ABSTRACT
Purpose: 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.
ABSTRACT
El síndrome doloroso regional complejo es una enfermedad crónica y compleja cuyo diagnóstico precoz es esencial para una evolución favorable así como para evitar complicaciones. Esta entidad pasa habitualmente desapercibida, realizándose su diagnóstico principalmente por la exploración clínica del paciente y siendo por tanto de fácil identificación si conocemos sus síntomas y formas de presentación. Podemos comenzar el tratamiento farmacológico desde Atención Primaria, realizando posteriormente una correcta derivación al médico rehabilitador para la prescripción de tratamiento fisioterápico y seguimiento evolutivo(AU)
Complex regional pain syndrome is a chronic, complex illness whose early diagnosis is essential for favourable progress and in order to avoid complications. This entity usually goes unnoticed, with diagnosis taking place mainly through medical examination of the patient, and thus resulting easy to identify if its symptoms and signs are known. Drug treatment can be commenced at primary health care with subsequent referral to a rehabilitator for the prescription of physiotherapeutic treatment and monitoring(AU)
