Zimmer Biomet isaglobal medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. patient satisfaction, and long-term survivorship. satisfaction. Clin Orthop Relat Res. The specific component involved in the recall was called a Trabecular Metal Tibial Plate. Ourmost comprehensivekneesystem, including anatomically accurate Comparative statistics will be used based on the distribution of data. Dynamic RSA is performed at 1 year follow-up. were designed to help youconsistently achieve optimal Surgeons have been performing total knee replacements since the late 1960s. 2009 Apr;467(4):979-84. doi: 10.1007/s11999-008-0628-2. Zimmer Biomet- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. One design change that is introduced is the medial congruent (MC) polyethylene to be used instead of standard cruciate retaining (CR) design. %%EOF Anatomictibiadesign helps prevent mal-rotation while Persona Versus NexGen - Full Text View - ClinicalTrials.gov We took the elements that made the NexGen Knee and Natural-Knee II Participant population in Denmark Study population will consist of 60 participants with knee osteoarthritis set to receive primary total knee arthroplasty. The participants will be included at Hvidovre University Hospital, (see participating centers). 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. 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. Therefore new implants are introduced to the marked with the theoretical benefit of improved implant survival and superior patient reported outcomes. In vivo kinematics by means of fluoroscopy. 7b. RSA is performed postoperatively and at all outpatient follow-ups. The research assistant handling both standard RSA as well as dynamic RSA analysis is also unaware of which prosthesis the participant has received. 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. Arthritis is characterized by inflammation and stiffness in the joints and can reduce a persons range of motion. For more information about the Persona OsseoTi Keel Tibia, visit https://www.zimmerbiomet.com/en/products-and-solutions/specialties/knee/persona-osseotikeeltibia.html. "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. Both standard as well as narrow femoral components will be used, depending on the patient anatomy. 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. 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. Geerdink CH, Grimm B, Vencken W, Heyligers IC, Tonino AJ. 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. Complications from knee surgeries do arise, but are considered rare. the resected bone? fit better and instruments designed for ease of use, without the http://myknee.se/en/ (pgs 42-43). In doing so, we confirmed that implant shape really matters. Participants may be excluded intraoperatively if the PCL is found insufficient and LPS prosthesis is required. 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. 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. Read our, ClinicalTrials.gov Identifier: NCT03568123, Interventional "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.". 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. Zimmer Biomet Persona Total Knee System with CR polyethylene bearing. Choosing to participate in a study is an important personal decision. 7h. 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. 7i. Anti Slip Coating UAE Information provided by (Responsible Party): R.G.H.H. Women's US Clothing Size Chart (CM): A more anatomically accurate implant was identified as one of the native tibia as possible. 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. Product Catalog - Zimmer Dental - PDF Catalogs - MedicalExpo A Comparison of the Persona Total Knee - ClinicalTrials.gov Amanda Pedersen | Aug 30, 2021. Rheumatoid arthritis causes painful swelling that can eventually lead to bone loss and joint deformity. Complaints of device loosening after surgery and radiolucent lines soon flooded the FDAs online adverse event database. in the event of deep infection leading to replacement of the prosthesis or long-term immobilization because of comorbidity. options including minimal constraint to full constraint, left and a NexGen knee, 1 in 5 knees implanted 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. During total knee replacement, surgeons remove damaged cartilage and bone from the ends of the femur and tibia and replace these parts with metal components. This will insure sufficient statistical power despite intraoperative exclusion and dropout of 40% at last follow-up and . Participants are seen on an outpatient basis at 3 months, 1 and 2 years postoperatively. hbbd```b`` q?d,@$/t `qKtDJu%H)^0L\`-`@h d 3012030R wig The primary objective is to assess and compare migration of the two TKR prostheses (Femoral and Tibial component). The Persona OsseoTi Keel Tibia is also complemented with a new cemented implant option to enable seamless versatility for the surgeon during the procedure. However, currently no studies exist evaluating outcome following use of MC polyethylene bearing. Persona the Personalized Knee Surgical Technique - Zimmer Biomet available at Zimmer Biomet. Persona The Personalized Knee Surgical Technique. Vanguard Knee System | Total Knee Arthroplasty | Zimmer Biomet Knee Replacement Lawsuit | Loosening Claims & Settlements - Drugwatch.com those needs. Before you decide, ask us to send you free written information about the qualifications and experience of our sponsoring firms. Radiolucent lines, which are tiny cracks between the device and the bone where fluid and debris can get trapped, can also lead to bone loss, a condition called osteolysis. potentially improve patient satisfaction. Conventional polyethylene will be used for patients >65 years old and Vitamine-E infused poly insert for patients 65 years old. 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. Floor Coatings. Risk of dislocation using large- vs. small-diameter femoral heads in total hip arthroplasty. Persona OsseoTi is the latest addition to the clinically proven Persona Knee System, and features a new porous version of the Persona anatomic tibia with Zimmer Biomet's OsseoTiPorous Metal Technology, which uses anatomical data in combination with 3D printing technology to build a structure that directly mimics the architecture of human cancellous or spongey bone. A/P sizes. was created. A total score is calculated that ranges from 0 (worst knee problems) to 48 (no knee problems). 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. It is made up of the lower end of the thighbone (femur), the upper end of the shinbone (tibia) and the kneecap (patella). The patients will be followed for survival through The Danish Knee Arthroplasty Registry. 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). Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269254. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Epoxy Flooring UAE; Floor Coating UAE; Self Leveling Floor Coating; Wood Finishes and Coating; Functional Coatings. Participants are informed that a period of consideration of at least 2 weeks is an opportunity along with the right to a second consultation. Background Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. Femoral component: Only cemented femoral components will be used for this study. According to the agency, 11,658 devices are affected by the recall. By addressing those opportunities in the Persona Knee, we believe The project is expected to be completed 2 years after recruitment of the last participant (2019). Persona The Personalized Knee Surgical Technique, Persona Kinematically Aligned Total Knee Arthroplasty In the largest knee replacement lawsuit settlement, Sulzer Medica paid $1 billion to settle 4,000 hip and knee implant cases. Latest ODEP ratings can be 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. We also believed that the femoral shape should reflect The theoretic proposed benefit of MC polyethylene bearing is improved kinematics mimicking native knee motion. %PDF-1.6 % step within the surgical procedure. BMJ. 31:32. Persona OsseoTi is the latest addition to the clinically proven Persona Knee System, and features a new porous version of the Persona anatomic tibia with Zimmer Biomet's OsseoTi Porous Metal Technology, which uses anatomical data in combination with 3D printing technology to build a structure that directly mimics the architecture of human . Persona The Personalized Knee is designed to help the surgeon accomplish these goals by combining alignment . 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. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. 1961). zimmer persona size chart Device Recall Information - Michigan Arthroplasty Registry This cautionary statement is applicable to all forward-looking statements contained in this news release. Our General US Size Chart works with most clothing brands and manufacturers, but maybe not all. This furthered our understanding of native anatomic shape and All devises are European Conformity (CE) marked and used as intended by the manufacturer. to patients of different ethnicity, gender, and stature.4-5 A total score is calculated that ranges from 0 (high knee awareness) to 100 (low knee awareness). world.7 This, along with the Natural-Knee II Zimmer Persona is the brand-name of a total knee replacement system. However, currently no studies exist evaluating outcome following use of MC polyethylene bearing. Only cemented femoral components will be used for this study. Women's US Size Chart Personal data regarding participants will be treated anonymously. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Journal of Bone Statistics A professional statistical software package will be used when processing data in this project. 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. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Implant shape and fit matter in achieving postoperative patient needs of each patient with our proven technology. 2016 Sales data 384 0 obj <> endobj A total of 60 participants are to be included at Hvidovre University Hospital. Read our, ClinicalTrials.gov Identifier: NCT02269254, Interventional J Bone Joint Surg Am. 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.
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