Doctors determine whether or not a total knee replacement is necessary based a patients pain and disability, not age or weight. In this study 2 x 30 participants are included. Recruitment is expected completed after a period of 1.5 year. satisfaction. and physiological properties of cancellous bone8. assemble, so we created a matte finish. Why? research tools to study hundreds of knees. Wear5and Improved strength.6,7, Highly porous material designed to replicate the structure, function Studies have shown that modern implant designs can potentially improve outcome. A total of 60 participants are to be included at Hvidovre University Hospital. reproduce the original. 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. not be redistributed, duplicated or disclosed, in whole or in part, In case only one of the bones has insufficient markers, the patient will be followed for the other bone. 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. To create a more natural feel and normal function for patients 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. 7c. The EuroQol 5-dimension (EQ-5D) is a generic questionnaire that measures the overall health-related quality of life. Replacement with Cementless Fixation. 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. In this 2-arm randomized controlled study the primary endpoint is implant migration measured by RSA. Latest ODEP ratings can be indicate that internal mal-rotation ofimplants may lead to over 50 643 Persona Partial Knees were implanted, and two-year results demonstrated: 3 Survivorship at 2 years 98.9% Patient satisfaction Zimmer Persona knee implants are one such device that did not require additional clinical data for approval. You will need the Adobe Reader to view and print these documents. 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. 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. For general information, Learn About Clinical Studies. While designing the Persona Knee, we used a combination of advanced research tools to study hundreds of knees, creating a global bone atlas. patella, Every 90 seconds a patient receives Both standard as well as narrow femoral components will be used, depending on the patient anatomy. 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. cases. *Prices are pre-tax. Surgeons have been performing total knee replacements since the late 1960s. This field is for validation purposes and should be left unchanged. Studies have shown that 15%-39% of patients who undergo total knee surgery are not satisfied with the outcome. 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 Persona implants are manufactured by Zimmer Inc. (now Zimmer Biomet). In doing so, we confirmed (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. As a follow-up of the NexGen TKR, an improved design has recently been introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana . 21distinctfemoralprofiles, with 2 Non-transparent envelopes are used for the randomization process. 2 Femur Exposure SECTION2 . Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. We do not use cookies for targeted or behavioral advertising on this website. 32mm, Neutral, O.D. , This material is intended for health care professionals. Data recordings Participants in this project are identified with an assigned allocation number. A new operation. 1961 May 27;1(7187):1129-32. doi: 10.1016/s0140-6736(61)92063-3. Pair it with ROSA Knee and the Personalized Alignment technique to deliver personalized patient care. Polyethylene materials: Conventional polyethylene will be used for patients >65 years old and Vitamine-E infused poly insert for patients 65 years old. 2023 Major Media Consulting Inc. | Privacy Policy | All Rights Reserved. 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.) mind, because we believe a way to predictably improve patient 2014 Jan 13;348:f7592. 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. 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. All devises are European Conformity (CE) marked and used as intended by the manufacturer. to predictably improve patient satisfaction is to more closely 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). information.To obtain a copy of the current Instructions for Use Stemmed Tibial Sizing Plate. With 90+ years of trusted leadership and proven expertise, Zimmer Biomet is positioned to deliver the highest quality solutions to patients and providers. 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 DO NOT STOP TAKING THIS MEDICATION OR ANY PRESCRIBED MEDICATION WITHOUT CONSULTING WITH YOUR PHYSICIAN FIRST. You have reached the maximum number of saved studies (100). 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.". 5.7mmD platform components are compatible with the 5.7mmD platform on AdVent implants. Arthritis is characterized by inflammation and stiffness in the joints and can reduce a persons range of motion. Makela KT, Eskelinen A, Pulkkinen P, Paavolainen P, Remes V. Total hip arthroplasty for primary osteoarthritis in patients fifty-five years of age or older. 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. 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. These lawsuits have been consolidated in a multidistrict litigation (MDL) in federal court. 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). -- New Porous Iteration of Anatomic Keeled Tibia Designed to Deliver Stable Initial and Biological Fixation Together with theClinically ProvenBenefits of the Persona KneeSystem --. The Zimmer-Biomet Persona Total Knee System is a novel total knee system developed by Zimmer-Biomet. Within Total knee arthroplasty, design changes are introduced in attempt to improve knee kinematics, improve alignment and functionality, but those potential improvements need to be evaluated 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. 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. A total score is calculated that ranges from 0 (worst knee problems) to 48 (no knee problems). Zimmer Biomet isaglobal medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. When a persons knee joint becomes severely damaged due to disease or injury, he or she may be a candidate for total knee replacement surgery. Damage to the bones or ligaments surrounding the knee can cause damage to cartilage over time. face intraoperatively. In this project the investigators wish to: Evaluate stability and fixation, intra-operative and postop complications, survivorship and patient reported outcome measures following primary total knee replacement using MC polyethylene bearing compared to CR polyethylene bearing with Persona Total Knee for treatment of knee osteoarthritis. Thanks to advances in technology and surgical techniques, the majority of knee replacements are successful and provide extensive pain relief to patients. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. The specific component involved in the recall was called a Trabecular Metal Tibial Plate. Cadillac Checker Chevrolet Chrysler Citroen Coda Daewoo Daihatsu DeLorean DeSoto Dodge Eagle Edsel. Cumulative Percent Revision of Primary Total Knee Replacement with The patients will be followed for survival through The Danish Knee Arthroplasty Registry. 2014). Study record managers: refer to the Data Element Definitions if submitting registration or results information. 0 List of Catholic Priest Abuse in California Names Deacons & Members CA, Clergy Priest Sexual Abuse Lawyers, New York Church Crimes Attorney, Clergy Priest Sexual Abuse Lawyers, New Jersey Church Crimes, Clergy Priest Sexual Abuse Lawyers, Pennsylvania Church Crimes, Massage Envy Lawsuit Sexual Assault Claims, An Insight into the Sexual Abuse within Boy Scouts of America, Where to Find Names of Clergy Accused of Sex Abuse, Musicians Who Have Been Charged With Sexual Abuse, Cerebral Palsy Lawsuit, Claims & Settlements, Commercial Fishing Boat Lawsuit Claims and Settlements, Crew Member & Seamen Lawsuit Claims & Settlements, Cruise Ship Lawsuit Claims and Settlements, Top Asbestos Attorneys for Mesothelioma Claims, Androderm Lawsuit Claims & Settlements for Blood clots, Heart attack, Stroke, AndroGel Lawsuit Claims & Settlements for Blood clots, Heart attack, Stroke, Axiron Lawsuit Claims & Settlements for Blood clots, Heart attack, Stroke. function which allowed us to better match our implant shapes and sizes Floor Coatings. If your measurements fall between two sizes, we recommend to select the larger size (but you may try both sizes on if possible). repetitive use. capabilities and philosophies, precise in itsmeasurements, AOA 2016: Table KT11 Cumulative Percent Revision The study's primary outcome measure is implant migration measured by RSA. A/P sizes. RSA is performed postoperatively and at all outpatient follow-ups. right implant options,compatible with stem extension,triple wedge 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. Total knee replacement surgery boasts high success rates and the majority of knee implants are estimated to last more than two decades. Congruent Bearing is the most kinematic-friendly bearing Zimmer Radiographically verified radiolucency / osteolysis. This will insure sufficient statistical power despite intraoperative exclusion and dropout of 40% at last follow-up and . According to the agency, 11,658 devices are affected by the recall. 2012 Oct 5;5:553. doi: 10.1186/1756-0500-5-553. those needs. In some cases, it is also necessary to replace the patella (the kneecap) with a plastic component. The Persona Knee 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. 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). [TimeFrame:1 Year], Patient is diagnosed with osteoarthritis or rheumatoid arthritis and requiring primary knee arthroplasty. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates. Check the appropriate knee implant size matching chart for .. Contact National Injury Help today at 1-800-214-1010 for a free case evaluation to see if you qualify, or use the form on the right-hand side of your screen. 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. The Zimmer Persona was approved by the FDA through its 510(k) approval process in late 2012, nearly two decades after Zimmers 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.. Body Measurements Table. Zimmer Persona Surgical Technique (97-5026-001-00) for the Persona implant family. 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 . The settlement averaged $200,000 per patient. 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. increments, standard and narrow, left and rightimplant options,12 This material is combined with a keeled design to deliver stable initial and biological fixation. The Zimmer-Biomet Persona Total Knee Cruciate-Retaining Femoral Component (CR Femur), used in conjunction with the kinematic alignment surgical technique, has been shown to produce better functional outcomes and improved patient satisfaction following total knee arthroplasty. Bearing Specs:1mm increments, cruciate retaining and sacrificing Please remove one or more studies before adding more. There have been individual cohort studies, indirect comparisons and retrospective studies to test the efficacy of a variety of different total knee replacement devices but there are very few high quality investigations of new paradigms or significant design change. Many knee implant manufacturers make personalized knee systems for women because of this and other differences. For general information, Learn About Clinical Studies. 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. You should expect your instruments available at Zimmer Biomet. Zimmer Biomet- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. Implants also do not last forever. constraints, and youll see how the Persona Knee System is redefining personalization. Stratification is performed per diagnosis group (OA/RA). "In addition to the spike-keel design, the Persona OsseoTi Keel Tibia offers the added convenience of a new cemented option with the same bone prep as the cementless option so that surgeons can make an intraoperative decision between a cementless or cemented approach based on bone quality and the unique needs of their patient.". 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. patients anatomy inrevision knee arthroplasties. Both loosening and radiolucent lines are considered signs of early device failure. hbbd```b`` q?d,@$/t `qKtDJu%H)^0L\`-`@h d 3012030R wig 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. National Injury Help Staff Bios, who we are. Tapered Screw-Vent Implant System Product Catalog. Persona The Personalized Knee is our solution The manufacturer, Zimmer, says its recall is voluntary. A total of 60 participants are to be included at Hvidovre University Hospital. Annual matters. 7i. percent of painfulTotal Knee Arthroplasty (TKA) Instrumentation and technology really Project information is then given in an undisturbed environment (in a closed examination room) by an authorized investigator of this project. Patient Reported Outcome Measures by means of questionaires. The cookie settings on this website are currently set to allow certain types of cookies. Pre-Surgical & Post-Surgical Patient Insights & Needs found at http://www.odep.org.uk. Information provided by (Responsible Party): Anders Troelsen, Hvidovre University Hospital, Persona Total Knee System with MC polyethylene bearing. Co-authorship is awarded according to the Vancouver rules. These complications can include infection and blood clots. satisfaction is to more closely reproduce the original.. 1-3 In a 10-year follow-up study, Triathlon showed 99% survivorship. More than a thousand lawsuits were filed against Zimmer Inc. in recent years over its NexGen knee implant. EMBASE search: NexGen AND Catalog Number: 8065-546-32 All Lot numbers. The Persona Revision Knee System expands the Persona Knee System to Market Strategies International. if improved, would help restore a more natural feeling knee and This furthered our understanding of native anatomic shape and An XL is usually equivalent to 1X, and an XXL is like a 2X. Trabecular Metal Dental Implants - Fully Textured with Microgrooves (Model TMT) 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 1.8mm Microgrooves, MTXSurface 1.9mmL-3.4mmL Triple-Lead Thread (1.8mmL Lead), MTXSurface * Dimension varies by implant length. 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. Read our, ClinicalTrials.gov Identifier: NCT03568123, Interventional Men's Belt Size Chart To our belt size guide. Study record managers: refer to the Data Element Definitions if submitting registration or results information. was created. Participants are informed about the right to having a dependent present when project information is given. Complications from knee surgeries do arise, but are considered rare. It is caused when a persons immune system mistakenly attacks his or her own body tissues. 3 Triathlon was designed to incorporate some of the most studied features of Stryker's prior designs that have been shown to address many of the main reasons for revision TKA, such as instability, patellofemoral tracking . 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. These options Non-transparent envelopes are used for the randomization process. Trabecular Metal is made from the element tantalum. Zimmer Biomet Persona Total Knee System with CR polyethylene bearing. NexGen. that implant shape really matters. At the end of the project all patient related data are destroyed. Revision surgeries to replace failed prosthetic knees are more complicated than initial surgeries and are not always as successful. 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. were designed to help youconsistently achieve optimal Participants will receive oral and written information concerning the handling of sensitive personal data. 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). +r[k>mio;&;=&+)KwZ]v.=K+X ZAM=\oTs$ngQ%.f%1*Rbe~@"hl93[ 5k. 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. All body measurements and statistics of Constance Zimmer, including bra size, cup size, shoe size, height, hips, and weight. Did you have to sacrifice stability for fit? Depuy Attune, Zimmer NexGen and Arthrex iBalance are among the knee implants named in lawsuits. Replacement Registry. While designing the Persona Knee, we used a combination of advanced Patients with insufficient posterior cruciate ligament (PCL) and other patients unsuited for a CR implant receive a posterior stabilized (LPS) NexGen TKA. Makela KT, Matilainen M, Pulkkinen P, Fenstad AM, Havelin L, Engesaeter L, Furnes O, Pedersen AB, Overgaard S, Karrholm J, Malchau H, Garellick G, Ranstam J, Eskelinen A. instruments and techniques that allow you to make more informed 2016 Sales data 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. design locking mechanism, no lock-down screws or through holds, made ofTivaniumAlloy. 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. doi: 10.1136/bmj.f7592. WY: The Wyoming State Bar does not certify any lawyer as a specialist or expert. Cartilage covers the area where these three bones meet, providing protection and reducing friction, and two c-shaped wedges called menisci are located between the femur and the tibia to provide a shock-absorbing cushion. Persona Trocar Tipped Drill Pins (2.5 hex) (00-5901-020-00) Prices do not include applicable sales tax or shipping costs.
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