Navigating the New EU Medical Devices Regulation: Retrospective Post-Market Follow-Up of Hyaluronic Acid Injections for Knee Osteoarthritis
Alejandro Alcina Navarro,1 Sara Gómez Valero,1 Mercedes Gimeno del Sol,2 María Pilar Coronel Granado2 1Rehabilitation Department, Hospital Universitario del Henares, Coslada, Madrid, Spain; 2Scientific Department, Meiji Pharma Spain, Alcalá de Henares, Madrid, SpainCorrespondence: María Pilar Corone...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2024-03-01
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| Series: | Open Access Rheumatology: Research and Reviews |
| Subjects: | |
| Online Access: | https://www.dovepress.com/navigating-the-new-eu-medical-devices-regulation-retrospective-post-ma-peer-reviewed-fulltext-article-OARRR |
| _version_ | 1827312151190044672 |
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| author | Alcina Navarro A Gómez Valero S Gimeno del Sol M Coronel Granado MP |
| author_facet | Alcina Navarro A Gómez Valero S Gimeno del Sol M Coronel Granado MP |
| author_sort | Alcina Navarro A |
| collection | DOAJ |
| description | Alejandro Alcina Navarro,1 Sara Gómez Valero,1 Mercedes Gimeno del Sol,2 María Pilar Coronel Granado2 1Rehabilitation Department, Hospital Universitario del Henares, Coslada, Madrid, Spain; 2Scientific Department, Meiji Pharma Spain, Alcalá de Henares, Madrid, SpainCorrespondence: María Pilar Coronel Granado, Scientific Department, Meiji Pharma Spain, Avda de Madrid, 94, Alcalá de Henares, Madrid, 28802, Spain, Tel +34 91 8870980, Email p.coronel@meiji.esPurpose: The entry into force of the new Medical Device Regulation (EU) 2017/745 highlights the need for post-market clinical follow-up to ensure the safety and efficacy throughout the life cycle of medical devices. This study evaluates the efficacy and safety of a single intra-articular hyaluronic acid injection in knee osteoarthritis in real-world conditions, over a six-month period, aligning with the summary of safety and clinical performance (SSCP) required by the new regulation.Patients and Methods: Patients over 18 years of age with knee osteoarthritis, treated with a single injection of HA (Adant® One, Meiji Pharma Spain, Spain) at a 3rd level hospital. Patients were treated and followed between January 1, 2020 and June 30, 2022. Demographic, clinical, and treatment-related data were collected, and efficacy regarding pain relief and/or function improvement was assessed using a Likert-type scale. Data were pseudo-anonymized and the comparison was performed using Fisher’ or Mann Whitney’ test. The study was approved by the Ethics Review Board of the Hospital Puerta de Hierro (Madrid, Spain).Results: We followed 20 patients with knee osteoarthritis, with a mean age of 61 years, 80% women, and with a high burden of comorbidities (90%). A total of 60% of patients presented Kellgren-Lawrence grade III–IV. Four patients (20%) returned before 6 months due to lack of efficacy. Of the other patients, 65% showed a clinical response that lasted more than 12 months in 38.5% of cases. Time until medical appointment and taking concomitant medication for knee osteoarthritis were associated with better clinical response (p < 0.05).Conclusion: The administration of a Adant® One single intra-articular hyaluronic acid injection in knee osteoarthritis is effective, safe, and maintains the improvement over a six-month period. Our findings also emphasize the need of using standardized tools for accurate efficacy assessment and optimal patient care.Keywords: rehabilitation, real clinical practice, rheumatology, traumatology |
| first_indexed | 2024-04-24T21:37:54Z |
| format | Article |
| id | doaj.art-fa408f562588446a8a203b3a39d852b3 |
| institution | Directory Open Access Journal |
| issn | 1179-156X |
| language | English |
| last_indexed | 2024-04-24T21:37:54Z |
| publishDate | 2024-03-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Open Access Rheumatology: Research and Reviews |
| spelling | doaj.art-fa408f562588446a8a203b3a39d852b32024-03-21T17:06:44ZengDove Medical PressOpen Access Rheumatology: Research and Reviews1179-156X2024-03-01Volume 16677391431Navigating the New EU Medical Devices Regulation: Retrospective Post-Market Follow-Up of Hyaluronic Acid Injections for Knee OsteoarthritisAlcina Navarro AGómez Valero SGimeno del Sol MCoronel Granado MPAlejandro Alcina Navarro,1 Sara Gómez Valero,1 Mercedes Gimeno del Sol,2 María Pilar Coronel Granado2 1Rehabilitation Department, Hospital Universitario del Henares, Coslada, Madrid, Spain; 2Scientific Department, Meiji Pharma Spain, Alcalá de Henares, Madrid, SpainCorrespondence: María Pilar Coronel Granado, Scientific Department, Meiji Pharma Spain, Avda de Madrid, 94, Alcalá de Henares, Madrid, 28802, Spain, Tel +34 91 8870980, Email p.coronel@meiji.esPurpose: The entry into force of the new Medical Device Regulation (EU) 2017/745 highlights the need for post-market clinical follow-up to ensure the safety and efficacy throughout the life cycle of medical devices. This study evaluates the efficacy and safety of a single intra-articular hyaluronic acid injection in knee osteoarthritis in real-world conditions, over a six-month period, aligning with the summary of safety and clinical performance (SSCP) required by the new regulation.Patients and Methods: Patients over 18 years of age with knee osteoarthritis, treated with a single injection of HA (Adant® One, Meiji Pharma Spain, Spain) at a 3rd level hospital. Patients were treated and followed between January 1, 2020 and June 30, 2022. Demographic, clinical, and treatment-related data were collected, and efficacy regarding pain relief and/or function improvement was assessed using a Likert-type scale. Data were pseudo-anonymized and the comparison was performed using Fisher’ or Mann Whitney’ test. The study was approved by the Ethics Review Board of the Hospital Puerta de Hierro (Madrid, Spain).Results: We followed 20 patients with knee osteoarthritis, with a mean age of 61 years, 80% women, and with a high burden of comorbidities (90%). A total of 60% of patients presented Kellgren-Lawrence grade III–IV. Four patients (20%) returned before 6 months due to lack of efficacy. Of the other patients, 65% showed a clinical response that lasted more than 12 months in 38.5% of cases. Time until medical appointment and taking concomitant medication for knee osteoarthritis were associated with better clinical response (p < 0.05).Conclusion: The administration of a Adant® One single intra-articular hyaluronic acid injection in knee osteoarthritis is effective, safe, and maintains the improvement over a six-month period. Our findings also emphasize the need of using standardized tools for accurate efficacy assessment and optimal patient care.Keywords: rehabilitation, real clinical practice, rheumatology, traumatologyhttps://www.dovepress.com/navigating-the-new-eu-medical-devices-regulation-retrospective-post-ma-peer-reviewed-fulltext-article-OARRRrehabilitationreal clinical practicerheumatologytraumatology |
| spellingShingle | Alcina Navarro A Gómez Valero S Gimeno del Sol M Coronel Granado MP Navigating the New EU Medical Devices Regulation: Retrospective Post-Market Follow-Up of Hyaluronic Acid Injections for Knee Osteoarthritis Open Access Rheumatology: Research and Reviews rehabilitation real clinical practice rheumatology traumatology |
| title | Navigating the New EU Medical Devices Regulation: Retrospective Post-Market Follow-Up of Hyaluronic Acid Injections for Knee Osteoarthritis |
| title_full | Navigating the New EU Medical Devices Regulation: Retrospective Post-Market Follow-Up of Hyaluronic Acid Injections for Knee Osteoarthritis |
| title_fullStr | Navigating the New EU Medical Devices Regulation: Retrospective Post-Market Follow-Up of Hyaluronic Acid Injections for Knee Osteoarthritis |
| title_full_unstemmed | Navigating the New EU Medical Devices Regulation: Retrospective Post-Market Follow-Up of Hyaluronic Acid Injections for Knee Osteoarthritis |
| title_short | Navigating the New EU Medical Devices Regulation: Retrospective Post-Market Follow-Up of Hyaluronic Acid Injections for Knee Osteoarthritis |
| title_sort | navigating the new eu medical devices regulation retrospective post market follow up of hyaluronic acid injections for knee osteoarthritis |
| topic | rehabilitation real clinical practice rheumatology traumatology |
| url | https://www.dovepress.com/navigating-the-new-eu-medical-devices-regulation-retrospective-post-ma-peer-reviewed-fulltext-article-OARRR |
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