The Persona Knee System gives you the ability to address the unique WY: The Wyoming State Bar does not certify any lawyer as a specialist or expert. The hiring of a lawyer is a very important decision that should not be based solely upon advertisements. 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. 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. 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). 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. Recruitment is expected completed after a period of 1 year. 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. In a market focused on matching the bone to the implant shape and Femoral component: Only cemented femoral components will be used for this study. The Zimmer-Biomet Persona Total Knee System is a novel total knee system developed by Zimmer-Biomet. These complications can include infection and blood clots. 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. Statistics A professional statistical software package will be used when processing data in this project. Journal of Bone Instrumentation and technology really matters. Persona Knee. Co-authorship is awarded according to the Vancouver rules. those needs. Project information is then given in an undisturbed environment (in a closed examination room) by an authorized investigator of this project. not be redistributed, duplicated or disclosed, in whole or in part, Now patients many of whom still have the recalled device implanted are filing lawsuits against the devices manufacturer. 2012). This type of arthritis occurs after a traumatic knee injury. Both standard as well as narrow femoral components will be used, depending on the patient anatomy. 31:32. 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. Comparative statistics will be used based on the distribution of data. Restoreligament balance with fivelevels of constraint in 1 mm The theoretic proposed benefit of MC polyethylene bearing is improved kinematics mimicking native knee motion. 384 0 obj <> endobj components with finer increments to helpsurgeonspersonalize the fit Zimmer Persona knee implants are available as both cemented and uncemented implants. Clin Orthop Relat Res. The project is expected to be completed 2 years after recruitment of the last participant (2019). that implant shape really matters. Persona Total Knee System with a CR polyethylene liner has been used as a standard implant of choice at Hvidovre Hospital since January 2016 for patients suited for a CR implant. Persona The Personalized Knee is designed to help the surgeon accomplish these goals by combining alignment accuracy with a simple, straight-forward technique. Altered pain perception and / or neurologic affection due to diabetes or other disorders. to deliver personalized patient care. in the event of deep infection leading to replacement of the prosthesis or long-term immobilization because of comorbidity. Pair it with ROSA Knee and the Personalized Alignment technique 7e. Participants are included when signed consent from the participant is obtained. Complaints of device loosening after surgery and radiolucent lines soon flooded the FDAs online adverse event database. What was the ethnicity and gender of the You have reached the maximum number of saved studies (100). Activities of daily living take higher priority in this patient group, and patients needing total joint replacement do not have many options that accommodate higher levels of activity. When osteoarthritis occurs, the cartilage that cushions the bones of the knees softens and wears away, leaving the bones to rub against each other causing stiffness and pain. atlas. 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. 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 Industrial Design Style, 10A* ODEP rating for CR and PS knees both with and without mmincrements available in standard andnarrow provide the most 00:00. representative; search this website for additional product Geerdink CH, Grimm B, Vencken W, Heyligers IC, Tonino AJ. Data recording Data relevant for this project will be registered in a data sheet. While you can expect excellent implant survivorship with many of Overnight delivery orders must be placed . Zimmer Biomet- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. There have been individual cohort studies, indirect comparisons and retrospective studies to test the efficacy of a variety of different total knee replacement devices but there are very few high quality investigations of new paradigms or significant design change. Talk with your doctor and family members or friends about deciding to join a study. Congruent Bearing is the most kinematic-friendly bearing Zimmer While designing the Persona Knee, we used a combination of advanced The project will be reported to the Danish Data Protection Agency. The devices to be used in this project are: The Zimmer-Biomet Persona Total Knee System. Risk of dislocation using large- vs. small-diameter femoral heads in total hip arthroplasty. 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. 2008 Oct;90(10):2160-70. doi: 10.2106/JBJS.G.00870. 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 project is financed by Zimmer-Biomet, Warsaw, Indiana, USA. Prosthesis placement and bone resection measured by means of CT and caliper measurements of the resected bone parts. By addressing those opportunities in the Persona Knee, we believe Partial Knee is redefining personalization in fixed bearing partial Study record managers: refer to the Data Element Definitions if submitting registration or results information. size, we found that the opposite needed to happen we need to match 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. to predictably improve patient satisfaction is to more closely 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. 2023All rights reserved (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. each procedure. 2023 Major Media Consulting Inc. | Privacy Policy | All Rights Reserved. In doing so, we confirmed that implant shape really matters. Australian Orthopaedic Association Participants are informed about the right to having a dependent present when project information is given. Nelissen, Prof. PhD MD Head of the Department of Orthopaedics, Leiden University Medical Center, 30 Patients with NexGen LPS prosthesis and 30 patients with Persona PS prosthesis for RSA, 15 Patients with NexGen LPS prosthesis and 15 patients with Persona PS prosthesis for Fluo. Systems so successful and looked for ways to further enhance those designs.. This furthered our understanding of native anatomic shape and Motion of the knee prosthesis during a step-up movement, measured by means of Fluoroscopic Motion Analysis. Our legacy continues to come to life today through our progressive culture of evolution and innovation. The Persona Revision Knee System expands the Persona Knee System to EMBASE search: NexGen AND 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. Adverse Events including intraoperative complications and revisions at any post-operative time points. The Persona Knee was designed with all these elements in 7b. Conventional polyethylene will be used for patients >65 years old and Vitamine-E infused poly insert for patients 65 years old. As for the RSA study all consecutive patients ("usual care") are included to prevent selection bias in the migration analysis. Anatomically accurate implants designed for optimal fit and function, Precise instrumentation with personalized control, Proven technology built on a legacy of clinical performance. Total knee systems are comprised of several different parts which mimic the anatomy of the knee. Publications The results of this project are expected published in an international medical journal. US Size. (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. With more medial stability and lateral mobility, the Persona Medial 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. Annual Report. indicate that internal mal-rotation ofimplants may lead to over 50 -, All Zimmer Dental catalogs and technical brochures, SAFESCRAPER TWIST Cortical Bone Collector, THE CHAIRSIDE ATTACHMENT PROCESSING MATERIAL, Packaging for Zimmer One-Piece Implants, SwissPlus Implant System Product Catalog, Trabecular MetalTM Dental Implant Brochure. All sensitive personal data regarding participants will be stored in accordance with guidelines presented by the Personal Data Act. In some cases, it is also necessary to replace the patella (the kneecap) with a plastic component. 7i. 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. Radiographically verified radiolucency / osteolysis. Radiologically verified stability and fixation is measured as the Maximum total point motion (MTPM) using RSA. comprehensive, and comfortable withrepetitive use. The Persona Partial Knee carries forward design elements of the Zimmer Miller Galante (M/G) Uni, which showed 98% survivorship at 10 years and 90% at 20 years 1 . Get to know Zimmer Biomets leadership team. warnings, precautions, potential adverse effects and patient 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. Total knee replacement surgery boasts high success rates and the majority of knee implants are estimated to last more than two decades. Doctors determine whether or not a total knee replacement is necessary based a patients pain and disability, not age or weight. These components can be made from several different materials. capabilities and philosophies, precise in itsmeasurements, 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. and Joint Surgery (British) 92-B:1238-44; 2010. on Persona Sizing Plate Handle 14 Set Tibial Rotation 15 Verify Overall Alignment 16 . The world has already listened to Sting. If your measurements fall between two sizes, we recommend to select the larger size (but you may try both sizes on if possible). Participants are informed that a period of consideration of at least 2 weeks is an opportunity along with the right to a second consultation. The settlement averaged $200,000 per patient. 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. No abstract available. Dynamic RSA is performed at 1 year follow-up. 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. for each patient and restore the unique identity of every knee anatomy. Many knee implant manufacturers make personalized knee systems for women because of this and other differences. Cadillac Checker Chevrolet Chrysler Citroen Coda Daewoo Daihatsu DeLorean DeSoto Dodge Eagle Edsel. The Zimmer Persona femoral and tibial components are made from Zimmers patented Trabecular Metal technology. Bust. Ourmost comprehensivekneesystem, including anatomically accurate 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. 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. 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. 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. most widely used and clinically proven total knee system in the 2009). Arthroscopy with meniscectomy / cartilage surgery / house cleaning is allowed. Nelissen, Leiden University Medical Center: Device: Persona PS Knee Prosthesis by Zimmer, Device: NexGen PS Knee Prosthesis by Zimmer. With more medial stability and lateral mobility, the Persona Medial Congruent Bearing is the most kinematic-friendly bearing Zimmer Biomet has designed. The specific component involved in the recall was called a Trabecular Metal Tibial Plate. 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 secondary objective is to assess and compare clinical data, kinematics, prosthesis placement and patient reported outcome measures. Latest ODEP ratings can be "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. the resected bone? However, currently no studies exist evaluating outcome following use of MC polyethylene bearing. Haleem Chaudhary MD Orthopedic Surgeon Cincinnati Ohio. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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. A/P sizes. A total of 60 participants are to be included at Hvidovre University Hospital. 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. In case only one of the bones has insufficient markers, the patient will be followed for the other bone. 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. patients anatomy inrevision knee arthroplasties. "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. reproduce the original. Adelaide. Adelaide.AOA 2016: Table KT9 Unlike osteoarthritis, rheumatoid arthritis is an autoimmune disorder. weve achieved a big leap forward in total knee arthroplasty, making All measurements in inches. 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. You should expect your instruments Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. The manufacturer, Zimmer, says its recall is voluntary. information.To obtain a copy of the current Instructions for Use research tools to study hundreds of knees. 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. 2012 Oct 5;5:553. doi: 10.1186/1756-0500-5-553. a NexGen knee, 1 in 5 knees implanted 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. Implant shape and fit matter in achieving postoperative patient Migration, measured by means of RSA. A more anatomically accurate implant was identified as one of Trabecular MetalMaterial, Predecessor to the Persona System, the NexGen Knee System is the Patients who received the uncemented device may be eligible for financial compensation in the form of a settlement. Declaration For California Compliance Law, Zimmer Biomet Bone Healing Technologies Notice of Privacy Practices. Both loosening and radiolucent lines are considered signs of early device failure. Zimmer Persona implants are manufactured by Zimmer Inc. (now Zimmer Biomet). 0 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. Vivacit-E Vitamin-E Highly Crosslinked Polyethylene available at Zimmer Biomet. More than 4.5 million Americans are living with a prosthetic knee implant called a total knee replacement. Depuy Attune, Zimmer NexGen and Arthrex iBalance are among the knee implants named in lawsuits. 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. Project information is given at the first outpatient consultation, when treatment with insertion of a TKA is decided. intraoperative glare from the instruments and make them easier to You have reached the maximum number of saved studies (100). 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. Biomet has designed. In vivo kinematics by means of fluoroscopy. http://myknee.se/en/ (pgs 42-43). With that, the Persona Anatomic Tibia View this study on Beta.ClinicalTrials.gov. Adult Reconstruction and Joint Replacement Service Primary Total Knee Arthroplasty with Zimmer Biomet Persona Personalized Knee System (Cadaveric) Orthopaedic Surgical Videos 15.9K subscribers. 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. 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. 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." With over 15 years and over 3 million implantations worldwide, Triathlon has a long clinical history. The purpose of the proposed Randomized Clinical Trial (RCT) is to evaluate the outcome and safety of a newly designed polyethylene bearing by comparing it with a control group of patients implanted with an established polyethylene bearing. repetitive use. Complications from knee surgeries do arise, but are considered rare. 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. 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. Big or plus sizes are marked as 1X, 2X, 3X, etc. 1961). 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. Femur specs:Anatomic design with21 distinct profilesin2mm 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. globally is a NexGen Knee. 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. Why Should I Register and Submit Results? Floor Coatings. knee design. compromises inherent with many systems today. 32mm, Neutral, O.D. Persona Total Knee System with a CR polyethylene liner. 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. 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. Select variants from the 2016 Swedish National Registry available at 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. 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. Anyone considering a lawyer should not rely upon advertisements or self-proclaimed expertise, and independently investigate the lawyer's credentials and ability. 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. satisfaction is to more closely reproduce the original.. Zimmer Biomet or its affiliates unless otherwise indicated, and must 7h. Rowley, D. Internal rotational error of the tibial component is a outcomes., Options available using Trabecular Metal Technology,Vivacit-E Arthritis can be caused by a disease or a traumatic injury. Knee motion following primary total knee replacement in both treatment Groups will be measured using fluoroscopic dynamic RSA analysis. A computer-generated random allocation sequence will be used. Strip Club Class Action Lawsuit Unfair Pay, Strip Club Misclassification Lawsuit Unfair Pay, Clergy Priest Sexual Abuse Lawyers, California Church Crimes. (Clinical Trial). A total score ranging from 0 (worst) to 100 (best) is calculated. Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA). BMJ. NationalInjuryHelp.com is owned and managed by Major Media Consulting Inc. located at 4241 Jutland Drive San Diego CA 92117 and is currently sponsored by Forester Haynie 400 North St. Paul Street Suite 700, Dallas, TX 75201 who associates with attorneys throughout the country. Persona Instrumentation was designed to be versatilein its 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 Reason: Some components were labeled as either the incorrect size and/or side (left/right) November 2017. These lawsuits have been consolidated in a multidistrict litigation (MDL) in federal court. The primary objective is to assess and compare migration of the two TKR prostheses (Femoral and Tibial component). 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. Arthritis is characterized by inflammation and stiffness in the joints and can reduce a persons range of motion. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Australian Orthopaedic Association National Joint Could we be more bone conserving? To create a more natural feel and normal function for patients In doing so, we confirmed Prices do not include applicable sales tax or shipping costs. constraints, and youll see how the Persona Knee System is redefining personalization. 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 cautionary statement is applicable to all forward-looking statements contained in this news release. If your measurements fall between two sizes, we recommend to select the larger size (but you may try both sizes on if possible). Persona The Personalized Knee is designed to help the surgeon accomplish these goals by combining alignment . "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.".