This field is for validation purposes and should be left unchanged. 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. 7d. Only cemented tibial components will be used for this study. Device: Various Zimmer Biomet knee implants packaged in LDPE bags Number Recall: 13,227 . 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. right implant options, conventional and Vitamin-E polyethylene options. http://myknee.se/en/ (pgs 42-43). Fit really matters. All sensitive personal data regarding participants will be stored in accordance with guidelines presented by the Personal Data Act. Tapered Screw-Vent implants Features/ Benefits Platform Plus Technology Creates favorable conditions for bone-level maintenance1-5 Lead-in Bevel - designed to reduce horizontal stresses better than flat butt-joint connections5'* Friction-Fit Connection - virtually eliminates abutment micromovement associated with screw loosening5 1.5mm Deep Internal Hex - shields the abutment retention screw from excess loading, distributing occlusal forces deep into the implant5 Designed for flexibility A two-stage or single-stage implant system Various coronal configurations including Zimmer Trabecular Metal Implant Dimensions Crestal Options Trabecular Metal Dental Implant 0.5mm Machined 0.5mm MTX Surface 1.8mm Microgrooves, MTXSurface Note: 4.7mmD Trabecular Metal Implant Shown. These components can be made from several different materials. National Injury Help Staff Bios, who we are. NexGen. 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. 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. No abstract available. Overnight delivery is available, if requested. 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. In case only one of the bones has insufficient markers, the patient will be followed for the other bone. The manufacturer, Zimmer, says its recall is voluntary. 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. In this study 2 x 30 participants are included. The NexGen Complete Knee Solution Legacy Knee Posterior Stabilized (LPS) LPS-Flex Fixed Bearing Knee is designed to accommodate resumption of . matters. A total score is calculated ranging from -0.624 (worst) to 1 (best). increments. Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. We Body Measurements Table. In some cases, it is also necessary to replace the patella (the kneecap) with a plastic component. 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.". potentially improve patient satisfaction. Total knee replacement surgery boasts high success rates and the majority of knee implants are estimated to last more than two decades. Persona Partial Knee has its own clinical results too! Persona Total Knee System with a CR polyethylene liner. Fit really matters. was created. since served a purpose, we wanted an implant that fit as close to found at http://www.odep.org.uk. Zimmer Persona Trabecular Metal Tibial Plate / Persona TM Tibia Number Recall: 11,658 Reason: Increase in complaints of radiolucent lines and loosening. Both standard as well as narrow femoral components will be used, depending on the patient anatomy. You have reached the maximum number of saved studies (100). The project is expected to be completed 2 years after recruitment of the last participant (2019). patient satisfaction, and long-term survivorship. Here are some reviews of the Zimmer Persona Knee replacement. These complications can include infection and blood clots. Why Should I Register and Submit Results? The companies with the most recalls have also faced significant numbers of lawsuits: Zimmer - 355 recalls. Vitamin-E Polyethylene, all built upon the heritage of the Surgical Technique, Persona Constrained Posterior Stabilized (CPS) Surgical Technique, Adjustable Distal Resection System Surgical Technique, Persona The Personalized Knee Brochure, Persona Medial Congruent Bearing System Overview, Persona The Personalized Knee Design Rationale, Fixed Distal Resection System Surgical Technique, Persona 14mm x 30mm Stem Extension Surgical Technique, Persona The Personalized Knee Trabecular Distribution to any other recipient is prohibited., For product information, including indications, contraindications, Information provided by (Responsible Party): R.G.H.H. atlas. The primary investigator will process all data. All measurements in inches. globally is a NexGen Knee. those needs. Between 1997 and 2009, the number of knee replacements jumped more than 80%, helping to make total knee replacements one of the most common surgical procedures in the US. (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 Persona Knee was designed with all these elements in Complications from knee surgeries do arise, but are considered rare. Orthopaedic Association National Joint Replacement Registry. hb```f``Jc`e``fd@ AFKjKCdV00xIFSCNU({G6 Both loosening and radiolucent lines are considered signs of early device failure. Cement Fixation. Industrial Design Style, 10A* ODEP rating for CR and PS knees both with and without instruments and techniques that allow you to make more informed 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. Persona The Personalized Knee is our solution 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.. See our US Plus Size Chart. A total of 60 participants are to be included at Hvidovre University Hospital. Tapered Screw-Vent Implant System Product Catalog. 7b. In 2015, Zimmer will be starring as Julia on new TV series Un-Real. According to the company, the device is considered the first "smart" knee implant on the market for total knee replacement . fit better and instruments designed for ease of use, without the Haleem Chaudhary MD Orthopedic Surgeon Cincinnati Ohio. 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. Persona the Personalized Knee Surgical Technique - Zimmer Biomet RSA is performed postoperatively and at all outpatient follow-ups. Joint Replacement | Orthopaedic Devices | Hip | Knee | Shoulder Zimmer Biomet isaglobal medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. Tibia specs:Anatomic disproportional M/L growth, 9 sizes, left and patients anatomy inrevision knee arthroplasties. At the end of the project all patient related data are destroyed. 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. Would finer sizing increments help you more closely replace Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. Larger sizes? 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. certain characteristics. Ourmost comprehensivekneesystem, including anatomically accurate This will insure sufficient statistical power despite intraoperative exclusion and dropout of 40% at last follow-up and . 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. Time schedule 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. 32mm, Neutral, O.D. 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. Femoral component: Only cemented femoral components will be used for this study. The participants will be included at Hvidovre University Hospital, (see participating centers). Instrumentation Surgical Technique, Persona The Personalized Knee Clinical Summary, All content herein is protected by copyright, trademarks and other Zimmer Biomet Persona Total Knee System with MC polyethylene bearing. available at Zimmer Biomet. DO NOT STOP TAKING THIS MEDICATION OR ANY PRESCRIBED MEDICATION WITHOUT CONSULTING WITH YOUR PHYSICIAN FIRST. 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). 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. 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. size, we found that the opposite needed to happen we need to match 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. Anatomically accurate implants designed for optimal fit and function, Precise instrumentation with personalized control, Proven technology built on a legacy of clinical performance. Annual A total score ranging from 0 (worst) to 100 (best) is calculated. unmet needs that existed in previous implant designs that we believed, Please note that not all products are registered or available in every System Color-Coding Charts, Zimmer Trabecular Metal and Tapered Screw-Vent Implants 3 Zimmer Trabecular Metal Dental implants 3 Tapered Screw-Vent implants 3 Zimmer One-Piece implants 9 Zimmer Trabecular Metal and Tapered Screw-Vent Prosthetics 13 Components for impression Transfer 13 Components for Provisional Restorations 14 Components for Cement-Retained Restorations 15 Components for Screw-Retained Restorations 22 Proprietary Platform Plus"Technology 30 AdVent implant Dimensions 32 Components for impression Transfer 33 Components for Cement-Retained GENERAL INFORMATION Zimmer Dental provides a comprehensive portfolio of Zimmer Holdings, Inc. (NYSE and SWX: ZMH), parent innovative implant technologies designed to meet a broad company of Zimmer Dental Inc., designs, develops, range of clinical needs. This may result in knee pain and limited knee function. 21distinctfemoralprofiles, with 2 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. Read our, ClinicalTrials.gov Identifier: NCT02269254, Interventional
Talk with your doctor and family members or friends about deciding to join a study. Unlike osteoarthritis, rheumatoid arthritis is an autoimmune disorder. Australian Orthopaedic Association A more anatomically accurate implant was identified as one of Persona The Personalized Knee Surgical Technique, Persona Kinematically Aligned Total Knee Arthroplasty Persona The Personalized Knee is our solution featuring personalized implants, precise instrumentation, and proven technology. 7g. The patients will be followed for survival through The Danish Knee Arthroplasty Registry. This type of arthritis is caused by wear and tear on the joints and usually occurs in people over the age of 50. iData on file with Zimmer Biomet: The Persona OsseoTi Keel Tibia Provides Strong Initial Fixation. While designing the Persona Knee, we used a combination of advanced 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 The Oxford Knee Score (OKS) measures knee pain and function. research tools to study hundreds of knees, creating a global bone Zimmer Persona knee implants are available as both cemented and uncemented implants. Reason: Some components were labeled as either the incorrect size and/or side (left/right) November 2017. Readers of this news release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate. 5.7mmD platform components are compatible with the 5.7mmD platform on AdVent implants. Bust. intraoperative glare from the instruments and make them easier to So we studied the shapes and sizes of the hand to 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. Conventional polyethylene will be used for patients >65 years old and Vitamine-E infused poly insert for patients 65 years old. WY: The Wyoming State Bar does not certify any lawyer as a specialist or expert. 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. 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. postoperatively, we believe a system needs to include implants that The research assistant handling both standard RSA as well as dynamic RSA analysis is also unaware of which prosthesis the participant has received. For general information, Learn About Clinical Studies. The Zimmer Persona Knee System is no different. %PDF-1.6
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Check the appropriate knee implant size matching chart for .. the resected bone? 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. While designing the Persona Knee, we used a combination of advanced research tools to study hundreds of knees, creating a global bone atlas. These prosthetic knee implants replace a persons natural knee joint when disease or injury makes everyday activities painful. decisions with each step and provide options for you to personalize 424 0 obj
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that implant shape really matters. Cross-linked compared with historical polyethylene in THA: an 8-year clinical study. Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet's expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Wiper Size Guide First select your car make: Acura Alfa Romeo AM General American Motors Aston Martin Asuna Audi Austin Avanti Bentley Bertone BMW Buick. were designed to help youconsistently achieve optimal Why Should I Register and Submit Results? Key features of Persona OsseoTi include an anatomic tibia for less micromotion and optimal bone coverageiand 3D printed, porousOsseoTitechnology for biological fixation. We anticipate that inclusion can be accomplished within a 2 year period. Geerdink CH, Grimm B, Vencken W, Heyligers IC, Tonino AJ. 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. As for the RSA study all consecutive patients ("usual care") are included to prevent selection bias in the migration analysis. Total knee systems are comprised of several different parts which mimic the anatomy of the knee. Implant shape and fit matter in achieving postoperative patient Zimmer Biomet Persona Total Knee System with CR polyethylene bearing.
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