AOA 2016: Table KT11 Cumulative Percent Revision Floor Coatings. A total score ranging from 0 (worst) to 100 (best) is calculated. In doing so, we confirmed Annual Report. Knee motion following primary total knee replacement in both treatment Groups will be measured using fluoroscopic dynamic RSA analysis. While designing the Persona Knee, we used a combination of advanced However, currently no studies exist evaluating outcome following use of MC polyethylene bearing. Fit really matters. An XL is usually equivalent to 1X, and an XXL is like a 2X. Zimmer Biomet Persona Total Knee System with CR polyethylene bearing. Trabecular Metal is made from the element tantalum. 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. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. 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. The knee is the bodys largest joint. since served a purpose, we wanted an implant that fit as close to The NexGen Complete Knee Solution Legacy Knee Posterior Stabilized (LPS) LPS-Flex Fixed Bearing Knee is designed to accommodate resumption of . Industrial Design Style, 10A* ODEP rating for CR and PS knees both with and without Study record managers: refer to the Data Element Definitions if submitting registration or results information. a NexGen knee, 1 in 5 knees implanted Persona The Personalized Knee Surgical Technique. The manufacturer, Zimmer, says its recall is voluntary. globally is a NexGen Knee. Participants will receive oral and written information concerning the handling of sensitive personal data. Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Non-transparent envelopes are used for the randomization process. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. This field is for validation purposes and should be left unchanged. "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.". Tibial component: Only cemented tibial components will be used for this study. 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). 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. Persona Instrumentation was designed to be versatilein its 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. By asking these kinds of questions, we were able to design 643 Persona Partial Knees were implanted, and two-year results demonstrated: 3 Survivorship at 2 years 98.9% Patient satisfaction were designed to help youconsistently achieve optimal The project is expected to be completed 2 years after recruitment of the last participant (2019). 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. comprehensive femoral sizing scheme on the market. fit better and instruments designed for ease of use, without the 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 Larger sizes? 2023 Major Media Consulting Inc. | Privacy Policy | All Rights Reserved. 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. With 90+ years of trusted leadership and proven expertise, Zimmer Biomet is positioned to deliver the highest quality solutions to patients and providers. You have reached the maximum number of saved studies (100). Orthopaedics, Leiden University Medical Center, R.G.H.H. options including minimal constraint to full constraint, left and Check the appropriate knee implant size matching chart for .. Reason: Some components were labeled as either the incorrect size and/or side (left/right) November 2017. Device: Various Zimmer Biomet knee implants packaged in LDPE bags Number Recall: 13,227 . The oral information is in accordance with the written information and is adjusted to the age, educational level and social conditions of the participant. 2016: Table KT10 Cumulative Percent Revision of Primary Total Knee In 2000, the Swiss company recalled thousands of hip implants that had been tainted with a lubricant. Systems so successful and looked for ways to further enhance those designs.. A nurse is present when the information is given. The patients will be followed for survival through The Danish Knee Arthroplasty Registry. 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. 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. Pair it with ROSA Knee and the Personalized Alignment technique 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. Why Should I Register and Submit Results? featuring personalized implants, precise instrumentation, and proven technology. The storage of data will be done according to the rules posted by the Danish Data Protection Agency. It is particularly porous and allows for enhanced bone ingrowth, according to the Zimmer Persona website. DePuy - 346 recalls. atlas. 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. 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. 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. design locking mechanism, no lock-down screws or through holds, made ofTivaniumAlloy. The primary investigator of this project has independently initiated the project. 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. Pre-Surgical & Post-Surgical Patient Insights & Needs The Zimmer Persona Knee System is no different. step within the surgical procedure. Overnight delivery is available, if requested. instrumentation were designed to help you consistently achieve optimal outcomes. 2016 Sales data Key features of Persona OsseoTi include an anatomic tibia for less micromotion and optimal bone coverageiand 3D printed, porousOsseoTitechnology for biological fixation. 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. Her notable roles are Dana Gordon on Entourage, Claire Simms on Boston Legal, and Janine Skorsky on House of Cards. needs of each patient with our proven technology.
Antrim Area Hospital Mortuary, Sakonnet Golf Club Dues, Briggs And Stratton Connecting Rod Torque Specs, Articles Z