For example, womens body shapes differ from that of men, resulting in a slightly different range of motion. Overnight delivery orders must be placed by 4:00 p.m. PST. Arthritis is characterized by inflammation and stiffness in the joints and can reduce a persons range of motion. 643 Persona Partial Knees were implanted, and two-year results demonstrated: 3 Survivorship at 2 years 98.9% Patient satisfaction 2009). decisions with each step and provide options for you to personalize were designed to help youconsistently achieve optimal to be accurate, but we didnt want to stop with just being precise. In some cases, it is also necessary to replace the patella (the kneecap) with a plastic component. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Zimmer, Inc. 1800 West Center Street Warsaw, Indiana 46580USA. Restoreligament balance with fivelevels of constraint in 1 mm The cookie settings on this website are currently set to allow certain types of cookies. 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. Motion of the knee prosthesis during a step-up movement, measured by means of Fluoroscopic Motion Analysis. In 2000, the Swiss company recalled thousands of hip implants that had been tainted with a lubricant. Non-transparent envelopes are used for the randomization process. 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. 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. Persona Knee. face intraoperatively. 1961 May 27;1(7187):1129-32. doi: 10.1016/s0140-6736(61)92063-3. counseling information, see the package insert or contact your local A total score is calculated that ranges from 0 (high knee awareness) to 100 (low knee awareness). Systems so successful and looked for ways to further enhance those designs.. General Health: EuroQol 5 Dimensional (EQ-5D) Health Questionnaire measured using patient questionnaire, Knee Function: Knee injury and Osteoarthritis Outcome Score (KOOS) measured using patient questionnaire, Pain score after activity and during rest; (Likert scale 0-10). Quickly find individual products and their details. Annual Report. Combine these enhancements with a full continuum of bearing These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet's filings with the SEC. antioxidant protection to help meet long-term performance needsand This type of arthritis is caused by wear and tear on the joints and usually occurs in people over the age of 50. 2008). Studies have shown that 15%-39% of patients who undergo total knee surgery are not satisfied with the outcome. Bearing Specs:1mm increments, cruciate retaining and sacrificing The primary investigator of this project has independently initiated the project. System, created the foundation for what would become the Persona Knee. Please remove one or more studies before adding more. 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. 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. intraoperative glare from the instruments and make them easier to Geerdink CH, Grimm B, Vencken W, Heyligers IC, Tonino AJ. Zimmer Persona knee implants are available as both cemented and uncemented implants. As for the RSA study all consecutive patients ("usual care") are included to prevent selection bias in the migration analysis. Please remove one or more studies before adding more. (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. Due to the changing demographics of joint replacement, the population of younger patients are seeking options that not only correct their disease or deformity, but do not limit them in activity (Geerdink et al. * While the implant platform color code for the 4.1mmD Tapered Screw-Vent implant is green, the implant surgical sequence is color-coded white on the surgical kit surface. each procedure. Charnley J. Arthroplasty of the hip. Femoral component: Only cemented femoral components will be used for this study. Catalog Number: 8065-546-32 All Lot numbers. 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. In 2015, Zimmer will be starring as Julia on new TV series Un-Real. Adelaide.AOA 2016: Table KT9 It is caused when a persons immune system mistakenly attacks his or her own body tissues. The devices to be used in this project are: The Zimmer-Biomet Persona Total Knee System. 7e. Both standard as well as narrow femoral components will be used, depending on the patient anatomy. -, 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. BMJ. Big or plus sizes are marked as 1X, 2X, 3X, etc. J Bone Joint Surg Am. available at Zimmer Biomet. endstream endobj startxref Study record managers: refer to the Data Element Definitions if submitting registration or results information. Smith & Nephew - 139 recalls. Talk with your doctor and family members or friends about deciding to join a study. March 12, 2015- FDA categorized Zimmer Persona Knee recall as "Class II Recall." Zimmer Persona Knee Reviews. options including minimal constraint to full constraint, left and Personal data regarding participants will be treated anonymously. 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. 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. It incorporates an Our legacy continues to come to life today through our progressive culture of evolution and innovation. provide a portfolio of personalized knee care in order toreplicate a 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. Distribution to any other recipient is prohibited., For product information, including indications, contraindications, Did you have to sacrifice stability for fit? Migration, measured by means of RSA. View this study on Beta.ClinicalTrials.gov. (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. Information provided by (Responsible Party): Anders Troelsen, Hvidovre University Hospital, Persona Total Knee System with MC polyethylene bearing. Arthroscopy with meniscectomy / cartilage surgery / house cleaning is allowed. Australian Orthopaedic Association Pair it with ROSA Knee and the Personalized Alignment technique In doing so, we confirmed that implant shape really matters. With more medial stability and lateral mobility, the Persona Medial Congruent Bearing is the most kinematic-friendly bearing Zimmer Biomet has designed. The specific knee implant used during surgery, however, is chosen based on a patients age, weight, gender and physical activity level, among other factors. Complaints of device loosening after surgery and radiolucent lines soon flooded the FDAs online adverse event database. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Anatomically accurate implants designed for optimal fit and function, Precise instrumentation with personalized control, Proven technology built on a legacy of clinical performance. Instrumentation Surgical Technique, Persona The Personalized Knee Clinical Summary, All content herein is protected by copyright, trademarks and other 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. EMBASE search: NexGen AND right implant options,compatible with stem extension,triple wedge Risk of dislocation using large- vs. small-diameter femoral heads in total hip arthroplasty. 2023 Major Media Consulting Inc. | Privacy Policy | All Rights Reserved. Surgeons have been performing total knee replacements since the late 1960s. The Persona Knee System gives you the ability to address the unique representative; search this website for additional product Participants may be excluded intraoperatively if the PCL is found insufficient and LPS prosthesis is required. atlas. It is ensured that the participant has understood the content of both the oral and written information before signed consent is given. Conventional polyethylene will be used for patients >65 years old and Vitamine-E infused poly insert for patients 65 years old. 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. 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Zimmer One-Piece implants feature: One-piece construction, eliminating micromovement and maximizing strength An integral, pre-contoured abutment, Zimmer One-Piece Implant Dimensions Zimmer One-Piece Implants 3.5mmD Emergence Profile with External Driving Flats 5.75mm Buccal/Labial Abutment Height 1.2mm Cuff Height 4.25mm Lingual Abutment Height 0.5mm Machined 1.2mmLLead (Triple-Lead Thread) MTX Textured Titanium surface 3.0mmD Zimmer One-Piece Implant (Straight Shown) 2.4mmD Apex Diameter. The NexGen Complete Knee Solution Legacy Knee Posterior Stabilized (LPS) LPS-Flex Fixed Bearing Knee is designed to accommodate resumption of . Stemmed Tibial Sizing Plate. Implant shape and fit matter in achieving postoperative patient Persona The Personalized Knee is designed to help the surgeon accomplish these goals by combining alignment .
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