matters. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. These complications can include infection and blood clots. research tools to study hundreds of knees, creating a global bone 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. For decades, Zimmer Dental has gained the trust of thousands of clinicians worldwide by helping them to deliver successful patient outcomes. 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). An XL is usually equivalent to 1X, and an XXL is like a 2X. atlas. The results of this project are also expected presented at national and international orthopedic conventions. Read our, ClinicalTrials.gov Identifier: NCT02269254, Interventional Zimmer Persona knee implants are one such device that did not require additional clinical data for approval. Adelaide. 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. Specifications and prices are subject to change without notification. 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. In a market focused on matching the bone to the implant shape and [TimeFrame:2 Years], Knee Prosthesis motion by means of Fluoroscopy. Non-transparent envelopes are used for the randomization process. The power calculation is based on reaching sufficient power when a comparison of the two study groups is carried out. Pair it with ROSA Knee and the Personalized Alignment technique to deliver personalized patient care. In this 2-arm randomized controlled study the primary endpoint is implant migration measured by RSA. Cross-linked compared with historical polyethylene in THA: an 8-year clinical study. Those cookies that we do use are designed to permit you to use the site functions and browse our site in the way that is favorable to you. Adelaide.AOA 2016: Table KT9 The Zimmer Persona Knee System is no different. Australian The participants will be included at Hvidovre University Hospital, (see participating centers). Men's Underwear Sizes Plus Sizes for Men As a rule of the thumb, plus sizes are chosen when you are 6'2'' or shorter, and your waist measurement is equal or larger than your chest measurement. increments. 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. According to the company, the device is considered the first "smart" knee implant on the market for total knee replacement . It is ensured that the participant has understood the content of both the oral and written information before signed consent is given. All devises are European Conformity (CE) marked and used as intended by the manufacturer. 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. in the event of deep infection leading to replacement of the prosthesis or long-term immobilization because of comorbidity. Select variants from the 2016 Swedish National Registry available at 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. 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. featuring personalized implants, precise instrumentation, and proven technology. analysis project on file at Zimmer Biomet. Implants also do not last forever. Participants are seen on an outpatient basis at 3 months, 1 and 2 years postoperatively. 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. 2014 Jan 13;348:f7592. It is made up of the lower end of the thighbone (femur), the upper end of the shinbone (tibia) and the kneecap (patella). Failure rate of cemented and uncemented total hip replacements: register study of combined Nordic database of four nations. world.7 This, along with the Natural-Knee II 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. Complaints of device loosening after surgery and radiolucent lines soon flooded the FDAs online adverse event database. certain characteristics. Project information is then given in an undisturbed environment (in a closed examination room) by an authorized investigator of this project. More than a thousand lawsuits were filed against Zimmer Inc. in recent years over its NexGen knee implant. instrumentation were designed to help you consistently achieve optimal outcomes. 00:00. "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. A new operation. 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). Now its time to listen to his victim. assemble, so we created a matte finish. Studies have shown that modern implant designs can potentially improve outcome. Patients with insufficient posterior cruciate ligament (PCL) and other patients unsuited for a CR implant receive a posterior stabilized (LPS) NexGen TKA. Vivacit-E Vitamin-E Highly Crosslinked Polyethylene Recruitment is expected completed after a period of 1 year. Both MC polyethylene bearing and CR polyethylene bearing will be used in this study. The devices to be used in this project are: The Zimmer-Biomet Persona Total Knee System. of Primary Total Knee Replacement with Hybrid Fixation. mmincrements available in standard andnarrow provide the most 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. Women's US Clothing Size Chart (CM): It should also be easy for users from outside USA/Canada to determine their US size. Side effects of failed Zimmer Persona knee implants reported by patients and their doctors include: When a knee implant fails the need for a second surgery, also called a replacement surgery or revision surgery, may be necessary. if improved, would help restore a more natural feeling knee and Persona Trocar Tipped Drill Pins (2.5 hex) (00-5901-020-00) Motion of the knee prosthesis during a step-up movement, measured by means of Fluoroscopic Motion Analysis. Overnight delivery is available, if requested. 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). Choosing to participate in a study is an important personal decision. Instrumentation Surgical Technique, Persona The Personalized Knee Clinical Summary, All content herein is protected by copyright, trademarks and other Prices do not include applicable sales tax or shipping costs. Comparative statistics will be used based on the distribution of data. Migration, measured by means of RSA. Amanda Pedersen | Aug 30, 2021. Persona The Personalized Knee is designed to help the surgeon accomplish these goals by combining alignment accuracy with a simple, straight-forward technique. In vivo kinematics by means of fluoroscopy. iData on file with Zimmer Biomet: The Persona OsseoTi Keel Tibia Provides Strong Initial Fixation. For general information, Learn About Clinical Studies. An interactive learning environment for enhancing education and training. representative; search this website for additional product 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). While symmetric and asymmetric tibial designs had long us very excited about the future of the Persona Knee. 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. Charnley J. Arthroplasty of the hip. Biomet has designed. 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. 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. Plate JF, Seyler TM, Stroh DA, Issa K, Akbar M, Mont MA. All knees are performed in a standardized fast-track setup with the same surgical technique as described below, immediate mobilization after surgery and clinical and radiological controls after 3 months, 1 and 2 years. See our US Plus Size Chart. 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. A total score is calculated ranging from -0.624 (worst) to 1 (best). (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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568123. Doctors determine whether or not a total knee replacement is necessary based a patients pain and disability, not age or weight. One design change that is introduced is the medial congruent (MC) polyethylene to be used instead of standard cruciate retaining (CR) design. 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. 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. If your measurements fall between two sizes, we recommend to select the larger size (but you may try both sizes on if possible). 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. 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. Publications The results of this project are expected published in an international medical journal. These lawsuits have been consolidated in a multidistrict litigation (MDL) in federal court. In one of the largest knee implant settlements, Sulzer Medica agreed to pay $1 billion to settle roughly 4,000 lawsuits over its hip and knee implants in 2002. 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. The oral information is in accordance with the written information and is adjusted to the age, educational level and social conditions of the participant. 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. Unlike osteoarthritis, rheumatoid arthritis is an autoimmune disorder. counseling information, see the package insert or contact your local and physiological properties of cancellous bone8. Our General US Size Chart works with most clothing brands and manufacturers, but maybe not all. The Zimmer Persona has been the subject of numerous recalls, mostly for unintentional manufacturing defects. You will need the Adobe Reader to view and print these documents. Stratification is performed per diagnosis group (OA/RA). March 30, 2009. Zimmer Biomet Instrumentation knee design. right implant options,compatible with stem extension,triple wedge The Persona Knee System gives you the ability to address the unique Epub 2008 Nov 22. You have reached the maximum number of saved studies (100). and Joint Surgery (British) 92-B:1238-44; 2010. After the FDA initiated the class II recall of the uncemented Persona implant in 2015, patients began filing lawsuits against Zimmer Inc. over the new device. Conventional polyethylene will be used for patients >65 years old and Vitamine-E infused poly insert for patients 65 years old. 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. Femoral component: Only cemented femoral components will be used for this study. 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. was designed with all these elements in mind, because we believe a way Fit really matters. With more medial stability and lateral mobility, the Persona Medial We took the elements that made the NexGen Knee and Natural-Knee II 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. Please remove one or more studies before adding more. A vision requires leadership to become reality. 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. In doing so, we confirmed that implant shape really matters. 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 The manufacturer, Zimmer, says its recall is voluntary. 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. Partial Knee is redefining personalization in fixed bearing partial Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269254. 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.
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