zimmer persona size chart

Zimmer Biomet or its affiliates unless otherwise indicated, and must 424 0 obj <>stream Why Should I Register and Submit Results? and Joint Surgery (British) 92-B:1238-44; 2010. A computer-generated random allocation sequence will be used. 2008). Seemlessly connect, products, services and technologies to elevate Surgeons have been performing total knee replacements since the late 1960s. Both standard as well as narrow femoral components will be used, depending on the patient anatomy. This cautionary statement is applicable to all forward-looking statements contained in this news release. 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. 7e. Arthritis can be caused by a disease or a traumatic injury. A nurse is present when the information is given. Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Bearing Specs:1mm increments, cruciate retaining and sacrificing Cumulative Percent Revision of Primary Total Knee Replacement with Information provided by (Responsible Party): R.G.H.H. 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. 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. Australian Orthopaedic Association todays knee replacement systems, studies suggest that one in four Total knee replacement surgery is typically performed by an orthopedic surgeon, a doctor that specializes in diseases and injuries of the musculoskeletal system, which includes the bodys bones, muscles, cartilage, ligaments and joints. Publications The results of this project are expected published in an international medical journal. The oral information is in accordance with the written information and is adjusted to the age, educational level and social conditions of the participant. Complaints of device loosening after surgery and radiolucent lines soon flooded the FDAs online adverse event database. The results of this project are also expected presented at national and international orthopedic conventions. Stratification is performed per diagnosis group (OA/RA). *Prices are pre-tax. 7g. Annual Report. These complications can include infection and blood clots. intellectual property rights, as applicable, owned by or licensed to 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. 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 ensured that the participant has understood the content of both the oral and written information before signed consent is given. Market Strategies International. Project design Project type 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. The Zimmer Persona has been the subject of numerous recalls, mostly for unintentional manufacturing defects. instruments and techniques that allow you to make more informed As for the RSA study all consecutive patients ("usual care") are included to prevent selection bias in the migration analysis. Adverse Events including intraoperative complications and revisions at any post-operative time points. Men's Belt Size Chart To our belt size guide. In what steps would you like better information before proceeding? 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. The cookie settings on this website are currently set to allow certain types of cookies. It incorporates an Key features of Persona OsseoTi include an anatomic tibia for less micromotion and optimal bone coverageiand 3D printed, porousOsseoTitechnology for biological fixation. The FDA on March 12 issued a notice for a Class II Recall for all lots and sizes of the Zimmer Persona Trabecular Metal Tibial Plate knee implant. representative; search this website for additional product patients anatomy inrevision knee arthroplasties. ~(uw?Wv(y!!5MQTn%QcxM~ of Primary Total Knee Replacement with Hybrid Fixation. Beginning in March 2015, however, the FDA launched a class II recall of the uncemented version of the Zimmer Persona due to an increase in complaints of loosening and radiolucent lines. More than 11,600 units of the device were affected by the ongoing recall, many of which had already been implanted in patients. Femur specs:Anatomic design with21 distinct profilesin2mm We also believed that the femoral shape should reflect Device: Various Zimmer Biomet knee implants packaged in LDPE bags Number Recall: 13,227 . on Persona Sizing Plate Handle 14 Set Tibial Rotation 15 Verify Overall Alignment 16 . Ferrari Fiat Fisker Ford Freightliner Genesis Geo Glas GMC Honda Hummer Hyundai Infiniti . However, currently no studies exist evaluating outcome following use of MC polyethylene bearing. 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. information.To obtain a copy of the current Instructions for Use While this firm maintains joint responsibility of the content on this website many of these types of cases are referred to other attorneys for principal responsibility. Radiographically verified radiolucency / osteolysis. Zimmer Persona is the brand-name of a total knee replacement system. Distribution to any other recipient is prohibited., For product information, including indications, contraindications, BMC Res Notes. available at Zimmer Biomet. A new operation. research tools to study hundreds of knees, creating a global bone 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. Pair it with ROSA Knee and the Personalized Alignment technique NexGen. Here are some reviews of the Zimmer Persona Knee replacement. Women's US Clothing Size Chart (CM): It should also be easy for users from outside USA/Canada to determine their US size. By addressing those opportunities in the Persona Knee, we believe comprehensive femoral sizing scheme on the market. We design locking mechanism, no lock-down screws or through holds, made ofTivaniumAlloy. Number of participants Patients at are randomized to receive either 1) Persona Total Knee System with MC polyethylene bearing or 2) Persona Total Knee System with CR polyethylene bearing. 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. The project is expected to be completed 2 years after recruitment of the last participant (2019). March 30, 2009. Zimmer Biomet Instrumentation 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. 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 . Patients with insufficient posterior cruciate ligament (PCL) and other patients unsuited for a CR implant receive a posterior stabilized (LPS) NexGen TKA. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Complications with the new devices arose merely months after their introduction to the market, sparking complaints from patients and an influx of adverse event reports to the FDA. Persona Total Knee System with a CR polyethylene liner. Failure rate of cemented and uncemented total hip replacements: register study of combined Nordic database of four nations. The Persona OsseoTi Keel Tibia is also complemented with a new cemented implant option to enable seamless versatility for the surgeon during the procedure. Amanda Pedersen | Aug 30, 2021. most widely used and clinically proven total knee system in the 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. Women's US Clothing Size Chart (CM): 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 Persona The Personalized Knee Surgical Technique, Persona Kinematically Aligned Total Knee Arthroplasty Most knee pain is caused by three types of arthritis, according to the American Academy of Orthopaedic Surgeons (AAOS), including osteoarthritis, rheumatoid arthritis and post-traumatic arthritis. Background Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. Participants may be excluded intraoperatively if the PCL is found insufficient and LPS prosthesis is required. So we studied the shapes and sizes of the hand to (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. The Zimmer Persona was approved by the FDA through its 510(k) approval process in late 2012, nearly two decades after Zimmer's 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." The EuroQol 5-dimension (EQ-5D) is a generic questionnaire that measures the overall health-related quality of life. without the express written consent of Zimmer Biomet. Persona The Personalized Knee is our solution featuring personalized implants, precise instrumentation, and proven technology. However, currently no studies exist evaluating outcome following use of MC polyethylene bearing. Ourmost comprehensivekneesystem, including anatomically accurate each procedure. The project is expected to be completed 2 years after recruitment of the last participant (2019). 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. 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. The Persona Knee was designed with all these elements in Vivacit-E Vitamin-E Highly Crosslinked Polyethylene For general information, Learn About Clinical Studies. was designed with all these elements in mind, because we believe a way 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. If you are visiting any of our drug pages please note: The FDA approved this medication after it determined that the benefits of the product outweigh the known risks for the intended use. Risk of dislocation using large- vs. small-diameter femoral heads in total hip arthroplasty. National Injury Help Staff Bios, who we are. [TimeFrame:2 Years], Knee Prosthesis motion by means of Fluoroscopy. The Forgotten Joint Score (FJS) measures the degree of joint awareness. 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. Comparative statistics will be used based on the distribution of data. To create a more natural feel and normal function for patients A plastic spacer is then inserted between the two metal components to create a smooth, frictionless surface. right implant options, conventional and Vitamin-E polyethylene options. A total score is calculated that ranges from 0 (high knee awareness) to 100 (low knee awareness). to deliver personalized patient care. 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. A class II recall means the probability of death or serious injury is remote but the use of the recalled device may cause temporary or reversible adverse health consequences. 384 0 obj <> endobj The knee is the bodys largest joint. All body measurements and statistics of Constance Zimmer, including bra size, cup size, shoe size, height, hips, and weight. Persona Ti-Nidium Femoral Components can be differentiated from CoCr components Weight 0.1310 kg - 0.3933 kg (0.29 lb - 0.87 lb) 0.0681 kg - 0.2031 kg (0.15 lb - 0.45 lb) Persona Tinidium Femoral Components are around 50% of the weight of CoCr Components Sizing Narrow:1-11 Standard: 1-12 Narrow:1-6 Standard: 4-12 Persona Ti-Nidium Implants include In the largest knee replacement lawsuit settlement, Sulzer Medica paid $1 billion to settle 4,000 hip and knee implant cases. 2023All rights reserved Lancet. System, created the foundation for what would become the Persona Knee. the implant to the shape and size of the resected bone. constraints, and youll see how the Persona Knee System is redefining personalization. Restoreligament balance with fivelevels of constraint in 1 mm 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 study's primary outcome measure is implant migration measured by RSA. Our legacy continues to come to life today through our progressive culture of evolution and innovation. 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. matters. Eventually parts wear out and need to be replaced, but it is estimated up to 85 percent of artificial knees still work after 20 years. The world has already listened to Sting. The Zimmer Persona femoral and tibial components are made from Zimmers patented Trabecular Metal technology. 2023 Major Media Consulting Inc. | Privacy Policy | All Rights Reserved. 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. Patient Reported Outcome Measures by means of questionaires. Now patients many of whom still have the recalled device implanted are filing lawsuits against the devices manufacturer. EMBASE search: NexGen AND Patients will be excluded intraoperative if CR implant is not suitable. increments, standard and narrow, left and rightimplant options,12 One design change that is introduced is the medial congruent (MC) polyethylene to be used instead of standard cruciate retaining (CR) design. The theoretic proposed benefit of MC polyethylene bearing is improved kinematics mimicking native knee motion. antioxidant protection to help meet long-term performance needsand Catalog excerpts. fit better and instruments designed for ease of use, without the In doing so, we confirmed that implant shape really matters. Orthopaedic Association National Joint Replacement Registry. This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Motion of the knee prosthesis during a step-up movement, measured by means of Fluoroscopic Motion Analysis. Adelaide. Your doctor prescribed this and/or any other medication to treat an underlying medical condition and stopping the use of any prescribed medication without consulting your physician is dangerous. In designing the Persona Knee, we identified several Only cemented femoral components will be used for this study. You have reached the maximum number of saved studies (100). weve achieved a big leap forward in total knee arthroplasty, making Project information is given at the first outpatient consultation, when treatment with insertion of a TKA is decided. An analysis of the Finnish arthroplasty registry. All measurements in inches. The 2015 Zimmer Persona knee implant recall was classified as class II by the FDA. Tapered Screw-Vent Implant System Product Catalog. step within the surgical procedure. The specific knee implant used during surgery, however, is chosen based on a patients age, weight, gender and physical activity level, among other factors. increments. Now its time to listen to his victim. 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. Patient has been classified ASA 1 or 2 (for the kinematic analysis) (Meyer Saklad, 1941). Tapered Screw-Vent Implant System Product Catalog. The primary investigator of this project has independently initiated the project. Zimmer Persona knee implants are one such device that did not require additional clinical data for approval. Nelissen, Leiden University Medical Center: Device: Persona PS Knee Prosthesis by Zimmer, Device: NexGen PS Knee Prosthesis by Zimmer. This type of arthritis occurs after a traumatic knee injury. Annual Report. satisfaction is to more closely reproduce the original.. According to the company, the device is considered the first "smart" knee implant on the market for total knee replacement . Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568123. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates. As a follow-up of the NexGen TKR, an improved design has recently been introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana . those needs. Declaration For California Compliance Law, Zimmer Biomet Bone Healing Technologies Notice of Privacy Practices. Joint Replacement | Orthopaedic Devices | Hip | Knee | Shoulder Ongoing research and development programs for knee replacement are increasingly taking account of the needs of the changing characteristics of the late stage OA knee population. The manufacturer, Zimmer, says its recall is voluntary. Epoxy Flooring UAE; Floor Coating UAE; Self Leveling Floor Coating; Wood Finishes and Coating; Functional Coatings. We took the elements that made the NexGen Knee and Natural-Knee II Adelaide.AOA 2016: Table KT9 +r[k>mio;&;=&+)KwZ]v.=K+X ZAM=\oTs$ngQ%.f%1*Rbe~@"hl93[ 5k. Adelaide.AOA 2009). Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. 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. "The predicted growth in the prevalence of arthritis in younger, active patients has made cementless total knee arthroplasty an increasingly essential option for surgeons," said Charles Lawrie, M.D., orthopedic surgeon at Baptist Health Orthopedic Care and Clinical Associate Professor at the Florida International University, Herbert Wertheim College of Medicine in Miami, FL, and a member of the Persona OsseoTi development team. While designing the Persona Knee, we used a combination of advanced research tools to study hundreds of knees, creating a global bone atlas. 2016 Sales data There are different approaches to prosthetic replacement and current practices and designs are often based on limited evidence (Plate et al. 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 arent fully satisfied with the feel of their new knee.1-3. 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. Plate JF, Seyler TM, Stroh DA, Issa K, Akbar M, Mont MA. 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. Industrial Design Style, 10A* ODEP rating for CR and PS knees both with and without To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Knee motion following primary total knee replacement in both treatment Groups will be measured using fluoroscopic dynamic RSA analysis. 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. The theoretic proposed benefit of MC polyethylene bearing is improved kinematics mimicking native knee motion. 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. Read our, ClinicalTrials.gov Identifier: NCT03568123, Interventional You have reached the maximum number of saved studies (100). 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. 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. While designing the Persona Knee, we used a combination of advanced 7i. 2014 Jan 13;348:f7592. Prosthesis placement and bone resection measured by means of CT and caliper measurements of the resected bone parts. Both standard as well as narrow femoral components will be used, depending on the patient anatomy. 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. Tibia specs:Anatomic disproportional M/L growth, 9 sizes, left and Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. 00:00. Total knee replacement surgery boasts high success rates and the majority of knee implants are estimated to last more than two decades. This furthered our understanding of native anatomic shape and the resected bone? We anticipate that inclusion can be accomplished within a 2 year period. Studies have shown that modern implant designs can potentially improve outcome. not be redistributed, duplicated or disclosed, in whole or in part, While symmetric and asymmetric tibial designs had long Arthroscopy with meniscectomy / cartilage surgery / house cleaning is allowed. National Joint Replacement Registry. Complications from knee surgeries do arise, but are considered rare. patella, Every 90 seconds a patient receives