EMBASE search: NexGen AND Patients will be excluded intraoperative if CR implant is not suitable. not be redistributed, duplicated or disclosed, in whole or in part, patella, Every 90 seconds a patient receives An individual data sheet will be kept for each recruited participant. Triathlon | Stryker Tapered Screw-Vent Implant System Product Catalog. Read our, ClinicalTrials.gov Identifier: NCT03568123, Interventional mmincrements available in standard andnarrow provide the most Product Catalog - Zimmer Dental - PDF Catalogs - MedicalExpo Brief Summary: 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. With more medial stability and lateral mobility, the Persona Medial Congruent Bearing is the most kinematic-friendly bearing Zimmer Biomet has designed. Both loosening and radiolucent lines are considered signs of early device failure. Allocation of the participants to one of the two treatment groups is done intraoperatively. In this study 2 x 30 participants are included. a NexGen knee, 1 in 5 knees implanted todays knee replacement systems, studies suggest that one in four 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). hbbd```b`` q?d,@$/t `qKtDJu%H)^0L\`-`@h d 3012030R wig potentially improve patient satisfaction. PDF Persona the Personalized Knee Surgical Technique - Zimmer Biomet Both standard as well as narrow femoral components will be used, depending on the patient anatomy. Radiologically verified stability and fixation is measured as the Maximum total point motion (MTPM) using RSA. %%EOF Persona The Personalized Knee is our solution This project is financed by Zimmer-Biomet, Warsaw, Indiana, USA. Many knee implant manufacturers make personalized knee systems for women because of this and other differences. Annually 40 TKA procedures are performed in our department, of which about 70% is Osteo Arthritis (OA) and 30% Reumatoid Arthritis (RA). Knee replacement lawsuits claim the devices loosened, became unstable and required revision surgery to correct the problems. 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." 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. 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). If your measurements fall between two sizes, we recommend to select the larger size (but you may try both sizes on if possible). 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. Pair it with ROSA Knee and the Personalized Alignment technique information.To obtain a copy of the current Instructions for Use Recruitment is expected completed after a period of 1.5 year. 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. Bust. FDA Clears Zimmer Biomet's Smart Knee Implant | mddionline.com This may result in knee pain and limited knee function. 2009). size, we found that the opposite needed to happen we need to match 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. The settlement averaged $200,000 per patient. (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. These options found within the Persona Knee Systems National Injury Help Staff Bios, who we are. There is an increasing demand for joint replacement in a younger population (Mkel et al. Could we be more bone conserving? 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. 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. According to the agency, 11,658 devices are affected by the recall. research tools to study hundreds of knees, creating a global bone Congruent Bearing is the most kinematic-friendly bearing Zimmer 384 0 obj <> endobj These complications can include infection and blood clots. Device: Various Zimmer Biomet knee implants packaged in LDPE bags Number Recall: 13,227 . To create a more natural feel and normal function for patients in the event of deep infection leading to replacement of the prosthesis or long-term immobilization because of comorbidity. US Size. certain characteristics. Read our, ClinicalTrials.gov Identifier: NCT02269254, Interventional Study record managers: refer to the Data Element Definitions if submitting registration or results information. Men's Size Charts & Conversions: Pants, Shirts, Waist, Chest iData on file with Zimmer Biomet: The Persona OsseoTi Keel Tibia Provides Strong Initial Fixation. Only cemented tibial components will be used for this study. A computer-generated random allocation sequence will be used. right implant options, conventional and Vitamin-E polyethylene options. 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. The patient is unable or unwilling to sign the Informed Consent specific to this study, Insufficient Dutch or English language skills, Patients indicated for revision arthroplasty. increments. 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 [TimeFrame:1 Year], Patient is diagnosed with osteoarthritis or rheumatoid arthritis and requiring primary knee arthroplasty. mind, because we believe a way to predictably improve patient Adelaide. options including minimal constraint to full constraint, left and antioxidant protection to help meet long-term performance needsand satisfaction is to more closely reproduce the original.. 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An XL is usually equivalent to 1X, and an XXL is like a 2X. Both standard as well as narrow femoral components will be used, depending on the patient anatomy. %PDF-1.6 % 7e. assemble, so we created a matte finish. 31:32. We also believed that the femoral shape should reflect List: Every abusive Catholic Church priest, clergy member named in every state in the past year. Participants are included when signed consent from the participant is obtained. Orthopaedic Association National Joint Replacement Registry. Zimmer Biomet Expands Persona Knee System Portfolio with FDA Clearance Stratification is performed per diagnosis group (OA/RA). (IFU) for full prescribing and risk information, please call 1-800-348-2759, press 4 for 411 Technical Support., Quantifying Your Patient Recovery with ZBEdges Persona IQ and the mymobility Care Management Platform, AAOS Las Vegas 03.08.23, Dealers Choice: ORIF vs. Total Hip Replacement AAOS Las Vegas 03.08.23, Zimmer Biomet Announces Fourth Quarter and Full-Year 2022 Financial Results, Zimmer Biomet Announces Webcast and Conference Call of Fourth Quarter 2022 Financial Results, Cemented and cementless total knee arthroplasty, Cruciate retainingand cruciatesacrificing options. Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. Annual 2016 Sales data 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 2015, Zimmer will be starring as Julia on new TV series Un-Real. cases. In a market focused on matching the bone to the implant shape and Fit really matters. Women's US Size Chart Tapered Screw-Vent Implant System Product Catalog. Femoral component: Only cemented femoral components will be used for this study. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. components with finer increments to helpsurgeonspersonalize the fit 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. For more information about the Persona OsseoTi Keel Tibia, visit https://www.zimmerbiomet.com/en/products-and-solutions/specialties/knee/persona-osseotikeeltibia.html. The project is expected to be completed 2 years after recruitment of the last participant (2019). The objective of this study is to accurately assess and compare migration, kinematics, prosthesis placement and patient reported outcomes of two TKR prostheses: the fixed bearing, cemented NexGen LPS, a proven design with an excellent clinical track record, and the fixed bearing, cemented Persona PS, a new design without clinical data (both designs by Zimmer, Warsaw, Indiana, USA). 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. You have reached the maximum number of saved studies (100). Patient outcomes can be driven by the precision and accuracy of each Zimmer Persona Trabecular Metal Tibial Plate / Persona TM Tibia Number Recall: 11,658 Reason: Increase in complaints of radiolucent lines and loosening. Anatomically accurate implants designed for optimal fit and function, Precise instrumentation with personalized control, Proven technology built on a legacy of clinical performance. In some cases, it is also necessary to replace the patella (the kneecap) with a plastic component. The specific component involved in the recall was called a Trabecular Metal Tibial Plate. 2023All rights reserved Adelaide.AOA 2016: Table KT9 Orthopaedics, Leiden University Medical Center, R.G.H.H. A Comparison of Total Knee Replacement Patients Using the Zimmer-Biomet Instrumentation and technology really matters. 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. Patients with insufficient posterior cruciate ligament (PCL) and other patients unsuited for a CR implant receive a posterior stabilized (LPS) NexGen TKA. 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. Nelissen, Leiden University Medical Center, Total Knee Replacement with Persona PS Knee Prosthesis by Zimmer, Total Knee Replacement with NexGen PS Knee Prosthesis by Zimmer. BMC Res Notes. 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. Persona The Personalized Knee Surgical Technique, Persona Kinematically Aligned Total Knee Arthroplasty The knee is the bodys largest joint. 2 Femur Exposure SECTION2 . In 2000, the Swiss company recalled thousands of hip implants that had been tainted with a lubricant. Knee Replacement Lawsuits | Settlements and Verdicts - Consumer Notice, LLC 2008 Oct;90(10):2160-70. doi: 10.2106/JBJS.G.00870. warnings, precautions, potential adverse effects and patient 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. ~(uw?Wv(y!!5MQTn%QcxM~ As a follow-up of the NexGen TKR, an improved design has recently been introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana . Comparative statistics will be used based on the distribution of data. Check the appropriate knee implant size matching chart for .. Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. With more medial stability and lateral mobility, the Persona Medial 00:00. 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. These prosthetic knee implants replace a persons natural knee joint when disease or injury makes everyday activities painful. Studies have shown that modern implant designs can potentially improve outcome. Key features of Persona OsseoTi include an anatomic tibia for less micromotion and optimal bone coverageiand 3D printed, porousOsseoTitechnology for 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. Cup with Spacers, 49 mm. Considering this success rate, it came as a shock when a new-generation knee implant manufactured by one of the largest orthopedic companies in the world was recalled due to device failure merely three years after it was introduced to the market. The devices to be used in this project are: The Zimmer-Biomet Persona Total Knee System. patient satisfaction, and long-term survivorship. counseling information, see the package insert or contact your local Both standard as well as narrow femoral components will be used, depending on the patient anatomy. With that, the Persona Anatomic Tibia Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA). fit better and instruments designed for ease of use, without the To make ordering easier, please have your customer number, the catalog number and the quantity of items you wish to order. 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. Arthroscopy with meniscectomy / cartilage surgery / house cleaning is allowed. Australian Studies have shown that 15%-39% of patients who undergo total knee surgery are not satisfied with the outcome. We anticipate that inclusion can be accomplished within a 2 year period. 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.
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