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"The predicted growth in the prevalence of arthritis in younger, active patients has made cementless total knee arthroplasty an increasingly essential option for surgeons," said Charles Lawrie, M.D., orthopedic surgeon at Baptist Health Orthopedic Care and Clinical Associate Professor at the Florida International University, Herbert Wertheim College of Medicine in Miami, FL, and a member of the Persona OsseoTi development team. -- New Porous Iteration of Anatomic Keeled Tibia Designed to Deliver Stable Initial and Biological Fixation Together with theClinically ProvenBenefits of the Persona KneeSystem --. The theoretic proposed benefit of MC polyethylene bearing is improved kinematics mimicking native knee motion. Orthopaedics, Leiden University Medical Center, R.G.H.H. 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 Partial Knee is redefining personalization in fixed bearing partial featuring personalized implants, precise instrumentation, and proven technology. 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. 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Revision surgeries to replace failed prosthetic knees are more complicated than initial surgeries and are not always as successful. 2008). 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). An individual data sheet will be kept for each recruited participant. 32mm, Neutral, O.D. Would finer sizing increments help you more closely replace 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. According to the agency, 11,658 devices are affected by the recall. "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. The primary objective is to assess and compare migration of the two TKR prostheses (Femoral and Tibial component). Signed consent, however, is to be given latest at admittance before surgery. Components are available in numerous designs for both systems, with cemented as well as cementless fixations and with numerous polyethylene inserts to accommodate the surgical demand based on patient characteristics. 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. See our US Plus Size Chart. BMJ. Cumulative Percent Revision of Primary Total Knee Replacement with View this study on Beta.ClinicalTrials.gov. Both standard as well as narrow femoral components will be used, depending on the patient anatomy. 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. It is caused when a persons immune system mistakenly attacks his or her own body tissues. In vivo kinematics by means of fluoroscopy. not be redistributed, duplicated or disclosed, in whole or in part, 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. Seemlessly connect, products, services and technologies to elevate Persona Trocar Tipped Drill Pins (2.5 hex) (00-5901-020-00) Damage to the bones or ligaments surrounding the knee can cause damage to cartilage over time. 2 Femur Exposure SECTION2 . We also believed that the femoral shape should reflect Reason: Some components were labeled as either the incorrect size and/or side (left/right) November 2017. Patient outcomes can be driven by the precision and accuracy of each 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. 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 participants will be included at Hvidovre University Hospital, (see participating centers). The Zimmer Persona Knee System is no different. Both standard as well as narrow femoral components will be used, depending on the patient anatomy. Depuy Attune, Zimmer NexGen and Arthrex iBalance are among the knee implants named in lawsuits. 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. 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). was created. A total of 60 participants are to be included at Hvidovre University Hospital. Read our, ClinicalTrials.gov Identifier: NCT02269254, Interventional 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. Co-authorship is awarded according to the Vancouver rules. Persona The Personalized Knee is our solution Total knee systems are comprised of several different parts which mimic the anatomy of the knee. Adult Reconstruction and Joint Replacement Service Primary Total Knee Arthroplasty with Zimmer Biomet Persona Personalized Knee System (Cadaveric) Orthopaedic Surgical Videos 15.9K subscribers. NationalInjuryHelp.com is owned and managed by Major Media Consulting Inc. located at 4241 Jutland Drive San Diego CA 92117 and is currently sponsored by Forester Haynie 400 North St. Paul Street Suite 700, Dallas, TX 75201 who associates with attorneys throughout the country. Fit really matters. in the event of deep infection leading to replacement of the prosthesis or long-term immobilization because of comorbidity. Implant shape and fit matter in achieving postoperative patient Prices do not include applicable sales tax or shipping costs. The cookie settings on this website are currently set to allow certain types of cookies. A total of 60 participants are to be included at Hvidovre University Hospital. The primary investigator will process all data. Talk with your doctor and family members or friends about deciding to join a study. most widely used and clinically proven total knee system in the Arthroscopy with meniscectomy / cartilage surgery / house cleaning is allowed. Now patients many of whom still have the recalled device implanted are filing lawsuits against the devices manufacturer. Prior surgery on the affected knee that includes osteosynthesis, anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/or collateral ligament surgery. The Oxford Knee Score (OKS) measures knee pain and function. Zimmer Biomet isaglobal medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. However, currently no studies exist evaluating outcome following use of MC polyethylene bearing. 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. Comparative statistics will be used based on the distribution of data. A vision requires leadership to become reality. major cause of pain after total knee replacement. We anticipate that inclusion can be accomplished within a 2 year period. 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. Catalog excerpts. A nurse is present when the information is given. The world has already listened to Sting. Pair it with ROSA Knee and the Personalized Alignment technique Therefore new implants are introduced to the marked with the theoretical benefit of improved implant survival and superior patient reported outcomes. Participants are informed about the right to having a dependent present when project information is given. of Primary Total Knee Replacement with Hybrid Fixation. Tapered Screw-Vent Implant System Product Catalog. While you can expect excellent implant survivorship with many of face intraoperatively. Zimmer, Inc. 1800 West Center Street Warsaw, Indiana 46580USA. The primary investigator of this project has independently initiated the project. So we studied the shapes and sizes of the hand to To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Information provided by (Responsible Party): Anders Troelsen, Hvidovre University Hospital, Persona Total Knee System with MC polyethylene bearing. Joint Replacement | Orthopaedic Devices | Hip | Knee | Shoulder Catalog Number: 8065-546-32 All Lot numbers. 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 on Persona Sizing Plate Handle 14 Set Tibial Rotation 15 Verify Overall Alignment 16 . Participant population in Denmark Study population will consist of 60 participants with knee osteoarthritis set to receive primary total knee arthroplasty. 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 furthered our understanding of native anatomic shape and %%EOF 2014 Jan 13;348:f7592. The theoretic proposed benefit of MC polyethylene bearing is improved kinematics mimicking native knee motion. comprehensive, and comfortable withrepetitive use. PPTX. 2023 Major Media Consulting Inc. | Privacy Policy | All Rights Reserved. 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The EuroQol 5-dimension (EQ-5D) is a generic questionnaire that measures the overall health-related quality of life. 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." With over 15 years and over 3 million implantations worldwide, Triathlon has a long clinical history. Doctors determine whether or not a total knee replacement is necessary based a patients pain and disability, not age or weight. 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. globally is a NexGen Knee. antioxidant protection to help meet long-term performance needsand satisfaction. 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. Prosthesis placement and bone resection measured by means of CT and caliper measurements of the resected bone parts. 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. [TimeFrame:1 Year], Patient is diagnosed with osteoarthritis or rheumatoid arthritis and requiring primary knee arthroplasty. Vivacit-E Vitamin E Highly Crosslinked Polyethylene is designed with Listing a study does not mean it has been evaluated by the U.S. Federal Government. All devises are European Conformity (CE) marked and used as intended by the manufacturer. We do not use cookies for targeted or behavioral advertising on this website. Select variants from the 2016 Swedish National Registry available at 424 0 obj <>stream hbbd```b`` q?d,@$/t `qKtDJu%H)^0L\`-`@h d 3012030R wig Instrumentation Surgical Technique, Persona The Personalized Knee Clinical Summary, All content herein is protected by copyright, trademarks and other DePuy - 346 recalls. a NexGen knee, 1 in 5 knees implanted Surgeons have been performing total knee replacements since the late 1960s. Men's Belt Size Chart To our belt size guide. Risk of dislocation using large- vs. small-diameter femoral heads in total hip arthroplasty. 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. Femur specs:Anatomic design with21 distinct profilesin2mm Before you decide, ask us to send you free written information about the qualifications and experience of our sponsoring firms. 31:32. The Persona Knee was designed with all these elements in Fit really matters. 2016: Table KT10 Cumulative Percent Revision of Primary Total Knee The Persona Revision Knee System expands the Persona Knee System to Most knee pain is caused by three types of arthritis, according to the American Academy of Orthopaedic Surgeons (AAOS), including osteoarthritis, rheumatoid arthritis and post-traumatic arthritis. 2009 Apr;467(4):979-84. doi: 10.1007/s11999-008-0628-2. Distribution to any other recipient is prohibited., For product information, including indications, contraindications, The specific component involved in the recall was called a Trabecular Metal Tibial Plate. Why Should I Register and Submit Results? 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. No abstract available. At the end of the project all patient related data are destroyed. instrumentation were designed to help you consistently achieve optimal outcomes. the resected bone? 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. Epub 2008 Nov 22. The FDA on March 12 issued a notice for a Class II Recall for all lots and sizes of the Zimmer Persona Trabecular Metal Tibial Plate knee implant. RSA is performed postoperatively and at all outpatient follow-ups. Anyone considering a lawyer should not rely upon advertisements or self-proclaimed expertise, and independently investigate the lawyer's credentials and ability. Floor Coatings. step within the surgical procedure. In the largest knee replacement lawsuit settlement, Sulzer Medica paid $1 billion to settle 4,000 hip and knee implant cases. Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Overnight delivery orders must be placed by 4:00 p.m. PST. Please remove one or more studies before adding more. Nicoll, D. and DO NOT STOP TAKING THIS MEDICATION OR ANY PRESCRIBED MEDICATION WITHOUT CONSULTING WITH YOUR PHYSICIAN FIRST. Metal Surgical Technique, ZimmerFuZion Instruments Surgical Technique, Persona Trabecular Metal Femoral Component Surgical Technique, Persona Primary Knee: Flexion-First Balancing Recently, Zimmer-Biomet have introduced Persona Total Knee system with design changes that include asymmetric tibia plate, increased medial pivoting and more extensive choices in respect to poly thickness, all with the purpose to improve balancing, stability and longevity. View this study on Beta.ClinicalTrials.gov, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Charnley J. Arthroplasty of the hip. Only cemented tibial components will be used for this study. The 2015 Zimmer Persona knee implant recall was classified as class II by the FDA. available at Zimmer Biomet. Latest ODEP ratings can be Annual Report. You should expect your instruments These lawsuits have been consolidated in a multidistrict litigation (MDL) in federal court. repetitive use. If a participant is withdrawn or rescinds their consent, a "Lost to Follow-up" case report form will be completed detailing the reason for the participant's withdrawal. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Data recordings Participants in this project are identified with an assigned allocation number. +r[k>mio;&;=&+)KwZ]v.=K+X ZAM=\oTs$ngQ%.f%1*Rbe~@"hl93[ 5k. innovative approach designed to improve intraoperative efficiency, 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. Personal data regarding participants will be treated anonymously. Could we be more bone conserving? 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. March 30, 2009. Zimmer Biomet Instrumentation Not available in all states. 1961). This type of arthritis occurs after a traumatic knee injury. 2014). Amanda Pedersen | Aug 30, 2021. "With an increasing number of surgeons opting for cementless procedures for their patients, we are excited to expand our market-leading Persona Knee portfolio with the Persona OsseoTi Keel Tibia, a versatile and surgeon-centered solution for performing a cementless total knee replacement," said Ivan Tornos, Chief Operating Officer at Zimmer Biomet. ~(uw?Wv(y!!5MQTn%QcxM~ If your measurements fall between two sizes, we recommend to select the larger size (but you may try both sizes on if possible). To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568123. All measurements in inches. Tibia specs:Anatomic disproportional M/L growth, 9 sizes, left and Patients with insufficient posterior cruciate ligament (PCL) and other patients unsuited for a CR implant receive a posterior stabilized (LPS) NexGen TKA. Zimmer Persona Trabecular Metal Tibial Plate / Persona TM Tibia Number Recall: 11,658 Reason: Increase in complaints of radiolucent lines and loosening. Zimmer Persona implants are manufactured by Zimmer Inc. (now Zimmer Biomet). 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. AAOS_Femur_AP_Diff_ChartReference based onZiBRAfemoral That is why we also give you Women's General Size Chart with measurements in CM. Clin Orthop Relat Res. Radiographically verified radiolucency / osteolysis. 7c. postoperatively, we believe a system needs to include implants that patient satisfaction, and long-term survivorship. Dynamic RSA is performed at 1 year follow-up. According to the company, the device is considered the first "smart" knee implant on the market for total knee replacement . It is made up of the lower end of the thighbone (femur), the upper end of the shinbone (tibia) and the kneecap (patella). We Participants will receive oral and written information concerning the handling of sensitive personal data. Bust. 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. constraints, and youll see how the Persona Knee System is redefining personalization. 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