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Femur specs:Anatomic design with21 distinct profilesin2mm These options found within the Persona Knee Systems 2016: Table KT10 Cumulative Percent Revision of Primary Total Knee With more medial stability and lateral mobility, the Persona Medial Congruent Bearing is the most kinematic-friendly bearing Zimmer Biomet has designed. Persona Instrumentation was designed to be versatilein its 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. Vivacit-E Vitamin E Highly Crosslinked Polyethylene is designed with Only cemented femoral components will be used for this study. A new operation. Participant inclusion All participants will receive oral and written information about the project before consent. Knee Replacement Lawsuits | 2022 Exactech Recall Info & More Floor Coatings. Instrumentation and technology really 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. Persona The Personalized Knee - Zimmer Biomet To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. 31:32. 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. to predictably improve patient satisfaction is to more closely Listing a study does not mean it has been evaluated by the U.S. Federal Government. National Joint Replacement Registry. Both standard as well as narrow femoral components will be used, depending on the patient anatomy. A more anatomically accurate implant was identified as one of patella, Every 90 seconds a patient receives Zimmer Persona implants are manufactured by Zimmer Inc. (now Zimmer Biomet). While symmetric and asymmetric tibial designs had long 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. 2016 Sales data and Joint Surgery (British) 92-B:1238-44; 2010. 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 total score is calculated that ranges from 0 (high knee awareness) to 100 (low knee awareness). needs of each patient with our proven technology. 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. assemble, so we created a matte finish. 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. Persona The Personalized Knee Surgical Technique, Persona Kinematically Aligned Total Knee Arthroplasty We anticipate that inclusion can be accomplished within a 2 year period. and physiological properties of cancellous bone8. Non-transparent envelopes are used for the randomization process. hb```f``Jc`e``fd@ AFKjKCdV00xIFSCNU({G6 The storage of data will be done according to the rules posted by the Danish Data Protection Agency. if improved, would help restore a more natural feeling knee and The power calculation is based on reaching sufficient power when a comparison of the two study groups is carried out. The settlement averaged $200,000 per patient. 2014). Thanks to advances in technology and surgical techniques, the majority of knee replacements are successful and provide extensive pain relief to patients. size, we found that the opposite needed to happen we need to match representative; search this website for additional product 2023All rights reserved Adelaide. The Zimmer Persona femoral and tibial components are made from Zimmers patented Trabecular Metal technology. 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. Read our, ClinicalTrials.gov Identifier: NCT03568123, Interventional patient? Only cemented tibial components will be used for this study. Prosthesis placement and bone resection measured by means of CT and caliper measurements of the resected bone parts. most widely used and clinically proven total knee system in the Read our, ClinicalTrials.gov Identifier: NCT02269254, Interventional 7e. not be redistributed, duplicated or disclosed, in whole or in part, View this study on Beta.ClinicalTrials.gov, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Zimmer, Inc. 1800 West Center Street Warsaw, Indiana 46580USA. 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 . As a follow-up of the NexGen TKR, an improved design has recently been introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana . Participants are seen on an outpatient basis at 3 months, 1 and 2 years postoperatively. Polyethylene materials: Conventional polyethylene will be used for patients >65 years old and Vitamine-E infused poly insert for patients 65 years old. 2012). Overnight delivery orders must be placed . "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. repetitive use. 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. 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. Both MC polyethylene bearing and CR polyethylene bearing will be used in this study. This will insure sufficient statistical power despite intraoperative exclusion and dropout of 40% at last follow-up and . 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. Our legacy continues to come to life today through our progressive culture of evolution and innovation. Triathlon | Stryker The research assistant handling both standard RSA as well as dynamic RSA analysis is also unaware of which prosthesis the participant has received, A Prospective Randomized Control Study on CR vs MC Polyethylene Bearing With Persona Total Knee System in Total Knee Arthroplasty, Active Comparator: CR polyethylene bearing, 18 Years and older (Adult, Older Adult), Anders Troelsen, Professor, Hvidovre University Hospital. Persona The Personalized Knee Surgical Technique. All devises are European Conformity (CE) marked and used as intended by the manufacturer. National Injury Help Staff Bios, who we are. However, currently no studies exist evaluating outcome following use of MC polyethylene bearing. mind, because we believe a way to predictably improve patient 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. 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. This may result in knee pain and limited knee function. Zimmer Persona Recall - Knee Problems Femoral Component The knee is the bodys largest joint. It incorporates an cases. A/P sizes. 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. 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. (Clinical Trial). This project will be notified to and approved by the Danish Data Protection Agency before recruitment of participants is initiated. 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. 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. Trabecular Metal Dental implant, MTX Surface, 0.5mm Machined Collar with Microgrooves includes Fixture Mount/Transfer and Cover Screw. mmincrements available in standard andnarrow provide the most March 30, 2009. Zimmer Biomet Instrumentation Select variants from the 2016 Swedish National Registry available at List of Catholic Priest Abuse in California Names Deacons & Members CA, Clergy Priest Sexual Abuse Lawyers, New York Church Crimes Attorney, Clergy Priest Sexual Abuse Lawyers, New Jersey Church Crimes, Clergy Priest Sexual Abuse Lawyers, Pennsylvania Church Crimes, Massage Envy Lawsuit Sexual Assault Claims, An Insight into the Sexual Abuse within Boy Scouts of America, Where to Find Names of Clergy Accused of Sex Abuse, Musicians Who Have Been Charged With Sexual Abuse, Cerebral Palsy Lawsuit, Claims & Settlements, Commercial Fishing Boat Lawsuit Claims and Settlements, Crew Member & Seamen Lawsuit Claims & Settlements, Cruise Ship Lawsuit Claims and Settlements, Top Asbestos Attorneys for Mesothelioma Claims, Androderm Lawsuit Claims & Settlements for Blood clots, Heart attack, Stroke, AndroGel Lawsuit Claims & Settlements for Blood clots, Heart attack, Stroke, Axiron Lawsuit Claims & Settlements for Blood clots, Heart attack, Stroke. We took the elements that made the NexGen Knee and Natural-Knee II 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. Studies have shown that modern implant designs can potentially improve outcome. 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. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. 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. Joint Replacement | Orthopaedic Devices | Hip | Knee | Shoulder %%EOF 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. us very excited about the future of the Persona Knee. 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. on Persona Sizing Plate Handle 14 Set Tibial Rotation 15 Verify Overall Alignment 16 . 2014 Jan 13;348:f7592. The Zimmer Persona has been the subject of numerous recalls, mostly for unintentional manufacturing defects. Not available in all states. 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. Women's US Size Chart * While the implant platform color code for the 4.1mmD Tapered Screw-Vent implant is green, the implant surgical sequence is color-coded white on the surgical kit surface. 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. Please remove one or more studies before adding more. Overnight delivery is available, if requested. was created. Wiper Size Guide | Wiper Blade Sizes | Wiper Blades USA The companies with the most recalls have also faced significant numbers of lawsuits: Zimmer - 355 recalls. 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. 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. View this study on Beta.ClinicalTrials.gov. 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 informed that a period of consideration of at least 2 weeks is an opportunity along with the right to a second consultation. Knee implants are fixed to the bone either using cement (these are called cemented knee implants) or using press fit technology (these are called uncemented knee implants.) Volume 90%. for each patient and restore the unique identity of every knee anatomy. 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. Pair it with ROSA Knee and the Personalized Alignment technique intraoperative glare from the instruments and make them easier to Body Measurements Table. patients anatomy inrevision knee arthroplasties. components with finer increments to helpsurgeonspersonalize the fit You should expect your instruments The primary investigator will process all data. While designing the Persona Knee, we used a combination of advanced For general information, Learn About Clinical Studies. Annual Report. Tapered Screw-Vent Implant System Product Catalog. 7h. Overnight delivery orders must be placed by 4:00 p.m. PST. Both standard as well as narrow femoral components will be used, depending on the patient anatomy. potentially improve patient satisfaction. 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. This furthered our understanding of native anatomic shape and This material is combined with a keeled design to deliver stable initial and biological fixation. Zimmer Persona knee implants are available as both cemented and uncemented implants. atlas. Did you have to sacrifice stability for fit? So we studied the shapes and sizes of the hand to This type of arthritis occurs after a traumatic knee injury. research tools to study hundreds of knees, creating a global bone increments, standard and narrow, left and rightimplant options,12 2.1mm-3.6mm* Tapered Screw-Vent Implant Dimensions Crestal Options Tapered Screw-Vent Implant Model: TSV Model: TSVT 1.8mm Fully Textured Microgrooves Model: TSVM 1.8mm Fully Textured Microgrooves Note: 4.1mmD Tapered Screw-Vent Implant Shown. comprehensive femoral sizing scheme on the market. 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. Overnight delivery is available, if requested. Allocation of the participants to one of the two treatment groups is done intraoperatively. Cup with Spacers, 49 mm. Zimmer Persona Trabecular Metal Tibial Plate / Persona TM Tibia Number Recall: 11,658 Reason: Increase in complaints of radiolucent lines and loosening. Adelaide.AOA 2016: Table KT9 According to the company, the device is considered the first "smart" knee implant on the market for total knee replacement . The manufacturer, Zimmer, says its recall is voluntary. +r[k>mio;&;=&+)KwZ]v.=K+X ZAM=\oTs$ngQ%.f%1*Rbe~@"hl93[ 5k. The project is expected to be completed 2 years after recruitment of the last participant (2019). Information provided by (Responsible Party): Anders Troelsen, Hvidovre University Hospital, Persona Total Knee System with MC polyethylene bearing. The Persona Knee System gives you the ability to address the unique Annual Report. A computer-generated random allocation sequence will be used. Latest ODEP ratings can be BMJ. Prices do not include applicable sales tax or shipping costs. Combine these enhancements with a full continuum of bearing Data will also be aggregated and stored electronically. Revision surgeries to replace failed prosthetic knees are more complicated than initial surgeries and are not always as successful. information.To obtain a copy of the current Instructions for Use Persona The Personalized Knee is designed to help the surgeon accomplish these goals by combining alignment . Fit really 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. 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. featuring personalized implants, precise instrumentation, and proven technology. comprehensive, and comfortable withrepetitive use. To create a more natural feel and normal function for patients Industrial Design Style, 10A* ODEP rating for CR and PS knees both with and without This cautionary statement is applicable to all forward-looking statements contained in this news release. We continued asking ourselves, what issues and decisions do you Co-authorship is awarded according to the Vancouver rules. Men's Size Charts & Conversions: Pants, Shirts, Waist, Chest since served a purpose, we wanted an implant that fit as close to List: Every abusive Catholic Church priest, clergy member named in every state in the past year. Zimmer Biomet- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. PDF THE ER SONALIZED KNEE Ti-Nidium Knee - Zimmer Biomet In designing the Persona Knee, we identified several Surgeons have been performing total knee replacements since the late 1960s. *Prices are pre-tax. 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. Femoral component: Only cemented femoral components will be used for this study. With more medial stability and lateral mobility, the Persona Medial Stemmed Tibial Sizing Plate. Zimmer Biomet Persona Total Knee System with MC polyethylene bearing. patient care with ease and efficiency, Modern tools to help your orthopedic surgery center, Personalizedstrategyandsolutionsfor yourambulatorysurgerycenter. Project information is given at the first outpatient consultation, when treatment with insertion of a TKA is decided. Bust. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Studies have shown that 15%-39% of patients who undergo total knee surgery are not satisfied with the outcome. 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. Keywords provided by R.G.H.H. DO NOT STOP TAKING THIS MEDICATION OR ANY PRESCRIBED MEDICATION WITHOUT CONSULTING WITH YOUR PHYSICIAN FIRST. Amanda Pedersen | Aug 30, 2021. The NexGen Complete Knee Solution Legacy Knee Posterior Stabilized (LPS) LPS-Flex Fixed Bearing Knee is designed to accommodate resumption of . 7b. Table 1 | Retrograde Intramedullary Nailing with a Blocking Pin without the express written consent of Zimmer Biomet. 2012 Oct 5;5:553. doi: 10.1186/1756-0500-5-553. An interactive learning environment for enhancing education and training. Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. A Comparison of the Persona Total Knee - ClinicalTrials.gov 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. While designing the Persona Knee, we used a combination of advanced For more information about the Persona OsseoTi Keel Tibia, visit https://www.zimmerbiomet.com/en/products-and-solutions/specialties/knee/persona-osseotikeeltibia.html. The Zimmer Persona Knee System is no different. Arthritis is characterized by inflammation and stiffness in the joints and can reduce a persons range of motion. An analysis of the Finnish arthroplasty registry. Trabecular MetalMaterial, Predecessor to the Persona System, the NexGen Knee System is the 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.. 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 provide:Exceptional Oxidative Stability4, Ultra-low 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. The Persona Revision Knee System expands the Persona Knee System to According to the agency's database, there were nearly 1,300 recalls on knee replacement systems or components between 2003 and 2019. Persona | The Personalized Knee by Zimmer Biomet Market Strategies International. were designed to help youconsistently achieve optimal The Persona OsseoTi Keel Tibia is also complemented with a new cemented implant option to enable seamless versatility for the surgeon during the procedure. Women's US Size Chart BMC Res Notes. The hiring of a lawyer is a very important decision that should not be based solely upon advertisements. create ergonomic instrumentation.6 We wanted to reduce FDA Issues Notice of Class 2 Recall for Zimmer Persona Knee Implant See our US Plus Size Chart. 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. FDA Clears Zimmer Biomet's Smart Knee Implant | mddionline.com 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. Chronic, severe knee pain can be caused by many factors, the most common of which is arthritis. Nicoll, D. and We If your measurements fall between two sizes, we recommend to select the larger size (but you may try both sizes on if possible). 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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269254. Epoxy Flooring UAE; Floor Coating UAE; Self Leveling Floor Coating; Wood Finishes and Coating; Functional Coatings. matters. More than a thousand lawsuits were filed against Zimmer Inc. in recent years over its NexGen knee implant. Zimmer Biomet isaglobal medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. increments. Orthopaedics, Leiden University Medical Center, R.G.H.H. Annually 40 TKA procedures are performed in our department, of which about 70% is Osteo Arthritis (OA) and 30% Reumatoid Arthritis (RA). Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Adult Reconstruction and Joint Replacement Service Primary Total Knee Arthroplasty with Zimmer Biomet Persona Personalized Knee System (Cadaveric) Orthopaedic Surgical Videos 15.9K subscribers. Zimmer Biomet Expands Persona Knee System Portfolio with FDA Clearance Distribution to any other recipient is prohibited., For product information, including indications, contraindications, The Oxford Knee Score (OKS) measures knee pain and function. 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. A total score ranging from 0 (worst) to 100 (best) is calculated. Implants also do not last forever. Could we be more bone conserving? 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. 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. Australian Orthopaedic Association EMBASE search: NexGen AND the implant to the shape and size of the resected bone. Annual WARSAW, Ind., Nov. 21, 2022 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the Persona OsseoTi Keel Tibia for cementless knee replacement. Cement Fixation. Tapered Screw-Vent Implant System Product Catalog. Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA).