labeled as either the incorrect size and/or side (left/right) November 2017. March 12, 2015- FDA categorized Zimmer Persona Knee recall as "Class II Recall." Zimmer Persona Knee Reviews. Therefore new implants are introduced to the marked with the theoretical benefit of improved implant survival and superior patient reported outcomes. Instrumentation Surgical Technique, Persona The Personalized Knee Clinical Summary, All content herein is protected by copyright, trademarks and other So we studied the shapes and sizes of the hand to According to the agency, 11,658 devices are affected by the recall. 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). 00:00. 7b. 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. A Comparison of Total Knee Replacement Patients Using the Zimmer-Biomet to deliver personalized patient care. Metal Surgical Technique, ZimmerFuZion Instruments Surgical Technique, Persona Trabecular Metal Femoral Component Surgical Technique, Persona Primary Knee: Flexion-First Balancing You have reached the maximum number of saved studies (100). 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. 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. View this study on Beta.ClinicalTrials.gov. AOA 2016: Table KT11 Cumulative Percent Revision System, created the foundation for what would become the Persona Knee. Zimmer Persona Trabecular Metal Tibial Plate / Persona TM Tibia Number Recall: 11,658 Reason: Increase in complaints of radiolucent lines and loosening. hbbd```b`` q?d,@$/t `qKtDJu%H)^0L\`-`@h d 3012030R wig The project is expected to be completed 2 years after recruitment of the last participant (2019). The world has already listened to Sting. Patient Reported Outcome Measures by means of questionaires. Femur specs:Anatomic design with21 distinct profilesin2mm Report. 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. 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. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. 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. Participants may be excluded intraoperatively if the PCL is found insufficient and LPS prosthesis is required. Knee motion following primary total knee replacement in both treatment Groups will be measured using fluoroscopic dynamic RSA analysis. This may result in knee pain and limited knee function. Tapered Screw-Vent Implant System Product Catalog. By asking these kinds of questions, we were able to design Stratification is performed per diagnosis group (OA/RA). 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. National Injury Help Staff Bios, who we are. 2012). Patients who received the uncemented device may be eligible for financial compensation in the form of a settlement. Haleem Chaudhary MD Orthopedic Surgeon Cincinnati Ohio. The Zimmer-Biomet Persona Total Knee System is a novel total knee system developed by Zimmer-Biomet. Annual Report. The power calculation is based on reaching sufficient power when a comparison of the two study groups is carried out. 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Orthopaedics, Leiden University Medical Center, R.G.H.H. The settlement averaged $200,000 per patient. Only cemented tibial components will be used for this study. There are different approaches to prosthetic replacement and current practices and designs are often based on limited evidence (Plate et al. In 2015, Zimmer will be starring as Julia on new TV series Un-Real. 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 . 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. 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. Floor Coatings. In vivo kinematics by means of fluoroscopy. Clin Orthop Relat Res. (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. Partial Knee is redefining personalization in fixed bearing partial innovative approach designed to improve intraoperative efficiency, 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. These components can be made from several different materials. compromises inherent with many systems today. reproduce the original. National Joint Replacement Registry. With more medial stability and lateral mobility, the Persona Medial A total score is calculated that ranges from 0 (high knee awareness) to 100 (low knee awareness). 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 Pre-Surgical & Post-Surgical Patient Insights & Needs See our US Plus Size Chart. Body Measurements Table. 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). It is ensured that the participant has understood the content of both the oral and written information before signed consent is given. 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. and physiological properties of cancellous bone8. The study's primary outcome measure is implant migration measured by RSA. Overnight delivery orders must be placed by 4:00 p.m. PST. While you can expect excellent implant survivorship with many of of Primary Total Knee Replacement with Hybrid Fixation. zimmer persona size chart That is why we also give you Women's General Size Chart with measurements in CM. http://myknee.se/en/ (pgs 42-43). What was the ethnicity and gender of the Why Should I Register and Submit Results? We continued asking ourselves, what issues and decisions do you Participant termination 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. The Persona Knee System gives you the ability to address the unique 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. The Zimmer Persona has been the subject of numerous recalls, mostly for unintentional manufacturing defects. 2023 Major Media Consulting Inc. | Privacy Policy | All Rights Reserved. 2014). fit better and instruments designed for ease of use, without the Zimmer Persona knee implants are available as both cemented and uncemented implants. In doing so, we confirmed that implant shape really matters. 424 0 obj <>stream Latest ODEP ratings can be 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. For more information about our product portfolio, our operations in 25+ countries and sales in 100+ countries or about joining our team, visitwww.zimmerbiomet.comor follow Zimmer Biomet on Twitter atwww.twitter.com/zimmerbiomet. Patients with insufficient posterior cruciate ligament (PCL) and other patients unsuited for a CR implant receive a posterior stabilized (LPS) NexGen TKA. Participants will receive oral and written information concerning the handling of sensitive personal data. No abstract available. Allocation of the participants to one of the two treatment groups is done intraoperatively. In case only one of the bones has insufficient markers, the patient will be followed for the other bone. intellectual property rights, as applicable, owned by or licensed to Anyone considering a lawyer should not rely upon advertisements or self-proclaimed expertise, and independently investigate the lawyer's credentials and ability. All measurements in inches. The theoretic proposed benefit of MC polyethylene bearing is improved kinematics mimicking native knee motion. 2008). Tapered Screw-Vent implants Features/ Benefits Platform Plus Technology Creates favorable conditions for bone-level maintenance1-5 Lead-in Bevel - designed to reduce horizontal stresses better than flat butt-joint connections5'* Friction-Fit Connection - virtually eliminates abutment micromovement associated with screw loosening5 1.5mm Deep Internal Hex - shields the abutment retention screw from excess loading, distributing occlusal forces deep into the implant5 Designed for flexibility A two-stage or single-stage implant system Various coronal configurations including Zimmer Trabecular Metal Implant Dimensions Crestal Options Trabecular Metal Dental Implant 0.5mm Machined 0.5mm MTX Surface 1.8mm Microgrooves, MTXSurface Note: 4.7mmD Trabecular Metal Implant Shown. 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. 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. Bearing Specs:1mm increments, cruciate retaining and sacrificing the implant to the shape and size of the resected bone. found at http://www.odep.org.uk. By addressing those opportunities in the Persona Knee, we believe capabilities and philosophies, precise in itsmeasurements, The project will be reported to the Danish Data Protection Agency. 643 Persona Partial Knees were implanted, and two-year results demonstrated: 3 Survivorship at 2 years 98.9% Patient satisfaction Radiologically verified stability and fixation is measured as the Maximum total point motion (MTPM) using RSA. Persona Instrumentation was designed to be versatilein its If you are visiting any of our drug pages please note: The FDA approved this medication after it determined that the benefits of the product outweigh the known risks for the intended use. Total knee replacement can help restore a patients range of motion in the knee joint and substantially cut down on pain caused by the diseased or injured joint. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Risk of dislocation using large- vs. small-diameter femoral heads in total hip arthroplasty. Industrial Design Style, 10A* ODEP rating for CR and PS knees both with and without Recruitment is expected completed after a period of 1.5 year. Persona The Personalized Knee Surgical Technique. This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You should expect your instruments counseling information, see the package insert or contact your local Participant population in Denmark Study population will consist of 60 participants with knee osteoarthritis set to receive primary total knee arthroplasty. provide a portfolio of personalized knee care in order toreplicate a Catalog Number: 8065-546-32 All Lot numbers. Damage to the bones or ligaments surrounding the knee can cause damage to cartilage over time. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269254. Your doctor prescribed this and/or any other medication to treat an underlying medical condition and stopping the use of any prescribed medication without consulting your physician is dangerous. It is particularly porous and allows for enhanced bone ingrowth, according to the Zimmer Persona website. WY: The Wyoming State Bar does not certify any lawyer as a specialist or expert. We seamlessly transform the patient experience through our innovative products and suite of integrated digital and robotic technologies that leverage data, data analytics and artificial intelligence. We anticipate that inclusion can be accomplished within a 2 year period. The hiring of a lawyer is a very important decision that should not be based solely upon advertisements. instrumentation were designed to help you consistently achieve optimal outcomes. Wiper Size Guide | Wiper Blade Sizes | Wiper Blades USA Both standard as well as narrow femoral components will be used, depending on the patient anatomy. 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. "Adding the Persona OsseoTi Keel Tibia to our well-established and clinically proven Persona Knee System allows surgeons to better address the needs of their patients with a comprehensive single system solution for a cementless or cemented application. Participants are seen on an outpatient basis at 3 months, 1 and 2 years postoperatively. Number of participants Patients at are randomized to receive either 1) Persona Total Knee System with MC polyethylene bearing or 2) Persona Total Knee System with CR polyethylene bearing. Vivacit-E Vitamin-E Highly Crosslinked Polyethylene to patients of different ethnicity, gender, and stature.4-5 Persona Total Knee System with a CR polyethylene liner. BMC Res Notes. Not available in all states. 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. 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. Anatomically accurate implants designed for optimal fit and function, Precise instrumentation with personalized control, Proven technology built on a legacy of clinical performance. Persona The Personalized Knee is our solution We strive to alleviate pain and improve the quality of life for people around the world. Overnight delivery orders must be placed . Adelaide. Vanguard Knee System | Total Knee Arthroplasty | Zimmer Biomet 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. Larger sizes? In the 1990s, Zimmer introduced a line of total knee replacement devices, called NexGen, which helped pave the way for newer versions of its prosthetics that did not require clinical data for FDA approval. We With over 15 years and over 3 million implantations worldwide, Triathlon has a long clinical history. those needs. An individual data sheet will be kept for each recruited participant. 2014 Jan 13;348:f7592. This material is combined with a keeled design to deliver stable initial and biological fixation. function which allowed us to better match our implant shapes and sizes Choosing to participate in a study is an important personal decision. 384 0 obj <> endobj Zimmer Biomet Persona Total Knee System with CR polyethylene bearing. More than a thousand lawsuits were filed against Zimmer Inc. in recent years over its NexGen knee implant. Wear5and Improved strength.6,7, Highly porous material designed to replicate the structure, function
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