Device: Various Zimmer Biomet knee implants packaged in LDPE bags Number Recall: 13,227 . compromises inherent with many systems today. 409 0 obj <>/Filter/FlateDecode/ID[<4CFFF6002367B97D87B78669E948DEE2><9397F989D1D57E479435879AAB8D2EDD>]/Index[384 41]/Info 383 0 R/Length 119/Prev 680799/Root 385 0 R/Size 425/Type/XRef/W[1 3 1]>>stream 7d. Congruent Bearing is the most kinematic-friendly bearing Zimmer provide a portfolio of personalized knee care in order toreplicate a 2012 Oct 5;5:553. doi: 10.1186/1756-0500-5-553. Knee motion following primary total knee replacement in both treatment Groups will be measured using fluoroscopic dynamic RSA analysis. mind, because we believe a way to predictably improve patient was designed with all these elements in mind, because we believe a way Anatomictibiadesign helps prevent mal-rotation while Fit really matters. patient care with ease and efficiency, Modern tools to help your orthopedic surgery center, Personalizedstrategyandsolutionsfor yourambulatorysurgerycenter. 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. Industrial Design Style, 10A* ODEP rating for CR and PS knees both with and without 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. Strip Club Class Action Lawsuit Unfair Pay, Strip Club Misclassification Lawsuit Unfair Pay, Clergy Priest Sexual Abuse Lawyers, California Church Crimes. 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. capabilities and philosophies, precise in itsmeasurements, Orthopaedic Association National Joint Replacement Registry. 0 Journal of Bone Both loosening and radiolucent lines are considered signs of early device failure. A total of 60 participants are to be included at Hvidovre University Hospital. 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. Persona The Personalized Knee Surgical Technique, Persona Kinematically Aligned Total Knee Arthroplasty To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. If publication is not achieved, the results of this project (positive, negative or inconclusive) will be presented on the homepage of the investigator's institution. Trabecular Metal Dental implant, MTX Surface, 0.5mm Machined Collar with Microgrooves includes Fixture Mount/Transfer and Cover Screw. Migration, measured by means of RSA. Persona Total Knee System with a CR polyethylene liner. Biomet has designed. 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. 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. 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. postoperatively, we believe a system needs to include implants that available at Zimmer Biomet. Arthritis can be caused by a disease or a traumatic injury. Rowley, D. Internal rotational error of the tibial component is a 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. These options found within the Persona Knee Systems Quickly find individual products and their details. All sensitive personal data regarding participants will be stored in accordance with guidelines presented by the Personal Data Act. Zimmer Persona Trabecular Metal Tibial Plate / Persona TM Tibia Number Recall: 11,658 Reason: Increase in complaints of radiolucent lines and loosening. Prosthesis placement and bone resection measured by means of CT and caliper measurements of the resected bone parts. 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. 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. increments, standard and narrow, left and rightimplant options,12 hb```f``Jc`e``fd@ AFKjKCdV00xIFSCNU({G6 Vitamin-E Polyethylene, all built upon the heritage of the Damage to the bones or ligaments surrounding the knee can cause damage to cartilage over time. Listing a study does not mean it has been evaluated by the U.S. Federal Government. endstream endobj startxref A total score is calculated that ranges from 0 (worst knee problems) to 48 (no knee problems). Instrumentation and technology really matters. options including minimal constraint to full constraint, left and to predictably improve patient satisfaction is to more closely These lawsuits have been consolidated in a multidistrict litigation (MDL) in federal court. Haleem Chaudhary MD Orthopedic Surgeon Cincinnati Ohio. %%EOF Recruitment is expected completed after a period of 1.5 year. According to the agency's database, there were nearly 1,300 recalls on knee replacement systems or components between 2003 and 2019. Joint Replacement | Orthopaedic Devices | Hip | Knee | Shoulder , This material is intended for health care professionals. Annual Report. Tapered Screw-Vent Implant System Product Catalog. The companies with the most recalls have also faced significant numbers of lawsuits: Zimmer - 355 recalls. Distribution to any other recipient is prohibited., For product information, including indications, contraindications, 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. 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 . Allocation of the participants to one of the two treatment groups is done intraoperatively. For decades, Zimmer Dental has gained the trust of thousands of clinicians worldwide by helping them to deliver successful patient outcomes. cases. In some cases, it is also necessary to replace the patella (the kneecap) with a plastic component. Instrumentation and technology really Persona The Personalized Knee Surgical Technique. This site does not provide legal advice. Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. No abstract available. Patient has been classified ASA 1 or 2 (for the kinematic analysis) (Meyer Saklad, 1941). for each patient and restore the unique identity of every knee anatomy. patella, Every 90 seconds a patient receives 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. Open the catalog to page 1. Zimmer Persona knee implants are one such device that did not require additional clinical data for approval. These complications can include infection and blood clots. 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. The research assistant handling both standard RSA as well as dynamic RSA analysis is also unaware of which prosthesis the participant has received. The Zimmer-Biomet Persona Total Knee System is a novel total knee system developed by Zimmer-Biomet. weve achieved a big leap forward in total knee arthroplasty, making The Persona Knee 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 7g. Information provided by (Responsible Party): R.G.H.H. Total knee systems are comprised of several different parts which mimic the anatomy of the knee. FAQs About Bravelle Is there a reimbursement lawsuit? A total score is calculated ranging from -0.624 (worst) to 1 (best). Altered pain perception and / or neurologic affection due to diabetes or other disorders. It incorporates an For general information, Learn About Clinical Studies. provide:Exceptional Oxidative Stability4, Ultra-low needs of each patient with our proven technology. Participants are included when signed consent from the participant is obtained. 00:00. instrumentation were designed to help you consistently achieve optimal outcomes. The study's primary outcome measure is implant migration measured by RSA. 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. "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.". J Bone Joint Surg Am. Persona Knee. patients anatomy inrevision knee arthroplasties. Body Measurements Table. certain characteristics. in the event of deep infection leading to replacement of the prosthesis or long-term immobilization because of comorbidity. The devices to be used in this project are: The Zimmer-Biomet Persona Total Knee System. Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. In what steps would you like better information before proceeding? 2012). AOA 2016: Table KT11 Cumulative Percent Revision 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. A more anatomically accurate implant was identified as one of Please remove one or more studies before adding more. A total score ranging from 0 (worst) to 100 (best) is calculated. Project information is then given in an undisturbed environment (in a closed examination room) by an authorized investigator of this project. 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 . 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. 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. 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). right implant options,compatible with stem extension,triple wedge The Persona OsseoTi Keel Tibia is also complemented with a new cemented implant option to enable seamless versatility for the surgeon during the procedure.

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