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      • Record: found
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      The Vega advanced third generation posterior stabilized total knee arthroplasty system enables the restoration of range of motion for high demanding daily activities – A 5-years follow-up study

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          Abstract

          Background

          The Vega System® PS (Aesculap AG, Tuttlingen, Germany) is an advanced, third generation fixed implant that aims to mimic natural knee kinematics by optimizing pivotal motion while reducing surface stress. This study evaluated mid-term survival and clinical outcomes, including range of motion (ROM) of the modern posterior stabilized implant in order to analyse whether this biomechanically successful implant reaches good results in situ.

          Methods

          The first 100 patients to receive the Vega PS System for total knee arthroplasty were invited to take part in this single centre, single surgeon study. Of these, 84 patients were clinically assessed 5–6 years postoperatively. Data which was obtained during this follow-up examination included revision data, range of motion and clinical scores.

          Results

          The 5-year survival rate for exchange of any component was 97.6%, whereby two patients required replacement of the polyethylene gliding surface. Secondary patella resurfacing was performed in 7 patients. Significantly improved results in comparison to the preoperative state could be obtained at the follow-up: KOOS improved from 39.4 to 78.8, SF-12 PCS improved from 32.1 to 42 SF-12 MCS improved from 46 to 53.8 and patella pain improved from 2.7 to 0.3. The mean ROM of the 84 patients after 5 years was 133.1° and mean total KSS was 189.9.

          Discussion & conclusions

          This study demonstrates a high survival rate of the Vega PS System® and significant improvements in clinical outcomes 5 years after implantation. The obtained mean ROM indicates that this implant provides good flexibility of the knee joint, allowing a high number of activities. However, due to the rate of secondary patella implantation, routine resurfacing of the patella for all PS TKA cases is highly recommended.

          Clinical trials registration

          The study was registered at clinicaltrials.gov ( NCT02802085).

          Related collections

          Most cited references38

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          A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity.

          J. Ware, M Kosinski, S Keller (1996)
          Regression methods were used to select and score 12 items from the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) to reproduce the Physical Component Summary and Mental Component Summary scales in the general US population (n=2,333). The resulting 12-item short-form (SF-12) achieved multiple R squares of 0.911 and 0.918 in predictions of the SF-36 Physical Component Summary and SF-36 Mental Component Summary scores, respectively. Scoring algorithms from the general population used to score 12-item versions of the two components (Physical Components Summary and Mental Component Summary) achieved R squares of 0.905 with the SF-36 Physical Component Summary and 0.938 with SF-36 Mental Component Summary when cross-validated in the Medical Outcomes Study. Test-retest (2-week)correlations of 0.89 and 0.76 were observed for the 12-item Physical Component Summary and the 12-item Mental Component Summary, respectively, in the general US population (n=232). Twenty cross-sectional and longitudinal tests of empirical validity previously published for the 36-item short-form scales and summary measures were replicated for the 12-item Physical Component Summary and the 12-item Mental Component Summary, including comparisons between patient groups known to differ or to change in terms of the presence and seriousness of physical and mental conditions, acute symptoms, age and aging, self-reported 1-year changes in health, and recovery for depression. In 14 validity tests involving physical criteria, relative validity estimates for the 12-item Physical Component Summary ranged from 0.43 to 0.93 (median=0.67) in comparison with the best 36-item short-form scale. Relative validity estimates for the 12-item Mental Component Summary in 6 tests involving mental criteria ranged from 0.60 to 107 (median=0.97) in relation to the best 36-item short-form scale. Average scores for the 2 summary measures, and those for most scales in the 8-scale profile based on the 12-item short-form, closely mirrored those for the 36-item short-form, although standard errors were nearly always larger for the 12-item short-form.
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            Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure.

            E M Roos, H. P. Roos, L S Lohmander … (1998)
            There is broad consensus that good outcome measures are needed to distinguish interventions that are effective from those that are not. This task requires standardized, patient-centered measures that can be administered at a low cost. We developed a questionnaire to assess short- and long-term patient-relevant outcomes following knee injury, based on the WOMAC Osteoarthritis Index, a literature review, an expert panel, and a pilot study. The Knee injury and Osteoarthritis Outcome Score (KOOS) is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. In this clinical study, the KOOS proved reliable, responsive to surgery and physical therapy, and valid for patients undergoing anterior cruciate ligament reconstruction. The KOOS meets basic criteria of outcome measures and can be used to evaluate the course of knee injury and treatment outcome.
            Article 0 comments Cited 523 times – based on 0 reviews     Review now
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              Rationale of the Knee Society clinical rating system.

              L Dorr, Kirstin Scott, J N Insall … (1989)
              A new total knee rating system has been developed by The Knee Society to provide an up-to-date more stringent evaluation form. The system is subdivided into a knee score that rates only the knee joint itself and a functional score that rates the patient's ability to walk and climb stairs. The dual rating system eliminates the problem of declining knee scores associated with patient infirmity.
              Article 0 comments Cited 265 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Ludger Gerdesmeyer:
                ORCID: https://orcid.org/0000-0003-2717-2892
                Role: ConceptualizationRole: Funding acquisitionRole: SupervisionRole: Writing – original draft
                Claudio Glowalla: Role: Formal analysisRole: MethodologyRole: Writing – original draftRole: Writing – review & editing
                Igor Lasic: Role: MethodologyRole: Project administrationRole: ValidationRole: Writing – review & editing
                Munjed Al Muderis: Role: ConceptualizationRole: Funding acquisitionRole: Project administrationRole: Writing – review & editing
                Matthias Weuster: Role: Data curationRole: MethodologyRole: Writing – review & editing
                Tim Klueter: Role: InvestigationRole: ResourcesRole: Writing – original draftRole: Writing – review & editing
                Luciana Labanca: Role: Editor
                Journal
                Journal ID (nlm-ta): PLoS One
                Journal ID (iso-abbrev): PLoS One
                Journal ID (publisher-id): plos
                Title: PLOS ONE
                Publisher: Public Library of Science (San Francisco, CA USA )
                ISSN (Electronic): 1932-6203
                Publication date (Electronic): 13 May 2024
                Publication date Collection: 2024
                Volume: 19
                Issue: 5
                Electronic Location Identifier: e0302885
                Affiliations
                [1 ] Department of Orthopaedic Surgery, Mare Klinik, Kiel-Kronshagen, Germany
                [2 ] Department of Orthopaedics and Sportorthopaedics, Klinikum Rechts der Isar, München, Germany
                [3 ] Macquarie University Hospital, Macquarie University, Sydney, Australia
                [4 ] Department of Orthopaedics and Traumatology, DIAKO Hospital, Flensburg, Germany
                [5 ] Department of Orthopaedic Surgery and Traumatology, University of Kiel, Kiel, Germany
                IRCCS Istituto Ortopedico Rizzoli, ITALY
                Author notes

                Competing Interests: The corresponding author (LG) is an advising surgeon in Aesculap R&D projects and is getting research funding in connection with these projects. All other authors have no conflict of interest to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

                Author information
                https://orcid.org/0000-0003-2717-2892
                Article
                Publisher ID: PONE-D-23-40538
                DOI: 10.1371/journal.pone.0302885
                PMC ID: 11090364
                PubMed ID: 38739584
                SO-VID: 4ebfba32-4841-4b58-9899-8207a4407e02
                Copyright © © 2024 Gerdesmeyer et al
                License:

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                Date received : 13 December 2023
                Date accepted : 10 April 2024
                Page count
                Figures: 2, Tables: 4, Pages: 13
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/100007534, B. Braun Melsungen;
                Award Recipient :
                ORCID: https://orcid.org/0000-0003-2717-2892
                This study was funded by Aesculap AG ( https://www.bbraun.de/de/ueber-uns/unternehmen/zahlen-und-fakten/aesculap-partner-der-chirurgie.html). The funder participated in data analysis and manuscript preparation.
                Categories
                Subject: Research Article
                Subject: Biology and Life Sciences
                Subject: Bioengineering
                Subject: Biotechnology
                Subject: Medical Devices and Equipment
                Subject: Medical Implants
                Subject: Engineering and Technology
                Subject: Bioengineering
                Subject: Biotechnology
                Subject: Medical Devices and Equipment
                Subject: Medical Implants
                Subject: Medicine and Health Sciences
                Subject: Medical Devices and Equipment
                Subject: Medical Implants
                Subject: Biology and Life Sciences
                Subject: Anatomy
                Subject: Musculoskeletal System
                Subject: Skeleton
                Subject: Skeletal Joints
                Subject: Knees
                Subject: Medicine and Health Sciences
                Subject: Anatomy
                Subject: Musculoskeletal System
                Subject: Skeleton
                Subject: Skeletal Joints
                Subject: Knees
                Subject: Biology and Life Sciences
                Subject: Anatomy
                Subject: Body Limbs
                Subject: Legs
                Subject: Knees
                Subject: Medicine and Health Sciences
                Subject: Anatomy
                Subject: Body Limbs
                Subject: Legs
                Subject: Knees
                Subject: Medicine and Health Sciences
                Subject: Clinical Medicine
                Subject: Signs and Symptoms
                Subject: Pain
                Subject: Medicine and Health Sciences
                Subject: Surgical and Invasive Medical Procedures
                Subject: Biology and Life Sciences
                Subject: Anatomy
                Subject: Musculoskeletal System
                Subject: Skeleton
                Subject: Patella
                Subject: Medicine and Health Sciences
                Subject: Anatomy
                Subject: Musculoskeletal System
                Subject: Skeleton
                Subject: Patella
                Subject: Medicine and Health Sciences
                Subject: Surgical and Invasive Medical Procedures
                Subject: Musculoskeletal System Procedures
                Subject: Arthroplasty
                Subject: Total Knee Arthroplasty
                Subject: Biology and Life Sciences
                Subject: Anatomy
                Subject: Musculoskeletal System
                Subject: Skeleton
                Subject: Skeletal Joints
                Subject: Knees
                Subject: Knee Joints
                Subject: Medicine and Health Sciences
                Subject: Anatomy
                Subject: Musculoskeletal System
                Subject: Skeleton
                Subject: Skeletal Joints
                Subject: Knees
                Subject: Knee Joints
                Subject: Biology and Life Sciences
                Subject: Anatomy
                Subject: Body Limbs
                Subject: Legs
                Subject: Knees
                Subject: Knee Joints
                Subject: Medicine and Health Sciences
                Subject: Anatomy
                Subject: Body Limbs
                Subject: Legs
                Subject: Knees
                Subject: Knee Joints
                Subject: Physical Sciences
                Subject: Physics
                Subject: Classical Mechanics
                Subject: Kinematics
                Custom metadata
                Data Availability All relevant data are within the manuscript and its Supporting Information files.

                ScienceOpen disciplines: Uncategorized
                Data availability:
                ScienceOpen disciplines: Uncategorized

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