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Kotlarz A, Froyman W, Valentin L, Testa A, Van Hove M, Van Calster B, Bourne T, Timmerman D. Impact of Medical Device Regulation on use of ultrasound-based prediction models in clinical practice. ULTRASOUND IN OBSTETRICS & GYNECOLOGY : THE OFFICIAL JOURNAL OF THE INTERNATIONAL SOCIETY OF ULTRASOUND IN OBSTETRICS AND GYNECOLOGY 2025; 65:404-406. [PMID: 38700069 DOI: 10.1002/uog.27675] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/08/2024] [Revised: 04/10/2024] [Accepted: 04/11/2024] [Indexed: 05/05/2024]
Affiliation(s)
- A Kotlarz
- Department of Gynecology and Oncology, Faculty of Medicine, Jagiellonian University Medical College, Krakow, Poland
| | - W Froyman
- Gynecology and Oncology Clinical Department, University Hospital, Krakow, Poland
- Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium
| | - L Valentin
- Department of Obstetrics and Gynecology, Skåne University Hospital, Malmö, Sweden
- Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden
| | - A Testa
- Department of Woman, Child and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
- Department of Life Science and Public Health, Catholic University of Sacred Heart Largo Agostino Gemelli, Rome, Italy
| | - M Van Hove
- Legal counsel, UZ Leuven, Leuven, Belgium
| | - B Van Calster
- Gynecology and Oncology Clinical Department, University Hospital, Krakow, Poland
- Department of Biomedical Data Sciences, Leiden University Medical Centre (LUMC), Leiden, The Netherlands
- Leuven Unit for Health Technology Assessment Research (LUHTAR), KU Leuven, Leuven, Belgium
| | - T Bourne
- Gynecology and Oncology Clinical Department, University Hospital, Krakow, Poland
- Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium
- Queen Charlotte's and Chelsea Hospital, Imperial College Healthcare NHS Trust, London, UK
| | - D Timmerman
- Gynecology and Oncology Clinical Department, University Hospital, Krakow, Poland
- Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium
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Menon V. Regulatory gaps in India’s medical device framework: The case of Johnson and Johnson’s faulty hip implants. World J Orthop 2024; 15:1124-1134. [DOI: 10.5312/wjo.v15.i12.1124] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/28/2024] [Revised: 10/08/2024] [Accepted: 11/12/2024] [Indexed: 12/17/2024] Open
Abstract
The Johnson and Johnson faulty hip implant case represents one of the most significant crises in medical device history, impacting nearly 93000 patients worldwide. In response to alarming failure rates and a global recall in August 2010, countries such as Australia, the United States, and the United Kingdom quickly implemented revision surgeries and reimbursement programs to protect patient safety. In stark contrast, India's response was alarmingly delayed; defective implants continued to be sold even after the global recall. By the time the import license was revoked, and the Central Drugs Standard Control Organization issued a recall notice, these implants had already been involved in 4700 surgeries across India. This paper explores the systemic weaknesses in India’s medical device regulatory framework that contributed to this delayed action, resulting in many patients suffering from serious health complications. It highlights deficiencies in monitoring and reporting mechanisms, inadequate regulatory oversight, and insufficient approval processes. Furthermore, the inability to trace affected patients and provide necessary compensation underscores significant gaps in regulation. Although subsequent legislative reforms were introduced, this paper argues that substantial loopholes remain, posing risks for future incidents. Thus, urgent, comprehensive, and enforceable regulatory measures are needed to increase patient safety.
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Affiliation(s)
- Vidya Menon
- Law, Gujarat National Law University, Ahmedabad 382426, Gujarat, India
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McCormack P. From embodiment to evidence: The harmful intersection of poor regulation of medical implants and obstructed narratives in embodied experiences of failed metal-on-metal hips. Health (London) 2024; 28:578-595. [PMID: 37272683 PMCID: PMC11149390 DOI: 10.1177/13634593231179026] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/06/2023]
Abstract
This research presents the results of a study about people with failed metal-on-metal hip implants, and draws on the STS concept of the technological imperative alongside research on the value of patient knowledge in clinical settings and the legitimacy of embodied stories. Popularly understood as positive and life changing, hip replacement surgery was hailed as 'the operation of the century', until a series of widespread failures of hundreds of thousands of hip implants, known collectively as metal-on-metal (MoM) hips, drew attention to the poor regulation of medical implants. This paper argues that poor regulation intersects with narratives of patients' pain, which are obstructed by surgeons and the UK regulatory body, with the effect of denying both patients' embodied experiences of implant failure, and their restitution to good health. Patient narratives about problems with their hip implant are the wellspring from which scientific evidence emerges which can indicate widespread implant failure. By obstructing these narratives the regulatory system undermines the very evidence it needs to operate effectively.
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van Daal M, de Kanter AFJ, Bredenoord AL, de Graeff N. Personalized 3D printed scaffolds: The ethical aspects. N Biotechnol 2023; 78:116-122. [PMID: 37848162 DOI: 10.1016/j.nbt.2023.10.006] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/15/2023] [Revised: 09/27/2023] [Accepted: 10/14/2023] [Indexed: 10/19/2023]
Abstract
Personalized 3D printed scaffolds are a new generation of implants for tissue engineering and regenerative medicine purposes. Scaffolds support cell growth, providing an artificial extracellular matrix for tissue repair and regeneration and can biodegrade once cells have assumed their physiological and structural roles. The ethical challenges and opportunities of these implants should be mapped in parallel with the life cycle of the scaffold to assist their development and implementation in a responsible, safe, and ethically sound manner. This article provides an overview of these relevant ethical aspects. We identified nine themes which were linked to three stages of the life cycle of the scaffold: the development process, clinical testing, and the implementation process. The described ethical issues are related to good research and clinical practices, such as privacy issues concerning digitalization, first-in-human trials, responsibility and commercialization. At the same time, this article also creates awareness for underexplored ethical issues, such as irreversibility, embodiment and the ontological status of these scaffolds. Moreover, it exemplifies how to include gender in the ethical assessment of new technologies. These issues are important for responsible development and implementation of personalized 3D printed scaffolds and in need of more attention within the additive manufacturing and tissue engineering field. Moreover, the insights of this review reveal unresolved qualitative empirical and normative questions that could further deepen the understanding and co-creation of the ethical implications of this new generation of implants.
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Affiliation(s)
- Manon van Daal
- Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.
| | - Anne-Floor J de Kanter
- Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands
| | - Annelien L Bredenoord
- Erasmus School of Philosophy, Erasmus University Rotterdam, Rotterdam, the Netherlands
| | - Nienke de Graeff
- Department of Medical Ethics and Health Law, Leiden University Medical Center, Leiden University, Leiden, the Netherlands
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Subbiah Ponniah H, Logishetty K, Edwards TC, Singer GC. Survivorship and risk factors for revision of metal-on-metal hip resurfacing. Bone Jt Open 2023; 4:853-858. [PMID: 37944559 PMCID: PMC10635743 DOI: 10.1302/2633-1462.411.bjo-2023-0084.r1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/12/2023] Open
Abstract
Aims Metal-on-metal hip resurfacing (MoM-HR) has seen decreased usage due to safety and longevity concerns. Joint registries have highlighted the risks in females, smaller hips, and hip dysplasia. This study aimed to identify if reported risk factors are linked to revision in a long-term follow-up of MoM-HR performed by a non-designer surgeon. Methods A retrospective review of consecutive MoM hip arthroplasties (MoM-HRAs) using Birmingham Hip Resurfacing was conducted. Data on procedure side, indication, implant sizes and orientation, highest blood cobalt and chromium ion concentrations, and all-cause revision were collected from local and UK National Joint Registry records. Results A total of 243 hips (205 patients (163 male, 80 female; mean age at surgery 55.3 years (range 25.7 to 75.3)) with MoM-HRA performed between April 2003 and October 2020 were included. Mean follow-up was 11.2 years (range 0.3 to 17.8). Osteoarthritis was the most common indication (93.8%), and 13 hips (5.3%; 7M:6F) showed dysplasia (lateral centre-edge angle < 25°). Acetabular cups were implanted at a median of 45.4° abduction (interquartile range 41.9° - 48.3°) and stems neutral or valgus to the native neck-shaft angle. In all, 11 hips (4.5%; one male, ten females) in ten patients underwent revision surgery at a mean of 7.4 years (range 2.8 to 14.2), giving a cumulative survival rate of 94.8% (95% confidence interval (CI) 91.6% to 98.0%) at ten years, and 93.4% (95% CI 89.3% to 97.6%) at 17 years. For aseptic revision, male survivorship was 100% at 17 years, and 89.6% (95% CI 83.1% to 96.7%) at ten and 17 years for females. Increased metal ion levels were implicated in 50% of female revisions, with the remaining being revised for unexplained pain or avascular necrosis. Conclusion The Birmingham MoM-HR showed 100% survivorship in males, exceeding the National Institute for Health and Care Excellence '5% at ten years' threshold. Female sex and small component sizes are independent risk factors. Dysplasia alone is not a contraindication to resurfacing.
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Miguela Alvarez SM, Luna Gutiérrez R, Surroca M, Bartra Ylla A, Angles Crespo F. [Translated article] Metal on metal total hip arthroplasty: Correlation between inclination of the acetabular and metal ion levels. Rev Esp Cir Ortop Traumatol (Engl Ed) 2023; 67:T233-T239. [PMID: 36863521 DOI: 10.1016/j.recot.2023.02.016] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/12/2021] [Accepted: 11/04/2022] [Indexed: 03/04/2023] Open
Abstract
Due to their low friction index, hip arthroplasties with metal-metal (M-M) friction torque have been an attractive option in young patients with high functional demand, currently they have suffered a decrease in their use due to the complications of some models and physiological reactions adverse reactions related to the elevation of metal ions in the blood. Our objective is to review the patients with M-M pair operated in our centre, correlating the ion level with the position of the acetabular component and with the size of the head. MATERIAL AND METHODS Retrospective review of 166 M-M hip prostheses operated between 2002 and 2011. Sixty five ruled out for different causes (death, loss of follow-up, no current ion control, no radiography or others), leaving a sample of 101 patients to be analysed. Follow-up time, cup inclination angle, blood ion level, Harris Hip Score (HHS), and complications were recorded. RESULTS One hundred and one patients (25 women and 76 men), 55 years of average age (between 26 and 70), of these 8 were surface prostheses and 93 total prostheses. The mean follow-up time was 10 years (between 5 and 17 years). The mean head diameter was 46.25 (between 38 and 56). The mean inclination of the butts was 45.7° (between 26° and 71°). The correlation force between the verticality of the cup and the increase in ions is moderate r=0.31 for Cr and slight r=0.25 for Co. The correlation force between head size and ion increase is weak and inverse r=-0.14 for Cr and r=0.1 for Co. Five patients (4.9%) required revision (2 [1%] due to increased ions with pseudotumor). The mean time to revision was 6.5 years in which the ions increased. The mean HHS was 94.01 (between 55.8 and 100). In the review of patients, we found 3 with a significant increase in ions who had not followed controls, all 3 had an HHS of 100. The angles of the acetabular components were 69°, 60° and 48° and the diameter of the head was 48.42 and 48mm, respectively. DISCUSSION AND CONCLUSIONS M-M prostheses have been a valid option in patients with high functional demand. A bi-annual analytical follow-up is recommended, since in our case we have detected 3 patients with HHS 100 who presented unacceptable elevation of cobalt >20μm/l (according to SECCA) of the ions and 4 with very abnormal elevation of cobalt ≥10μm/l (according to SECCA), all of them with cup orientation angles >50°. With our review we can conclude that there is a moderate correlation between the verticality of the acetabular component and the increase in blood ions and that the follow-up of this patient with angles >50° is essential.
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Affiliation(s)
| | - R Luna Gutiérrez
- Hospital Universitari Mútua de Terrassa, Terrassa, Barcelona, Spain
| | - M Surroca
- Hospital Universitari Mútua de Terrassa, Terrassa, Barcelona, Spain
| | - A Bartra Ylla
- Hospital Universitari Mútua de Terrassa, Terrassa, Barcelona, Spain
| | - F Angles Crespo
- Hospital Universitari Mútua de Terrassa, Terrassa, Barcelona, Spain
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Huusko J, Kinnunen UM, Saranto K. Medical device regulation (MDR) in health technology enterprises - perspectives of managers and regulatory professionals. BMC Health Serv Res 2023; 23:310. [PMID: 36997978 PMCID: PMC10062684 DOI: 10.1186/s12913-023-09316-8] [Citation(s) in RCA: 10] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/16/2022] [Accepted: 03/21/2023] [Indexed: 04/01/2023] Open
Abstract
BACKGROUND In the European Union (EU), there are over half a million medical devices, varying from pacemakers to software. Medical devices play an important role in health care as they are used in diagnosis, prevention, monitoring, prediction, prognosis, treatment, or to alleviate disease. Medical devices are regulated in the EU by the Medical Device Regulation (MDR), which came into force on 25 April 2017 and into application on 26 May 2021. The demand for regulation arose from the need to establish a transparent, robust, predictable, and sustainable regulatory framework. This study aims to examine how the managers and regulatory professionals in health technology enterprises perceived the application of the MDR and what were their information needs regarding the MDR. METHODS A link to an online questionnaire was sent to 405 managers and regulatory professionals representing health technology enterprises in Finland. The study included 74 respondents. Descriptive statistics were used to describe and summarise the characteristics of the dataset. RESULTS Information related to the MDR was fragmented and the necessary information was sought from multiple information sources, while the Finnish Medicines Agency (Fimea) was regarded as the most important source of information and training provider. To some extent, the managers and regulatory professionals expressed their dissatisfaction with the performance of Fimea. The managers and regulatory professionals were not very familiar with the ICT systems provided by the EU. The size of an enterprise affected how many medical devices it manufactures and generally affected the views about the MDR. CONCLUSIONS The managers and regulatory professionals understood the role of the MDR regarding the safety and transparency of medical devices. The available information regarding the MDR did not properly fit the needs of users and there seemed to be a gap in information quality. The managers and regulatory professionals had some difficulties understanding the available information. Based on our findings, we believe it is paramount to evaluate the challenges faced by Fimea and how it could improve its performance. To some extent, the MDR is regarded as a burden for smaller enterprises. It is important to highlight the benefits of ICT systems and to develop them to better meet the information needs of enterprises.
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Affiliation(s)
- Juhamatti Huusko
- Department of Health and Social Management, University of Eastern Finland, Yliopistonranta 1, Kuopio, 70210, Finland.
| | - Ulla-Mari Kinnunen
- Department of Health and Social Management, University of Eastern Finland, Yliopistonranta 1, Kuopio, 70210, Finland
| | - Kaija Saranto
- Department of Health and Social Management, University of Eastern Finland, Yliopistonranta 1, Kuopio, 70210, Finland
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Miguela Alvarez SM, Luna Gutiérrez R, Surroca M, Bartra Ylla A, Angles Crespo F. Metal on metal total hip arthroplasty: Correlation between inclination of the acetabular and metal ion levels. Rev Esp Cir Ortop Traumatol (Engl Ed) 2022; 67:233-239. [PMID: 36513347 DOI: 10.1016/j.recot.2022.11.001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/12/2021] [Revised: 10/27/2022] [Accepted: 11/04/2022] [Indexed: 12/14/2022] Open
Abstract
Due to their low friction index, hip arthroplasties with metal-metal (M-M) friction torque have been an attractive option in young patients with high functional demand, currently they have suffered a decrease in their use due to the complications of some models and physiological reactions adverse reactions related to the elevation of metal ions in the blood. Our objective is to review the patients with M-M pair operated in our center, correlating the ion level with the position of the acetabular component and with the size of the head. MATERIAL AND METHODS Retrospective review of 166 M-M hip prostheses operated between 2002 and 2011. Sixty five ruled out for different causes (death, loss of follow-up, no current ion control, no radiography or others), leaving a sample of 101 patients to be analyzed. Follow-up time, cup inclination angle, blood ion level, Harris Hip Score (HHS), and complications were recorded. RESULTS One hundred and one patients (25 women and 76 men), 55years of average age (between 26 and 70), of these 8 were surface prostheses and 93 total prostheses. The mean follow-up time was 10years (between 5 and 17years). The mean head diameters was 46.25 (between 38 and 56). The mean inclination of the butts was 45.7° (between 26° and 71°). The correlation force between the verticality of the cup and the increase in ions is moderate r=0.31 for Cr and slight r=0.25 for Co. The correlation force between head size and ion increase is weak and inverse r=-0.14 for Cr and r=0.1 for Co. Five patients (4.9%) required revision (2 [1%] due to increased ions with pseudotumor). The mean time to revision was 6.5years in which the ions increased. The mean HHS was 94.01 (between 55.8 and 100). In the review of patients, we found 3 with a significant increase in ions who had not followed controls, all 3 had an HHS of 100. The angles of the acetabular components were 69°, 60° and 48° and the diameter of the head was 48.42 and 48mm, respectively. DISCUSSION AND CONCLUSIONS M-M prostheses have been a valid option in patients with high functional demand. A bi-annual analytical follow-up is recommended, since in our case we have detected 3patients with HHS100 who presented unacceptable elevation of cobalt >20μm/L (according to SECCA) of the ions and 4 with very abnormal elevation of cobalt ≥10μm/L (according to SECCA), all of them with cup orientation angles >50°. With our review we can conclude that there is a moderate correlation between the verticality of the acetabular component and the increase in blood ions and that the follow-up of this patient with angles >50° is essential.
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Affiliation(s)
| | - R Luna Gutiérrez
- Hospital Universitari Mútua de Terrassa, Terrassa, Barcelona, España
| | - M Surroca
- Hospital Universitari Mútua de Terrassa, Terrassa, Barcelona, España
| | - A Bartra Ylla
- Hospital Universitari Mútua de Terrassa, Terrassa, Barcelona, España
| | - F Angles Crespo
- Hospital Universitari Mútua de Terrassa, Terrassa, Barcelona, España
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Theivendran K. Response to letter: Carbon fibre reinforced PEEK versus traditional metallic implants for orthopaedic trauma surgery: A systematic review. J Clin Orthop Trauma 2022; 26:101779. [PMID: 35145850 PMCID: PMC8814686 DOI: 10.1016/j.jcot.2022.101779] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/31/2023] Open
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Augustyn A, Stołtny T, Rokicka D, Wróbel M, Pająk J, Werner K, Ochocki K, Strojek K, Koczy B. Revision arthroplasty using a custom-made implant in the course of acetabular loosening of the J&J DePuy ASR replacement system - case report. Medicine (Baltimore) 2022; 101:e28475. [PMID: 35089189 PMCID: PMC8797610 DOI: 10.1097/md.0000000000028475] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/09/2021] [Accepted: 12/15/2021] [Indexed: 01/05/2023] Open
Abstract
RATIONALE Resurfacing arthroplasty using the J&J DePuy ASR system was withdrawn from surgical treatment due to the necessity of frequent revision procedures after its application. There have been many studies concerning treatment of acetabular bone loss using different operating techniques. However, we felt that data of custom - made implant usage in such cases is highly insufficient, and there is lack of evidence on its application in treatment of loosening of the previous implant. The aim of the study was to evaluate the effectiveness of surgical treatment with a custom-made implant in a patient with extensive acetabular bone loss after aseptic loosening of the acetabular component of the J&J DePuy ASR surface prosthesis in the early period of observation. PATIENT CONCERNS A 74-year-old patient was taken to the Orthopaedic Trauma Emergency Room due to increasing pain in the right hip for about 3 months. Nine years earlier he underwent resurfacing arthroplasty of the right hip using the J&J DePuy ASR method. DIAGNOSES The imaging diagnostics (X-ray, computed tomography, ultrasound) revealed the presence of a pseudotumor and lysis around the acetabular implant, which caused a fracture in the acetabulum. INTERVENTIONS Revision arthroplasty of the right hip joint was performed with the removal of the ASR implant. During the procedure extensive bone defects were visualized, preventing the insertion of the revision acetabulum. After extensive plasticization of the defects with the use of allogeneic cancellous chips the "hanging hip" was left with the intention of making another attempt to insert the implant after the reconstitution of the acetabular bone. A computed tomography examination 2.5 years after the ASR removal revealed the lack of an adequate degree of bone remodeling for the planned implant. Arthroplasty using custom - made aMace Acetabular Revision System by Materialize was performed 3 years after the removal of ASR. OUTCOMES Optimal implant adherence to the bone base and full osseointegration with the pelvic bone bearing has been achieved. Significant improvement in clinical parameters has been noted, with no complications in the postoperative period. LESSONS The use of an individual custom-made implant in extensive acetabular bone loss after aseptic loosening of the acetabular component of the J&J DePuy ASR surface prosthesis in patients is an effective method of surgical treatment.
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Affiliation(s)
- Aleksander Augustyn
- District Hospital of Orthopaedics and Trauma Surgery in Piekary Śląskie, Bytomska St. 62, Piekary Śląskie, Poland
| | - Tomasz Stołtny
- District Hospital of Orthopaedics and Trauma Surgery in Piekary Śląskie, Bytomska St. 62, Piekary Śląskie, Poland
| | - Dominika Rokicka
- Department of Internal Diseases, Diabetology, and Cardiometabolic Diseases, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Silesian Centre for Heart Diseases in Zabrze, M. Curie-Skłodowskiej St. 9, Zabrze, Poland
| | - Marta Wróbel
- Department of Internal Diseases, Diabetology, and Cardiometabolic Diseases, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Silesian Centre for Heart Diseases in Zabrze, M. Curie-Skłodowskiej St. 9, Zabrze, Poland
| | - Jan Pająk
- District Hospital of Orthopaedics and Trauma Surgery in Piekary Śląskie, Bytomska St. 62, Piekary Śląskie, Poland
| | - Krystian Werner
- District Hospital of Orthopaedics and Trauma Surgery in Piekary Śląskie, Bytomska St. 62, Piekary Śląskie, Poland
| | - Karol Ochocki
- District Hospital of Orthopaedics and Trauma Surgery in Piekary Śląskie, Bytomska St. 62, Piekary Śląskie, Poland
| | - Krzysztof Strojek
- Department of Internal Diseases, Diabetology, and Cardiometabolic Diseases, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Silesian Centre for Heart Diseases in Zabrze, M. Curie-Skłodowskiej St. 9, Zabrze, Poland
| | - Bogdan Koczy
- District Hospital of Orthopaedics and Trauma Surgery in Piekary Śląskie, Bytomska St. 62, Piekary Śląskie, Poland
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Phillips JRA, Tucker K. Implant brand portfolios, the potential for camouflage of data, and the role of the Orthopaedic Data Evaluation Panel in total knee arthroplasty. Bone Joint J 2021; 103-B:1555-1560. [PMID: 34587804 DOI: 10.1302/0301-620x.103b10.bjj-2021-0284.r1] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/05/2022]
Abstract
AIMS Knee arthroplasty surgery is a highly effective treatment for arthritis and disorders of the knee. There are a wide variety of implant brands and types of knee arthroplasty available to surgeons. As a result of a number of highly publicized failures, arthroplasty surgery is highly regulated in the UK and many other countries through national registries, introduced to monitor implant performance, surgeons, and hospitals. With time, the options available within many brand portfolios have grown, with alternative tibial or femoral components, tibial insert materials, or shapes and patella resurfacings. In this study we have investigated the effect of the expansion of implant brand portfolios and where there may be a lack of transparency around a brand name. We also aimed to establish the potential numbers of compatible implant construct combinations. METHODS Hypothetical implant brand portfolios were proposed, and the number of compatible implant construct combinations was calculated. RESULTS A simple knee portfolio with cemented cruciate-retaining (CR) and posterior-stabilized (PS) components, with and without a patella, has four combinations. If there are two options available for each component, the numbers double for each option, resulting in 32 combinations. The effect of adding a third option multiplies the number by 1.3. Introducing compatible uncemented options, with the effect of hybrids, multiplies the number by 4. An implant portfolio with two femoral components (both in CR and PS), with two insert options and a patella, all in cemented and uncemented versions leads to 192 possible compatible implant construct combinations. There are implant brands available to surgeons with many more than two options. CONCLUSION This study demonstrates that the addition of multiple variants within a knee brand portfolio leads to a large number (many hundreds) of compatible implant construct combinations. Revision rates of implant combinations are not currently reviewed at this level of granularity, leading to the risk of camouflage of true outcomes. Cite this article: Bone Joint J 2021;103-B(10):1555-1560.
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Bitar C, Krupic F, Felländer-Tsai L, Crnalic S, Wretenberg P. Living with a recalled implant: a qualitative study of patients' experiences with ASR hip resurfacing arthroplasty. Patient Saf Surg 2021; 15:2. [PMID: 33407687 PMCID: PMC7788783 DOI: 10.1186/s13037-020-00278-y] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/16/2020] [Accepted: 12/07/2020] [Indexed: 11/15/2022] Open
Abstract
Background Total hip arthroplasty is the traditional treatment for osteoarthritis in the hip joint. Hip resurfacing arthroplasty, with metal on metal bearing, is a modern concept initially developed mainly for young active people. The metal-on-metal hip arthroplasty implant, Articular Surface Replacement (ASR), was implanted in approximately 93,000 patients before it was recalled in 2010 due to a high complication rate. This study aimed to evaluate patients’ own experiences living with an implant that they knew had a high complication rate and had been recalled from the market. Methods A total of 14 patients, still living with the implant, of a cohort of 34 patients were available for follow-up. Qualitative semi-structured interviews were conducted with 14 patients where a majority actively sought for metal-on-metal hip resurfacing arthroplasty (HRA), and subsequently underwent HRA with an ASR prosthesis between 11/21/2006 and 09/28/2009. The responses were analyzed using content analysis described by Graneheim and Lundman to compress text and identify categories and subcategories. Results The results showed that most patients had already decided that they wanted a metal-on-metal HRA implant before meeting the surgeon. They expressed that the implant made it possible to live an active life. A majority did not think about the fact that they had a hip implant, because they lacked subjective pain. Most of the patients were positive about the annual exams at the hospital and wanted them to continue. None of them felt that their trust towards the healthcare system had changed after the implant recall. They expressed a belief that they would need new surgery sooner than they first thought. Conclusions Despite all the attention when the ASR prosthesis was recalled, patients with ASR-HRA did not report themselves negatively affected by the recall in this group of patients where a majority had actively sought for an HRA procedure. The healthcare system has an obligation to continue the annual exams, even if the implant provider does not continue reimbursement. Supplementary Information The online version contains supplementary material available at 10.1186/s13037-020-00278-y.
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Affiliation(s)
- Christian Bitar
- Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden. .,Department of Orthopedics, Karolinska University Hospital, Stockholm, Sweden.
| | - Ferid Krupic
- Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
| | - Li Felländer-Tsai
- Division of Orthopedics and Biothechnology, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.,Department of Orthopedics, Karolinska University Hospital, Stockholm, Sweden
| | - Sead Crnalic
- Department of Surgical and Perioperative Sciences (Orthopaedics), Umeå University, Umeå, Sweden
| | - Per Wretenberg
- Department of Orthopaedics, School of Medical Sciences, Örebro University and Örebro University Hospital, Örebro, Sweden
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Carulli C, Sani G, Matassi F, Civinini R, Innocenti M. A Mid- to Long-Term Follow-Up Experience with a Specific Metal-on-Metal Total Hip Arthroplasty Design. JOINTS 2020; 7:91-97. [PMID: 34195536 PMCID: PMC8236331 DOI: 10.1055/s-0040-1710388] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 11/25/2017] [Accepted: 04/04/2020] [Indexed: 11/09/2022]
Abstract
Purrpose
Metal-on-metal (MoM) total hip arthroplasty (THA) has been a subject of recent discussion and concern due to the early failures caused by local and systemic adverse reactions related to specific designs. The aim of this study is to analyze the outcomes and survival rates of a single brand of MoM implants implanted in a consecutive series of patients at a single institution.
Methods
Between 2007 and 2012, 116 (118 hips) patients were evaluated at a mean follow-up of 6.6 years after primary THA. The diagnosis leading to surgery was osteoarthritis (80 patients) and proximal femoral fracture (36 patients). A single design of THA was implanted. All patients were evaluated before surgery and postoperatively at 1, 3, 6, and 12 months by clinical scores and radiographic studies. The data analysis was made using Student's
t
-test.
Results
The minimum follow-up was of 4 years, with a mean follow-up of 6.6 years. Two aseptic loosenings of the acetabular component were recorded (one per group), which were not associated with local or systemic complications related to metal ion release. Both were revised by an isolated acetabular cup substitution with metal-on-polyethylene couplings. Nonprogressive radiolucency lines < 2 mm in zone 2 were observed in other six patients around the acetabular component without clinical manifestation (four in the arthritis group and two in the fracture group). Postoperative Harris Hip Score and SF-36 (36-Item Short Form Survey) score improved in both groups.
Conclusion
Despite several MoM implants showing early complications and failures, a specific MoM design may be associated with good clinical results at a mid- to long-term follow-up.
Level of Evidence
This is a therapeutic case series, Level 4 study.
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Affiliation(s)
| | - Giacomo Sani
- Orthopaedic Clinic, University of Florence, Florence, Italy
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14
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Van Der Straeten C, Calistri A, Grammatopoulos G, De Smet K. Radiographic evaluation of hip resurfacing: the role of x-rays in the diagnosis of a problematic resurfaced hip. Hip Int 2020; 30:167-175. [PMID: 31431088 DOI: 10.1177/1120700019836373] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
INTRODUCTION Hip resurfacing (HRA) requires a new standardised radiographic evaluation protocol. Evaluation of acetabular components is similar to total hip arthroplasty (THA) but femoral components require different criteria. This study evaluates the efficacy of a new femoral zonal system for radiographic HRA assessment in identifying clinical problems. METHODS A new proximal femoral zonal system divides implant-cement-bone interfaces at head and neck into 7 DeSmet zones. 611 in situ and 100 revised HRA were assessed for component positioning, borderline findings (reactive lines, cortical thickening, cancellous condensation) or sinister findings (lucent lines, bone resorption, osteolysis). Findings were correlated with gender, size, implant survival, clinical scores, metal ions, and adverse soft tissue reactions (ALTR). RESULTS Radiological changes were found in 265 hips (37.3%), 154 sinister (21.7%) and 111 borderline (15.6%). 84% of revisions had sinister findings versus 11.4% of in situ HRA (p < 0.001). The mean number of abnormal acetabular and femoral zones was 3.3 in revised compared to 0.6 in situ HRA (p < 0.001). Sinister findings were associated with female gender, lower clinical scores, smaller sizes or ASR design (all: p < 0.001). Metal ions were higher with sinister (p < 0.001) and borderline (p < 0.01) findings compared to normal radiographs. Pathological findings in ⩾4 zones had a sensitivity of 50% and specificity of 94.2% (AUC = 0.898) in detecting hips with ALTR (odds ratio = 49). CONCLUSION In order to accurately evaluate progressive radiographic changes in HRA, specific zones have been established around the femoral component. There was a high correlation between radiographic findings and outcome measures. 84% of problematic hips and 90.4% of proven ALTR had sinister changes.
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15
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Goderecci R, Fidanza A, Necozione S, Francione V, Indelli PF, Calvisi V. Ultrasound-based decision making following metal-on-metal hip arthroplasty. J Clin Orthop Trauma 2020; 11:79-84. [PMID: 32001990 PMCID: PMC6985022 DOI: 10.1016/j.jcot.2019.04.009] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/18/2018] [Revised: 04/13/2019] [Accepted: 04/15/2019] [Indexed: 02/08/2023] Open
Abstract
BACKGROUND Metal-on-Metal (MoM) total hip arthroplasty (THA) represents a very controversial procedure because of the possibility of postoperative adverse local tissue reaction (ALTR). This study investigates the reliability of the ultrasound scan as a diagnostic tool to quantify a clinically useful threshold in the level of periprosthetic fluid collection to suggest implant revision. METHODS This study includes 116 patients (123 implants) who received an Articular Surface Replacement XL (ASRTMXL, De Puy Synthes, USA) MoM THA. The study group included 56 males and 60 females with a mean age of 66.6 years (range, 15-86 years). All patients were clinically and radiologically annually evaluated (according to the Harris Hip Score) up to a mean follow-up of 7.5 years (min. 1.4 - max. 10.3 years) from the primary surgery: all patients underwent standard ultrasound evaluation of the affected hip and Cobalt/Chromium blood detection testing according to a custom-made diagnostic algorithm for MoM THA revision. RESULTS At final follow-up, 51 (43.1%) of 117 implants underwent revision after a mean of 6 years (1.79-9.26) from the primary ASR implant. The authors found a statistically significant correlation between Cr (p = 0.015) and Co (p = 0.009) blood values and different ultrasound grades. Statistical analysis showed a significant association between periprosthetic fluid collection and revision surgery (p < 0.0001) and the final revision risk was estimated to be 7 times greater in patients with ultrasound grade ≥ 2 (peri-prosthetic collection ≥ 20 mm). CONCLUSIONS This study confirms the reliability of ultrasound evaluation in detecting clinically significant peri-prosthetic joint effusions: a new diagnostic algorithm for MoM THA revision is here presented. Longer follow up studies are mandatory to better understand the potential advantages of this diagnostic protocol.
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Affiliation(s)
- Remo Goderecci
- Department of Life, Health & Environmental Sciences, University of L'Aquila, Piazzale Salvatore Tommasi 1, Blocco 11, 67100, L'Aquila, Italy
- Corresponding author. Department of Life, Health & Environmental Sciences, University of L'Aquila, Piazzale Salvatore Tommasi 1, Blocco 11, 67100, L'Aquila, Italy.
| | - Andrea Fidanza
- Department of Life, Health & Environmental Sciences, University of L'Aquila, Piazzale Salvatore Tommasi 1, Blocco 11, 67100, L'Aquila, Italy
| | - Stefano Necozione
- Department of Life, Health & Environmental Sciences, University of L'Aquila, Piazzale Salvatore Tommasi 1, Blocco 11, 67100, L'Aquila, Italy
| | - Vincenzo Francione
- Unità di Ortopedia, Casa di Cura Privata Villa Anna, Via Toscana 159, 63039, San Benedetto del Tronto, AP, Italy
| | - Pier Francesco Indelli
- Department of Orthopaedic Surgery and Bioengineering, Stanford University School of Medicine, 450 Broadway, Redwood City, CA, 94063, USA
| | - Vittorio Calvisi
- Department of Life, Health & Environmental Sciences, University of L'Aquila, Piazzale Salvatore Tommasi 1, Blocco 11, 67100, L'Aquila, Italy
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16
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Maniatopoulos G, Hopkins C, Joyce TJ, Brittain K. Framing the failure of medical implants: Media representations of the ASR hip replacements in the UK. Health Expect 2019; 22:518-527. [PMID: 30891890 PMCID: PMC6543155 DOI: 10.1111/hex.12877] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/23/2018] [Revised: 11/01/2018] [Accepted: 02/02/2019] [Indexed: 11/30/2022] Open
Abstract
BACKGROUND During the twentieth century, hip replacement became one of the most popular and successful operations. In the 1990s, a new type of hip replacement namely the metal-on-metal hip resurfacing was developed. This paper draws on one of the available implants, namely the DePuy Orthopaedics' Articular Surface Replacement (ASR) hip system which was withdrawn from the market because of higher than expected rates of failure. It examines media representations on the failure of the ASR metal-on-metal hip replacement device and its subsequent withdrawal from the market. METHODS Drawing on content analysis this paper explores how systemic failure of the medical implant was framed and performed by press media in the UK. RESULTS Two narratives were particularly important in framing press media coverage of the ASR case: the role of patients as passive recipients of care and a distinction between health and disability identities as related to how individuals' narratives about the past shaped their sense of present and future. In all cases, the voice of the orthopaedic surgeons responsible for the selection and implantation of the ASR devices remains silent. CONCLUSIONS Press media coverage of medically induced harm in the UK is significantly less common than coverage of any other patient safety issues and public health debates. This study aims to contribute to the evidence base on how public discourse on medically induced harm becomes framed through the reported experiences of individuals in press media and also how this process influences the legitimacy of various solutions to medical errors or unanticipated outcomes.
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Affiliation(s)
| | - Clare Hopkins
- Institute of Health and SocietyNewcastle UniversityNewcastle upon TyneUK
| | - Thomas J Joyce
- School of EngineeringNewcastle UniversityNewcastle upon TyneUK
| | - Katie Brittain
- Department of Nursing, Midwifery and HealthNorthumbria UniversityNewcastle upon TyneUK
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17
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Saikko V. Effect of wear, acetabular cup inclination angle, load and serum degradation on the friction of a large diameter metal-on-metal hip prosthesis. Clin Biomech (Bristol, Avon) 2019; 63:1-9. [PMID: 30784784 DOI: 10.1016/j.clinbiomech.2019.02.005] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/23/2018] [Revised: 02/06/2019] [Accepted: 02/12/2019] [Indexed: 02/07/2023]
Abstract
BACKGROUND The large-scale clinical problem caused by unacceptable tribological behaviour of certain large diameter metal-on-metal prosthetic hips has directed attention to adverse condition testing. High metal-on-metal wear is connected with adverse reaction to metal debris. Friction is important because high friction may be associated with high wear, risk the fixation of the cup, and cause detrimental heating of periprosthetic tissues. METHODS A friction measurement system was added to a multidirectional, established hip joint wear simulator, and its functionality was evaluated. In preliminary tests, a 50 mm diameter metal-on-metal prosthesis was tested in an optimal acetabular cup inclination angle (48°) and in a steep angle (70°) using a normal peak load (2 kN) and an increased peak load (3 kN). The test length was 100 h. Long-term adverse condition tests of 3 million cycles were run for three 52 mm metal-on-metal prostheses. The lubricant was diluted calf serum at 37 °C. FINDINGS In the 100 h tests, metal-on-metal frictional torque was not highly sensitive to the angle, load and serum degradation, and it was close to that of a conventional 28 mm prosthesis with a polyethylene cup, mostly below 5 Nm. However, a manyfold higher frictional torque (10 to 20 Nm) was observed in long-term metal-on-metal tests with substantial wear. INTERPRETATION To obtain a realistic prediction of the frictional behaviour of a hip design, long-term, multidirectional wear tests are necessary. The friction should preferably be measured during the wear test. In addition to normal conditions, adverse condition testing is strongly recommended.
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Affiliation(s)
- Vesa Saikko
- Aalto University School of Engineering, Department of Mechanical Engineering, PO Box 14300, FI-00076 Aalto, Finland.
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18
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Maurer-Ertl W, Friesenbichler J, Holzer LA, Leitner L, Ogris K, Maier M, Leithner A. Recall of the ASR XL Head and Hip Resurfacing Systems. Orthopedics 2017; 40:e340-e347. [PMID: 27992643 DOI: 10.3928/01477447-20161213-04] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/03/2016] [Accepted: 10/31/2016] [Indexed: 02/03/2023]
Abstract
At the beginning of the 21st century, use of large-diameter, metal-on-metal devices was a popular procedure for hip replacement in young and physically active patients; however, within a few years, the number of revisions increased, resulting in a worldwide recall for the articular surface replacement (ASR) system. Complication rates for the ASR devices implanted at the authors' department are reported, with revision rates of 32% and 30% in the ASR XL Head and ASR Resurfacing groups, respectively. Reasons for revision surgery were serum metal ion elevation, luxation or subluxation, aseptic loosening, soft tissue compromise (adverse reactions to metal debris [ARMD]), and infection. The calculated implant survival for the ASR XL Head system and the ASR Resurfacing device (DePuy Orthopaedics Inc, Warsaw, Indiana) in the current series was 79% and 90%, respectively, at 60 months. Symptomatic patients with metal-on-metal devices, with or without elevated metal ion concentrations, should undergo cross sectional imaging to exclude ARMD. In cases of increased metal ion concentrations, local pain, or ARMD, revision surgery has to be evaluated. In the future, closer monitoring of new implants is needed to prevent high failure rates, as seen with the ASR design. Furthermore, the withdrawal of the device highlights the importance of national implant registries. [Orthopedics. 2017; 40(2):e340-e347.].
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19
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Beraudi A, Bianconi E, Catalani S, Canaider S, De Pasquale D, Apostoli P, Bordini B, Stea S, Toni A, Facchin F. In vivo response of heme-oxygenase-1 to metal ions released from metal-on-metal hip prostheses. Mol Med Rep 2016; 14:474-80. [PMID: 27176599 DOI: 10.3892/mmr.2016.5245] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/22/2015] [Accepted: 01/20/2016] [Indexed: 11/06/2022] Open
Abstract
Metal ion release and accumulation is considered to be a factor responsible for the high failure rates of metal-on-metal (MoM) hip implants. Numerous studies have associated the presence of these ions, besides other factors, including a hypoxia‑like response and changes in pH due to metal corrosion leading to the induction of the oxidative stress response. The aim of the present study was to verify whether, in patients with a MoM hip prosthesis, mRNA and protein expression of HMOX‑1 was modulated by the presence of metal ions and whether patients without prostheses exhibit a different expression pattern of this enzyme. The study was conducted on 22 matched pairs of patients with and without prostheses, for a total of 44 samples. Ion dosage was determined using inductively coupled plasma mass spectrometry equipped with dynamic cell reaction. HMOX‑1 gene expression was quantified by reverse transcription-quantitative polymerase chain reaction and HMOX‑1 protein expression was analyzed using an enzyme-linked immunosorbent assay. The results demonstrated that although there were significant differences in the metallic ion concentrations amongst the two groups of patients, there was no correlation between circulating levels of cobalt (Co) and chromium (Cr), and HMOX‑1 gene and protein expression. Additionally, there was no significant difference in the protein expression levels of HMOX‑1 between the two groups. In conclusion, it was demonstrated that circulating Co and Cr ions released by articular prosthetics do not induce an increase in HMOX‑1 mRNA and protein expression at least 3.5 years after the implant insertion. The present study suggests that involvement of HMOX‑1 may be excluded from future studies and suggests that other antioxidant enzymes, including superoxide dismutase, glutathione peroxidase and reductase should be investigated.
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Affiliation(s)
- Alina Beraudi
- Medical Technology Laboratory, Rizzoli RIT Department ‑ Research, Innovation and Technology, Rizzoli Orthopaedic Institute, I‑40136 Bologna, Italy
| | - Eva Bianconi
- Department of Experimental, Diagnostic and Specialty Medicine, (DIMES), Unit of Histology, Embryology and Applied Biology, University of Bologna, I‑40136 Bologna, Italy
| | - Simona Catalani
- Unit of Occupational Health and Industrial Hygiene, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, I‑25100 Brescia, Italy
| | - Silvia Canaider
- Department of Experimental, Diagnostic and Specialty Medicine, (DIMES), Unit of Histology, Embryology and Applied Biology, University of Bologna, I‑40136 Bologna, Italy
| | - Dalila De Pasquale
- Medical Technology Laboratory, Rizzoli RIT Department ‑ Research, Innovation and Technology, Rizzoli Orthopaedic Institute, I‑40136 Bologna, Italy
| | - Pietro Apostoli
- Unit of Occupational Health and Industrial Hygiene, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, I‑25100 Brescia, Italy
| | - Barbara Bordini
- Medical Technology Laboratory, Rizzoli RIT Department ‑ Research, Innovation and Technology, Rizzoli Orthopaedic Institute, I‑40136 Bologna, Italy
| | - Susanna Stea
- Medical Technology Laboratory, Rizzoli RIT Department ‑ Research, Innovation and Technology, Rizzoli Orthopaedic Institute, I‑40136 Bologna, Italy
| | - Aldo Toni
- Medical Technology Laboratory, Rizzoli RIT Department ‑ Research, Innovation and Technology, Rizzoli Orthopaedic Institute, I‑40136 Bologna, Italy
| | - Federica Facchin
- Department of Experimental, Diagnostic and Specialty Medicine, (DIMES), Unit of Histology, Embryology and Applied Biology, University of Bologna, I‑40136 Bologna, Italy
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The Tribology of Explanted Hip Resurfacings Following Early Fracture of the Femur. J Funct Biomater 2015; 6:1021-35. [PMID: 26501331 PMCID: PMC4695908 DOI: 10.3390/jfb6041021] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/02/2015] [Revised: 10/03/2015] [Accepted: 10/10/2015] [Indexed: 01/22/2023] Open
Abstract
A recognized issue related to metal-on-metal hip resurfacings is early fracture of the femur. Most theories regarding the cause of fracture relate to clinical factors but an engineering analysis of failed hip resurfacings has not previously been reported. The objective of this work was to determine the wear volumes and surface roughness values of a cohort of retrieved hip resurfacings which were removed due to early femoral fracture, infection and avascular necrosis (AVN). Nine resurfacing femoral heads were obtained following early fracture of the femur, a further five were retrieved due to infection and AVN. All fourteen were measured for volumetric wear using a co-ordinate measuring machine. Wear rates were then calculated and regions of the articulating surface were divided into "worn" and "unworn". Roughness values in these regions were measured using a non-contacting profilometer. The mean time to fracture was 3.7 months compared with 44.4 months for retrieval due to infection and AVN. Average wear rates in the early fracture heads were 64 times greater than those in the infection and AVN retrievals. Given the high wear rates of the early fracture components, such wear may be linked to an increased risk of femoral neck fracture.
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